T he American Diabetes Association

Transcription

1 Introdution T he Amerian Diabetes Assoiation (ADA) has been atively involved in the development and dissemination of diabetes are standards, guidelines, and related douments for many years. These statements are published in one or more of the Assoiation s professional journals. This supplement ontains the latest update of the ADA s major position statement, Standards of Medial Care in Diabetes, whih ontains all of the Assoiation skey reommendations. In addition, ontained herein are seleted position statements on ertain topis not adequately overed in the Standards. ADA hopes that this is a onvenient and important resoure for all health are professionals who are for people with diabetes. ADA Clinial Pratie Reommendations onsist of position statements that represent offiial ADA opinion as denoted by formal review and approval by the Professional Pratie Committee and the Exeutive Committee of the Board of Diretors. Consensus reports and systemati reviews are not offiial ADA reommendations; however, they are produed under the auspies of the Assoiation by invited experts. These publiations may be used by the Professional Pratie Committee as soure douments to update the Standards. ADA has adopted the following definitions for its linially related reports. position statements is inluded on p. e3 of this supplement. ADA sientifi statement. A sholarly synopsis of a topi related to diabetes, whih may or may not ontain linial or researh reommendations. Any reommendations inluded represent the offiial point of view or belief of the ADA. Work Group Reports fall into this ategory. Sientifi statements are published in the ADA journals and other sientifi/medial publiations as appropriate. Sientifi statements must be reviewed and approved by the Professional Pratie Committee and, subsequently, by the Exeutive Committee of the Board of Diretors. A list of reent sientifi statements is inluded on p. e4 of this supplement. Systemati review. A balaned review and analysis of the literature on a sientifi or medial topi related to diabetes. Effetive January 2010, tehnial reviews were replaed by systemati reviews, for whih a priori searh and inlusion/ exlusion riteria are developed and published. The systemati review provides a sientifi rationale for a position statement and undergoes ritial peer review before submission to the Professional Pratie Committee for approval. A list of past systemati reviews is inluded on p. e1 of this supplement. represents the panel s olletive analysis, evaluation, and opinion at that point in time based in part on the onferene proeedings. The need for a onsensus report arises when liniians or sientists desire guidane on a subjet for whih the evidene is ontraditory or inomplete. One written by the panel, a onsensus report is not subjet to subsequent review or approval and does not represent offiial Assoiation opinion. A list of reent onsensus reports is inluded on p. e2 of this supplement. Professional Pratie Committee. The Assoiation s Professional Pratie Committee is responsible for reviewing ADA systemati reviews, sientifistatements, and position statements, as well as for overseeing revisions of the latter as needed. Appointment to the Professional Pratie Committee is based on exellene in linial pratie and/or researh. The ommittee omprises physiians, diabetes eduators, registered dietitians, and others who have expertise in a range of areas, inluding adult and pediatri endorinology, epidemiology, and publi health, lipid researh, hypertension, and preoneption and pregnany are. All members of the Professional Pratie Committee are required to dislose potential onflits of interest (listed on p. S109). ADA position statement. An offiial point of view or belief of the ADA. Position statements are issued on sientifi or medial issues related to diabetes. They may be authored or unauthored and are published in ADA journals and other sientifi/medial publiations as appropriate. Position statements must be reviewed and approved by the Professional Pratie Committee and, subsequently, by the Exeutive Committee of the Board of Diretors. ADA position statements aretypiallybasedonasystematireview or other review of published literature. They are reviewed on an annual basis and updated as needed. A list of reent Consensus report. A omprehensive examination by a panel of experts (i.e., onsensus panel) of a sientifi or medial issue related to diabetes. Effetive January 2010, onsensus statements were renamed onsensus reports. The ategory may also inlude task fore and expert ommittee reports. Consensus reports do not have the Assoiation s name inluded in the title or subtitle and inlude a dislaimer in the introdution stating that any reommendations are not ADA position. A onsensus report is typially developed immediately following a onsensus onferene at whih presentations are made on the issue under review. The statement DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. Grading of sientifi evidene. There has been onsiderable evolution in the evaluation of sientifi evidene and in the development of evidene-based guidelines sine the ADA first began publishing pratie guidelines. Aordingly, we developed a lassifiation system to grade the quality of sientifi evidene supporting ADA reommendations for all new and revised ADA position statements. Reommendations are assigned ratings of A, B, or C, depending on the quality of evidene (Table 1). Expert opinion (E) is a separate ategory for reommendations in whih there is as yet no evidene from linial trials, in whih linial trials may be impratial, or in whih there is onfliting evidene. Reommendations with an A rating are based on large well-designed linial trials or well-done meta-analyses. are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S1

2 Introdution Table 1dADA evidene-grading system for linial pratie reommendations Level of evidene A B C E Generally, these reommendations have the best hane of improving outomes when applied to the population to whih they are appropriate. Reommendations Desription Clear evidene from well-onduted, generalizable, randomized ontrolled trials Ć that are adequately powered, inluding: Evidene from a well-onduted multienter trial Evidene from a meta-analysis that inorporated quality ratings in the Ć analysis Compelling nonexperimental evidene, i.e., the all or none rule developed by Ć the Centre for Evidene-Based Mediine at Oxford Supportive evidene from well-onduted randomized ontrolled trials that are Ć adequately powered, inluding: Evidene from a well-onduted trial at one or more institutions Evidene from a meta-analysis that inorporated quality ratings in the Ć analysis Supportive evidene from well-onduted ohort studies, inluding: Evidene from a well-onduted prospetive ohort study or registry Evidene from a well-onduted meta-analysis of ohort studies Supportive evidene from a well-onduted ase-ontrol study Supportive evidene from poorly ontrolled or unontrolled studies, inluding: Evidene from randomized linial trials with one or more major or Ćthree or more Ć minor methodologial flaws that ould invalidate the results Evidene from observational studies with high potential for bias (suh as ase Ć series with omparison to historial ontrols) Evidene from ase series or ase reports Confliting evidene with the weight of evidene supporting the reommendation Expert onsensus or linial experiene with lower levels of evidene may be equally important but are not as well supported. The level of evidene supporting a given reommendation is noted either as a heading for a group of reommendations or in parentheses after a given reommendation. Of ourse, evidene is only one omponent of linial deision making. Cliniians are for patients, not populations; guidelines must always be interpreted with the needs of the individual patient in mind. Individual irumstanes, suh as omorbid and oexisting diseases, age, eduation, disability, and, above all, patients values and preferenes, must also be onsidered and may lead to different treatment targets and strategies. Also, onventional evidene hierarhies, suh as the one adapted by the ADA, may miss some nuanes that are important in diabetes are. For example, while there is exellent evidene from linial trials supporting the importane of ahieving multiple risk fator ontrol, the optimal way to ahieve this result is less lear. It is diffiult to assess eah omponent of suh a omplex intervention. ADA will ontinue to improve and update the Clinial Pratie Reommendations to ensure that liniians, health plans, and poliymakers an ontinue to rely on them as the most authoritative and urrent guidelines for diabetes are. Our Clinial Pratie Reommendations are also available on the Assoiation s website at org/diabetesare. S2 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

3 S U M M A R Y O F R E V I S I O N S Summary of Revisions for the 2013 Clinial Pratie Reommendations Revisions to the Standards of Medial Care in Diabetesd2013 In addition to many small hanges related to new evidene sine the prior year, and to larify reommendations, the following setions have undergone more substantive hanges: Setion II.C. Sreening for Type 1 Diabetes has been revised to inlude more speifi reommendations. Setion IV. Prevention/Delay of Type 2 Diabetes has been revised to reflet the importane of sreening for and treating other ardiovasular risk fators. Setion V.C.a. Gluose Monitoring has been revised to highlight the need for patients on intensive insulin regimens to do frequent self-monitoring of blood gluose. Setion V.D. Pharmaologial and Overall Approahes to Treatment has been revised to add a setion with more speifi reommendations for insulin therapy in type 1 diabetes. Setion V.F. Diabetes Self-Management Eduation and Support has been revised to be onsistent with the newly revised National Standards for Diabetes Self- Management Eduation and Support. Setion V.K. Hypoglyemia has been revised to emphasize the need to assess hypoglyemia and ognitive funtion when indiated. Setion V.M. Immunization has been updated to inlude the new Centers for Disease Control and Prevention (CDC) reommendations for hepatitis B vaination for people with diabetes. Setion VI.A.1. Hypertension/Blood Pressure Control has been revised to suggest that the systoli blood pressure goal for many people with diabetes and hypertension should be,140 mmhg, but that lower systoli targets (suh as,130 mmhg) may be appropriate for ertain individuals, suh as younger patients, if it an be ahieved without undue treatment burden. Setion VI.A.2. Dyslipidemia/Lipid Management and Table 10 have been revised to emphasize the importane of statin therapy over partiular LDL holesterol goals in high-risk patients. Setion VI.B. Nephropathy Sreening and Treatment and Table 11 have been revised to highlight inreased urinary albumin exretion over the terms miro- and maroalbuminuria, other than when disussion of past studies requires the distintion. Setion VI.C. Retinopathy Sreening and Treatment has been revised to inlude anti vasular endothelial growth fator therapy for diabeti maular edema. Setion IX.A. Diabetes Care in the Hospital has been revised to inlude a reommendation to onsider obtaining an A1C in patients with risk fators for undiagnosed diabetes who exhibit hyperglyemia in the hospital. Revised Position Statement The position statement Diagnosis and Classifiation of Diabetes Mellitus has been revised slightly to add newer information about monogeni forms of diabetes. Revisions to the National Standards for Diabetes Self-Management Eduation and Support The task fore report National Standards for Diabetes Self-Management Eduation and Support represents a major revision ompletedin2012. DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S3

4 E X E C U T I V E S U M M A R Y Exeutive Summary: Standards of MedialCareinDiabetesd2013 Current riteria for the diagnosis of diabetes A1C $6.5%. The test should be performed in a laboratory using a method that is NGSP ertified and standardized to the Diabetes Control and Compliations Trial (DCCT) assay; or fasting plasma gluose (FPG) $126 mg/dl (7.0 mmol/l). Fasting is defined as no alori intake for at least 8h;or 2-h plasma gluose $200 mg/dl (11.1 mmol/l) during an oral gluose tolerane test (OGTT). The test should be performed as desribed by the World Health Organization, using a gluose load ontaining the equivalent of 75 g anhydrous gluose dissolved in water; or in a patient with lassi symptoms of hyperglyemia or hyperglyemi risis, a random plasma gluose $200 mg/dl (11.1 mmol/l); in the absene of unequivoal hyperglyemia, result should be onfirmed by repeat testing. Testing for diabetes in asymptomati patients Testing to detet type 2 diabetes and prediabetes in asymptomati people should be onsidered in adults of any age who are overweight or obese (BMI $25 kg/m 2 ) and who have one or more additional risk fators for diabetes (see Table 4 of the Standards of Medial Care in Diabetesd2013 ). In those without these risk fators, testing should begin at age 45 years. (B) If tests are normal, repeat testing at least at 3-year intervals is reasonable. (E) To test for diabetes or prediabetes, the A1C, FPG, or 75-g 2-h OGTT are appropriate. (B) In those identified with prediabetes, identify and, if appropriate, treat other ardiovasular disease (CVD) risk fators. (B) Sreening for type 2 diabetes in hildren Testing to detet type 2 diabetes and prediabetes should be onsidered in hildren and adolesents who are overweight and who have two or more additional risk fators for diabetes (see Table 5 of the Standards of Medial Care in Diabetesd2013 ). (E) Sreening for type 1 diabetes Consider referring relatives of those with type 1 diabetes for antibody testing for risk assessment in the setting of a linial researh study. (E) Detetion and diagnosis of gestational diabetes mellitus Sreen for undiagnosed type 2 diabetes at the first prenatal visit in those with risk fators, using standard diagnosti riteria. (B) In pregnant women not previously known to have diabetes, sreen for gestational diabetes mellitus (GDM) at weeks of gestation, using a 75-g 2-h OGTT and the diagnosti ut points in Table 6 of the Standards of Medial Care in Diabetesd2013. (B) Sreen women with GDM for persistent diabetes at 6 12 weeks postpartum, using the OGTT and nonpregnany diagnosti riteria. (E) Women with a history of GDM should have lifelong sreening for the development of diabetes or prediabetes at least every 3 years. (B) Women with a history of GDM found to have prediabetes should reeive lifestyle interventions or metformin to prevent diabetes. (A) Prevention/delay of type 2 diabetes Patients with impaired gluose tolerane (IGT) (A), impaired fasting gluose DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. (IFG) (E), or an A1C % (E) should be referred to an effetive ongoing support program targeting weight loss of 7% of body weight and inreasing physial ativity to at least 150 min/week of moderate ativity suh as walking. Follow-up ounseling appears to be important for suess. (B) Based on the ost-effetiveness of diabetes prevention, suh programs should be overed by third-party payers. (B) Metformin therapy for prevention of type 2 diabetes may be onsidered in those with IGT (A), IFG (E), or an A1C % (E), espeially for those with BMI.35 kg/m 2, aged,60 years, and women with prior GDM. (A) At least annual monitoring for the development of diabetes in those with prediabetes is suggested. (E) Sreening for and treatment of modifiable risk fators for CVD is suggested. (B) Gluose monitoring Patients on multiple-dose insulin (MDI) or insulin pump therapy should do self-monitoring of blood gluose (SMBG) at least prior to meals and snaks, oasionally postprandially, at bedtime, prior to exerise, when they suspet low blood gluose, after treating low blood gluose until they are normoglyemi, and prior to ritial tasks suh as driving. (B) When presribed as part of a broader eduational ontext, SMBG results may be helpful to guide treatment deisions and/or patient self-management for patients using less frequent insulin injetions or noninsulin therapies. (E) When presribing SMBG, ensure that patients reeive ongoing instrution and regular evaluation of SMBG tehnique and SMBG results, as well as their ability to use SMBG data to adjust therapy. (E) Continuous gluose monitoring (CGM) in onjuntion with intensive insulin regimens an be a useful tool to lower A1C in seleted adults (aged $25 years) with type 1 diabetes. (A) Although the evidene for A1C lowering is less strong in hildren, teens, and S4 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

5 younger adults, CGM may be helpful in these groups. Suess orrelates with adherene to ongoing use of the devie. (C) CGM may be a supplemental tool to SMBG in those with hypoglyemia unawareness and/or frequent hypoglyemi episodes. (E) A1C Perform the A1C test at least two times a year in patients who are meeting treatment goals (and who have stable glyemi ontrol). (E) Perform the A1C test quarterly in patients whose therapy has hanged or who are not meeting glyemi goals. (E) Use of point-of-are testing for A1C provides the opportunity for more timely treatment hanges. (E) Glyemi goals in adults Lowering A1C to below or around 7% has been shown to redue mirovasular ompliations of diabetes, and if implemented soon after the diagnosisofdiabetesisassoiatedwith long-term redution in marovasular disease. Therefore, a reasonable A1C goal for many nonpregnant adults is,7%. (B) Providers might reasonably suggest more stringent A1C goals (suh as,6.5%) for seleted individual patients, if this an be ahieved without signifiant hypoglyemia or other adverse effets of treatment. Appropriate patients might inlude those with short duration of diabetes, long life expetany, and no signifiant CVD. (C) Less stringent A1C goals (suh as,8%) may be appropriate for patients with a history of severe hypoglyemia, limited life expetany, advaned mirovasular or marovasular ompliations, extensive omorbid onditions, and those with long-standing diabetes in whom the general goal is diffiult to attain despite diabetes self-management eduation (DSME), appropriate gluose monitoring, and effetive doses of multiple gluose-lowering agents inluding insulin. (B) Pharmaologial and overall approahes to treatment Insulin therapy for type 1 diabetes Most people with type 1 diabetes should be treated with MDI injetions (three to four injetions per day of basal and prandial insulin) or ontinuous subutaneous insulin infusion (CSII). (A) Most people with type 1 diabetes should be eduated in how to math prandial insulin dose to arbohydrate intake, premeal blood gluose, and antiipated ativity. (E) Most people with type 1 diabetes should use insulin analogs to redue hypoglyemia risk. (A) Consider sreening those with type 1 diabetes for other autoimmune diseases (thyroid, vitamin B12 defiieny, elia) as appropriate. (B) Pharmaologial therapy for hyperglyemia in type 2 diabetes Metformin, if not ontraindiated and if tolerated, is the preferred initial pharmaologial agent for type 2 diabetes. (A) In newly diagnosed type 2 diabeti patients with markedly symptomati and/or elevated blood gluose levels or A1C, onsider insulin therapy, with or without additional agents, from the outset. (E) If noninsulin monotherapy at maximal tolerated dose does not ahieve or maintain the A1C target over 3 6 months, add a seond oral agent, a gluagon-like peptide-1 (GLP-1) reeptor agonist, or insulin. (A) A patient-entered approah should be used to guide hoie of pharmaologial agents. Considerations inlude effiay, ost, potential side effets, effets on weight, omorbidities, hypoglyemia risk, and patient preferenes. (E) Due to the progressive nature of type 2 diabetes, insulin therapy is eventually indiated for many patients with type 2 diabetes. (B) Medial nutrition therapy General reommendations Individuals who have prediabetes or diabetes should reeive individualized medial nutrition therapy (MNT) as needed to ahieve treatment goals, preferably provided by a registered dietitian familiar with the omponents of diabetes MNT. (A) Beause MNT an result in ost-savings and improved outomes (B), MNT should be adequately overed by insurane and other payers. (E) Energy balane, overweight, and obesity Weight loss is reommended for all overweight or obese individuals who have or are at risk for diabetes. (A) For weight loss, either low-arbohydrate, low-fat alorie-restrited, or Mediterranean diets may be effetive in the short term (up to 2 years). (A) For patients on low-arbohydrate diets, monitor lipid profiles, renal funtion, and protein intake (in those with nephropathy) and adjust hypoglyemi therapy as needed. (E) Physial ativity and behavior modifiation are important omponents of weight loss programs and are most helpful in maintenane of weight loss. (B) Reommendations for primary prevention of type 2 diabetes Among individuals at high risk for developing type 2 diabetes, strutured programs that emphasize lifestyle hanges that inlude moderate weight loss (7% body weight) and regular physial ativity (150 min/week), with dietary strategies inluding redued alories and redued intake of dietary fat, an redue the risk for developing diabetes and are therefore reommended. (A) Individuals at risk for type 2 diabetes should be enouraged to ahieve the U.S. Department of Agriulture (USDA) reommendation for dietary fiber (14 g fiber/1,000 kal) and foods ontaining whole grains (one-half of grain intake). (B) Individuals at risk for type 2 diabetes should be enouraged to limit their intake of sugar-sweetened beverages (SSBs). (B) Reommendations for management of diabetes Maronutrients in diabetes management The mix of arbohydrate, protein, and fat may be adjusted to meet the metaboli goals and individual preferenes of the person with diabetes. (C) Monitoring arbohydrate, whether by arbohydrate ounting, hoies, or experiene-based estimation, remains a key strategy in ahieving glyemi ontrol. (B) Saturated fat intake should be,7% of total alories. (B) Reduing intake of trans fat lowers LDL holesterol and inreases HDL holesterol (A); therefore, intake of trans fat should be minimized. (E) Other nutrition reommendations Exeutive Summary If adults with diabetes hoose to use alohol, they should limit intake to a moderate amount (one drink per day or less for adult women and two drinks per day or less for adult men) and are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S5

6 Exeutive Summary should take extra preautions to prevent hypoglyemia. (E) Routine supplementation with antioxidants, suh as vitamins E and C and arotene, is not advised beause of lak of evidene of effiay and onern related to long-term safety. (A) It is reommended that individualized meal planning inlude optimization of food hoies to meet reommended dietary allowane (RDA)/dietary referene intake (DRI) for all mironutrients. (E) Diabetes self-management eduation and support People with diabetes should reeive DSME and diabetes self-management support (DSMS) aording to National Standards for Diabetes Self-Management Eduation and Support when their diabetes is diagnosed and as needed thereafter. (B) Effetive self-management and quality of life are the key outomes of DSME and DSMS and should be measured and monitored as part of are. (C) DSME and DSMS should address psyhosoial issues, sine emotional well-being is assoiated with positive diabetes outomes. (C) DSME and DSMS programs are appropriate venues for people with prediabetes to reeive eduation and support to develop and maintain behaviors that an prevent or delay the onset of diabetes. (C) Beause DSME and DSMS an result in ost-savings and improved outomes (B), DSME and DSMS should be adequately reimbursed by third-party payers. (E) Physial ativity Adults with diabetes should be advised to perform at least 150 min/week of moderate-intensity aerobi physial ativity (50 70% of maximum heart rate), spread over at least 3 days/week with no more than 2 onseutive days without exerise. (A) In the absene of ontraindiations, adults with type 2 diabetes should be enouraged to perform resistane training at least twie per week. (A) Psyhosoial assessment and are It is reasonable to inlude assessment of the patient s psyhologial and soial situation as an ongoing part of the medial management of diabetes. (E) Psyhosoial sreening and follow-up may inlude, but are not limited to, attitudes about the illness, expetations for medial management and outomes, affet/mood, general and diabetes-related quality of life, resoures (finanial, soial, and emotional), and psyhiatri history. (E) Sreen for psyhosoial problems suh as depression and diabetes-related distress, anxiety, eating disorders, and ognitive impairment when selfmanagement is poor. (B) Hypoglyemia Individuals at risk for hypoglyemia should be asked about symptomati and asymptomati hypoglyemia at eah enounter. (C) Gluose (15 20 g) is the preferred treatment for the onsious individual with hypoglyemia, although any form of arbohydrate that ontains gluose may be used. If SMBG 15 min after treatment shows ontinued hypoglyemia, the treatment should be repeated. One SMBG gluose returns to normal, the individual should onsume a meal or snak to prevent reurrene of hypoglyemia. (E) Gluagon should be presribed for all individuals at signifiant risk of severe hypoglyemia, and aregivers or family members of these individuals should be instruted on its administration. Gluagon administration is not limited to health are professionals. (E) Hypoglyemia unawareness or one or more episodes of severe hypoglyemia should trigger re-evaluation of the treatment regimen. (E) Insulin-treated patients with hypoglyemia unawareness or an episode of severe hypoglyemia should be advised to raise their glyemi targets to stritly avoid further hypoglyemia for at least several weeks, to partially reverse hypoglyemia unawareness, and to redue risk of future episodes. (A) Ongoing assessment of ognitive funtion is suggested with inreased vigilane for hypoglyemia by the liniian, patient, and aregivers if low ognition and/or delining ognition is found. (B) Bariatri surgery Bariatri surgery may be onsidered for adults with BMI $35 kg/m 2 and type 2 diabetes, espeially if the diabetes or assoiated omorbidities are diffiult to ontrol with lifestyle and pharmaologial therapy. (B) Patients with type 2 diabetes who have undergone bariatri surgery need lifelong lifestyle support and medial monitoring. (B) Although small trials have shown glyemi benefit of bariatri surgery in patients with type 2 diabetes and BMI kg/m 2, there is urrently insuffiient evidene to generally reommend surgery in patients with BMI,35 kg/m 2 outside of a researh protool. (E) The long-term benefits, ost-effetiveness, and risks of bariatri surgery in individuals with type 2 diabetes should be studied in well-designed ontrolled trials with optimal medial and lifestyle therapy as the omparator. (E) Immunization Annually provide an influenza vaine to all diabeti patients $6 months of age. (C) Administer pneumooal polysaharide vaine to all diabeti patients $2 years of age. A one-time revaination is reommended for individuals.64 years of age previously immunized when they were,65 years of age if the vaine was administered.5 years ago. Other indiations for repeat vaination inlude nephroti syndrome, hroni renal disease, and other immunoompromised states, suh as after transplantation. (C) Administer hepatitis B vaination to unvainated adults with diabetes who are aged 19 through 59 years. (C) Consider administering hepatitis B vaination to unvainated adults with diabetes who are aged $60 years. (C) Hypertension/blood pressure ontrol Sreening and diagnosis Blood pressure should be measured at every routine visit. Patients found to have elevated blood pressure should have blood pressure onfirmed on a separate day. (B) Goals People with diabetes and hypertension should be treated to a systoli blood pressure goal of,140 mmhg. (B) Lower systoli targets, suh as,130 mmhg, may be appropriate for ertain individuals, suh as younger patients, if it an be ahieved without undue treatment burden. (C) Patients with diabetes should be treated to a diastoli blood pressure,80 mmhg. (B) S6 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

7 Treatment Patients with a blood pressure.120/80 mmhg should be advised on lifestyle hanges to redue blood pressure. (B) Patients with onfirmed blood pressure $140/80 mmhg should, in addition to lifestyle therapy, have prompt initiation and timely subsequent titration of pharmaologial therapy to ahieve blood pressure goals. (B) Lifestyle therapy for elevated blood pressure onsists of weight loss, if overweight; Dietary Approahes to Stop Hypertension (DASH)-style dietary pattern inluding reduing sodium and inreasing potassium intake; moderation of alohol intake; and inreased physial ativity. (B) Pharmaologial therapy for patients with diabetes and hypertension should be with a regimen that inludes either an ACE inhibitor or an angiotensin reeptor bloker (ARB). If one lass is not tolerated, the other should be substituted. (C) Multiple-drug therapy (two or more agents at maximal doses) is generally required to ahieve blood pressure targets. (B) Administer one or more antihypertensive mediations at bedtime. (A) If ACE inhibitors, ARBs, or diuretis are used, serum reatinine/estimated glomerular filtration rate (egfr) and serum potassium levels should be monitored. (E) In pregnant patients with diabetes and hroni hypertension, blood pressure target goals of /65 79 mmhg are suggested in the interest of longterm maternal health and minimizing impaired fetal growth. ACE inhibitors and ARBs are ontraindiated during pregnany. (E) Dyslipidemia/lipid management Sreening In most adult patients with diabetes, measure fasting lipid profile at least annually. (B) In adults with low-risk lipid values (LDL holesterol,100 mg/dl, HDL holesterol.50 mg/dl, and triglyerides,150 mg/dl), lipid assessments may be repeated every 2 years. (E) Treatment reommendations and goals Lifestyle modifiation fousing on the redution of saturated fat, trans fat, and holesterol intake; inrease of n-3 fatty aids, visous fiber and plant stanols/ sterols; weight loss (if indiated); and inreased physial ativity should be reommended to improve the lipid profile in patients with diabetes. (A) Statin therapy should be added to lifestyle therapy, regardless of baseline lipid levels, for diabeti patients: with overt CVD (A) without CVD who are over the age of 40 years and have one or more other CVD risk fators (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria). (A) For lower-risk patients than the above (e.g., without overt CVD and under the age of 40 years), statin therapy should be onsidered in addition to lifestyle therapy if LDL holesterol remains above 100 mg/dl or in those with multiple CVD risk fators. (C) In individuals without overt CVD, the goal is LDL holesterol,100 mg/dl (2.6 mmol/l). (B) In individuals with overt CVD, a lower LDL holesterol goal of,70 mg/dl (1.8 mmol/l), using a high dose of a statin, is an option. (B) If drug-treated patients do not reah the above targets on maximal tolerated statin therapy, a redution in LDL holesterol of ;30 40% from baseline is an alternative therapeuti goal. (B) Triglyeride levels,150 mg/dl (1.7 mmol/l) and HDL holesterol.40 mg/dl(1.0mmol/l)inmenand.50 mg/dl (1.3 mmol/l) in women are desirable (C). However, LDL holesterol targeted statin therapy remains the preferred strategy. (A) Combination therapy has been shown not to provide additional ardiovasular benefit above statin therapy alone and is not generally reommended. (A) Statin therapy is ontraindiated in pregnany. (B) Antiplatelet agents Consider aspirin therapy ( mg/ day) as a primary prevention strategy in those with type 1 or type 2 diabetes at inreased ardiovasular risk (10-year risk.10%). This inludes most men aged.50 years or women aged.60 years who have at least one additional major risk fator (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria). (C) Aspirin should not be reommended for CVD prevention for adults with diabetes at low CVD risk (10-year CVD risk,5%,suhasinmenaged,50 years and women aged,60 years with no major additional CVD risk fators), sine the potential adverse effets from bleeding likely offset the potential benefits. (C) In patients in these age-groups with multiple other risk fators (e.g., 10- year risk 5 10%), linial judgment is required. (E) Use aspirin therapy ( mg/day) as a seondary prevention strategy in those with diabetes with a history of CVD. (A) For patients with CVD and doumented aspirin allergy, lopidogrel (75 mg/day) should be used. (B) Combination therapy with aspirin ( mg/day) and lopidogrel (75 mg/day) is reasonable for up to a year after an aute oronary syndrome. (B) Exeutive Summary Smoking essation Advise all patients not to smoke or use tobao produts. (A) Inlude smoking essation ounseling and other forms of treatment as a routine omponent of diabetes are. (B) Coronary heart disease sreening and treatment Sreening In asymptomati patients, routine sreening for oronary artery disease (CAD) is not reommended, as it does not improve outomes as long as CVD risk fators are treated. (A) Treatment In patients with known CVD, onsider ACE inhibitor therapy (C) and use aspirin and statin therapy (A) (if not ontraindiated) to redue the risk of ardiovasular events. In patients with a prior myoardial infartion, b-blokers should be ontinued for at least 2 years after the event. (B) Avoid thiazolidinedione treatment in patients with symptomati heartfailure.(c) Metformin may be used in patients with stable ongestive heart failure (CHF) if renal funtion is normal. It should be avoided in unstable or hospitalized patients with CHF. (C) Nephropathy sreening and treatment General reommendations To redue the risk or slow the progression of nephropathy, optimize gluose ontrol. (A) are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S7

8 Exeutive Summary To redue the risk or slow the progression of nephropathy, optimize blood pressure ontrol. (A) Sreening Perform an annual test to assess urine albumin exretion in type 1 diabeti patients with diabetes duration of $5 years and in all type 2 diabeti patients starting at diagnosis. (B) Measure serum reatinine at least annually in all adults with diabetes regardless of the degree of urine albumin exretion. The serum reatinine should be used to estimate glomerular filtration rate (GFR) and stage the level of hroni kidney disease (CKD), if present. (E) Treatment In the treatment of the nonpregnant patient with modestly elevated ( mg/day) (C) or higher levels ($300 mg/day) of urinary albumin exretion (A), either ACE inhibitors or ARBs are reommended. Redution of protein intake to g/kg body wt per day in individuals with diabetes and the earlier stages of CKD and to 0.8 g/kg body wt per day in the later stages of CKD may improve measures of renal funtion (urine albumin exretion rate, GFR) and is reommended. (C) When ACE inhibitors, ARBs, or diuretis are used, monitor serum reatinine and potassium levels for the development of inreased reatinine or hanges in potassium. (E) Continued monitoring of urine albumin exretion to assess both response to therapy and progression of disease is reasonable. (E) When egfr is,60 ml/min/1.73 m 2, evaluate and manage potential ompliations of CKD. (E) Consider referral to a physiian experiened in the are of kidney disease for unertainty about the etiology of kidney disease, diffiult management issues, or advaned kidney disease. (B) Retinopathy sreening and treatment General reommendations To redue the risk or slow the progression of retinopathy, optimize glyemi ontrol. (A) To redue the risk or slow the progression of retinopathy, optimize blood pressure ontrol. (A) Sreening Adults and hildren aged $10 years with type 1 diabetes should have an initial dilated and omprehensive eye examination by an ophthalmologist or optometrist within 5 years after the onset of diabetes. (B) Patients with type 2 diabetes should have an initial dilated and omprehensive eye examination by an ophthalmologist or optometrist shortly after the diagnosis of diabetes. (B) Subsequent examinations for type 1 and type 2 diabeti patients should be repeated annually by an ophthalmologist or optometrist. Less frequent exams (every 2 3 years) may be onsidered following one or more normal eye exams. Examinations will be required more frequently if retinopathy is pro- gressing. (B) High-quality fundus photographs an detet most linially signifiant diabeti retinopathy. Interpretation of the images should be performed by a trained eye are provider. While retinal photography may serve as a sreening tool for retinopathy, it is not a substitute for a omprehensive eye exam, whih should be performed at least initially and at intervals thereafter as reommended by an eye are professional. (E) Women with pre-existing diabetes who are planning pregnany or who have beome pregnant should have a omprehensive eye examination and be ounseled on the risk of development and/or progression of diabeti retinopathy. Eye examination should our in the first trimester with lose follow-up throughout pregnany and for 1 year postpartum. (B) Treatment Promptly refer patients with any level of maular edema, severe nonproliferative diabeti retinopathy (NPDR), or any proliferative diabeti retinopathy (PDR) to an ophthalmologist who is knowledgeable and experiened in the management and treatment of diabeti retinopathy. (A) Laser photooagulation therapy is indiated to redue the risk of vision loss in patients with high-risk PDR, linially signifiant maular edema, and in some ases of severe NPDR. (A) Anti vasular endothelial growth fator (VEGF) therapy is indiated for diabeti maular edema. (A) The presene of retinopathy is not a ontraindiation to aspirin therapy for ardioprotetion, as this therapy does not inrease the risk of retinal hemorrhage. (A) Neuropathy sreening and treatment All patients should be sreened for distal symmetri polyneuropathy (DPN) starting at diagnosis of type 2 diabetes and 5 years after the diagnosis of type 1 diabetes and at least annually thereafter, using simple linial tests. (B) Eletrophysiologial testing is rarely needed, exept in situations where the linial features are atypial. (E) Sreening for signs and symptoms of ardiovasular autonomi neuropathy (CAN) should be instituted at diagnosis of type 2 diabetes and 5 years after the diagnosis of type 1 diabetes. Speial testing is rarely needed and may not affet management or outomes. (E) Mediations for the relief of speifi symptoms related to painful DPN and autonomi neuropathy are reommended, as they improve the quality of life of the patient. (E) Foot are For all patients with diabetes, perform an annual omprehensive foot examination to identify risk fators preditive of ulers and amputations. The foot examination should inlude inspetion, assessment of foot pulses, and testing for loss of protetive sensation (LOPS) (10-g monofilament plus testing any one of the following: vibration using 128-Hz tuning fork, pinprik sensation, ankle reflexes, or vibration pereption threshold). (B) Provide general foot self-are eduation to all patients with diabetes. (B) A multidisiplinary approah is reommended for individuals with foot ulers and high-risk feet, espeially those with a history of prior uler or amputation. (B) Refer patients who smoke, have LOPS and strutural abnormalities, or have a history of prior lower-extremity ompliations to foot are speialists for ongoing preventive are and lifelong surveillane. (C) Initial sreening for peripheral arterial disease (PAD) should inlude a history for laudiation and an assessment of the pedal pulses. Consider obtaining an ankle-brahial index (ABI), as many patients with PAD are asymptomati. (C) S8 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

9 Refer patients with signifiant laudiation or a positive ABI for further vasular assessment and onsider exerise, mediations, and surgial options. (C) Assessment of ommon omorbid onditions For patients with risk fators, signs, or symptoms, onsider assessment and treatment for ommon diabetesassoiated onditions (see Table 14 of the Standards of Medial Care in Diabetesd2013 ). (B) Children and adolesents As is the ase for all hildren, hildren with diabetes or prediabetes should be enouraged to engage in at least 60 min of physial ativity eah day. (B) Type 1 diabetes Glyemi ontrol Consider age when setting glyemi goals in hildren and adolesents with type 1 diabetes. (E) Sreening and management of hroni ompliations in hildren and adolesents with type 1 diabetes Nephropathy Annual sreening for miroalbuminuria, with a random spot urine sample for albumin-to-reatinine ratio (ACR), should be onsidered one the hild is 10 years of age and has had diabetes for 5 years. (B) Treatment with an ACE inhibitor, titrated to normalization of albumin exretion, should be onsidered when elevated ACR is subsequently onfirmed on two additional speimens from different days. (E) Hypertension Blood pressure should be measured at eah routine visit. Children found to have high-normal blood pressure or hypertension should have blood pressure onfirmed on a separate day. (B) Initial treatment of high-normal blood pressure (systoli or diastoli blood pressure onsistently above the 90th perentile for age, sex, and height) inludes dietary intervention and exerise, aimed at weight ontrol and inreased physial ativity, if appropriate. If target blood pressure is not reahed with 3 6 months of lifestyle intervention, pharmaologial treatment should be onsidered. (E) Pharmaologial treatment of hypertension (systoli or diastoli blood pressure onsistently above the 95th perentile for age, sex, and height or onsistently.130/80 mmhg, if 95% exeeds that value) should be onsidered as soon as the diagnosis is onfirmed. (E) ACE inhibitors should be onsidered for the initial treatment of hypertension, following appropriate reprodutive ounseling due to its potential teratogeni effets. (E) The goal of treatment is a blood pressure onsistently,130/80 or below the 90th perentile for age, sex, and height, whihever is lower. (E) Dyslipidemia Sreening If there is a family history of hyperholesterolemia or a ardiovasular event before age 55 years, or if family history is unknown, then onsider obtaining a fasting lipid profile on hildren.2 years of age soon after diagnosis (after gluose ontrol has been established). If family history is not of onern, then onsider the first lipid sreening at puberty ($10 years of age). For hildren diagnosed with diabetes at or after puberty, onsider obtaining a fasting lipid profile soon after the diagnosis (after gluose ontrol has been established). (E) For both age-groups, if lipids are abnormal, annual monitoring is reasonable. If LDL holesterol values are within the aepted risk levels (,100 mg/dl [2.6 mmol/l]), a lipid profile repeated every 5 years is reasonable. (E) Treatment Initial therapy may onsist of optimization of gluose ontrol and MNT using a Step 2 Amerian Heart Assoiation (AHA) diet aimed at a derease in the amount of saturated fat in the diet. (E) After the age of 10 years, the addition of a statin in patients who, after MNT and lifestyle hanges, have LDL holesterol.160 mg/dl (4.1 mmol/l) or LDL holesterol.130 mg/dl (3.4 mmol/l) and one or more CVD risk fators is reasonable. (E) The goal of therapy is an LDL holesterol value,100 mg/dl (2.6 mmol/l). (E) Retinopathy The first ophthalmologi examination should be obtained one the hild is $10 years of age and has had diabetes for 3 5 years.(b) After the initial examination, annual routine follow-up is generally reommended. Less frequent examinations may be aeptable on the advie of an eye are professional. (E) Celia disease Consider sreening hildren with type 1 diabetes for elia disease by measuring tissue transglutaminase or antiendomysial antibodies, with doumentation of normal total serum IgA levels, soon after the diagnosis of diabetes. (E) Testing should be onsidered in hildren with growth failure, failure to gain weight, weight loss, diarrhea, flatulene, abdominal pain, or signs of malabsorption or in hildren with frequent unexplained hypoglyemia or Exeutive Summary deterioration in glyemi ontrol. (E) Consider referral to a gastroenterologistforevaluationwithpossibleendosopy and biopsy for onfirmation of elia disease in asymptomati hildren with positive antibodies. (E) Children with biopsy-onfirmed elia disease should be plaed on a gluten-free diet and have onsultation with a dietitian experiened in managing both diabetes and elia disease. (B) Hypothyroidism Consider sreening hildren with type 1 diabetes for thyroid peroxidase and thyroglobulin antibodies soon after diagnosis. (E) Measuring thyroid-stimulating hormone (TSH) onentrations soon after diagnosis of type 1 diabetes, after metaboli ontrol has been established, is reasonable. If normal, onsider reheking every 1 2 years, espeially if the patient develops symptoms of thyroid dysfuntion, thyromegaly, or an abnormal growth rate. (E) Transition from pediatri to adult are As teens transition into emerging adulthood, health are providers and families must reognize their many vulnerabilities (B) and prepare the developing teen, beginning in early to mid adolesene and at least 1 year prior to the transition. (E) Both pediatriians and adult health are providers should assist in providing support and links to resoures for the teen and emerging adult. (B) Preoneption are A1C levels should be as lose to normal as possible (,7%) in an individual patient before oneption is attempted. (B) are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S9

10 Exeutive Summary Starting at puberty, preoneption ounseling should be inorporated in the routine diabetes lini visit for all women of hildbearing potential. (C) Women with diabetes who are ontemplating pregnany should be evaluated and, if indiated, treated for diabeti retinopathy, nephropathy, neuropathy, and CVD. (B) Mediations used by suh women should be evaluated prior to oneption, sine drugs ommonly used to treat diabetes and its ompliations may be ontraindiated or not reommended in pregnany, inluding statins, ACE inhibitors, ARBs, and most noninsulin therapies. (E) Sine many pregnanies are unplanned, onsider the potential risks and benefits of mediations that are ontraindiated in pregnany in all women of hildbearing potential and ounsel women using suh mediations aordingly. (E) Older adults Older adults who are funtional, ognitively intat, and have signifiant life expetany should reeive diabetes are with goals similar to those developed for younger adults. (E) Glyemi goals for some older adults might reasonably be relaxed, using individual riteria, but hyperglyemia leading to symptoms or risk of aute hyperglyemi ompliations should be avoided in all patients. (E) Other ardiovasular risk fators should be treated in older adults with onsideration of the time frame of benefit and the individual patient. Treatment of hypertension is indiated in virtually all older adults, and lipid and aspirin therapy may benefit those with life expetany at least equal to the time frame of primary or seondary prevention trials. (E) Sreening for diabetes ompliations should be individualized in older adults, but partiular attention should be paid to ompliations that would lead to funtional impairment. (E) Cysti fibrosis related diabetes Annual sreening for ysti fibrosis related diabetes (CFRD) with OGTT should begin by age 10 years in all patients with ysti fibrosis who do not have CFRD (B). Use of A1C as a sreening test for CFRD is not reommended. (B) During a period of stable health, the diagnosis of CFRD an be made in ysti fibrosis patients aording to usual gluose riteria. (E) Patients with CFRD should be treated with insulin to attain individualized glyemi goals. (A) Annual monitoring for ompliations of diabetes is reommended, beginning 5 years after the diagnosis of CFRD. (E) Diabetes are in the hospital All patients with diabetes admitted to the hospital should have their diabetes learly identified in the medial reord. (E) All patients with diabetes should have an order for blood gluose monitoring, with results available to all members of the health are team. (E) Goals for blood gluose levels: Critially ill patients: Insulin therapy should be initiated for treatment of persistent hyperglyemia starting at a threshold of no greater than 180 mg/dl (10 mmol/l). One insulin therapy is started, a gluose range of mg/dl ( mmol/l) is reommended for the majority of ritially ill patients. (A) More stringent goals, suh as mg/dl ( mmol/l) may be appropriate for seleted patients, as long as this an be ahieved without signifiant hypoglyemia. (C) Critially ill patients require an intravenous insulin protool that has demonstrated effiay and safety in ahieving the desired gluose range without inreasing risk for severe hypoglyemia. (E) Non ritially ill patients: There is no lear evidene for speifi blood gluose goals. If treated with insulin, the premeal blood gluose targets generally,140 mg/dl (7.8 mmol/l) with random blood gluose,180 mg/dl (10.0 mmol/l) are reasonable, provided these targets an be safely ahieved. More stringent targets may be appropriate in stable patients with previous tight glyemi ontrol. Less stringent targets may be appropriate in those with severe omorbidities. (E) Sheduled subutaneous insulin with basal, nutritional, and orretion omponents is the preferred method for ahieving and maintaining gluose ontrol in non ritially ill patients. (C) Gluose monitoring should be initiated in any patient not known to be diabeti who reeives therapy assoiated with high risk for hyperglyemia, inluding high-dose gluoortioid therapy, initiation of enteral or parenteral nutrition, or other mediations suh as otreotide or immunosuppressive mediations (B). If hyperglyemia is doumented and persistent, onsider treating suh patients to the same glyemi goals as patients with known diabetes. (E) A hypoglyemia management protool should be adopted and implemented by eah hospital or hospital system. A plan for preventing and treating hypoglyemia should be established for eah patient. Episodes of hypoglyemia in the hospital should be doumented in the medial reord and traked. (E) Consider obtaining an A1C on patients with diabetes admitted to the hospital if the result of testing in the previous 2 3 months is not available. (E) Consider obtaining an A1C in patients with risk fators for undiagnosed diabetes who exhibit hyperglyemia in the hospital. (E) Patients with hyperglyemia in the hospital who do not have a prior diagnosis of diabetes should have appropriate plans for follow-up testing and are doumented at disharge. (E) Strategies for improving diabetes are Care should be aligned with omponents of the Chroni Care Model (CCM) to ensure produtive interations between a prepared proative pratie team and an informed ativated patient. (A) When feasible, are systems should support team-based are, ommunity involvement, patient registries, and embedded deision support tools to meet patient needs. (B) Treatment deisions should be timely and based on evidene-based guidelines that are tailored to individual patient preferenes, prognoses, and omorbidities. (B) A patient-entered ommuniation style should be employed that inorporates patient preferenes, assesses literay and numeray, and addresses ultural barriers to are. (B) S10 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

11 P O S I T I O N S T A T E M E N T Standards of Medial Care in Diabetesd2013 AMERICAN DIABETES ASSOCIATION D iabetes mellitus is a hroni illness that requires ontinuing medial are and ongoing patient self-management eduation and support to prevent aute ompliations and to redue the risk of long-term ompliations. Diabetes are is omplex and requires multifatorial risk redution strategies beyond glyemi ontrol. A large body of evidene exists that supports a range of interventions to improve diabetes outomes. These standards of are are intended to provide liniians, patients, researhers, payers, and other interested individuals with the omponents of diabetes are, general treatment goals, and tools to evaluate the quality of are. Although individual preferenes, omorbidities, and other patient fators may require modifiation of goals, targets that are desirable for most patients with diabetes are provided. Speifially titled setions of the standards address hildren with diabetes, pregnant women, and people with prediabetes. These standards are not intended to prelude linial judgment or more extensive evaluation and management of the patient by other speialists as needed. For more detailed information about management of diabetes, refer to referenes (1 3). The reommendations inluded are sreening, diagnosti, and therapeuti ations that are known or believed to favorably affet health outomes of patients with diabetes. A large number of these interventions have been shown to be osteffetive (4). A grading system (Table 1), developed by the Amerian Diabetes Assoiation (ADA) and modeled after existing methods, was utilized to larify and odify the evidene that forms the basis for the reommendations. The level of evidene that supports eah reommendation is listed after eah reommendation using the letters A, B, C, or E. These standards of are are revised annually by the ADA s multidisiplinary Professional Pratie Committee, inorporating new evidene. For the urrent revision, ommittee members systematially searhed Medline for human studies related to eah subsetion and published sine 1 January Reommendations (bulleted at the beginning of eah subsetion and also listed in the Exeutive Summary: Standards of Medial Care in Diabetesd2013 ) were revised based on new evidene or, in some ases, to larify the prior reommendation or math the strength of the wording to the strength of the evidene. A table linking the hanges in reommendations to new evidene an be reviewed at org/cpr. As is the ase for all position statements, these standards of are were reviewed and approved by the Exeutive Committee of ADA s Board of Diretors, whih inludes health are professionals, sientists, and lay people. Feedbak from the larger linial ommunity was valuable for the 2013 revision of the standards. Readers who wish to omment on the Standards of Medial Care in Diabetesd2013 are invitedtodosoathttp://professional. diabetes.org/cpr. Members of the Professional Pratie Committee dislose all potential finanial onflits of interest with industry. These dislosures were disussed at the onset of the standards revision meeting. Members of the ommittee, their employer, and their dislosed onflits of interest are listed in the Professional Pratie Committee for the 2013 Clinial Pratie Reommendations table (see p. S109). The ADA funds development of the standards and all its position statements out of its general revenues and Originally approved Most reent review/revision Otober DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. does not use industry support for these purposes. I. CLASSIFICATION AND DIAGNOSIS A. Classifiation The lassifiation of diabetes inludes four linial lasses: Type 1 diabetes (results from b-ell destrution, usually leading to absolute insulin defiieny) Type 2 diabetes (results from a progressive insulin seretory defet on the bakground of insulin resistane) Other speifi types of diabetes due to other auses, e.g., geneti defets in b-ell funtion, geneti defets in insulin ation, diseases of the exorine panreas (suh as ysti fibrosis), and drug- or hemial-indued (suh as in the treatment of HIV/AIDS or after organ transplantation) Gestational diabetes mellitus (GDM) (diabetes diagnosed during pregnany that is not learly overt diabetes) Some patients annot be learly lassified as type 1 or type 2 diabeti. Clinial presentation and disease progression vary onsiderably in both types of diabetes. Oasionally, patients who otherwise have type 2 diabetes may present with ketoaidosis. Similarly, patients with type 1 diabetes may have a late onset and slow (but relentless) progression of disease despite having features of autoimmune disease. Suh diffiultiesindiagnosismay our in hildren, adolesents, and adults. The true diagnosis may beome more obvious over time. B. Diagnosis of diabetes For deades, the diagnosis of diabetes was based on plasma gluose riteria, either the fasting plasma gluose (FPG) or the 2-h value in the 75-g oral gluose tolerane test (OGTT) (5). In 2009, an International Expert Committee that inluded representatives of the ADA, the International Diabetes are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S11

12 Position Statement Table 1dADA evidene grading system for linial pratie reommendations Level of evidene A B C E Federation (IDF), and the European Assoiation for the Study of Diabetes (EASD) reommended the use of the A1C test to diagnose diabetes, with a threshold of $6.5% (6), and the ADA adopted this riterion in 2010 (5). The diagnosti test should be performed using a method that is ertified by the NGSP and standardized or traeable to the Diabetes Control and Compliations Trial (DCCT) referene assay. Although point-of-are (POC) A1C assays may be NGSP ertified, profiieny testing is not mandated for performing the test, so use of these assays for diagnosti purposes ould be problemati. Epidemiologial datasets show a similar relationship for A1C to the risk of retinopathy as has been shown for the orresponding FPG and 2-h PG thresholds. The A1C has several advantages to the FPG and OGTT, inluding greater onveniene (sine fasting is not required), evidene to suggest greater preanalytial stability, and less day-to-day perturbations during periods of stress and illness. These advantages must be balaned by greater ost, the limited availability of A1C testing in ertain regions of the developing world, and the inomplete orrelation between A1C and average gluose in ertain individuals. In addition, HbA 1 levels may vary with patients rae/ethniity (7,8). Some Desription Clear evidene from well-onduted, generalizable RCTs that are adequately powered, inluding: Evidene from a well-onduted multienter trial Evidene from a meta-analysis that inorporated quality ratings in the analysis Compelling nonexperimental evidene, i.e., all or none rule developed by the Centre for Evidene-Based Mediine at the University of Oxford Supportive evidene from well-onduted RCTs that are adequately powered, inluding: Evidene from a well-onduted trial at one or more institutions Evidene from a meta-analysis that inorporated quality ratings in the analysis Supportive evidene from well-onduted ohort studies Evidene from a well-onduted prospetive ohort study or registry Evidene from a well-onduted meta-analysis of ohort studies Supportive evidene from a well-onduted ase-ontrol study Supportive evidene from poorly ontrolled or unontrolled studies Evidene from randomized linial trials with one or more major or three or more minor methodologial flaws that ould invalidate the results Evidene from observational studies with high potential for bias (suh as ase series with omparison with historial ontrols) Evidene from ase series or ase reports Confliting evidene with the weight of evidene supporting the reommendation Expert onsensus or linial experiene have posited that glyation rates differ by rae (with, for example, Afrian Amerians having higher rates of glyation), but this is ontroversial. A reent epidemiologial study found that, when mathed for FPG, Afrian Amerians (with and without diabetes) indeed had higher A1C than whites, but also had higher levels of frutosamine and glyated albumin and lower levels of 1,5 anhydrogluitol, suggesting that their glyemi burden (partiularly postprandially) may be higher (9). Epidemiologial studies forming the framework for reommending use of the A1C to diagnose diabetes have all been in adult populations. Whether the ut point would be the same to diagnose hildren or adolesents with type 2 diabetes is an area of unertainty (3,10). A1C inaurately reflets glyemia with ertain anemias and hemoglobinopathies. For patients with an abnormal hemoglobin but normal red ell turnover, suh as sikle ell trait, an A1C assay without interferene from abnormal hemoglobins should be used (an updated list is available at www. ngsp.org/interf.asp). For onditions with abnormal red ell turnover, suh as pregnany, reent blood loss or transfusion, or some anemias, the diagnosis of diabetes must employ gluose riteria exlusively. The established gluose riteria for the diagnosis of diabetes (FPG and 2-h PG) remain valid as well (Table 2). Just as there is less than 100% onordane between the FPG and 2-h PG tests, there is no perfet onordane between A1C and either gluose-based test. Analyses of the National Health and Nutrition Examination Survey (NHANES) data indiate that, assuming universal sreening of the undiagnosed, the A1C ut point of $6.5% identifies one-third fewer ases of undiagnosed diabetes than a fasting gluose ut point of $126 mg/dl (7.0 mmol/l) (11), and numerous studies have onfirmed that at these ut points the 2-h OGTT value diagnoses more sreened people with diabetes (12). However, in pratie, a large portion of the diabeti population remains unaware of its ondition. Thus, the lower sensitivity of A1C at the designated ut point may well be offset by the test s greater pratiality, and wider appliation of a more onvenient test (A1C) may atually inrease the number of diagnoses made. As with most diagnosti tests, a test result diagnosti of diabetes should be repeated to rule out laboratory error, unless the diagnosis is lear on linial grounds, suh as a patient with a hyperglyemi risis or lassi symptoms of hyperglyemia and a random plasma gluose $200 mg/dl. It is preferable that the same test be repeated for onfirmation, sine there will be a greater likelihood of onurrene in this ase. For example, if the A1C is 7.0% and a repeat result is 6.8%, the diagnosis of diabetes is onfirmed. However, if two different tests (suh as A1C and FPG) are both above the diagnosti thresholds, the diagnosis of diabetes is also onfirmed. On the other hand, if two different tests are available in an individual and the results are disordant, the test whose result is above the diagnosti ut point should be repeated, and the diagnosis is made based on the onfirmed test. That is, if a patient meets the diabetes riterion of the A1C (two results $6.5%) but not the FPG (,126 mg/ dl or 7.0 mmol/l), or vie versa, that person should be onsidered to have diabetes. Sine there is preanalytial and analytial variability of all the tests, it is also possible that when a test whose result was above the diagnosti threshold is repeated, the seond value will be below the diagnosti ut point. This is least likely for A1C, somewhat more likely for FPG, and most likely for the 2-h PG. Barring a laboratory error, suh patients are likely to have test results near the margins of the threshold for a diagnosis. The health are professional might opt to S12 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

13 follow the patient losely and repeat the testing in 3 6 months. The urrent diagnosti riteria for diabetes are summarized in Table 2. C. Categories of inreased risk for diabetes (prediabetes) In 1997 and 2003, the Expert Committee on Diagnosis and Classifiation of Diabetes Mellitus (13,14) reognized an intermediate group of individuals whose gluose levels, although not meeting riteria for diabetes, are nevertheless too high to be onsidered normal. These persons were defined as having impaired fasting gluose (IFG) (FPG levels 100 mg/dl [5.6 mmol/l] to 125 mg/dl [6.9 mmol/l]) or impaired gluose tolerane (IGT) (2-h values in the OGTT of 140 mg/dl [7.8 mmol/l] to 199 mg/dl [11.0 mmol/l]). It should be noted that the World Health Organization (WHO) and a number of other diabetes organizations define the utoff for IFG at 110 mg/dl (6.1 mmol/l). Individuals with IFG and/or IGT have been referred to as having prediabetes, indiating the relatively high risk for the future development of diabetes. IFG and IGT should not be viewed as linial entities in their own right but rather risk fators for diabetes as well as ardiovasular disease (CVD). IFG and IGT are assoiated with obesity (espeially abdominal or viseral obesity), dyslipidemia with high triglyerides and/or low HDL holesterol, and hypertension. As is the ase with the gluose measures, several prospetive studies that Table 2dCriteria for the diagnosis of diabetes A1C $6.5%. The test should be performed in a laboratory using a method that is NGSP ertified and standardized to the DCCT assay.* OR FPG $126 mg/dl (7.0 mmol/l). Fasting is defined as no alori intake for at least 8 h.* OR 2-h plasma gluose $200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as desribed by the WHO, using a gluose load ontaining the equivalent of 75 g anhydrous gluose dissolved in water.* OR In a patient with lassi symptoms of hyperglyemia or hyperglyemi risis, arandomplasmagluose$200 mg/dl (11.1 mmol/l). *In the absene of unequivoal hyperglyemia, result should be onfirmed by repeat testing. used A1C to predit the progression to diabetes demonstrated a strong, ontinuous assoiation between A1C and subsequent diabetes. In a systemati review of 44,203 individuals from 16 ohort studies with a follow-up interval averaging 5.6 years (range years), those with an A1C between 5.5 and 6.0% had a substantially inreased risk of diabetes with 5-year inidenes ranging from 9 to 25%. An A1C range of % had a 5-year risk of developing diabetes between 25 to 50% and relative risk (RR) 20 times higher ompared with an A1C of 5.0% (15). In a ommunitybased study of blak and white adults without diabetes, baseline A1C was a stronger preditor of subsequent diabetes and ardiovasular events than was fasting gluose (16). Other analyses suggest that an A1C of 5.7% is assoiated with diabetes risk similar to that in the highrisk partiipants in the Diabetes Prevention Program (DPP) (17). Hene, it is reasonable to onsider an A1C range of % as identifying individuals with prediabetes. As is the ase for individuals found to have IFG and IGT, individuals with an A1C of % should be informed of their inreased risk for diabetes as well as CVD and ounseled about effetive strategies to lower their risks (see Setion IV). As with gluose measurements, the ontinuum of risk is urvilinear, so that as A1C rises, the risk of diabetes rises disproportionately (15). Aordingly, interventions should be most intensive and follow-up partiularly vigilant for those with A1Cs above 6.0%, who should be onsidered to be at very high risk. Table 3 summarizes the ategories of prediabetes. II. TESTING FOR DIABETES IN ASYMPTOMATIC PATIENTS Reommendations Testing to detet type 2 diabetes and prediabetes in asymptomati people should be onsidered in adults of any age who are overweight or obese (BMI $25 kg/m 2 ) and who have one or more additional risk fators for diabetes (Table 4). In those without these risk fators, testing should begin at age 45. (B) If tests are normal, repeat testing at least at 3-year intervals is reasonable. (E) To test for diabetes or prediabetes, the A1C, FPG, or 75-g 2-h OGTT are appropriate. (B) In those identified with prediabetes, identify and, if appropriate, treat other CVD risk fators. (B) Position Statement Table 3dCategories of inreased risk for diabetes (prediabetes)* FPG 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l) (IFG) OR 2-h plasma gluose in the 75-g OGTT 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l) (IGT) OR A1C % *For all three tests, risk is ontinuous, extending below the lower limit of the range and beoming disproportionately greater at higher ends of the range. For many illnesses, there is a major distintion between sreening and diagnosti testing. However, for diabetes, the same tests would be used for sreening as for diagnosis. Diabetes may be identified anywhere along a spetrum of linial senarios ranging from a seemingly low-risk individual who happens to have gluose testing, to a higher-risk individual whom the provider tests beause of high suspiion of diabetes, to the symptomati patient. The disussion herein is primarily framed as testing for diabetes in those without symptoms. The same assays used for testing for diabetes will also detet individuals with prediabetes. A. Testing for type 2 diabetes and risk of future diabetes in adults Prediabetes and diabetes meet established riteria for onditions in whih early detetion is appropriate. Both onditions are ommon, inreasing in prevalene, and impose signifiantpublihealth burdens. There is a long presymptomati phase before the diagnosis of type 2 diabetes is usually made. Relatively simple tests are available to detet prelinial disease. Additionally, the duration of glyemi burden is a strong preditor of adverse outomes, and effetive interventions exist to prevent progression of prediabetes to diabetes (see Setion IV) and to redue risk of ompliations of diabetes (see Setion VI). Type 2 diabetes is frequently not diagnosed until ompliations appear, and approximately one-fourth of all people with diabetes in the U.S. may be undiagnosed. The effetiveness of early identifiation of prediabetes and diabetes through mass testing of asymptomati individuals has not been proven definitively, and rigorous trials to provide suh proof are unlikely to our. In a large randomized ontrolled trial (RCT) in Europe, general pratie patients between the ages of years were sreened for diabetes and are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S13

14 Position Statement then randomly assigned by pratie to routine are of diabetes or intensive treatment of multiple risk fators. After 5.3 years of follow-up, CVD risk fators were modestly but signifiantly more improved with intensive treatment. Inidene of first CVD event and mortality rates were not signifiantly different between groups (18). This study would seem to add support for early treatment of sreen-deteted diabetes, as risk fator ontrol was exellent even in the routine treatment arm and both groups had lower event rates than predited. The absene of a ontrol unsreened arm limits the ability to definitely prove that sreening impats outomes. Mathematial modeling studies suggest that sreening independent of risk fators beginning at age 30 years or age 45 years is highly ost-effetive (,$11,000 per quality-adjusted lifeyear gained) (19). Reommendations for testing for diabetes in asymptomati, undiagnosed adults are listed in Table 4. Testing should be onsidered in adults of any age with BMI $25 kg/m 2 and one or more of the known risk fators for diabetes. In addition to the listed risk fators, ertain mediations, suh as gluoortioids and antipsyhotis (20), are known to inrease the risk of type 2 diabetes. There is ompelling evidene that lower BMI ut points suggest diabetes risk in some raial and ethni groups. In a large multiethni ohort study, for an equivalent inidene rate of diabetes onferred by a BMI of 30 kg/m 2 in whites, the BMI utoff value was 24 kg/m 2 in South Asians, 25 kg/m 2 in Chinese, and 26 kg/m 2 in Afrian Amerians (21). Disparities in sreening rates, not explainable by insurane status, are highlighted by evidene that despite muh higher prevalene of type 2 diabetes, non-cauasians in an insured population are no more likely than Cauasians to be sreened for diabetes (22). Beause ageisamajorriskfatorfordiabetes,testing of those without other risk fators should begin no later than age 45 years. The A1C, FPG, or the 2-h OGTT are appropriate for testing. It should be noted that the tests do not neessarily detet diabetes in the same individuals. The effiay of interventions for primary prevention of type 2 diabetes (23 29) has primarily been demonstrated among individuals with IGT, not for individuals with isolated IFG or for individuals with speifi A1C levels. The appropriate interval between testsisnotknown(30).therationale for the 3-year interval is that false negatives will be repeated before substantial time elapses, and there is little likelihood that an individual will develop signifiant ompliations of diabetes within 3 years of a negative test result. In the modeling study, repeat sreening every 3 or 5 years was ost-effetive (19). Beause of the need for follow-up and disussion of abnormal results, testing should be arried out within the health are setting. Community sreening outside a health are setting is not reommended beause people with positive tests may not Table 4dCriteria for testing for diabetes in asymptomati adult individuals 1. Testing should be onsidered in all adults who are overweight (BMI $25 kg/m 2 *) and have additional risk fators: physial inativity first-degree relative with diabetes high-risk rae/ethniity (e.g., Afrian Amerian, Latino, Native Amerian, Asian Amerian, Paifi Islander) women who delivered a baby weighing.9 lb or were diagnosed with GDM hypertension ($140/90 mmhg or on therapy for hypertension) HDL holesterol level,35 mg/dl (0.90 mmol/l) and/or a triglyeride level.250 mg/dl (2.82 mmol/l) women with polyysti ovary syndrome A1C $5.7%, IGT, or IFG on previous testing other linial onditions assoiated with insulin resistane (e.g., severe obesity, aanthosis nigrians) history of CVD 2. In the absene of the above riteria, testing for diabetes should begin at age 45 years. 3. If results are normal, testing should be repeated at least at 3-year intervals, with onsideration of more frequent testing depending on initial results (e.g., those with prediabetes should be tested yearly) and risk status. *At-risk BMI may be lower in some ethni groups. seek, or have aess to, appropriate follow-up testing and are. Conversely, there may be failure to ensure appropriate repeat testing for individuals who test negative. Community sreening may also be poorly targeted; i. e.,itmayfailtoreahthegroupsmostatrisk and inappropriately test those at low risk (the worried well) or even those already diagnosed. B. Sreening for type 2 diabetes in hildren Reommendations Testing to detet type 2 diabetes and prediabetesshouldbeonsideredinhildren and adolesents who are overweight and who have two or more additional risk fators for diabetes (Table 5). (E) The inidene of type 2 diabetes in adolesents has inreased dramatially in the last deade, espeially in minority populations (31), although the disease remains rare in the general pediatri population (32). Consistent with reommendations for adults, hildren and youth at inreased risk for the presene or the development of type 2 diabetes should be tested within the health are setting (33). The reommendations of the ADA onsensus statement Type 2 Diabetes in Children and Adolesents, with some modifiations, are summarized in Table 5. C. Sreening for type 1 diabetes Reommendations Consider referring relatives of those with type 1 diabetes for antibody testing for risk assessment in the setting of a linial researh study. (E) Generally, people with type 1 diabetes present with aute symptoms of diabetes and markedly elevated blood gluose levels, and some ases are diagnosed with life-threatening ketoaidosis. Evidene from several studies suggests that measurement of islet autoantibodies in relatives of those with type 1 diabetes identifies individuals who are at risk for developing type 1 diabetes. Suh testing, oupled with eduation about symptoms of diabetes and follow-up in an observational linial study, may allow earlier identifiation of onset of type 1 diabetes and lessen presentation with ketoaidosis at time of diagnosis. This testing may be appropriate in those who have relatives with type 1 diabetes, in the ontext of S14 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

15 Position Statement Table 5dTesting for type 2 diabetes in asymptomati hildren* Criteria Overweight (BMI.85th perentile for age and sex, weight for height.85th perentile, or weight.120% of ideal for height) Plus any two of the following risk fators: Family history of type 2 diabetes in first- or seond-degree relative Rae/ethniity (Native Amerian, Afrian Amerian, Latino, Asian Amerian, Paifi Islander) Signs of insulin resistane or onditions assoiated with insulin resistane (aanthosis nigrians, hypertension, dyslipidemia, polyysti ovary syndrome, or small-for-gestationalage birth weight) Maternal history of diabetes or GDM during the hild s gestation Age of initiation: age 10 years or at onset of puberty, if puberty ours at a younger age Frequeny: every 3 years *Persons aged 18 years and younger. linial researh studies (see, for example, However, widespread linial testing of asymptomati low-risk individuals annot urrently be reommended, as it would identify very few individuals in the general population who are at risk. Individuals who sreen positive should be ounseled about their risk of developing diabetes and symptoms of diabetes, followed losely to prevent development of diabeti ketoaidosis, and informed about linial trials. Clinial studies are being onduted to test various methods of preventing type 1 diabetes in those with evidene of autoimmunity. Some interventions have demonstrated modest effiay in slowing b-ell loss early in type 1 diabetes (34,35), and further researh is needed to determine whether they may be effetive in preventing type 1 diabetes. III. DETECTION AND DIAGNOSIS OF GDM Reommendations Sreen for undiagnosed type 2 diabetes at the first prenatal visit in those with risk fators, using standard diagnosti riteria. (B) In pregnant women not previously known to have diabetes, sreen for GDM at weeks of gestation, usinga75-g2-hogttandthediagnosti ut points in Table 6. (B) Sreen women with GDM for persistent diabetes at 6 12 weeks postpartum, using the OGTT and nonpregnany diagnosti riteria. (E) Women with a history of GDM should have lifelong sreening for the development of diabetes or prediabetes at least every 3 years. (B) Women with a history of GDM found to have prediabetes should reeive lifestyle interventions or metformin to prevent diabetes. (A) For many years, GDM was defined as any degree of gluose intolerane with onset or first reognition during pregnany (13), whether or not the ondition persisted after pregnany, and not exluding the possibility that unreognized gluose intolerane may have antedated or begun onomitantly with the pregnany. This definition failitated a uniform strategy for detetion and lassifiation of GDM, but its limitations were reognized for many years. As the ongoing epidemi of obesity and diabetes has led to more type 2 diabetes in women of hildbearing age, the number of pregnant women with undiagnosed type 2 diabetes has inreased (36). Beause of this, it is reasonable to Table 6dSreening for and diagnosis of GDM Perform a 75-g OGTT, with plasma gluose measurement fasting and at 1 and 2 h, at weeks of gestation in women not previously diagnosed with overt diabetes. The OGTT should be performed in the morning after an overnight fast of at least 8 h. The diagnosis of GDM is made when any of the following plasma gluose values are exeeded: Fasting: $92 mg/dl (5.1 mmol/l) 1h:$180 mg/dl (10.0 mmol/l) 2h:$153 mg/dl (8.5 mmol/l) sreen women with risk fators for type 2 diabetes (Table 4) for diabetes at their initial prenatal visit, using standard diagnosti riteria (Table 2). Women with diabetes found at this visit should reeive a diagnosis of overt, not gestational, diabetes. GDM arries risks for the mother and neonate. The Hyperglyemia and AdversePregnanyOutome(HAPO)study (37), a large-sale (;25,000 pregnant women) multinational epidemiologial study, demonstrated that risk of adverse maternal, fetal, and neonatal outomes ontinuously inreased as a funtion of maternal glyemia at weeks, even within ranges previously onsidered normal for pregnany. For most ompliations, there was no threshold for risk. These results have led to areful reonsideration of the diagnosti riteria for GDM. After deliberations in , the International Assoiation of Diabetes and Pregnany Study Groups (IADPSG), an international onsensus groupwithrepresentatives from multiple obstetrial and diabetes organizations, inluding ADA, developed revised reommendations for diagnosing GDM. The group reommended that all women not known to have prior diabetes undergo a 75-g OGTT at weeks of gestation. Additionally, the group developed diagnosti ut points for the fasting, 1-h, and 2-h plasma gluose measurements that onveyed an odds ratio for adverse outomes of at least 1.75 ompared with women with the mean gluose levels in the HAPO study. Current sreening and diagnosti strategies, based on the IADPSG statement (38), are outlined in Table 6. These new riteria will signifiantly inrease the prevalene of GDM, primarily beause only one abnormal value, not two, is suffiient to make the diagnosis. The ADA reognizes the antiipated signifiant inrease in the inidene of GDM diagnosed by these riteria and is sensitive to onerns about the medialization of pregnanies previously ategorized as normal. These diagnosti riteria hanges are being made in the ontext of worrisome worldwide inreases in obesity and diabetes rates, with the intent of optimizing gestational outomes for women and their babies. Admittedly, there are few data from randomized linial trials regarding therapeuti interventions in women who will now be diagnosed with GDM based on only one blood gluose value above the are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S15

16 Position Statement speified ut points (in ontrast to the older riteria that stipulated at least two abnormal values). However, there is emerging observational and retrospetive evidene that women diagnosed with the new riteria (even if they would not have been diagnosed with older riteria) have inreased rates of poor pregnany outomes similar to those of women with GDM by prior riteria (39,40). Expeted benefits to these pregnanies and offspring are inferred from intervention trials that foused on women with more mild hyperglyemia than identified using older GDM diagnosti riteria and that found modest benefits (41,42). The frequeny of followup and blood gluose monitoring for these women is not yet lear, but likely to be less intensive than for women diagnosed by the older riteria. It is important to note that 80 90% of women in both of the mild GDM studies (whose gluose values overlapped with the thresholds reommended herein) ould be managed with lifestyle therapy alone. The Amerian College of Obstetriians and Gyneologists announed in 2011 that they ontinue to reommend use of prior diagnosti riteria for GDM (43). Several other ountries have adopted the new riteria, and a report from the WHO on this topi is pending at the time of publiation of these standards. The National Institutes of Health is planning to hold a onsensus development onferene on this topi in Beause some ases of GDM may represent pre-existing undiagnosed type 2 diabetes, women with a history of GDM should be sreened for diabetes 6 12 weeks postpartum, using nonpregnant OGTT riteria. Beause of their prepartum treatment for hyperglyemia, use of the A1C for diagnosis of persistent diabetes at the postpartum visit is not reommended (44). Women with a history of GDM have a greatly inreased subsequent risk for diabetes (45) and should befollowedupwithsubsequentsreening for the development of diabetes or prediabetes, as outlined in Setion II. Lifestyle interventions or metformin should be offered to women with a history of GDM who develop prediabetes, as disussed in Setion IV. In the prospetive Nurses Health Study II, risk of subsequent diabetes after a history of GDM was signifiantly lower in women who followed healthy eating patterns. Adjusting for BMI moderately, but not ompletely, attenuated this assoiation (46). IV. PREVENTION/DELAY OF TYPE 2 DIABETES Reommendations Patients with IGT (A), IFG (E), or an A1C of % (E) should be referred to an effetive ongoing support program targeting weight loss of 7% of body weight and inreasing physial ativity to at least 150 min/week of moderate ativity suh as walking. Follow-up ounseling appears to be important for suess. (B) Based on the ost-effetiveness of diabetes prevention, suh programs should be overed by third-party payers. (B) Metformin therapy for prevention of type 2 diabetes may be onsidered in those with IGT (A), IFG (E), or an A1C of % (E), espeially for those with BMI.35 kg/m 2, aged,60 years, and women with prior GDM. (A) At least annual monitoring for the development of diabetes in those with prediabetes is suggested. (E) Sreening for and treatment of modifiable risk fators for CVD is suggested. (B) RCTs have shown that individuals at high risk for developing type 2 diabetes (those with IFG, IGT, or both) an signifiantly derease the rate of onset of diabetes with partiular interventions (23 29). These inlude intensive lifestyle modifiation programs that have been shown to be very effetive (;58% redution after 3 years) and use of the pharmaologial agents metformin, a-gluosidase inhibitors, orlistat, and thiazolidinediones, eah of whih has been shown to derease inident diabetes to various degrees. Follow-up of all three large studies of lifestyle intervention has shown sustained redution in the rate of onversion to type 2 diabetes, with 43% redution at 20 years in the Da Qing study (47), 43% redution at 7 years in the Finnish Diabetes Prevention Study (DPS) (48), and 34% redution at 10 years in the U.S. Diabetes Prevention Program Outomes Study (DPPOS) (49). A osteffetiveness model suggested that lifestyle interventions as delivered in the DPP are ost-effetive (50), and atual ost data from the DPP and DPPOS onfirm that lifestyle interventions are highly ost-effetive (51). Group delivery of the DPP intervention in ommunity settings has the potential to be signifiantly less expensive while still ahieving similar weight loss (52). Based on the results of linial trials and the known risks of progression of prediabetes to diabetes, persons with an A1C of %, IGT, or IFG should be ounseled on lifestyle hanges with goals similar to those of the DPP (7% weight loss and moderate physial ativity of at least 150 min/week). Regarding drug therapy for diabetes prevention, metformin has a strong evidene base and demonstrated long-term safety (53). For other drugs, issues of ost, side effets, and lak of persistene of effet in some studies (54) require onsideration. Metformin was less effetive than lifestyle modifiation in the DPP and DPPOS, but may be ost-saving over a 10-year period (51). It was as effetive as lifestyle modifiation in partiipants with a BMI of at least 35 kg/m 2, but not signifiantly better than plaebo than those over age 60 years (23). In women in the DPP with a history of GDM, metformin and intensive lifestyle modifiation led to an equivalent 50% redution in the risk of diabetes (55). Metformin therefore might reasonably be reommended for very high-risk individuals (those with a history of GDM, the very obese, and/or those with more severe or progressive hyperglyemia). People with prediabetes often have other ardiovasular risk fators, suh as obesity, hypertension, and dyslipidemia. Assessing and treating these risk fators is an important aspet of reduing ardiometaboli risk. In the DPP and DPPOS, ardiovasular event rates have been very low, perhaps due to appropriate management of ardiovasular risk fators in all arms of the study (56). V. DIABETES CARE A. Initial evaluation A omplete medial evaluation should be performed to lassify the diabetes, detet the presene of diabetes ompliations, review previous treatment and risk fator ontrol in patients with established diabetes, assist in formulating a management plan, and provide a basis for ontinuing are. Laboratory tests appropriate to the evaluation of eah patient s medial ondition should be performed. A fous on the omponents of omprehensive are (Table 7) will assist the health are team to ensure optimal management of the patient with diabetes. B. Management People with diabetes should reeive medial are from a team that may inlude physiians, nurse pratitioners, physiian s assistants, nurses, dietitians, pharmaists, and mental health professionals with S16 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

17 Position Statement Table 7dComponents of the omprehensive diabetes evaluation Medial history Age and harateristis of onset of diabetes (e.g., DKA, asymptomati laboratory finding) Eating patterns, physial ativity habits, nutritional status, and weight history; growth and development in hildren and adolesents Diabetes eduation history Review of previous treatment regimens and response to therapy (A1C reords) Current treatment of diabetes, inluding mediations, mediation adherene and barriers thereto, meal plan, physial ativity patterns, and readiness for behavior hange Results of gluose monitoring and patient s use of data DKA frequeny, severity, and ause Hypoglyemi episodes Hypoglyemia awareness Any severe hypoglyemia: frequeny and ause History of diabetes-related ompliations Mirovasular: retinopathy, nephropathy, neuropathy (sensory, inluding history of foot lesions; autonomi, inluding sexual dysfuntion and gastroparesis) Marovasular: CHD, erebrovasular disease, and PAD Other: psyhosoial problems*, dental disease* Physial examination Height, weight, BMI Blood pressure determination, inluding orthostati measurements when indiated Fundosopi examination* Thyroid palpation Skin examination (for aanthosis nigrians and insulin injetion sites) Comprehensive foot examination Inspetion Palpation of dorsalis pedis and posterior tibial pulses Presene/absene of patellar and Ahilles reflexes Determination of proprioeption, vibration, and monofilament sensation Laboratory evaluation A1C, if results not available within past 2 3 months If not performed/available within past year Fasting lipid profile, inluding total, LDL and HDL holesterol and triglyerides Liver funtion tests Test for urine albumin exretion with spot urine albumin-to-reatinine ratio Serum reatinine and alulated GFR TSH in type 1 diabetes, dyslipidemia or women over age 50 years Referrals Eye are professional for annual dilated eye exam Family planning for women of reprodutive age Registered dietitian for MNT DSME Dentist for omprehensive periodontal examination Mental health professional, if needed *See appropriate referrals for these ategories. expertise and a speial interest in diabetes. It is essential in this ollaborative and integrated team approah that individuals with diabetes assume an ative role in their are. The management plan should be formulated as a ollaborative therapeuti alliane among the patient and family, the physiian, and other members of the health are team. A variety of strategies and tehniques should be used to provide adequate eduation and development of problem-solving skills in the various aspets of diabetes management. Implementation of the management plan requires that the goals and treatment plan are individualized and take patient preferenes into aount. The management plan should reognize diabetes selfmanagement eduation (DSME) and ongoing diabetes support as an integral omponent of are. In developing the plan, onsideration should be given to the patient s age, shool or work shedule and onditions, physial ativity, eating patterns, soial situation and ultural fators, and presene of ompliations of diabetes or other medial onditions. C. Glyemi ontrol 1. Assessment of glyemi ontrol Two primary tehniques are available for health providers and patients to assess the effetiveness of the management plan on glyemi ontrol: patient self-monitoring of blood gluose (SMBG) or interstitial gluose, and A1C. a. Gluose monitoring Reommendations Patients on multiple-dose insulin (MDI) or insulin pump therapy should do SMBG at least prior to meals and snaks, oasionally postprandially, at bedtime, prior to exerise, when they suspet low blood gluose, after treating low blood gluose until they are normoglyemi, and prior to ritial tasks suh as driving. (B) When presribed as part of a broader eduational ontext, SMBG results may be helpful to guide treatment deisions and/or patient self-management for patients using less frequent insulin injetions or noninsulin therapies. (E) When presribing SMBG, ensure that patients reeive ongoing instrution and regular evaluation of SMBG tehnique and SMBG results, as well as their ability to use SMBG data to adjust therapy. (E) Continuous gluose monitoring (CGM) in onjuntion with intensive insulin regimens an be a useful tool to lower A1C in seleted adults (aged $25 years) with type 1 diabetes. (A) Although the evidene for A1C lowering is less strong in hildren, teens, and younger adults, CGM may be helpful in these groups. Suess orrelates with adherene to ongoing use of the devie. (C) CGM may be a supplemental tool to SMBG in those with hypoglyemia unawareness and/or frequent hypoglyemi episodes. (E) Major linial trials of insulin-treated patients that demonstrated the benefits of intensive glyemi ontrol on diabetes ompliations have inluded SMBG as part of multifatorial interventions, suggesting that SMBG is a omponent of effetive therapy. SMBG allows patients to evaluate their individual response to are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S17

18 Position Statement therapy and assess whether glyemi targets are being ahieved. Results of SMBG an be useful in preventing hypoglyemia and adjusting mediations (partiularly prandial insulin doses), medial nutrition therapy (MNT), and physial ativity. The frequeny and timing of SMBG should be ditated by the partiular needs and goals of the patient. SMBG is espeially important for patients treated with insulin to monitor for and prevent asymptomati hypoglyemia and hyperglyemia. Most patients with type 1 diabetes and others on intensive insulin regimens (MDI or insulin pump therapy) should do SMBG at least prior to meals and snaks, oasionally postprandially, at bedtime, prior to exerise, when they suspet low blood gluose, after treating low blood gluose until they are normoglyemi, and prior to ritial tasks suh as driving. For many patients, this will require testing 6 8 times daily, although individual needs may be greater. Although there are few rigorous studies, a database study of almost 27,000 hildren and adolesents with type 1 diabetes showed that, after adjustment for multiple onfounders, inreased daily frequeny of SMBG was signifiantly assoiated with lower A1C (20.2% per additional test per day, leveling off at five tests per day) and with fewer aute ompliations (57). The optimal frequeny of SMBG for patients on nonintensive regimens, suh as those with type 2 diabetes on basal insulin, is not known, although a number of studies have used fasting SMBG for patient or provider titration of the basal insulin dose. The evidene base for SMBG for patients with type 2 diabetes on noninsulin therapy is somewhat mixed. Several randomized trials have alled into question the linial utility and ost-effetiveness of routine SMBG in non insulin-treated patients (58 60). A reent meta-analysis suggested that SMBG redued A1C by 0.25% at 6 months (61), while a Cohrane review onluded that the overall effet of SMBG in suh patients is small up to 6 months after initiation and subsides after 12 months (62). Beause the auray of SMBG is instrument and user dependent (63), it is important to evaluate eah patient s monitoring tehnique, both initially and at regular intervals thereafter. Optimal use of SMBG requires proper review and interpretation of the data, both by the patient and provider. Among patients who heked their blood gluose at least one daily, many reported taking no ation when results were high or low (64). In one study of insulin-naïve patients with suboptimal initial glyemi ontrol, use of strutured SMBG (a paper tool to ollet and interpret 7-point SMBG profiles over 3 days at least quarterly) redued A1C by 0.3% more than in an ative ontrol group (65). Patients should be taught how to use SMBG data to adjust food intake, exerise, or pharmaologial therapy to ahieve speifi goals, and the ongoing need for and frequeny of SMBG should be re-evaluated at eah routine visit. Real-time CGM through the measurement of interstitial gluose (whih orrelates well with plasma gluose) is available. These sensors require alibration with SMBG, and the latter are still reommended for making aute treatment deisions. CGM devies have alarms for hypo- and hyperglyemi exursions. A 26-week randomized trial of 322 type 1 diabeti patients showed that adults aged $25 years using intensive insulin therapy and CGM experiened a 0.5% redution in A1C (from ;7.6 to 7.1%) ompared with usual intensive insulin therapy with SMBG (66). Sensor use in hildren, teens, and adults to age 24 years did not result in signifiant A1C lowering, and there was no signifiant differene in hypoglyemia in any group. Importantly, the greatest preditor of A1C lowering in this study for all age-groups was frequeny of sensor use, whih was lower in younger age-groups. In a smaller RCT of 129 adults and hildren with baseline A1C,7.0%, outomes ombining A1C and hypoglyemia favored the group utilizing CGM, suggesting that CGM is also benefiial for individuals with type 1 diabetes who have already ahieved exellent ontrol (67). A trial omparing CGM plus insulin pump to SMBG plus multiple injetions of insulin in adults and hildren with type 1 diabetes showed signifiantly greater improvements in A1C with sensoraugmented pump therapy (68,69), but this trial did not isolate the effet of CGM itself. Overall, meta-analyses suggest that ompared with SMBG, CGM lowers A1C by ;0.26% (70). Altogether, these data suggest that, in appropriately seleted patients who are motivated to wear it most of the time, CGM redues A1C. The tehnology may be partiularly useful in those with hypoglyemia unawareness and/or frequent episodes of hypoglyemia, although studies as yet have not shown signifiant redutions in severe hypoglyemia (70). CGM forms the underpinning for the development of pumps that suspend insulin delivery when hypoglyemia is developing and for the burgeoning work on artifiial panreas systems. b. A1C Reommendations Perform the A1C test at least two times a year in patients who are meeting treatment goals (and who have stable glyemi ontrol). (E) Perform the A1C test quarterly in patients whose therapy has hanged or who are not meeting glyemi goals. (E) Use of POC testing for A1C provides the opportunity for more timely treatment hanges. (E) Beause A1C is thought to reflet average glyemia over several months (63) and has strong preditive value for diabetes ompliations (71,72), A1C testing should be performed routinely in all patients with diabetes, at initial assessment and then as part of ontinuing are. Measurement approximately every 3 months determines whether patient s glyemi targets have been reahed and maintained. For any individual patient, the frequeny of A1C testing should be dependent on the linial situation, the treatment regimen used, and the judgment of the liniian. Some patients with stable glyemia well within target may do well with testing only twie per year, while unstable or highly intensively managed patients (e.g., pregnant type 1 diabeti women) may be tested more frequently than every 3 months. The availability of the A1C result at the time that the patient is seen (POC testing) has been reported in small studies to result in inreased intensifiation of therapy and improvement in glyemi ontrol (73,74). However, two reent systemati reviews and meta-analyses found no signifiant differene in A1C between POC and laboratory A1C usage (75,76). The A1C test is subjet to ertain limitations. Conditions that affet erythroyte turnover (hemolysis, blood loss) and hemoglobin variants must be onsidered, partiularly when the A1C result does not orrelate with the patient s linial situation (63). In addition, A1C does not provide a measure of glyemi variability or hypoglyemia. For patients prone to glyemi variability (espeially type 1 diabeti patients or type 2 diabeti patients with severe insulin defiieny), glyemi ontrol is best judged by the ombination of results of self-monitoring and the A1C. The A1C may also serve as a hek on the auray of the patient s meter (or the patient s reported SMBG S18 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

19 results) and the adequay of the SMBG testing shedule. Table 8 ontains the orrelation between A1C levels and mean plasma gluose levels based on data from the international A1C-Derived Average Gluose (ADAG) trial utilizing frequent SMBG and CGM in 507 adults (83% Cauasian) with type 1, type 2, and no diabetes (77). The ADA and the Amerian Assoiation for Clinial Chemistry have determined that the orrelation (r ) is strong enough to justify reporting both an A1C result and an estimated average gluose (eag) result when a liniian orders the A1C test. The table in pre versions of the Standards of Medial Care in Diabetes desribing the orrelation between A1C and mean gluose was derived from relatively sparse data (one 7-point profile over 1 day per A1C reading) in the primarily Cauasian type 1 diabeti partiipants in the DCCT (78). Cliniians should note that the numbers in the table are now different, as they are based on ;2,800 readings per A1C in the ADAG trial. In the ADAG trial, there were no signifiant differenes among raial and ethni groups in the regression lines between A1C and mean gluose, although there was a trend toward a differene between Afrian/Afrian Amerian partiipants and Cauasian ones. A small study omparing A1C to CGM data in type 1 diabeti hildren found a highly statistially signifiant orrelation between A1C and mean blood gluose, although the orrelation (r 5 0.7) was signifiantly lower than in the ADAG trial (79). Whether Table 8dCorrelation of A1C with average gluose A1C (%) Mean plasma gluose mg/dl mmol/l These estimates are based on ADAG data of ;2,700 gluose measurements over 3 months per A1C measurement in 507 adults with type 1, type 2, and no diabetes. The orrelation between A1C and average gluose was 0.92 (ref. 77). A alulator for onverting A1C results into eag, in either mg/dl or mmol/l, is available at there are signifiant differenes in how A1C relates to average gluose in hildren or in Afrian Amerian patients is an area for further study. For the time being, the question has not led to different reommendations about testing A1C or to different interpretations of the linial meaning of given levels of A1C in those populations. For patients in whom A1C/eAG and measured blood gluose appear disrepant, liniians should onsider the possibilities of hemoglobinopathy or altered red ell turnover, and the options of more frequent and/or different timing of SMBG or use of CGM. Other measures of hroni glyemia suh as frutosamine are available, but their linkage to average gluose and their prognosti signifiane are not as lear as is the ase for A1C. 2. Glyemi goals in adults Reommendations Lowering A1C to below or around 7% has been shown to redue mirovasular ompliations of diabetes and if implemented soon after the diagnosis of diabetes is assoiated with long-term redution in marovasular disease. Therefore, a reasonable A1C goal for many nonpregnant adults is,7%. (B) Providers might reasonably suggest more stringent A1C goals (suh as,6.5%) for seleted individual patients, if this an be ahieved without signifiant hypoglyemia or other adverse effets of treatment. Appropriate patients might inlude those with short duration of diabetes, long life expetany, and no signifiant CVD. (C) Less stringent A1C goals (suh as,8%) may be appropriate for patients with a history of severe hypoglyemia, limited life expetany, advaned mirovasular or marovasular ompliations, extensive omorbid onditions, and those with long-standing diabetes in whom the general goal is diffiult to attain despite DSME, appropriate gluose monitoring, and effetive doses of multiple gluose-lowering agents inluding insulin. (B) Hyperglyemia defines diabetes, and glyemi ontrol is fundamental to the management of diabetes. The DCCT (71), a prospetive RCT of intensive versus standard glyemi ontrol in patients with relatively reently diagnosed type 1 diabetes, showed definitively that improved glyemi ontrol is assoiated with signifiantly dereased rates of Position Statement mirovasular (retinopathy and nephropathy) and neuropathi ompliations. Follow-up of the DCCT ohorts in the Epidemiology of Diabetes Interventions and Compliations (EDIC) study (80,81) demonstrated persistene of these mirovasular benefits in previously intensively treated subjets, even though their glyemi ontrol approximated that of previous standard arm subjets during follow-up. The Kumamoto Study (82) and UK Prospetive Diabetes Study (UKPDS) (83,84) onfirmed that intensive glyemi ontrol was assoiated with signifiantly dereased rates of mirovasular and neuropathi ompliations in patients with type 2 diabetes. Long-term follow-up of the UKPDS ohorts showed persistene of the effet of early glyemi ontrol on most mirovasular ompliations (85). Subsequent trials in patients with more long-standing type 2 diabetes, designed primarily to look at the role of intensive glyemi ontrol on ardiovasular outomes, also onfirmed a benefit, although more modest, on onset or progression of mirovasular ompliations. The Veterans Affairs Diabetes Trial (VADT) showed signifiant redutions in albuminuria with intensive (ahieved median A1C 6.9%) ompared with standard glyemi ontrol, but no differene in retinopathy and neuropathy (86,87). The Ation in Diabetes and Vasular Disease: Preterax and Diamiron MR Controlled Evaluation (ADVANCE) study of intensive versus standard glyemi ontrol in type 2 diabetes found a statistially signifiant redution in albuminuria, but not in neuropathy or retinopathy, with an A1C target of,6.5% (ahieved median A1C 6.3%) ompared with standard therapy ahieving a median A1C of 7.0% (88). Analyses from the Ation to Control Cardiovasular Risk in Diabetes (ACCORD) trial have shown lower rates of onset or progression of early-stage mirovasular ompliations in the intensive glyemi ontrol arm ompared with the standard arm (89,90). Epidemiologial analyses of the DCCT and UKPDS (71,72) demonstrate a urvilinear relationship between A1C and mirovasular ompliations. Suh analyses suggest that, on a population level, the greatest number of ompliations will be averted by taking patients from very poor ontrol to fair or good ontrol. These analyses also suggest that further lowering of A1C from 7 to 6% is assoiated with further redution in the risk of mirovasular ompliations, albeit the absolute risk are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S19

20 Position Statement redutions beome muh smaller. Given the substantially inreased risk of hypoglyemia (partiularly in those with type 1 diabetes, but also in the reent type 2 diabetes trials), the onerning mortality findings in the ACCORD trial (91), and the relatively muh greater effort required to ahieve near-normoglyemia, the risks of lower glyemi targets may outweigh the potential benefits on mirovasular ompliations on a population level. However, seleted individual patients, espeially those with little omorbidity and long life expetany (who may reap the benefits of further lowering of glyemia below 7%), may, based on provider judgment and patient preferenes, adopt more intensive glyemi targets (e.g., an A1C target,6.5%) as long as signifiant hypoglyemia does not beome abarrier. CVD, a more ommon ause of death in populations with diabetes than mirovasular ompliations, is less learly impated by levels of hyperglyemia or the intensity of glyemi ontrol. In the DCCT, there was a trend toward lower risk of CVD events with intensive ontrol, and in 9-year post-dcct follow-up of the EDIC ohort partiipants previously randomized to the intensive arm had a signifiant 57% redution in the risk of nonfatal myoardial infartion (MI), stroke, or CVD death ompared with those previously in the standard arm (92). The benefit of intensive glyemi ontrol in this type 1 diabeti ohort has reently been shown to persist for several deades (93). In type 2 diabetes, there is evidene that more intensive treatment of glyemia in newly diagnosed patients may redue long-term CVD rates. During the UKPDS trial, there was a 16% redution in ardiovasular events (ombined fatal or nonfatal MI and sudden death) in the intensive glyemi ontrol arm that did not reah statistial signifiane (P ), and there was no suggestion of benefit on other CVD outomes suh as stroke. However, after 10 years of followup, those originally randomized to intensive glyemi ontrol had signifiant long-term redutions in MI (15% with sulfonylurea or insulin as initial pharmaotherapy, 33% with metformin as initial pharmaotherapy) and in all-ause mortality (13% and 27%, respetively) (85). Three more reent large trials (ACCORD, ADVANCE, and VADT) suggested no signifiant redution in CVD outomes with intensive glyemi ontrol in partiipants who had more advaned type 2 diabetes than UKPDS partiipants. All three of these trials were onduted in partiipants with more long-standing diabetes (mean duration 8 11 years) and either known CVD or multiple ardiovasular risk fators. Details of these three studies are reviewed extensively in an ADA position statement (94). The ACCORD study enrolled partiipants with either known CVD or two or more major ardiovasular risk fators and randomized them to intensive glyemi ontrol (goal A1C,6%) or standard glyemi ontrol (goal A1C 7 8%). The glyemi ontrol omparison was halted early due to the finding of an inreased rate of mortality in the intensive arm ompared with the standard arm (1.41% vs. 1.14% per year; HR 1.22; 95% CI ), with a similar inrease in ardiovasular deaths. This inrease in mortality in the intensive glyemi ontrol arm was seen in all prespeified patient subgroups. The primary outome of ACCORD (nonfatal MI, nonfatal stroke, or ardiovasular death) was nonsignifiantly lower in the intensive glyemi ontrol group due to a redution in nonfatal MI, both when the glyemi ontrol omparison was halted and all partiipants transitioned to the standard glyemi ontrol intervention (91), and at ompletion of the planned follow-up (95). Exploratory analyses of the mortality findings of ACCORD (evaluating variables inluding weight gain, use of any speifi drug or drug ombination, and hypoglyemia) were reportedly unable to identify a lear explanation for the exess mortality in the intensive arm (91). The ACCORD investigators subsequently published additional epidemiologial analyses showing no inrease in mortality in the intensive arm partiipants who ahieved A1C levels below 7% nor in those who lowered their A1C quikly after trial enrollment. In fat, although there was no A1C level at whih intensive arm partiipants had signifiantly lower mortality than standard arm partiipants, the highest risk for mortality was observed in intensive arm partiipants with the highest A1C levels (96). The role of hypoglyemia in the exess mortality findings was also omplex. Severe hypoglyemia was signifiantly more likely in partiipants randomized to the intensive glyemi ontrol arm. However, exess mortality in the intensive versus standard arms was only signifiant for partiipants with no severe hypoglyemia, and not for those with one or more episodes. Severe hypoglyemia was assoiated with exess mortality in either arm, but the assoiation was stronger in those randomized to the standard glyemi ontrol arm (97). Unlike the ase with the DCCT trial, where lower ahieved A1C levels were related to signifiantly inreased rates of severe hypoglyemia, in ACCORD every 1% deline in A1C from baseline to 4 months into the trial was assoiated with a signifiant derease in the rate of severe hypoglyemia in both arms (96). The primary outome of ADVANCE was a ombination of mirovasular events (nephropathy and retinopathy) and major adverse ardiovasular events (MI, stroke, and ardiovasular death). Intensive glyemi ontrol (to a goal A1C,6.5% vs. treatment to loal standards) signifiantly redued the primary end point. However, this was due to a signifiant redution in the mirovasular outome, primarily development of maroalbuminuria, with no signifiant redution in the marovasular outome. There was no differene in overall or ardiovasular mortality between the intensive ompared with the standard glyemi ontrol arms (88). The VADT randomized partiipants with type 2 diabetes unontrolled on insulin or maximal-dose oral agents (median entry A1C 9.4%) to a strategy of intensive glyemi ontrol (goal A1C,6.0%) or standard glyemi ontrol, with a planned A1C separation of at least 1.5%. The primary outome of the VADT was a omposite of CVD events. The umulative primary outome was nonsignifiantly lower in the intensive arm (86). An anillary study of the VADT demonstrated that intensive glyemi ontrol signifiantly redued the primary CVD outome in individuals with less atheroslerosis at baseline (assessed by oronary alium) but not in persons with more extensive baseline atheroslerosis(98).aposthoanalysisshoweda omplex relationship between duration of diabetes before glyemi intensifiation and mortality: mortality in the intensive vs. standard glyemi ontrol arm was inversely related to duration of diabetes at the time of study enrollment. Those with diabetes duration less than 15 years had a mortality benefit in the intensive arm, while those with duration of 20 years or more had higher mortality in the intensive arm (99). The evidene for a ardiovasular benefit of intensive glyemi ontrol primarily rests on long-term follow-up of study ohorts treated early in the ourse of type S20 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

21 1 and type 2 diabetes and subset analyses of ACCORD, ADVANCE, and VADT. A group-level meta-analysis of the latter three trials suggests that gluose lowering has a modest (9%) but statistially signifiant redution in major CVD outomes, primarily nonfatal MI, with no signifiant effet on mortality. However, heterogeneity of the mortality effets aross studies was noted, preluding firm summary measures of the mortality effets. A prespeified subgroup analysis suggested that major CVD outome redution ourred in patients without known CVD at baseline (HR 0.84, 95% CI ) (100). Conversely, the mortality findings in ACCORD and subgroup analyses of the VADT suggest that the potential risks of intensive glyemi ontrol may outweigh its benefits in some patients, suh as those with very long duration of diabetes, known history of severe hypoglyemia, advaned atheroslerosis, and advaned age/frailty. Certainly, providers should be vigilant in preventing severe hypoglyemia in patients with advaned disease and should not aggressively attempt to ahieve near-normal A1C levels in patients in whom suh a target annot be safely and reasonably easily ahieved. Severe or frequent hypoglyemia is an absolute indiation for the modifiation of treatment regimens, inluding setting higher glyemi goals. Many fators, inluding patient preferenes, should be taken into aount when developing a patient s individualized goals (101). Reommended glyemi goals for many nonpregnant adults are shown in Table 9. The reommendations are based on those for A1C values, with listed blood gluose levels that appear to orrelate with ahievement of an A1C of,7%. The issue of pre- versus postprandial SMBG targets is omplex (102). Elevated posthallenge (2-h OGTT) gluose values have been assoiated with inreased ardiovasular risk independent of FPG in some epidemiologial studies. In diabeti subjets, some surrogate measures of vasular pathology, suh as endothelial dysfuntion, are negatively affeted by postprandial hyperglyemia (103). It is lear that postprandial hyperglyemia, like preprandial hyperglyemia, ontributes to elevated A1C levels, with its relative ontribution being higher at A1C levels that are loser to 7%. However, outome studies have learly shown A1C to be the primary preditor of ompliations, and landmark glyemi ontrol trials suh as the DCCT and UKPDS relied overwhelmingly on preprandial SMBG. Additionally, an RCT in patients with known CVD found no CVD benefit of insulin regimens targeting postprandial gluose ompared with those targeting preprandial gluose (104). A reasonable reommendation for postprandial testing and targets is that for individuals who have premeal gluose values within target but have A1C values above target, monitoring postprandial plasma gluose (PPG) 1 2 h after the start of the meal and treatment aimed at reduing PPG values to,180 mg/dl may help lower A1C. Glyemi goals for hildren are provided in Setion VIII.A.1.a. As regards goals for glyemi ontrol for women with GDM, reommendations from the Fifth International Workshop-Conferene on Gestational Diabetes Mellitus (105) were to target maternal apillary gluose onentrations of: Position Statement preprandial: #95 mg/dl (5.3 mmol/l), and either: 1-h postmeal: #140 mg/dl (7.8 mmol/l) or 2-h postmeal: #120 mg/dl (6.7 mmol/l) For women with pre-existing type 1 or type 2 diabetes who beome pregnant, a reent onsensus statement (106) reommended the following as optimal glyemi goals, if they an be ahieved without exessive hypoglyemia: premeal, bedtime, and overnight gluose mg/dl ( mmol/l) peak postprandial gluose mg/dl ( mmol/l) A1C,6.0% D. Pharmaologial and overall approahes to treatment 1. Insulin therapy for type 1 diabetes Reommendations Most people with type 1 diabetes should be treated with MDI injetions (three to four injetions per day of basal and prandial insulin) or ontinuous subutaneous insulin infusion (CSII). (A) Most people with type 1 diabetes should be eduated in how to math prandial insulin dose to arbohydrate intake, premeal blood gluose, and antiipated ativity. (E) Most people with type 1 diabetes should use insulin analogs to redue hypoglyemia risk. (A) Consider sreening those with type 1 diabetes for other autoimmune diseases (thyroid, vitamin B12 defiieny, elia) as appropriate. (B) Table 9dSummary of glyemi reommendations for many nonpregnant adults with diabetes A1C,7.0%* Preprandial apillary plasma gluose mg/dl* ( mmol/l) Peak postprandial apillary plasma gluose,180 mg/dl* (,10.0 mmol/l) *Goals should be individualized based on: duration of diabetes age/life expetany omorbid onditions known CVD or advaned mirovasular ompliations hypoglyemia unawareness individual patient onsiderations More or less stringent glyemi goals may be appropriate for individual patients Postprandial gluose may be targeted if A1C goals are not met despite reahing preprandial gluose goals Postprandial gluose measurements should be made 1 2 h after the beginning of the meal, generally peak levels in patients with diabetes. The DCCT learly showed that intensive insulin therapy (three or more injetions per day of insulin, CSII, or insulin pump therapy) was a key part of improved glyemia and better outomes (71,92). At the time of the study, therapy was arried out with short- and intermediate-ating human insulins. Despite better mirovasular outomes, intensive insulin therapy was assoiated with a high rate in severe hypoglyemia (62 episodes per 100 patient-years of therapy). Sine the time of the DCCT, a number of rapid-ating and long-ating insulin analogs have been developed. These analogs are assoiated with less hypoglyemia with equal A1C lowering in type 1 diabetes (107,108). Reommended therapy for type 1 diabetes onsists of the following omponents: are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S21

22 Position Statement 1) use of MDI injetions (three to four injetions per day of basal and prandial insulin) or CSII therapy; 2) mathing of prandial insulin to arbohydrate intake, premeal blood gluose, and antiipated ativity; and 3) for most patients (espeially if hypoglyemia is a problem), use of insulin analogs. There are exellent reviews available that guide the initiation and management of insulin therapy to ahieve desired glyemi goals (107,109,110). Although most studies of MDI versus pump therapy have been small and of short duration, a systemati review and meta-analysis onluded that there were no systemati differenes in A1C or rates of severe hypoglyemia in hildren and adults between the two forms of intensive insulin therapy (70). Beause of the inreased frequeny of other autoimmune diseases in type 1 diabetes, sreening for thyroid dysfuntion, vitamin B12 defiieny, or elia disease should be onsidered based on signs and symptoms. Periodi sreening in absene of symptoms has been reommended, but the effetiveness and optimal frequeny are unlear. 2. Pharmaologial therapy for hyperglyemia in type 2 diabetes Reommendations Metformin, if not ontraindiated and if tolerated, is the preferred initial pharmaologial agent for type 2 diabetes. (A) In newly diagnosed type 2 diabeti patients with markedly symptomati and/or elevated blood gluose levels or A1C, onsider insulin therapy, with or without additional agents, from the outset. (E) If noninsulin monotherapy at maximal tolerated dose does not ahieve or maintain the A1C target over 3 6 months, add a seond oral agent, a gluagon-like peptide-1 (GLP-1) reeptor agonist, or insulin. (A) A patient-entered approah should be used to guide hoie of pharmaologial agents. Considerations inlude effiay, ost, potential side effets, effets on weight, omorbidities, hypoglyemia risk, and patient preferenes. (E) Due to the progressive nature of type 2 diabetes, insulin therapy is eventually indiated for many patients with type 2 diabetes. (B) The ADA and EASD have reently partnered on guidane for individualization of use of mediation lasses and ombinations in patients with type 2 diabetes (111). This 2012 position statement is less presriptive than prior algorithms and disusses advantages and disadvantages of the available mediation lasses and onsiderations for their use. A patient-entered approah is stressed, taking into aount patient preferenes, ost and potential side effets of eah lass, effets on body weight, and hypoglyemia risk. The position statement reaffirms metformin as the preferred initial agent, barring ontraindiation or intolerane, either in addition to lifestyle ounseling and support for weight loss and exerise, or when lifestyle efforts alone have not ahieved or maintained glyemi goals. Metformin has a long-standing evidene base for effiay and safety, is inexpensive, and may redue risk of ardiovasular events (85). When metformin fails to ahieve or maintain glyemi goals, another agent should be added. Although there are a number of trials omparing dual therapy to metformin alone, few diretly ompare drugs as add-on therapy. Comparative effetiveness meta-analyses (112) suggest that overall eah new lass of noninsulin agents added to initial therapy lowers A1C around %. Many patients with type 2 diabetes eventually benefit from insulin therapy. The progressive nature of type 2 diabetes and its therapies should regularly be explained in a matter-of-fat manner to patients, avoiding using insulin as a threat or desribing it as a failure or punishment. Providing patients with an algorithm for self-titration of insulin doses based on SMBG results improves glyemi ontrol in type 2 diabeti patients initiating insulin (113). For more details on pharmaotherapy for hyperglyemia in type 2 diabetes, inluding a table of information about urrently approved lasses of mediations for treating hyperglyemia in type 2 diabetes, readers are referred to the ADA-EASD position statement (111). E. MNT General reommendations Individuals who have prediabetes or diabetes should reeive individualized MNT as needed to ahieve treatment goals, preferably provided by a registered dietitian familiar with the omponents of diabetes MNT. (A) Beause MNT an result in ost-savings and improved outomes (B), MNT should be adequately overed by insurane and other payers. (E) Energy balane, overweight, and obesity Weight loss is reommended for all overweight or obese individuals who have or are at risk for diabetes. (A) For weight loss, either low-arbohydrate, low-fat alorie-restrited, or Mediterranean diets may be effetive in the shortterm (up to 2 years). (A) For patients on low-arbohydrate diets, monitor lipid profiles, renal funtion, and protein intake (in those with nephropathy) and adjust hypoglyemi therapy as needed. (E) Physial ativity and behavior modifiation are important omponents of weight loss programs and are most helpful in maintenane of weight loss. (B) Reommendations for primary prevention of type 2 diabetes Among individuals at high risk for developing type 2 diabetes, strutured programs that emphasize lifestyle hanges that inlude moderate weight loss (7% body weight) and regular physial ativity (150 min/week), with dietary strategies inluding redued alories and redued intake of dietary fat, an redue the risk for developing diabetes and are therefore reommended. (A) Individuals at risk for type 2 diabetes should be enouraged to ahieve the U.S. Department of Agriulture (USDA) reommendation for dietary fiber (14 g fiber/1,000 kal) and foods ontaining whole grains (one-half of grain intake). (B) Individuals at risk for type 2 diabetes should be enouraged to limit their intake of sugar-sweetened beverages (SSBs). (B) Reommendations for management of diabetes Maronutrients in diabetes management The mix of arbohydrate, protein, and fat may be adjusted to meet the metaboli goals and individual preferenes of the person with diabetes. (C) Monitoring arbohydrate, whether by arbohydrate ounting, hoies, or experiene-based estimation, remains a key strategy in ahieving glyemi ontrol. (B) Saturated fat intake should be,7% of total alories. (B) Reduing intake of trans fat lowers LDL holesterol and inreases HDL holesterol (A); therefore, intake of trans fat should be minimized. (E) S22 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

23 Other nutrition reommendations If adults with diabetes hoose to use alohol, they should limit intake to a moderate amount (one drink per day or less for adult women and two drinks per day or less for adult men) and should take extra preautions to prevent hypoglyemia. (E) Routine supplementation with antioxidants, suh as vitamins E and C and arotene, is not advised beause of lak of evidene of effiay and onern related to long-term safety. (A) It is reommended that individualized meal planning inlude optimization of food hoies to meet reommended dietary allowane (RDA)/dietary referene intake (DRI) for all mironutrients. (E) MNT is an integral omponent of diabetes prevention, management, and selfmanagement eduation. In addition to its role in preventing and ontrolling diabetes, the ADA reognizes the importane of nutrition as an essential omponent of an overall healthy lifestyle. A full review of the evidene regarding nutrition in preventing and ontrolling diabetes and its ompliations and additional nutrition-related reommendations an be found in the ADA position statement Nutrition Reommendations and Interventions for Diabetes (114), whih is being updated as of Ahieving nutrition-related goals requires a oordinated team effort that inludes the ative involvement of the person with prediabetes or diabetes. Beause of the omplexity of nutrition issues, it is reommended that a registered dietitian who is knowledgeable and skilled in implementing nutrition therapy into diabetes management and eduation be the team member who provides MNT. Clinial trials/outome studies of MNT have reported dereases in A1C at 3 6 months ranging from 0.25 to 2.9% with higher redutions seen in type 2 diabetes of shorter duration. Multiple studies have demonstrated sustained improvements in A1C at 12 months and longer when a registered dietitian provided follow-up visits ranging from monthly to 3 sessions per year ( ). Studies in nondiabeti individuals suggest that MNT redues LDL holesterol by mg/dl up to 16% (123) and support a role for lifestyle modifiation in treating hypertension (123,124). Although the importane of weight loss for overweight and obese individuals is well doumented, an optimal maronutrient distribution and dietary pattern of weight loss diets has not been established. A systemati review of 80 weight loss studies of $1-year duration demonstrated that moderate weight loss ahieved through diet alone, diet and exerise, and meal replaements an be ahieved and maintained (4.8 8% weight loss at 12 months) (125). Both low-fat low-arbohydrate and Mediterranean style eating patterns have been shown to promote weight loss with similar results after 1 to 2 years of followup ( ). A meta-analysis showed that at 6 months, low-arbohydrate diets were assoiated with greater improvements in triglyeride and HDL holesterol onentrations than low-fat diets; however, LDL holesterol was signifiantly higher on the low-arbohydrate diets (130). Beause of the effets of obesity on insulin resistane, weight loss is an important therapeuti objetive for overweight or obese individuals who are at risk for diabetes (131). The multifatorial intensive lifestyle intervention used in the DPP, whih inluded redued intake of fat and alories, led to weight loss averaging 7% at 6 months and maintenane of 5% weight loss at 3 years, assoiated with a 58% redution in inidene of type 2 diabetes (23). An RCT looking at high-risk individuals in Spain showed that the Mediterranean dietary pattern redued the inidene of diabetes in the absene of weight loss by 52% ompared with the low-fat ontrol group (132). Although our soiety abounds with examples of high-alorie nutrient-poor foods, large inreases in the onsumption of SSBs have oinided with the epidemis of obesity and type 2 diabetes. In a metaanalysis of eight prospetive ohort studies (n 5 310,819), a diet high in onsumption of SSBs was assoiated with the development of type 2 diabetes (n 5 15,043). Individuals in the highest versus lowest quantile of SSB intake had a 26% greater risk of developing diabetes (133). For individuals with type 2 diabetes, studies have demonstrated that moderate weight loss (5% of body weight) is assoiated with dereased insulin resistane, improved measures of glyemia and lipemia, and redued blood pressure (134); longerterm studies ($52 weeks) showed mixed effets on A1C in adults with type 2 diabetes ( ), and in some studies results were onfounded by pharmaologial weight loss therapy. Look AHEAD (Ation for Health in Diabetes) is a large linial trial designed to determine whether long-term weight loss will improve glyemia and prevent ardiovasular events in subjets with Position Statement type 2 diabetes. One-year results of the intensive lifestyle intervention in this trial show an average 8.6% weight loss, signifiant redution of A1C, and redution in several CVD risk fators (138), with benefits sustained at 4 years (139). At the time this artile was going to press, the Look AHEAD trial was halted early, after 11 years of follow-up, beause there was no signifiant differene in the primary ardiovasular outome between the weight loss and standard are group ( health/ot2012/niddk-19.htm). Multiple ardiovasular risk fators were improved with weight loss, and those partiipants on average were on fewer mediations to ahieve these improvements. Although numerous studies have attempted to identify the optimal mix of maronutrients for meal plans of people with diabetes, a reent systemati review (140) onfirms that there is no most effetive mix that applies broadly, and that maronutrient proportions should be individualized. It must be learly reognized that regardless of the maronutrient mix, total alori intake must be appropriate to weight management goal. Further, individualization of the maronutrient omposition will depend on the metaboli status of the patient (e.g., lipid profile, renal funtion) and/or food preferenes. A variety of dietary meal patterns are likely effetive in managing diabetes inluding Mediterranean-style, plant-based (vegan or vegetarian), low-fat and lower-arbohydrate eating patterns (127, ). It should be noted that the RDA for digestible arbohydrate is 130 g/day and is based on providing adequate gluose as the required fuel for the entral nervous system without reliane on gluose prodution from ingested protein or fat. Although brain fuel needs an be met on lower arbohydrate diets, long-term metaboli effets of very low-arbohydrate diets are unlear and suh diets eliminate many foods that are important soures of energy, fiber, vitamins, and minerals and are important in dietary palatability (144). Saturated and trans fatty aids are the prinipal dietary determinants of plasma LDL holesterol. There is a lak of evidene on the effets of speifi fatty aids on people with diabetes, so the reommended goals are onsistent with those for individuals with CVD (123,145). Reimbursement for MNT MNT, when delivered by a registered dietitian aording to nutrition pratie guidelines, is reimbursed as part of the are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S23

24 Position Statement Mediare program as overseen by the Centers for Mediare and Mediaid Servies (CMS), as well as many health insurane plans. F. Diabetes self-management eduation and support Reommendations People with diabetes should reeive DSME and diabetes self-management support (DSMS) aording to National Standards for Diabetes Self-Management Eduation and Support when their diabetes is diagnosed and as needed thereafter. (B) Effetive self-management and quality of life are the key outomes of DSME and DSMS and should be measured and monitored as part of are. (C) DSME and DSMS should address psyhosoial issues, sine emotional well-being is assoiated with positive diabetes outomes. (C) DSME and DSMS programs are appropriate venues for people with prediabetes to reeive eduation and support to develop and maintain behaviors that an prevent or delay the onset of diabetes. (C) Beause DSME and DSMS an result in ost-savings and improved outomes (B), DSME and DSMS should be adequately reimbursed by third-party payers. (E) DSME and DSMS are essential elements of diabetes are ( ), and reently updated National Standards for Diabetes Self-Management Eduation and Support (152) are based on evidene for its benefits. Eduation helps people with diabetes initiate effetive self-management and ope with diabetes when they are first diagnosed. Ongoing DSME and DSMS also help people with diabetes maintain effetive self-management throughout a lifetime of diabetes as they fae new hallenges and treatment advanes beome available. DSME helps patients optimize metaboli ontrol, prevent and manage ompliations, and maximize quality of life in a ost-effetive manner (153). DSME and DSMS are the ongoing proesses of failitating the knowledge, skill, and ability neessary for diabetes self-are. This proess inorporates the needs, goals, and life experienes of the person with diabetes. The overall objetives of DSME and DSMS are to support informed deision making, self-are behaviors, problem-solving, and ative ollaboration with the health are team to improve linial outomes, health status, and quality of life in a ost-effetive manner (152). Current best pratie of DSME is a skill-based approah that fouses on helping those with diabetes make informed self-management hoies. DSME has hanged from a didati approah fousing on providing information to more theoretially based empowerment models that fous on helping those with diabetes make informed self-management deisions. Care of diabetes has shifted to an approah that is more patient entered and plaes the person with diabetes and his or her family at the enter of the are model working in ollaboration with health are professionals. Patiententered are is respetful of and responsive to individual patient preferenes, needs, and values and ensures that patient values guide all deision making (154). Evidene for the benefits of DSME and DSMS Multiple studies have found that DSME is assoiated with improved diabetes knowledge and improved self-are behavior (146), improved linial outomes suh as lower A1C (147,148,150,151, ), lower self-reported weight (146), improved quality of life (149,156,159), healthy oping (160), and lower osts (161). Better outomes were reported for DSME interventions that were longer and inluded follow-up support (DSMS) (146, ), that were ulturally (166,167) and age appropriate (168,169) and were tailored to individual needs and preferenes, and that addressed psyhosoial issues and inorporated behavioral strategies (146,150,170,171). Both individual and group approahes have been found effetive (172,173). There is growing evidene for the role of ommunity health workers and peer ( ) and lay leaders (181) in delivering DSME and DSMS in onjuntion with the ore team (182). Diabetes eduation is assoiated with inreased use of primary and preventive servies (161,183) and lower use of aute, inpatient hospital servies (161). Patients who partiipate in diabetes eduation are more likely to follow best pratie treatment reommendations, partiularly among the Mediare population, and have lower Mediare and ommerial laim osts (184,185). The National Standards for Diabetes Self-Management Eduation and Support The National Standards for Diabetes Self- Management Eduation and Support are designed to define quality DSME and DSMS and to assist diabetes eduators in a variety of settings to provide evidenebased eduation and self-management support (152). The standards, reently updated, are reviewed and updated every 5 years by a task fore representing key organizations involved in the field of diabetes eduation and are. DSME and DSMS providers and people with prediabetes The new standards for DSME and DSMS also apply to the eduation and support of people with prediabetes. Currently, there are signifiant barriers to the provision of eduation and support to those with prediabetes. However, the strategies for supporting suessful behavior hange and the healthy behaviors reommended for people with prediabetes are largely idential to those for people with diabetes. As barriers to are are overome, providers of DSME and DSMS, given their training and experiene, are partiularly well equipped to assist people with prediabetes in developing and maintaining behaviors that an prevent or delay the onset of diabetes (152,186). Reimbursement for DSME and DSMS DSME, when provided by a program that meets national standards for DSME and is reognized by the ADA or other approval bodies, is reimbursed as part of the Mediare program as overseen by the CMS. DSME is also overed by most health insurane plans. Although DSMS has been shown to be instrumental for improving outomes, as desribed in the Evidene for the benefits of DSME and DSMS, and an be provided in formats suh as phone alls and via telehealth, it urrently has limited reimbursement as fae-to-fae visits inluded as follow-up to DSME. G. Physial ativity Reommendations Adults with diabetes should be advised to perform at least 150 min/week of moderate-intensity aerobi physial ativity (50 70% of maximum heart rate), spread over at least 3 days/week with no more than two onseutive days without exerise. (A) In the absene of ontraindiations, adults with type 2 diabetes should be enouraged to perform resistane training at least twie per week. (A) Exerise is an important part of the diabetes management plan. Regular exerise has been shown to improve blood S24 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

25 gluose ontrol, redue ardiovasular risk fators, ontribute to weight loss, and improve well-being. Furthermore, regular exerise may prevent type 2 diabetes in high-risk individuals (23 25). Strutured exerise interventions of at least 8 weeks duration have been shown to lower A1C by an average of 0.66% in people with type 2 diabetes, even with no signifiant hange in BMI (187). Higher levels of exerise intensity are assoiated with greater improvements in A1C and in fitness (188). A joint position statement of the ADA and the Amerian College of Sports Mediine (ACSM) summarizes the evidene for the benefits of exerise in people with type 2 diabetes (189). Frequeny and type of exerise The U.S. Department of Health and Human Servies Physial Ativity Guidelines for Amerians (190) suggest that adults over age 18 years do 150 min/week of moderate-intensity, or 75 min/week of vigorous aerobi physial ativity, or an equivalent ombination of the two. In addition, the guidelines suggest that adults also do musle-strengthening ativities that involve all major musle groups $2 days/ week. The guidelines suggest that adults over age 65 years, or those with disabilities, follow the adult guidelines if possible or (if this is not possible) be as physially ative as they are able. Studies inluded in the meta-analysis of effets of exerise interventions on glyemi ontrol (187) had a mean number of sessions per week of 3.4, with a mean of 49 min per session. The DPP lifestyle intervention, whih inluded 150 min/week of moderate-intensity exerise, had a benefiial effet on glyemia in those with prediabetes. Therefore, it seems reasonable to reommend that people with diabetes try to follow the physial ativity guidelines for the general population. Progressive resistane exerise improves insulin sensitivity in older men with type 2 diabetes to the same or even a greater extent as aerobi exerise (191). Clinial trials have provided strong evidene for the A1C lowering value of resistane training in older adults with type 2 diabetes (192,193) and for an additive benefit of ombined aerobi and resistane exerise in adults with type 2 diabetes (194,195). In the absene of ontraindiations, patients with type 2 diabetes should be enouraged to do at least two weekly sessions of resistane exerise (exerise with free weights or weight mahines), with eah session onsisting of at least one set of five or more different resistane exerises involving the large musle groups (189). Evaluation of the diabeti patient before reommending an exerise program Prior guidelines suggested that before reommending a program of physial ativity, the provider should assess patients with multiple ardiovasular risk fators for oronary artery disease (CAD). As disussed more fully in Setion VI.A.5, the area of sreening asymptomati diabeti patients for CAD remains unlear, and a reent ADA onsensus statement on this issue onluded that routine sreening is not reommended (196). Providers should use linial judgment in this area. Certainly, high-risk patients should be enouraged to start with short periods of low-intensity exerise and inrease the intensity and duration slowly. Providers should assess patients for onditions that might ontraindiate ertain types of exerise or predispose to injury, suh as unontrolled hypertension, severe autonomi neuropathy, severe peripheral neuropathy or history of foot lesions, and unstable proliferative retinopathy. The patient s ageandprevious physial ativity level should be onsidered. Exerise in the presene of nonoptimal glyemi ontrol Hyperglyemia. When people with type 1 diabetes are deprived of insulin for h and are ketoti, exerise an worsen hyperglyemia and ketosis (197); therefore, vigorous ativity should be avoided in the presene of ketosis. However, it is not neessary to postpone exerise based simply on hyperglyemia, provided the patient feels well and urine and/or blood ketones are negative. Hypoglyemia. In individuals taking insulin and/or insulin seretagogues, physial ativity an ause hypoglyemia if mediation dose or arbohydrate onsumption is not altered. For individuals on these therapies, added arbohydrate should be ingested if pre-exerise gluose levels are,100 mg/dl (5.6 mmol/l). Hypoglyemia is rare in diabeti individuals who are not treated with insulin or insulin seretagogues, and no preventive measures for hypoglyemia are usually advised in these ases. Exerise in the presene of speifi long-term ompliations of diabetes Retinopathy. In the presene of proliferative diabeti retinopathy (PDR) or severe Position Statement non-pdr (NPDR), vigorous aerobi or resistane exerise may be ontraindiated beause of the risk of triggering vitreous hemorrhage or retinal detahment (198). Peripheral neuropathy. Dereased pain sensation in the extremities results in inreased risk of skin breakdown and infetion and of Charot joint destrution. Prior reommendations have advised non weight-bearing exerise for patients with severe peripheral neuropathy. However, studies have shown that moderate-intensity walking may not lead to inreased risk of foot ulers or reuleration in those with peripheral neuropathy (199). All individuals with peripheral neuropathy should wear proper footwear and examine their feet daily to detet lesions early. Anyone with a foot injury or open sore should be restrited to non weight-bearing ativities. Autonomi neuropathy. Autonomi neuropathy an inrease the risk of exeriseindued injury or adverse event through dereased ardia responsiveness to exerise,posturalhypotension,impairedthermoregulation, impaired night vision due to impaired papillary reation, and unpreditable arbohydrate delivery from gastroparesis predisposing to hypoglyemia (200). Autonomi neuropathy is also strongly assoiated with CVD in people with diabetes (201,202). People with diabeti autonomi neuropathy should undergo ardia investigation before beginning physial ativity more intense than that to whih they are austomed. Albuminuria and nephropathy. Physial ativity an autely inrease urinary protein exretion. However, there is no evidene that vigorous exerise inreases the rate of progression of diabeti kidney disease, and there is likely no need for any speifi exerise restritions for people with diabeti kidney disease (203). H. Psyhosoial assessment and are Reommendations It is reasonable to inlude assessment of the patient s psyhologial and soial situation as an ongoing part of the medial management of diabetes. (E) Psyhosoial sreening and follow-up may inlude, but is not limited to, attitudes about the illness, expetations for medial management and outomes, affet/mood, general and diabetes-related quality of life, resoures (finanial, soial, and emotional), and psyhiatri history. (E) are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S25

26 Position Statement Sreen for psyhosoial problems suh as depression and diabetes-related distress, anxiety, eating disorders, and ognitive impairment when selfmanagement is poor. (B) It is important to establish that emotional well-being is part of diabetes are and selfmanagement. Psyhologial and soial problems an impair the individual s ( ) or family s ability to arry out diabetes are tasks and therefore ompromise health status. There are opportunities for the liniian to assess psyhosoial status in a timely and effiient manner so that referral for appropriate servies an be aomplished. A systemati review and meta-analysis showed that psyhosoial interventions modestly but signifiantly improved A1C (standardized mean differene 20.29%) and mental health outomes. However, there was a limited assoiation between the effets on A1C and mental health, and no intervention harateristis predited benefit on both outomes (208). Key opportunities for sreening of psyhosoial status our at diagnosis, during regularly sheduled management visits, during hospitalizations, at disovery of ompliations, or when problems with gluose ontrol, quality of life, or adherene are identified. Patients are likely to exhibit psyhologial vulnerability at diagnosis and when their medial status hanges (e.g., the end of the honeymoon period), when the need for intensified treatment is evident, and when ompliations are disovered (206). Depression affets about 20 25% of people with diabetes (207) and inreases the risk for MI and post-mi (209,210) and all-ause (211) mortality. Other issues known to impat self-management and health outomes inlude but are not limited to attitudes about the illness, expetations for medial management and outomes, affet/mood, general and diabetes-related quality of life, diabetes-related distress (212,213), resoures (finanial, soial, and emotional) (214), and psyhiatri history ( ). Sreening tools are available for a number of these areas (170). Indiations for referral to a mental health speialist familiar with diabetes management may inlude gross disregard for the medial regimen (by self or others) (217), depression, possibility of self-harm, debilitating anxiety (alone or with depression), indiations of an eating disorder (218), or ognitive funtioning that signifiantly impairs judgment. It is preferable to inorporate psyhologial assessment and treatment into routine are rather than waiting for identifiation of a speifi problem or deterioration in psyhologial status (170). Although the liniian may not feel qualified to treat psyhologial problems (219), utilizing the patientprovider relationship as a foundation an inrease the likelihood that the patient will aept referral for other servies. Collaborative are interventions and using a team approah have demonstrated effiay in diabetes and depression (220,221). I. When treatment goals are not met For a variety of reasons, some people with diabetes and their health are providers do not ahieve the desired goals of treatment (Table 9). Rethinking the treatment regimen may require assessment of barriers inluding inome, health literay, diabetes distress, depression, and ompeting demands, inluding those related to family responsibilities and dynamis. Other strategies may inlude ulturally appropriate and enhaned DSME and DSMS, o-management with a diabetes team, referral to a medial soial worker for assistane with insurane overage, or hange in pharmaologial therapy. Initiation of or inrease in SMBG, utilization of CGM, frequent ontat with the patient, or referral to a mental health professional or physiian with speial expertise in diabetes may be useful. J. Interurrent illness The stress of illness, trauma, and/or surgery frequently aggravates glyemi ontrol and may preipitate diabeti ketoaidosis (DKA) or nonketoti hyperosmolar statedlife-threatening onditions that require immediate medial are to prevent ompliations and death. Any ondition leading to deterioration in glyemi ontrol neessitates more frequent monitoring of blood gluose and (in ketosis-prone patients) urine or blood ketones. Marked hyperglyemia requires temporary adjustment of the treatment program and, if aompanied by ketosis, vomiting, or alteration in level of onsiousness, immediate interation with the diabetes are team. The patient treated with noninsulin therapies or MNT alone may temporarily require insulin. Adequate fluid and alori intake must be assured. Infetion or dehydration is more likely to neessitate hospitalization of the person with diabetes than the person without diabetes. The hospitalized patient should be treated by a physiian with expertise in the management of diabetes. For further information on management of patients with hyperglyemia in the hospital, see Setion IX.A. For further information on management of DKA or hyperglyemi nonketoti hyperosmolar state, refer to the ADA statement on hyperglyemi rises (222). K. Hypoglyemia Reommendations Individuals at risk for hypoglyemia should be asked about symptomati and asymptomati hypoglyemia at eah enounter. (C) Gluose (15 20 g) is the preferred treatment for the onsious individual with hypoglyemia, although any form of arbohydrate that ontains gluose may be used. If SMBG 15 min after treatment shows ontinued hypoglyemia, the treatment should be repeated. One SMBG gluose returns to normal, the individual should onsume a meal or snak to prevent reurrene of hypoglyemia. (E) Gluagon should be presribed for all individuals at signifiant risk of severe hypoglyemia, and aregivers or family members of these individuals should be instruted on its administration. Gluagon administration is not limited to health are professionals. (E) Hypoglyemia unawareness or one or more episodes of severe hypoglyemia should trigger re-evaluation of the treatment regimen. (E) Insulin-treated patients with hypoglyemia unawareness or an episode of severe hypoglyemia should be advised to raise their glyemi targets to stritly avoid further hypoglyemia for at least several weeks, to partially reverse hypoglyemia unawareness, and to redue risk of future episodes. (A) Ongoing assessment of ognitive funtion is suggested with inreased vigilane for hypoglyemia by the liniian, patient, and aregivers if low ognition and/or delining ognition is found. (B) Hypoglyemia is the leading limiting fator in the glyemi management of type 1 and insulin-treated type 2 diabetes (223). Mild hypoglyemia may be inonvenient or frightening to patients with diabetes, and more severe hypoglyemia an ause aute harm to the person with diabetes or others, if it auses falls, motor vehile S26 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

27 aidents, or other injury. A large ohort study suggested that among older adults with type 2 diabetes, a history of severe hypoglyemia was assoiated with greater risk of dementia (224). Conversely, in a substudy of the ACCORD trial, ognitive impairment at baseline or deline in ognitive funtion during the trial was signifiantly assoiated with subsequent episodes of severe hypoglyemia (225). Evidene from the DCCT/EDIC trial, whih involved younger adults and adolesents with type 1 diabetes, suggested no assoiation of frequeny of severe hypoglyemia with ognitive deline (226). As disussed in the Setion VIII.A.1.a, a few studies have suggested that severe hypoglyemia in very young hildren is assoiated with mild impairments in ognitive funtion. As desribed in the Setion V.b.2, severe hypoglyemia was assoiated with mortality in partiipants in both the standard and intensive glyemia arms of the ACCORD trial, but the relationships with ahieved A1C and treatment intensity were not straightforward. An assoiation of severe hypoglyemia with mortality was also found in the ADVANCE trial (227), but its assoiation with other outomes suh as pulmonary and skin disorders raises the question of whether severe hypoglyemia is a marker for a siker patient, rather than a ause of mortality. An assoiation of self-reported severe hypoglyemia with 5-year mortality has also been reported in linial pratie (228). At the time this statement went to press, the ADA and The Endorine Soiety were finalizing a Hypoglyemia Work Group report, where the auses of and assoiations with hypoglyemia are disussed in depth. Treatment of hypoglyemia (plasma gluose,70 mg/dl) requires ingestion of gluose- or arbohydrate-ontaining foods. The aute glyemi response orrelates better with the gluose ontent than with the arbohydrate ontent of the food. Although pure gluose is the preferred treatment, any form of arbohydrate that ontains gluose will raise blood gluose. Added fat may retard and then prolong the aute glyemi response. Ongoing ativity of insulin or insulin seretagogues may lead to reurrene of hypoglyemia unless further food is ingested after reovery. Severe hypoglyemia (where the individual requires the assistane of another person and annot be treated with oral arbohydrate due to onfusion or unonsiousness) should be treated using emergeny gluagon kits, whih require a presription. Those in lose ontat with, or having ustodial are of, people with hypoglyemia-prone diabetes (family members, roommates, shool personnel, hild are providers, orretional institution staff, or oworkers) should be instruted in use of suh kits. An individual does not need to be a health are professional to safely administer gluagon. Care should be taken to ensure that unexpired gluagon kits are available. Prevention of hypoglyemia is a ritial omponent of diabetes management. Partiularly for insulin-treated patients, SMBG and, for some patients, CGM to detet inipient hypoglyemia and assess adequay of treatment are a key omponent of safe therapy. Patients should understand situations that inrease their risk of hypoglyemia, suh as when fasting for tests or proedures, during or after intense exerise, and during sleep and that inrease the risk of harm to self or others from hypoglyemia, suh as with driving. Teahing people with diabetes to balane insulin use, arbohydrate intake, and exerise is a neessary but not always suffiient strategy for prevention. In type 1 diabetes and severely insulin-defiient type 2 diabetes, the syndrome of hypoglyemia unawareness, or hypoglyemiaassoiated autonomi failure, an severely ompromise stringent diabetes ontrol and quality of life. The defiient ounterregulatory hormone release and autonomi responses in this syndrome are both risk fators for, and aused by, hypoglyemia. A orollary to this viious yle is that several weeks of avoidane of hypoglyemia has been demonstrated to improve ounter-regulation and awareness to some extent in many patients (229). Hene, patients with one or more episodes of severe hypoglyemia may benefit from at least short-term relaxation of glyemi targets. L. Bariatri surgery Reommendations Bariatri surgery may be onsidered for adults with BMI $35 kg/m 2 and type 2 diabetes, espeially if the diabetes or assoiated omorbidities are diffiult to ontrol with lifestyle and pharmaologial therapy. (B) Patients with type 2 diabetes who have undergone bariatri surgery need lifelong lifestyle support and medial monitoring. (B) Position Statement Although small trials have shown glyemi benefit of bariatri surgery in patients with type 2 diabetes and BMI kg/m 2, there is urrently insuffiient evidene to generally reommend surgery in patients with BMI,35 kg/m 2 outside of a researh protool. (E) The long-term benefits, ost-effetiveness, and risks of bariatri surgery in individuals with type 2 diabetes should be studied in well-designed ontrolled trials with optimal medial and lifestyle therapy as the omparator. (E) Gastri redution surgery, either gastri banding or proedures that involve bypassing, transposing, or reseting setions of the small intestine, when part of a omprehensive team approah, an be an effetive weight loss treatment for severe obesity, and national guidelines support its onsideration for people with type 2 diabetes who have BMI of 35 kg/m 2 or greater. Bariatri surgery has been shown to lead to near- or omplete normalization of glyemia in ;40 95% of patients with type 2 diabetes, depending on the study and the surgial proedure ( ). A meta-analysis of studies of bariatri surgery involving 3,188 patients with diabetes reported that 78% had remission of diabetes (normalization of blood gluose levels in the absene of mediations) and that the remission rates were sustained in studies that had followup exeeding 2 years (233). Remission rates tend to be lower with proedures that only onstrit the stomah and higher with those that bypass portions of the small intestine. Additionally, there is a suggestion that intestinal bypass proedures may have glyemi effets that are independent of their effets on weight, perhaps involving the inretin axis. There is also evidene for diabetes remission in subjets who are less obese. One randomized trial ompared adjustable gastri banding to best available medial and lifestyle therapy in subjets with type 2 diabetes and BMI kg/m 2 (234). Overall, 73% of surgially treated patients ahieved remission of their diabetes ompared with 13% of those treated medially. The latter group lost only 1.7% of body weight, suggesting that their therapy was not optimal. Overall the trial had 60 subjets, and only 13 had a BMI under 35 kg/m 2, making it diffiult to generalize these results widely to diabeti patients who are less severely obese or with longer duration of diabetes. are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S27

28 Position Statement In a reent nonrandomized study of 66 people with BMI of kg/m 2,88% of partiipants had remission of their type 2 diabetes up to 6 years after surgery (235). Bariatri surgery is ostly in the shortterm and has some risks. Rates of morbidity and mortality diretly related to the surgery have been redued onsiderably in reent years, with 30-day mortality rates now 0.28%, similar to those of laparosopi holeystetomy (236). Longer-term onerns inlude vitamin and mineral defiienies, osteoporosis, and rare but often severe hypoglyemia from insulin hyperseretion. Cohort studies attempting to math subjets suggest that the proedure may redue longer-term mortality rates (237). Reent retrospetive analyses and modeling studies suggest that these proedures may be ost-effetive, when one onsiders redution in subsequent health are osts ( ). Some aution about the benefits of bariatri surgery might ome from reent studies. Propensity sore adjusted analyses of older severely obese patients with high baseline mortality in Veterans Affairs Medial Centers found that the use of bariatri surgery was not assoiated with dereased mortality ompared with usual are during a mean 6.7 years of follow-up (241). A study that followed patients who had undergone laparosopi adjustable gastri banding (LAGB) for 12 years found that 60% were satisfiedwiththe proedure. Nearly one out of three patients experiened band erosion, and almost half required removal of their bands. The authors onlusion was that LAGB appears to result in relatively poor long-term outomes (242). Studies of the mehanisms of glyemi improvement and long-term benefits and risks of bariatri surgery in individuals with type 2 diabetes, espeially those who are not severely obese, will require well-designed linial trials, with optimal medial and lifestyle therapy of diabetes and ardiovasular risk fators as the omparator. M. Immunization Reommendations Annually provide an influenza vaine to all diabeti patients $6 months of age. (C) Administer pneumooal polysaharide vaine to all diabeti patients $2 years of age. A one-time revaination is reommended for individuals.64 years of age previously immunized when they were,65 years of age if the vaine was administered.5 years ago. Other indiations for repeat vaination inlude nephroti syndrome, hroni renal disease, and other immunoompromised states, suh as after transplantation. (C) Administer hepatitis B vaination to unvainated adults with diabetes who are aged 19 through 59 years. (C) Consider administering hepatitis B vaination to unvainated adults with diabetes who are aged $60 years. (C) Influenza and pneumonia are ommon, preventable infetious diseases assoiated with high mortality and morbidity in the elderly and in people with hroni diseases. Though there are limited studies reporting the morbidity and mortality of influenza and pneumooal pneumonia speifially in people with diabetes, observational studies of patients with a variety of hroni illnesses, inluding diabetes, show that these onditions are assoiated with an inrease in hospitalizations for influenza and its ompliations. People with diabetes may be at inreased risk of the bateremi form of pneumooal infetion and have been reported to have a high risk of nosoomial bateremia, whih has a mortality rate as high as 50% (243). Safe and effetive vaines are available that an greatly redue the risk of serious ompliations from these diseases (244,245). In a ase-ontrol series, influenza vaine was shown to redue diabetes-related hospital admission by as muh as 79% during flu epidemis (244). There is suffiient evidene to support that people with diabetes have appropriate serologial and linial responses to these vainations. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Praties reommends influenza and pneumooal vaines for all individuals with diabetes ( gov/vaines/res/). Late in 2012, the Advisory Committee on Immunization Praties of the CDC reommended that all previously unvainated adults with diabetes aged 19 through 59 years be vainated against hepatitis B virus (HBV) as soon as possible after a diagnosis of diabetes is made and that vaination be onsidered for those aged $60 years, after assessing risk and likelihood of an adequate immune response (246). At least 29 outbreaks of HBV in long-term are failities and hospitals have been reported to the CDC, with the majority involving adults with diabetes reeiving assisted blood gluose monitoring, in whih suh monitoring is done by a health are professional with responsibility for more than one patient. HBV is highly transmissible and stable for long periods of time on surfaes suh as laning devies and blood gluose meters, even when no blood is visible. Blood suffiient to transmit the virus has also been found in the reservoirs of insulin pens, resulting in warnings against sharing suh devies between patients. The CDC analyses suggest that, exluding persons with HBV-related risk behaviors, aute HBV infetion is about twie as high among adults with diabetes aged $23 years ompared with adults without diabetes. Seroprevalene of antibody to HBV ore antigen, suggesting past or urrent infetion, is 60% higher among adults with diabetes than those without, and there is some evidene that diabetes imparts a higher HBV ase fatality rate. The age differentiation in the reommendations stems from CDC eonomi models suggesting that vaination of adults with diabetes who were aged 20 59years would ost an estimated $75,000 per quality-adjusted life-year saved, while ost per quality-adjusted life-year saved inreased signifiantly at higher ages. In addition to ompeting auses of mortality in older adults, the immune response to the vaine delines with age (246). These new reommendations regarding HBV vainations serve as a reminder to liniians that hildren and adults with diabetes need a number of vainations, both those speifially indiated beause of diabetes as well as those reommended for the general population ( d.gov/vaines/res/). VI. PREVENTION AND MANAGEMENT OF DIABETES COMPLICATIONS A. CVD CVD is the major ause of morbidity and mortality for individuals with diabetes and the largest ontributor to the diret and indiret osts of diabetes. The ommon onditions oexisting with type 2 diabetes (e.g., hypertension and dyslipidemia) are lear risk fators for CVD, and diabetes itself onfers independent risk. Numerous studies have shown the effiay of ontrolling individual ardiovasular risk fators in preventing or slowing CVD in S28 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

29 people with diabetes. Large benefits are seen when multiple risk fators are addressed globally (247,248). There is evidene that measures of 10-year oronary heart disease (CHD) risk among U.S. adults with diabetes have improved signifiantly over the past deade (249). 1. Hypertension/blood pressure ontrol Reommendations Sreening and diagnosis Blood pressure should be measured at every routine visit. Patients found to have elevated blood pressure should have blood pressure onfirmed on a separate day. (B) Goals People with diabetes and hypertension should be treated to a systoli blood pressure goal of,140 mmhg. (B) Lower systoli targets, suh as,130 mmhg, may be appropriate for ertain individuals, suh as younger patients, if it an be ahieved without undue treatment burden. (C) Patients with diabetes should be treated to a diastoli blood pressure,80 mmhg. (B) Treatment Patients with a blood pressure.120/ 80 mmhg should be advised on lifestyle hanges to redue blood pressure. (B) Patients with onfirmed blood pressure $140/80 mmhg should, in addition to lifestyle therapy, have prompt initiation and timely subsequent titration of pharmaologial therapy to ahieve blood pressure goals. (B) Lifestyle therapy for elevated blood pressure onsists of weight loss, if overweight; Dietary Approahes to Stop Hypertension (DASH)-style dietary pattern inluding reduing sodium and inreasing potassium intake; moderation of alohol intake; and inreased physial ativity. (B) Pharmaologial therapy for patients with diabetes and hypertension should be with a regimen that inludes either an ACE inhibitor or an angiotensin reeptor bloker (ARB). If one lass is not tolerated, the other should be substituted. (C) Multiple-drug therapy (two or more agents at maximal doses) is generally required to ahieve blood pressure targets. (B) Administer one or more antihypertensive mediations at bedtime. (A) If ACE inhibitors, ARBs, or diuretis are used, serum reatinine/estimated glomerular filtration rate (egfr) and serum potassium levels should be monitored. (E) In pregnant patients with diabetes and hroni hypertension, blood pressure target goals of /65 79 mmhg are suggested in the interest of longterm maternal health and minimizing impaired fetal growth. ACE inhibitors and ARBs are ontraindiated during pregnany. (E) Hypertension is a ommon omorbidity of diabetes, affeting the majority of patients, with prevalene depending on type of diabetes, age, obesity, and ethniity. Hypertension is a major risk fator for both CVD and mirovasular ompliations. In type 1 diabetes, hypertension is often the result of underlying nephropathy, while in type 2 diabetes it usually oexists with other ardiometaboli risk fators. Sreening and diagnosis Measurement of blood pressure in the offie should be done by a trained individual and follow the guidelines established for nondiabeti individuals: measurement in the seated position, with feet on the floor and arm supported at heart level, after 5 min of rest. Cuff size should be appropriate for the upper arm irumferene. Elevated values should be onfirmed on a separate day. Home blood pressure self-monitoring and 24-h ambulatory blood pressure monitoring may provide additional evidene of white oat and masked hypertension and other disrepanies between offie and true blood pressure. Studies in nondiabeti populations found that home measurements may better orrelate with CVD risk than offie measurements (250,251). However, the preponderane of the evidene of benefits of treatment of hypertension in people with diabetes is basedonoffie measurements. Treatment goals Epidemiologial analyses show that blood pressure.115/75 mmhg is assoiated with inreased ardiovasular event rates and mortality in individuals with diabetes ( ) and that systoli blood pressure above 120 mmhg predits long-term end-stage renal disease (ESRD). Randomized linial trials have demonstrated the benefit (redution of CHD events, stroke, and nephropathy) of lowering blood Position Statement pressure to,140 mmhg systoli and,80 mmhg diastoli in individuals with diabetes (252, ). Theevidene for benefits from lower systoli blood pressure targets is, however, limited. The ACCORD trial examined whether blood pressure lowering to systoli blood pressure,120 mmhg provides greater ardiovasular protetion thanasystolibloodpressurelevelof mmhg in patients with type 2 diabetes at high risk for CVD (258). The blood pressure ahieved in the intensive group was 119/64 mmhg and in the standard group 133/70 mmhg; the goals were attained with an average of 3.4 mediations per partiipant in the intensive group and 2.1 in the standard therapy group. The hazard ratio for the primary end point (nonfatal MI, nonfatal stroke, and CVD death) in the intensive group was 0.88 (95% CI , P ). Of the prespeified seondaryend points, only stroke and nonfatal stroke were statistially signifiantly redued by intensive blood pressure treatment, with a hazard ratio of 0.59 (95% CI , P ) and 0.63 (95% CI , P ), respetively. Absolute stroke event rates were low; the number needed to treat to prevent one stroke over the ourse of 5 years with intensive blood pressure management is 89. Serious adverse event rates (inluding synope and hyperkalemia) were higher with intensive targets (3.3% vs. 1.3%, P ). Rates of albuminuria were redued with more intensive blood pressure goals, but there were no differenes in renal funtion in this 5-year trial (and in fat more adverse events related to redued egfr with more intensive goals) nor in other mirovasular ompliations. Other reent randomized trial data inlude those of the ADVANCE trial in whih treatment with an ACE inhibitor and a thiazide-type diureti redued the rate of death but not the omposite marovasular outome. However, the ADVANCE trial had no speified targets for the randomized omparison, and the mean systoli blood pressure in the intensive group (135 mmhg) was not as low as the mean systoli blood pressure even in the ACCORD standard-therapy group (259). Post ho analysis of ahieved blood pressure in several hypertension treatment trials has suggested no benefit of lower ahieved systoli blood pressure. As an example, among 6,400 patients with diabetes and CAD enrolled in one trial, tight ontrol (ahieved systoli are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S29

30 Position Statement blood pressure,130mmhg) wasnotassoiated with improved ardiovasular outomes ompared with usual are (ahieved systoli blood pressure mmhg) (260). Similar finding emerged from an analysis of another trial, but additionally those with ahieved systoli blood pressure (,115 mmhg) had inreased rates of CVD events (though lower rates of stroke) (261). Observational data, inluding those derived from linial trials, may be inappropriate to use for defining blood pressure targets sine siker patients may have low blood pressure or, onversely, healthier or more adherent patients may ahieve goals more readily. A reent meta-analysis of randomized trials of adults with type 2 diabetes omparing prespeified blood pressure targets found no signifiant redution in mortality or nonfatal MI. There was a statistially signifiant 35% relative redution in stroke, but the absolute risk redution was only 1% (262). Other outomes, suh as indiators of mirovasular ompliations, were not examined. Another meta-analysis that inluded both trials omparing blood pressure goals and trials omparing treatment strategies onluded that a systoli treatment goal of mmhg was aeptable. With goals,130 mmhg, there were greater redutions in stroke, a 10% redution in mortality, but no redution of other CVD events and inreased rates of serious adverse events. Systoli blood pressure,130 mmhg was assoiated with redued onset and progression of albuminuria. However, there was heterogeneity in the measure, rates of more advaned renal disease outomes were not affeted, and there were no signifiant hanges in retinopathy or neuropathy (263). This hange in the default systoli blood pressure target is not meant to downplay the importane of treating hypertension in patients with diabetes or to imply that lower targets than,140 mmhg are generally inappropriate. The lear body of evidene that systoli blood pressure over 140 mmhg is harmful suggests that liniians should promptly initiate and titrate therapy in an ongoing fashion to ahieve and maintain systoli blood pressure below 140 mmhg in virtually all patients. Additionally, patients with long life expetany (in whom there may be renal benefits from long-term striter blood pressure ontrol) or those in whom stroke risk is a onern might, as part of shared deision making, appropriately have lower systoli targets suh as,130 mmhg. This would espeially be the ase if this an be ahieved with few drugs and without side effets of therapy. Treatment strategies Although there are no well-ontrolled studies of diet and exerise in the treatment of elevated blood pressure or hypertension in individuals with diabetes, the DASH study in nondiabeti individuals has shown antihypertensive effets similar to pharmaologial monotherapy. Lifestyle therapy onsists of reduing sodium intake (to below 1,500 mg/day) and exess body weight; inreasing onsumption of fruits, vegetables (8 10 servings per day), and low-fat dairy produts (2 3 servings per day); avoiding exessive alohol onsumption (no more than two servings per day for men and no more than one serving per day for women) (264); and inreasing ativity levels (252). These nonpharmaologial strategies may also positively affet glyemia and lipid ontrol and as a result should be enouraged in those with even mildly elevated blood pressure. Their effets on ardiovasular events have not been established. Nonpharmaologial therapy is reasonable in diabeti individuals with mildly elevated blood pressure (systoli blood pressure.120 mmhg or diastoli blood pressure.80 mmhg). If the blood pressure is onfirmed to be $140 mmhg systoli and/or $80 mmhg diastoli, pharmaologial therapy should be initiated along with nonpharmaologial therapy (252). Lowering of blood pressure with regimens based on a variety of antihypertensive drugs, inluding ACE inhibitors, ARBs, b-blokers, diuretis, and alium hannel blokers, has been shown to be effetive in reduing ardiovasular events. Several studies suggested that ACE inhibitors may be superior to dihydropyridine alium hannel blokers in reduing ardiovasular events ( ). However, a variety of other studies have shown no speifi advantage to ACE inhibitors as initial treatment of hypertension in the general hypertensive population, but rather an advantage on ardiovasular outomes of initial therapy with low-dose thiazide diuretis (252,268,269). In people with diabetes, inhibitors of the renin-angiotensin system (RAS) may have unique advantages for initial or early therapy of hypertension. In a nonhypertension trial of high-risk individuals, inluding a large subset with diabetes, an ACE inhibitor redued CVD outomes (270). In patients with ongestive heart failure (CHF), inluding diabeti subgroups, ARBs have been shown to redue major CVD outomes ( ), and in type 2 diabeti patients with signifiant nephropathy, ARBs were superior to alium hannel blokers for reduing heart failure (275). Though evidene for distint advantages of RAS inhibitors on CVD outomes in diabetes remains onfliting (255,269), the high CVD risks assoiated with diabetes, and the high prevalene of undiagnosed CVD, may still favor reommendations for their use as first-line hypertension therapy in people with diabetes (252). Reently, the blood pressure arm of the ADVANCE trial demonstrated that routine administration of a fixed ombination of the ACE inhibitor perindopril and the diureti indapamide signifiantly redued ombined mirovasular and marovasular outomes, as well as CVD and total mortality. The improved outomes ould also have been due to lower ahieved blood pressure in the perindopril-indapamide arm (259). Another trial showed a derease in morbidity and mortality in those reeiving benazepril and amlodipine ompared with benazepril and hydrohlorothiazide (HCTZ). The ompelling benefits of RAS inhibitors in diabeti patients with albuminuria or renal insuffiieny provide additional rationale for use of these agents (see Setion VI.B). If needed to ahieve blood pressure targets, amlodipine, HCTZ, or hlorthalidone an be added. If egfr is,30 ml/ min/m 2, a loop diureti rather than HCTZ or hlorthalidone should be presribed. Titration of and/or addition of further blood pressure mediations should be made in timely fashion to overome linial inertia in ahieving blood pressure targets. Evidene is emerging that health information tehnology an be used safely and effetively as a tool to enable attainment of blood pressure goals. Using a telemonitoring intervention to diret titrations of antihypertensive mediations between medial offie visits has been demonstrated to have a profound impat on systoli blood pressure ontrol (276). An important aveat is that most patients with hypertension require multiple-drug therapy to reah treatment goals (252). Identifying and addressing barriers to mediation adherene (suh as ost and side effets) should routinely S30 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

31 be done. If blood pressure is refratory despite onfirmed adherene to optimal doses of at least three antihypertensive agents of different lassifiations, one of whih should be a diureti, liniians should onsider an evaluation for seondary forms of hypertension. Growing evidene suggests that there is an assoiation between inrease in sleep-time blood pressure and inidene of CVD events. A reent RCT of 448 partiipants with type 2 diabetes and hypertension demonstrated redued ardiovasular events and mortality with median follow-up of 5.4 years if at least one antihypertensive mediation was given at bedtime (277). During pregnany in diabeti women with hroni hypertension, target blood pressure goals of systoli blood pressure mmhg and diastoli blood pressure mmhg are reasonable, as they ontribute to long-term maternal health. Lower blood pressure levels may be assoiated with impaired fetal growth. During pregnany, treatment with ACE inhibitors and ARBs is ontraindiated beause they an ause fetal damage. Antihypertensive drugs known to be effetive and safe in pregnany inlude methyldopa, labetalol, diltiazem, lonidine, and prazosin. Chroni diureti use during pregnany has been assoiated with restrited maternal plasma volume, whih might redue uteroplaental perfusion (278). 2. Dyslipidemia/lipid management Reommendations Sreening In most adult patients with diabetes, measure fasting lipid profile at least annually. (B) In adults with low-risk lipid values (LDL holesterol,100 mg/dl, HDL holesterol.50 mg/dl, and triglyerides,150 mg/dl), lipid assessments may be repeated every 2 years. (E) Treatment reommendations and goals Lifestyle modifiation fousing on the redution of saturated fat,trans fat, and holesterol intake; inrease of n-3 fatty aids, visous fiber, and plant stanols/ sterols; weight loss (if indiated); and inreased physial ativity should be reommended to improve the lipid profile in patients with diabetes. (A) Statin therapy should be added to lifestyle therapy, regardless of baseline lipid levels, for diabeti patients: with overt CVD (A) without CVD who are over the age of 40 years and have one or more other CVD risk fators (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria) (A) For lower-risk patients than the above (e.g., without overt CVD and under the age of 40 years), statin therapy should be onsidered in addition to lifestyle therapy if LDL holesterol remains above 100 mg/dl or in those with multiple CVD risk fators. (C) In individuals without overt CVD, the goal is LDL holesterol,100 mg/dl (2.6 mmol/l). (B) In individuals with overt CVD, a lower LDL holesterol goal of,70 mg/dl (1.8 mmol/l), using a high dose of a statin, is an option. (B) If drug-treated patients do not reah the above targets on maximal tolerated statin therapy, a redution in LDL holesterol of ;30 40% from baseline is an alternative therapeuti goal. (B) Triglyerides levels,150 mg/dl (1.7 mmol/l) and HDL holesterol.40 mg/dl (1.0 mmol/l) in men and.50 mg/dl (1.3 mmol/l) in women are desirable (C). However, LDL holesterol targeted statin therapy remains the preferred strategy. (A) Combination therapy has been shown not to provide additional ardiovasular benefit above statin therapy alone and is not generally reommended. (A) Statin therapy is ontraindiated in pregnany. (B) Evidene for benefits of lipid-lowering therapy Patients with type 2 diabetes have an inreased prevalene of lipid abnormalities, ontributing to their high risk of CVD. Multiple linial trials demonstrated signifianteffets ofpharmaologial (primarily statin) therapy on CVD outomes in subjets with CHD and for primary CVD prevention (279,280). Subanalyses of diabeti subgroups of larger trials ( ) and trials speifially in subjets with diabetes (286,287) showed signifiant primary and seondary prevention of CVD events 1/2 CHD deaths in diabeti populations. Meta-analyses inluding data from over 18,000 patients with diabetes from 14 randomized trials of statin therapy, followed for a mean of 4.3 years, demonstrate a 9% proportional redution in all-ause mortality and 13% redution in vasular mortality, for eah mmol/l redution in LDL holesterol (288). As is the ase in nondiabeti individuals, absolute redutions in hard CVD outomes (CHD death and nonfatal Position Statement MI) are greatest in people with high baseline CVD risk (known CVD and/or very high LDL holesterol levels), but overall the benefits of statin therapy in people with diabetes at moderate or high risk for CVD are onvining. There is an inreased risk of inident diabetes with statin use (289,290), whih may be limited to those with risk fators for diabetes. These patients may benefit additionally from diabetes sreening when on statin therapy. In an analysis of one of the initial studies suggesting that statins are linked to risk of diabetes, the ardiovasular event rate redution with statins outweighed the risk of inident diabetes even for patients at highest risk for diabetes. The absolute risk inrease was small (over 5 years of follow-up, 1.2% of partiipants on plaebo developed diabetes and 1.5% on rosuvastatin) (291). The relative risk-benefit ratio favoring statins is further supported by meta-analysis of individual data of over 170,000 persons from 27 randomized trials. This demonstrated that individuals at low risk of vasular disease, inluding those undergoing primary prevention, reeived benefits from statins that inluded redutions in major vasular events and vasular death without inrease in inidene of aner or deaths from other auses (280). Low levels of HDL holesterol, often assoiated with elevated triglyeride levels, are the most prevalent pattern of dyslipidemia in persons with type 2 diabetes. However, the evidene base for drugs that target these lipid frations is signifiantly less robust than that for statin therapy (292). Niotini aid has been shown to redue CVD outomes (293), although the study was done in a nondiabeti ohort. Gemfibrozil has been shown to derease rates of CVD events in subjets without diabetes (294,295) and in the diabeti subgroup of one of the larger trials (294). However, in a large trial speifi todiabetipatients,fenofibrate failed to redue overall ardiovasular outomes (296). Combination therapy, with a statin and a fibrate or statin and niain, may be effiaious for treatment for all three lipid frations, but this ombination is assoiated with an inreased risk for abnormal transaminase levels, myositis, or rhabdomyolysis. The risk of rhabdomyolysis is higher with higher doses of statins and with renal insuffiieny and seems to be lower when statins are ombined with fenofibrate than gemfibrozil (297). In the ACCORD study, the ombination of are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S31

32 Position Statement fenofibrate and simvastatin did not redue the rate of fatal ardiovasular events, nonfatal MI, or nonfatal stroke, as ompared with simvastatin alone, in patients with type 2 diabetes who were at high risk for CVD. Prespeified subgroup analyses suggested heterogeneity in treatment effets aording to sex, with a benefit of ombination therapy for men and possible harm for women, and a possible benefit for patients with both triglyeride level $204 mg/dl and HDL holesterol level #34 mg/dl (298). The AIM-HIGH trial randomized over 3,000 patients (about one-third with diabetes) with established CVD, low levels of HDL holesterol, and triglyeride levels of mg/dl to statin therapy plus extended release niain or mathing plaebo. The trial was halted early due to lak of effiay on the primary CVD outome and a possible inrease in ishemi stroke in those on ombination therapy (299). Hene, ombination lipid-lowering therapy annot be broadly reommended. Dyslipidemia treatment and target lipid levels For most patients with diabetes, the first priority of dyslipidemia therapy (unless severe hypertriglyeridemia with risk of panreatitis is the immediate issue) is to lower LDL holesterol to a target goal of,100 mg/dl (2.60 mmol/l) (300). Lifestyle intervention, inluding MNT, inreased physial ativity, weight loss, and smoking essation, may allow some patients to reah lipid goals. Nutrition intervention should be tailored aording to eah patient s age, type of diabetes, pharmaologial treatment, lipid levels, and other medial onditions and should fous on the redution of saturated fat, holesterol, and trans unsaturated fat intake and inreases in n-3 fatty aids, visous fiber (suh as in oats, legumes, itrus), and plant stanols/sterols. Glyemi ontrol an also benefiially modify plasma lipid levels, partiularly in patients with very high triglyerides and poor glyemi ontrol. In those with linial CVD or over age 40 years with other CVD risk fators, pharmaologial treatment should be added to lifestyle therapy regardless of baseline lipid levels. Statins are the drugs of hoie for LDL holesterol lowering and ardioprotetion. In patients other than those desribed above, statin treatment should be onsidered if there is an inadequate LDL holesterol response to lifestyle modifiations and improved gluose ontrol, or if the patient has inreased ardiovasular risk (e.g., multiple ardiovasular risk fators or long duration of diabetes). Very little linial trial evidene exists for type 2 diabeti patients under the age 40 years, or for type 1 diabeti patients of any age. In the Heart Protetion Study (lower age limit 40 years), the subgroup of ;600 patients with type 1 diabetes had a redution in risk proportionately similar to that of patients with type 2 diabetes, although not statistially signifiant (282). Although the data are not definitive, onsideration should be given to similar lipid-lowering goals in type 1 diabeti patients as in type 2diabetipatients,partiularly if they have other ardiovasular risk fators. Alternative lipoprotein goals Virtually all trials of statins and CVD outome tested speifi doses of statins against plaebo, other doses of statin, or other statins, rather than aiming for speifi LDL holesterol goals (301). Plaeboontrolled trials generally ahieved LDL holesterol redutions of 30 40% from baseline. Hene, LDL holesterol lowering of this magnitude is an aeptable outome for patients who annot reah LDL holesterol goals due to severe baseline elevations in LDL holesterol and/or intolerane of maximal, or any, statin doses. Additionally for those with baseline LDL holesterol minimally above 100 mg/dl, presribing statin therapy to lower LDL holesterol about 30 40% from baseline is probably more effetive than presribing just enough to get LDL holesterol slightly below 100 mg/dl. Clinial trials in high-risk patients, suh as those with aute oronary syndromes or previous ardiovasular events ( ), have demonstrated that more aggressive therapy with high doses of statins to ahieve an LDL holesterol of,70 mg/dl led to a signifiant redution in further events. Therefore, a redution in LDL holesterol to a goal of,70 mg/dl is an option in very high-risk diabeti patients with overt CVD (305). Some experts reommend a greater fous on non HDL holesterol, apolipoprotein B (apob), or lipoprotein partile measurementstoassessresidualcvdriskin statin-treated patients who are likely to have small LDL partiles, suh as people with diabetes (306), but it is unlear whether linial management would hange with these measurements. In individual patients, LDL holesterol lowering with statins is highly variable, and this variable response is poorly understood (307). Redution of CVD events with statins orrelates very losely with LDL holesterol lowering (279). If initial attempts to presribe a statin leads to side effets, liniians should attempt to find a dose or alternative statin that the patient an tolerate. There is evidene for signifiant LDL holesterol lowering from even extremely low, less than daily, statin doses (308). When maximally tolerated doses of statins fail to signifiantly lower LDL holesterol (,30% redution from the patient s baseline), there is no strong evidene that ombination therapy should be used to ahieve additional LDL holesterol lowering. Niain, fenofibrate, ezetimibe, and bile aid sequestrants all offer additional LDL holesterol lowering to statins alone, but without evidene that suh ombination therapy for LDL holesterol lowering provides a signifiant inrement in CVD risk redution over statin therapy alone. Treatment of other lipoprotein frations or targets Hypertriglyeridemia should be addressed with dietary and lifestyle hanges. Severe hypertriglyeridemia (.1,000 mg/dl) may warrant immediate pharmaologial therapy (fibri aid derivative, niain, or fish oil) to redue the risk of aute panreatitis. In the absene of severe hypertriglyeridemia, therapy targeting HDL holesterol or triglyerides laks the strong evidene base of statin therapy. If the HDL holesterol is,40 mg/dl and the LDL holesterol is between 100 and 129 mg/dl, a fibrate or niain might be used, espeially if a patient is intolerant to statins. Niain is the most effetive drug for raising HDL holesterol. It an signifiantly inrease blood gluose at high doses, but at modest doses(750 2,000 mg/day) signifiant improvements in LDL holesterol, HDL holesterol, and triglyeride levels are aompanied by only modest hanges in gluose that are generally amenable to adjustment of diabetes therapy (299,309,310). Table 10 summarizes ommon treatment goals for A1C, blood pressure, and LDL holesterol. 3. Antiplatelet agents Reommendations Consider aspirin therapy ( mg/day) as a primary prevention strategy in those with type 1 or type 2 diabetes S32 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

33 Position Statement at inreased ardiovasular risk (10-year risk.10%). This inludes most men aged.50 years or women aged.60 years who have at least one additional major risk fator (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria). (C) Aspirin should not be reommended for CVD prevention for adults with diabetes at low CVD risk (10-year CVD risk,5%, suh as in men aged,50 years andwomen aged,60 years with no major additional CVD risk fators), sine the potential adverse effets from bleeding likely offset the potential benefits. (C) In patients in these age-groups with multiple other risk fators (e.g., 10- year risk 5 10%), linial judgment is required. (E) Use aspirin therapy ( mg/day) as a seondary prevention strategy in those with diabetes with a history of CVD. (A) For patients with CVD and doumented aspirin allergy, lopidogrel (75 mg/day) should be used. (B) Combination therapy with aspirin ( mg/day) and lopidogrel (75 mg/day) is reasonable for up to a year after an aute oronary syndrome. (B) Aspirin has been shown to be effetive in reduing ardiovasular morbidity and mortality in high-risk patients with previous MI or stroke (seondary prevention). Its net benefit in primary prevention among patients with no previous ardiovasular events is more ontroversial, both for patients with and without a history of diabetes (311). Two reent RCTs of aspirin speifially in patients with diabetes failed to show a signifiant redution in CVD end points, raising further questions about the effiay of aspirin for primary prevention in people with diabetes (312,313). The Antithromboti Trialists (ATT) ollaborators reently published an individual patient-level meta-analysis of the six large trials of aspirin for primary prevention in the general population. These trials olletively enrolled over 95,000 partiipants, inluding almost 4,000 with diabetes. Overall, they found that aspirin redued the risk of vasular events by 12% (RR 0.88, 95% CI ). The largest redution was for nonfatal MI with little effet on CHD death (RR 0.95, 95% CI ) or total stroke. There was some evidene of a differene in aspirin effet by sex. Aspirin signifiantly redued CHD events in men but not in women. Conversely, aspirin had no effet on stroke in men but signifiantly redued stroke in women. Notably, sex differenes in aspirin s effets have not been observed in studies of seondary prevention (311). In the six trials examined by the ATT ollaborators, the effets of aspirin on major vasular events were similar for patients with or without diabetes: RR 0.88 (95% CI ) and 0.87 (95% CI ), respetively. The onfidene interval was wider for those with diabetes beause of their smaller number. Basedontheurrentlyavailableevidene, aspirin appears to have a modest effet on ishemi vasular events with the absolute derease in events depending on the underlying CVD risk. The main adverse effets appear to be an inreased risk of gastrointestinal bleeding. The exess risk may be as high as 1 5 per 1,000 per year in real-world settings. In adults with CVD risk greater than 1% per year, the number of CVD events prevented will be similar to or greater than the number of episodes of bleeding indued, although these ompliations do not have equal effets on long-term health (314). Table 10dSummary of reommendations for glyemi, blood pressure, and lipid ontrol for most adults with diabetes A1C,7.0%* Blood pressure Lipids LDL holesterol,140/80 mmhg**,100 mg/dl (,2.6 mmol/l) Statin therapy for those with history of MI or age over 401 other risk fators *More or less stringent glyemi goals may be appropriate for individual patients. Goals should be individualized based on duration of diabetes, age/life expetany, omorbid onditions, known CVD or advaned mirovasular ompliations, hypoglyemia unawareness, and individual patient onsiderations. **Based on patient harateristis and response to therapy, lower systoli blood pressure targets may be appropriate. In individuals with overt CVD, a lower LDL holesterol goal of,70 mg/dl (1.8 mmol/l), using a high dose of a statin, is an option. In 2010, a position statement of the ADA, the Amerian Heart Assoiation (AHA), and the Amerian College of Cardiology Foundation (ACCF) updated prior joint reommendations for primary prevention (315). Low-dose ( mg/day) aspirin use for primary prevention is reasonable for adults with diabetes and no previous history of vasular disease who are at inreased CVD risk (10- yearriskofcvdeventsover10%)and who are not at inreased risk for bleeding. This generally inludes most men over age 50 years and women over age 60 years who also have one or more of the following major risk fators: 1)smoking,2)hypertension, 3) dyslipidemia, 4) family history of premature CVD, and 5) albuminuria. However, aspirin is no longer reommended for those at low CVD risk (women under age 60 years and men under age 50 years with no major CVD risk fators; 10-year CVD risk under 5%) as the low benefit is likely to be outweighed by the risks of signifiant bleeding. Clinial judgment should be used for those at intermediate risk (younger patients with one or more risk fators, or older patients with no risk fators; those with 10-year CVD risk of 5 10%) until further researh is available. Use of aspirin in patients under the age of 21 years is ontraindiated due to the assoiated risk of Reye syndrome. Average daily dosages used in most linial trials involving patients with diabetes ranged from 50 to 650 mg but were mostly in the range of 100 to 325 mg/day. There is little evidene to support any speifi dose, but using the lowest possible dosage may help redue side effets (316). In the U.S., the most ommon low dose tablet is 81 mg. Although platelets from patients with diabetes have altered funtion, it is unlear what,ifany,impatthatfinding has on therequireddoseofaspirinforardioprotetive effets in the patient with diabetes. Many alternate pathways for platelet ativation exist that are independent of thromboxane A 2 and thus not sensitive to the effets of aspirin (317). Therefore, while aspirin resistane appears higher in the diabeti patients when measured by a variety of ex vivo and in vitro methods (platelet aggregometry, measurement of thromboxane B 2 ), these observations alone are insuffiient to empirially reommend higher doses of aspirin be used in the diabeti patient at this time. are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S33

34 Position Statement Clopidogrel has been demonstrated to redue CVD events in diabeti individuals (318). It is reommended as adjuntive therapy in the first year after an aute oronary syndrome or as alternative therapy in aspirin-intolerant patients. 4. Smoking essation Reommendations Advise all patients not to smoke or use tobao produts. (A) Inlude smoking essation ounseling and other forms of treatment as a routine omponent of diabetes are. (B) A large body of evidene from epidemiologial, ase-ontrol, and ohort studies provides onvining doumentation of the ausal link between igarette smoking and health risks. Muh of the work doumenting the impat of smoking on health did not separately disuss results on subsets of individuals with diabetes, but suggests that the identified risks are at least equivalent to those found in the general population. Other studies of individuals with diabetes onsistently demonstrate that smokers have a heightened risk of CVD, premature death, and inreased rate of mirovasular ompliations of diabetes. Smoking may have a role in the development of type 2 diabetes. One study in smokers with newly diagnosed type 2 diabetes found that smoking essation was assoiated with amelioration of metaboli parameters and redued blood pressure and albuminuria at 1 year (319). The routine and thorough assessment of tobao use is important as a means of preventing smoking or enouraging essation. A number of large randomized linial trials have demonstrated the effiay and ost-effetiveness of brief ounseling in smoking essation, inluding the use of quitlines, in the redution of tobao use. For the patient motivated to quit, the addition of pharmaologial therapy to ounseling is more effetive than either treatment alone. Speial onsiderations should inlude assessment of level of niotine dependene, whih is assoiated with diffiulty in quitting and relapse (320). 5. CHD sreening and treatment Reommendations Sreening In asymptomati patients, routine sreening for CAD is not reommended, as it does not improve outomes as long as CVD risk fators are treated. (A) Treatment In patients with known CVD, onsider ACE inhibitor therapy (C) and use aspirin and statin therapy (A) (if not ontraindiated) to redue the risk of ardiovasular events. In patients with a prior MI, b-blokers should be ontinued for at least 2 years after the event. (B) Avoid thiazolidinedione treatment in patients with symptomati heart failure. (C) Metformin may be used in patients with stable CHF if renal funtion is normal. It should be avoided in unstable or hospitalized patients with CHF. (C) SreeningforCADisreviewedina reently updated onsensus statement (196). To identify the presene of CAD in diabeti patients without lear or suggestive symptoms, a risk fator based approah to the initial diagnosti evaluation and subsequent follow-up has intuitive appeal. However, reent studies onluded that using this approah fails to identify whih patients with type 2 diabetes will have silent ishemia on sreening tests (201,321). Candidates for ardia testing inlude those with 1) typial or atypial ardia symptoms and 2) anabnormalresting ECG. The sreening of asymptomati patients remains ontroversial. Intensive medial therapy that would be indiated anyway for diabeti patients at high risk for CVD seems to provide equal outomes to invasive revasularization (322,323). There is also some evidene that silent myoardial ishemia may reverse over time, adding to the ontroversy onerning aggressive sreening strategies (324). Finally, a reent randomized observational trial demonstrated no linial benefit to routine sreening of asymptomati patients with type 2 diabetes and normal ECGs (325). Despite abnormal myoardial perfusion imaging in more than one in five patients, ardia outomes were essentially equal (and very low) in sreened ompared with unsreened patients. Aordingly, the overall effetiveness, espeially the ost-effetiveness, of suh an indisriminate sreening strategy is now questioned. Newer noninvasive CAD sreening methods, suh as omputed tomography (CT) and CT angiography have gained in popularity. These tests infer the presene of oronary atheroslerosis by measuring the amount of alium in oronary arteries and, in some irumstanes, by diret visualization of luminal stenoses. Although asymptomati diabeti patients found to have a higher oronary disease burden have more future ardia events ( ), the role of these tests beyond risk stratifiation is not lear. Their routine use leads to radiation exposure and may result in unneessary invasive testing suh as oronary angiography and revasularization proedures. The ultimate balane of benefit, ost, and risks of suh an approah in asymptomati patients remains ontroversial, partiularly in the modern setting of aggressive CVD risk fator ontrol. In all patients with diabetes, ardiovasular risk fators should be assessed at least annually. These risk fators inlude dyslipidemia, hypertension, smoking, a positive family history of premature oronary disease, and the presene of miro- or maroalbuminuria. Abnormal risk fators should be treated as desribed elsewhere in these guidelines. Patients at inreased CHD risk should reeive aspirin and a statin, and ACE inhibitor or ARB therapy if hypertensive, unless there are ontraindiations to a partiular drug lass. Although lear benefit exists for ACE inhibitor and ARB therapy in patients with nephropathy or hypertension, the benefits in patients with CVD in the absene of these onditions are less lear, espeially when LDL holesterol is onomitantly ontrolled (329,330). B. Nephropathy sreening and treatment Reommendations General reommendations To redue the risk or slow the progression of nephropathy, optimize gluose ontrol. (A) To redue the risk or slow the progression of nephropathy, optimize blood pressure ontrol. (A) Sreening Perform an annual test to assess urine albumin exretion in type 1 diabeti patients with diabetes duration of $5 years and in all type 2 diabeti patients starting at diagnosis. (B) Measure serum reatinine at least annually in all adults with diabetes regardless of the degree of urine albumin exretion. The serum reatinine should be used to estimate GFR and stage the level of hroni kidney disease (CKD), if present. (E) Treatment In the treatment of the nonpregnant patient with modestly elevated ( S34 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

35 mg/day) (C) or higher levels ($300 mg/day) of urinary albumin exretion (A), either ACE inhibitors or ARBs are reommended. Redution of protein intake to g/kg body wt per day in individuals with diabetes and the earlier stages of CKD and to 0.8 g/kg body wt per day in the later stages of CKD may improve measures of renal funtion (urine albumin exretion rate, GFR) and is reommended. (C) When ACE inhibitors, ARBs, or diuretis are used, monitor serum reatinine and potassium levels for the development of inreased reatinine or hanges in potassium. (E) Continued monitoring of urine albumin exretion to assess both response to therapy and progression of disease is reasonable. (E) When egfr,60 ml/min/1.73 m 2, evaluate and manage potential ompliations of CKD. (E) Consider referral to a physiian experiened in the are of kidney disease for unertainty about the etiology of kidney disease, diffiult management issues, or advaned kidney disease. (B) Diabeti nephropathy ours in 20 40% of patients with diabetes and is the single leading ause of ESRD. Persistent albuminuria in the range of mg/24 h (historially alled miroalbuminuria) has been shown to be the earliest stage of diabeti nephropathy in type 1 diabetes and a marker for development of nephropathy in type 2 diabetes. It is also a wellestablished marker of inreased CVD risk (331,332). Patients with miroalbuminuria who progress to more signifiant levels ($300 mg/24 h, historially alled maroalbuminuria) are likely to progress to ESRD (333,334). However, a number of interventions have been demonstrated to redue the risk and slow the progression of renal disease. Intensive diabetes management with the goal of ahieving near-normoglyemia has been shown in large prospetive randomized studies to delay the onset and progression of inreased urinary albumin exretion in patients with type 1 (335,336) and type 2 (83,84,88,89) diabetes. The UKPDS provided strong evidene that ontrol of blood pressure an redue the development of nephropathy (255). In addition, large prospetive randomized studies in patients with type 1 diabetes have demonstrated that ahievement of lower levels of systoli blood pressure (,140 mmhg) resulting from treatment using ACE inhibitors provides a seletive benefit over other antihypertensive drug lasses in delaying the progression of inreased urinary albumin exretion and an slow the deline in GFR in patients with higher levels of albuminuria ( ). In type 2 diabetes with hypertension and normoalbuminuria, RAS inhibition has been demonstrated to delay onset of miroalbuminuria (340,341). In the latter study, there was an unexpeted higher rate of fatal ardiovasular events with olmesartan among patients with preexisting CHD. ACE inhibitors have been shown to redue major CVD outomes (i.e., MI, stroke, death) in patients with diabetes (270), thus further supporting the use of these agents in patients with albuminuria, a CVD risk fator. ARBs do not prevent onset of albuminuria in normotensive patients with type 1 or type 2 diabetes (342,343); however, ARBs have been shown to redue the rate of progression from miro- to maroalbuminuria as well as ESRD in patients with type 2 diabetes ( ). Some evidene suggests that ARBs have a smaller magnitude of rise in potassium ompared with ACE inhibitors in people with nephropathy (347,348). Combinations of drugs that blok the renin-angiotensinaldosterone system (e.g., an ACE inhibitor plus an ARB, a mineraloortioid antagonist, or a diret renin inhibitor) provide additional lowering of albuminuria ( ). However, suh ombinations have been found to provide no additional ardiovasular benefit and have higher adverse event rates (353), and their effets on major renal outomes have not yet been proven. Other drugs, suh as diuretis, alium hannel blokers, and b-blokers, should be used as additional therapy to further lower blood pressure in patients already treated with ACE inhibitors or ARBs (275), or as alternate therapy in the rare individual unable to tolerate ACE inhibitors or ARBs. Studies in patients with varying stages of nephropathy have shown that protein restrition of dietary protein helps slow the progression of albuminuria, GFR deline, and ourrene of ESRD ( ), although more reent studies have provided onfliting results (140). Dietary protein restrition might be onsidered partiularly in patients whose nephropathy seems to be progressing despite optimal gluose and blood pressure ontrol and use of ACE inhibitor and/or ARBs (357). Assessment of albuminuria status and renal funtion Sreening for inreased urinary albumin exretion an be performed by measurement of the albumin-to-reatinine ratio in a random spot olletion; 24-h or timed olletions are more burdensome and add little to predition or auray (358,359). Measurement of a spot urine for albumin only, whether by immunoassay or by using a dipstik test speifi for miroalbumin, without simultaneously measuring urine reatinine, is somewhat less expensive but suseptible to falsenegative and false-positive determinations as a result of variation in urine onentration due to hydration and other fators. Abnormalities of albumin exretion and the linkage between albumin-toreatinine ratio and 24-h albumin exretion are defined in Table 11. Beause of variability in urinary albumin exretion, two of three speimens olleted within a 3- to 6-month period should be abnormal before onsidering a patient to have developed inreased urinary albumin exretion or had a progression in albuminuria. Exerise within 24 h, infetion, fever, CHF, marked hyperglyemia, and marked hypertension may elevate urinary albumin exretion over baseline values. Information on presene of abnormal urine albumin exretion in addition to level of GFR may be used to stage CKD. The National Kidney Foundation lassifiation (Table 12) is primarily based on GFR levels and therefore differs from other systems, in whih staging is based primarily on urinary albumin exretion (360). Studies have found dereased GFR in the absene of inreased urine albumin exretion in a substantial perentage of adults with diabetes (361). Serum reatinine should therefore be measured at least annually in all adults with Table 11dDefinitions of abnormalities in albumin exretion Category Position Statement Spot olletion (mg/mg reatinine) Normal,30 Inreased urinary albumin exretion* $30 *Historially, ratios between 30 and 299 have been alled miroalbuminuria and those 300 or greater have been alled maroalbuminuria (or linial albuminuria). are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S35

36 Position Statement diabetes, regardless of the degree of urine albumin exretion. Serum reatinine should be used to estimate GFR and to stage the level of CKD, if present. egfr is ommonly oreported by laboratories or an be estimated using formulae suh as the Modifiation of Diet in Renal Disease (MDRD) study equation (362). Reent reports have indiated that the MDRD is more aurate for the diagnosis and stratifiation of CKD in patients with diabetes than the Cokroft-Gault formula (363). GFR alulators are available at The role of ontinued annual quantitative assessment of albumin exretion after diagnosis of albuminuria and institution of ACE inhibitor or ARB therapy and blood pressure ontrol is unlear. Continued surveillane an assess both response to therapy and progression of disease. Some suggest that reduing albuminuria to the normal (,30 mg/g) or near-normal range may improve renal and ardiovasular prognosis, but this approah has not been formally evaluated in prospetive trials. Compliations of kidney disease orrelate with level of kidney funtion. When the egfr is,60 ml/min/1.73 m 2,sreening for ompliations of CKD is indiated (Table 13). Early vaination against hepatitis B is indiated in patients likely to progress to end-stage kidney disease. Consider referral to a physiian experiened in the are of kidney disease when there is unertainty about the etiology of kidney disease (heavy proteinuria, ative urine sediment, absene of retinopathy, rapid deline in GFR, resistant hypertension). Other triggers for referral may inlude diffiult management issues (anemia, seondary hyperparathyroidism, metaboli bone disease, or eletrolyte disturbane) or advaned kidney disease. The threshold for referral may vary depending on the frequeny with whih a provider enounters diabeti patients with signifiant kidney Table 12dStages of CKD Stage Desription disease. Consultation with a nephrologist when stage 4 CKD develops has been found to redue ost, improve quality of are, and keep people off dialysis longer (364). However, nonrenal speialists should not delay eduating their patients about the progressive nature of diabeti kidney disease; the renal preservation benefits of aggressive treatment of blood pressure, blood gluose, and hyperlipidemia; and the potential need for renal replaement therapy. C. Retinopathy sreening and treatment Reommendations General reommendations To redue the risk or slow the progression of retinopathy, optimize glyemi ontrol. (A) To redue the risk or slow the progression of retinopathy, optimize blood pressure ontrol. (A) Sreening Adults and hildren aged $10 years with type 1 diabetes should have an initial dilated and omprehensive eye examination by an ophthalmologist or optometrist within 5 years after the onset of diabetes. (B) Patients with type 2 diabetes should have an initial dilated and omprehensive eye examination by an ophthalmologist or optometrist shortly after the diagnosis of diabetes. (B) Subsequent examinations for type 1 and type 2 diabeti patients should be repeated annually by an ophthalmologist or optometrist. Less frequent exams (every 2 3 years) may be onsidered following one or more normal eye exams. Examinations will be required more frequently if retinopathy is progressing. (B) High-quality fundus photographs an detet most linially signifiant diabeti retinopathy. Interpretation of the images should be performed by a trained eye are provider. While retinal photography may serve as a sreening tool for retinopathy, it is not a substitute GFR (ml/min/1.73 m 2 body surfae area) 1 Kidney damage* with normal or inreased GFR $90 2 Kidney damage* with mildly dereased GFR Moderately dereased GFR Severely dereased GFR Kidney failure,15 or dialysis *Kidney damage defined as abnormalities on pathologial, urine, blood, or imaging tests. Adapted from ref for a omprehensive eye exam, whih should be performed at least initially and at intervals thereafter as reommended by an eye are professional. (E) Women with pre-existing diabetes who are planning pregnany or who have beome pregnant should have a omprehensive eye examination and be ounseled on the risk of development and/or progression of diabeti retinopathy. Eye examination should our in the first trimester with lose follow-up throughout pregnany and for 1 year postpartum. (B) Treatment Promptly refer patients with any level of maular edema, severe NPDR, or any PDR to an ophthalmologist who is knowledgeable and experiened in the management and treatment of diabeti retinopathy. (A) Laser photooagulation therapy is indiated to redue the risk of vision loss in patients with high-risk PDR, linially signifiant maular edema, and in some ases of severe NPDR. (A) Anti vasular endothelial growth fator (VEGF) therapy is indiated for diabeti maular edema. (A) The presene of retinopathy is not a ontraindiation to aspirin therapy for ardioprotetion, as this therapy does not inrease the risk of retinal hemorrhage. (A) Diabeti retinopathy is a highly speifi vasular ompliation of both type 1 and type 2 diabetes, with prevalene strongly related to the duration of diabetes. Diabeti retinopathy is the most frequent ause of new ases of blindness among adults aged years. Glauoma, atarats, and other disorders of the eye our earlier and more frequently in people with diabetes. In addition to duration of diabetes, other fators that inrease the risk of, or are assoiated with, retinopathy inlude hroni hyperglyemia (365), nephropathy (366), and hypertension (367). Intensive diabetes management with the goal of ahieving near-normoglyemia has been shown in large prospetive randomized studies to prevent and/or delay the onset and progression of diabeti retinopathy (71,83,84,90). Lowering blood pressure has been shown to derease the progression of retinopathy (255), although tight targets (systoli,120 mmhg) do not impart additional benefit (90). Several ase series and a ontrolled prospetive study suggest that pregnany S36 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

37 Position Statement Table 13dManagement of CKD in diabetes GFR Reommended All patients Yearly measurement of reatinine, urinary albumin exretion, potassium Referral to nephrology if possibility for nondiabeti kidney disease exists (duration of type 1 diabetes,10 years, heavy proteinuria, abnormal findings on renal ultrasound, resistant hypertension, rapid fall in GFR, or ative urinary sediment on ultrasound) Consider need for dose adjustment of mediations Monitor egfr every 6 months Monitor eletrolytes, biarbonate, hemoglobin, alium, phosphorus, parathyroid hormone at least yearly Assure vitamin D suffiieny Consider bone density testing Referral for dietary ounseling Monitor egfr every 3 months Monitor eletrolytes, biarbonate, alium, phosphorus, parathyroid hormone, hemoglobin, albumin, weight every 3 6months Consider need for dose adjustment of mediations,30 Referral to nephrologist Adapted from risk of development of signifiant retinopathy with a 3-year interval after a normal examination (376). Examinations will be required more frequently if retinopathy is progressing (377). The use of retinal photography with remote reading by experts has great potential in areas where qualified eye are professionals are not available and may also enhane effiieny and redue osts when the expertise of ophthalmologists an be utilized for more omplex examinations and for therapy (378). In-person exams are still neessary when the photos are unaeptable and for follow-up of abnormalities deteted. Photos are not a substitute for a omprehensive eye exam, whih should be performed at least initially and at intervals thereafter as reommended by an eye are professional. Results of eye examinations should be doumented and transmitted to the referring health are professional. in type 1 diabeti patients may aggravate retinopathy (368,369); laser photooagulation surgery an minimize this risk (369). One of the main motivations for sreening for diabeti retinopathy is the long-established effiay of laser photooagulation surgery in preventing visual loss. Two large trials, the Diabeti Retinopathy Study (DRS) in patients with PDR and the Early Treatment Diabeti Retinopathy Study (ETDRS) in patients with maular edema, provide the strongest support for the therapeuti benefits of photooagulation surgery. The DRS (370) showed that panretinal photooagulation surgery redued the risk of severe vision loss from PDR from 15.9% in untreated eyes to 6.4% in treated eyes, with greatest risk-benefit ratio in those with baseline disease (dis neovasularization or vitreous hemorrhage). The ETDRS (371) established the benefit of foal laser photooagulation surgery in eyes with maular edema, partiularly those with linially signifiant maular edema, with redution of doubling of the visual angle (e.g., 20/50 to 20/100) from 20% in untreated eyes to 8% in treated eyes. The ETDRS also verified the benefits of panretinal photooagulation for high-risk PDR and in olderonset patients with severe NPDR or lessthan-high-risk PDR. Laser photooagulation surgery in both trials was benefiial in reduing the risk of further visual loss, but generally not benefiial in reversing already diminished auity. Reombinant monolonal neutralizing antibody to VEGF is a newly approved therapy that improves vision and redues the need for laser photooagulation in patients with maular edema (372). Other emerging therapies for retinopathy inlude sustained intravitreal delivery of fluoinolone (373) and the possibility of prevention with fenofibrate (374,375). The preventive effets of therapy and the fat that patients with PDR or maular edema may be asymptomati provide strong support for a sreening program to detet diabeti retinopathy. As retinopathy is estimated to take at least 5 years to develop after the onset of hyperglyemia, patients with type 1 diabetes should have an initial dilated and omprehensive eye examination within 5 years after the onset of diabetes. Patients with type 2 diabetes, who generally have had years of undiagnosed diabetes and who have a signifiant risk of prevalent diabeti retinopathy at time of diabetes diagnosis, should have an initial dilated and omprehensive eye examination soon after diagnosis. Examinations shouldbeperformedbyanophthalmologist or optometrist who is knowledgeable and experiened in diagnosing the presene of diabeti retinopathy and is aware of its management. Subsequent examinations for type 1 and type 2 diabeti patients are generally repeated annually. Less frequent exams (every 2 3 years) may be ost effetive after one or more normal eye exams, and in a population with well-ontrolled type 2 diabetes there was essentially no D. Neuropathy sreening and treatment Reommendations All patients should be sreened for distal symmetri polyneuropathy (DPN) starting at diagnosis of type 2 diabetes and 5 years after the diagnosis of type 1 diabetes and at least annually thereafter, using simple linial tests. (B) Eletrophysiologial testing is rarely needed, exept in situations where the linial features are atypial. (E) Sreening for signs and symptoms of ardiovasular autonomi neuropathy (CAN) should be instituted at diagnosis oftype2diabetesand5yearsafterthe diagnosis of type 1 diabetes. Speial testing is rarely needed and may not affet management or outomes. (E) Mediations for the relief of speifi symptoms related to painful DPN and autonomi neuropathy are reommended, as they improve the quality of life of the patient. (E) The diabeti neuropathies are heterogeneous with diverse linial manifestations. They may be foal or diffuse. Most ommon among the neuropathies are hroni sensorimotor DPN and autonomi neuropathy. Although DPN is a diagnosis of exlusion, omplex investigations to exlude other onditions are rarely needed. The early reognition and appropriate management of neuropathy in the patient with diabetes is important for a number of reasons: 1) nondiabeti are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S37

38 Position Statement neuropathies may be present in patients with diabetes and may be treatable; 2) a number of treatment options exist for symptomati diabeti neuropathy; 3) up to 50% of DPN may be asymptomati and patients are at risk for insensate injury to their feet; and 4) autonomi neuropathy, and partiularly CAN, is assoiated with substantial morbidity and even mortality. Speifi treatment for the underlying nerve damage is urrently not available, other than improved glyemi ontrol, whih may modestly slow progression (89) but not reverse neuronal loss. Effetive symptomati treatments are available for some manifestations of DPN (379) and autonomi neuropathy. Diagnosis of neuropathy DPN. Patients with diabetes should be sreened annually for DPN using tests suh as pinprik sensation, vibration pereption (using a 128-Hz tuning fork), 10-g monofilament pressure sensation at the distal plantar aspet of both great toes and metatarsal joints, and assessment of ankle reflexes. Combinations of more than one test have.87% sensitivity in deteting DPN. Loss of 10-g monofilament pereption and redued vibration pereption predit foot ulers (380). Importantly, in patients with neuropathy, partiularly when severe, auses other than diabetes should always be onsidered, suh as neurotoxi mediations, heavy metal poisoning, alohol abuse, vitamin B12 defiieny (espeially in those taking metformin for prolonged periods (381), renal disease, hroni inflammatory demyelinating neuropathy, inherited neuropathies, and vasulitis (382). Diabeti autonomi neuropathy. The symptoms and signs of autonomi dysfuntion should be eliited arefully during the history and physial examination. Major linial manifestations of diabeti autonomi neuropathy inlude resting tahyardia, exerise intolerane, orthostati hypotension, onstipation, gastroparesis, eretile dysfuntion, sudomotor dysfuntion, impaired neurovasular funtion, and, potentially, autonomi failure in response to hypoglyemia (383). CAN, a CVD risk fator (93), is the most studied and linially important form of diabeti autonomi neuropathy. CAN may be indiated by resting tahyardia (.100 bpm), orthostasis (a fall in systoli blood pressure.20 mmhgupon standing without an appropriate heart rate response); it is also assoiated with inreased ardia event rates. Although some soieties have developed guidelines for sreening for CAN, the benefits of sophistiated testing beyond risk stratifiation are not lear (384). Gastrointestinal neuropathies (e.g., esophageal enteropathy, gastroparesis, onstipation, diarrhea, feal inontinene) are ommon, and any setion of the gastrointestinal trat may be affeted. Gastroparesis should be suspeted in individuals with errati gluose ontrol or with upper gastrointestinal symptoms without other identified ause. Evaluation of solid-phase gastri emptying using double-isotope sintigraphy may be done if symptoms are suggestive, but test results often orrelate poorly with symptoms. Constipation is the most ommon lower-gastrointestinal symptom but an alternate with episodes of diarrhea. Diabeti autonomi neuropathy is also assoiated with genitourinary trat disturbanes. In men, diabeti autonomi neuropathy may ause eretile dysfuntion and/or retrograde ejaulation. Evaluation of bladder dysfuntion should be performed for individuals with diabetes who have reurrent urinary trat infetions, pyelonephritis, inontinene, or a palpable bladder. Symptomati treatments DPN. The first step in management of patients with DPN should be to aim for stable and optimal glyemi ontrol. Although ontrolled trial evidene is laking, several observational studies suggest that neuropathi symptoms improve not only with optimization of ontrol, but also with the avoidane of extreme blood gluose flutuations. Patients with painful DPN may benefit from pharmaologial treatment of their symptoms: many agents have onfirmed or probable effiay onfirmed in systemati reviews of RCTs (379), with several U.S. Food and Drug Administration (FDA)-approved for the management of painful DPN. Treatment of autonomi neuropathy. Gastroparesis symptoms may improve with dietary hanges and prokineti agents suh as metolopramide or erythromyin. Treatments for eretile dysfuntion may inlude phosphodiesterase type 5 inhibitors, intraorporeal or intraurethral prostaglandins, vauum devies, or penile prostheses. Interventions for other manifestations of autonomi neuropathy are desribed in the ADA statement on neuropathy (380). As with DPN treatments, these interventions do not hange the underlying pathology and natural history of the disease proess, but may have a positive impat on the quality of life of the patient. E. Foot are Reommendations For all patients with diabetes, perform an annual omprehensive foot examination to identify risk fators preditive of ulers and amputations. The foot examination should inlude inspetion, assessment of foot pulses, and testing for loss of protetive sensation (LOPS) (10-g monofilament plus testing any one of the following: vibration using 128-Hz tuning fork, pinprik sensation, ankle reflexes, or vibration pereption threshold). (B) Provide general foot self-are eduation to all patients with diabetes. (B) A multidisiplinary approah is reommended for individuals with foot ulers and high-risk feet, espeially those with a history of prior uler or amputation. (B) Refer patients who smoke, have LOPS and strutural abnormalities, or have history of prior lower-extremity ompliations to foot are speialists for ongoing preventive are and lifelong surveillane. (C) Initial sreening for peripheral arterial disease (PAD) should inlude a history for laudiation and an assessment of the pedal pulses. Consider obtaining an ankle-brahial index (ABI), as many patients with PAD are asymptomati. (C) Refer patients with signifiant laudiation or a positive ABI for further vasular assessment and onsider exerise, mediations, and surgial options. (C) Amputation and foot uleration, onsequenes of diabeti neuropathy and/or PAD, are ommon and major auses of morbidity and disability in people with diabetes. Early reognition and management of risk fators an prevent or delay adverse outomes. The risk of ulers or amputations is inreased in people who have the following risk fators: Previous amputation Past foot uler history Peripheral neuropathy Foot deformity Peripheral vasular disease Visual impairment S38 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

39 Diabeti nephropathy (espeially patients on dialysis) Poor glyemi ontrol Cigarette smoking Many studies have been published proposing a range of tests that might usefully identify patients at risk for foot uleration, reating onfusion among pratitioners as to whih sreening tests should be adopted in linial pratie. An ADA task fore was therefore assembled in 2008 to onisely summarize reent literature in this area and then reommend what should be inluded in the omprehensive foot exam for adult patients with diabetes. Their reommendations are summarized below, but liniians should refer to the task fore report (385) for further details and pratial desriptions of how to perform omponents of the omprehensive foot examination. At least annually, all adults with diabetes should undergo a omprehensive foot examination to identify high-risk onditions. Cliniians should ask about history of previous foot uleration or amputation, neuropathi or peripheral vasular symptoms, impaired vision, tobao use, and foot are praties. A generalinspetionofskinintegrityand musuloskeletal deformities should be done in a well-lit room. Vasular assessment would inlude inspetion and assessment of pedal pulses. The neurologi exam reommended is designed to identify LOPS rather than early neuropathy. The linial examination to identify LOPS is simple and requires no expensive equipment. Five simple linial tests (use of a 10-g monofilament, vibration testing using a 128-Hz tuning fork, tests of pinprik sensation, ankle reflex assessment, and testing vibration pereption threshold with a biothesiometer), eah with evidene from well-onduted prospetive linial ohort studies, are onsidered useful in the diagnosis of LOPS in the diabeti foot. The task fore agrees that any of the five tests listed ould be used by liniians to identify LOPS, although ideally two of these should be regularly performed duringthesreeningexamdnormally the 10-g monofilament and one other test. One or more abnormal tests would suggest LOPS, while at least two normal tests (and no abnormal test) would rule out LOPS. The last test listed, vibration assessment using a biothesiometer or similar instrument, is widely used in the U.S.; however, identifiation of the patient with LOPS an easily be arried out without this or other expensive equipment. Initial sreening for PAD should inlude a history for laudiation and an assessment of the pedal pulses. A diagnosti ABI should be performed in any patient with symptoms of PAD. Due to the high estimated prevalene of PAD in patients with diabetes and the fat that many patients with PAD are asymptomati, an ADA onsensus statement on PAD (386) suggested that a sreening ABI be performed in patients over 50 years of age and be onsidered in patients under 50 years of age who have other PAD risk fators (e.g., smoking, hypertension, hyperlipidemia, or duration of diabetes.10 years). Refer patients with signifiant symptoms or a positive ABI for further vasular assessment and onsider exerise, mediations, and surgial options (386). Patients with diabetes and high-risk foot onditions should be eduated regarding their risk fators and appropriate management. Patients at risk should understand the impliations of the loss of protetive sensation, the importane of foot monitoring on a daily basis, the proper are of the foot, inluding nail and skin are, and the seletion of appropriate footwear. Patients with LOPS should be eduated on ways to substitute other sensory modalities (hand palpation, visual inspetion) for surveillane of early foot problems. The patients understanding of these issues and their physial ability to ondut proper foot surveillane and are should be assessed. Patients with visual diffiulties, physial onstraints preventing movement, or ognitive problems that impair their ability to assess the ondition of the foot and to institute appropriate responses will need other people, suh as family members, to assist in their are. People with neuropathy or evidene of inreased plantar pressure (e.g., erythema, warmth, allus, or measured pressure) may be adequately managed with well-fitted walking shoes or athleti shoes that ushion the feet and redistribute pressure. Callus an be debrided with a salpel by a foot are speialist or other health professional with experiene and training in foot are. People with bony deformities (e.g., hammertoes, prominent metatarsal heads, bunions) may need extra-wide or -depth shoes. People with extreme bony deformities (e.g., Charot foot) who annot be aommodated with ommerial therapeuti footwear may need ustommolded shoes. Foot ulers and wound are may require are by a podiatrist, orthopedi or vasular surgeon, or rehabilitation speialist experiened in the management of individuals with diabetes. Guidelines for treatment of diabeti foot ulers have reently been updated (387). VII. ASSESSMENT OF COMMON COMORBID CONDITIONS Position Statement Reommendations For patients with risk fators, signs or symptoms, onsider assessment and treatment for ommon diabetes-assoiated onditions (see Table 14). (B) In addition to the ommonly appreiated omorbidities of obesity, hypertension, and dyslipidemia, diabetes is also assoiated with other diseases or onditions at rates higher than those of agemathed people without diabetes. A few of the more ommon omorbidities are desribed herein and listed in Table 14. Hearing impairment Hearing impairment, both high frequeny and low/mid frequeny, is more ommon in people with diabetes, perhaps due to neuropathy and/or vasular disease. In an NHANES analysis, hearing impairment wasabouttwieasgreatinpeoplewith diabetes ompared with those without, after adjusting for age and other risk fators for hearing impairment (388). Controlling for age, rae, and other demographi fators, high frequeny loss in those with diabetes was signifiantly assoiated with history of CHD and with peripheral neuropathy, while low/mid frequeny loss was assoiated with low HDL holesterol and with poor reported health status (389). Table 14dCommon omorbidities for whih inreased risk is assoiated with diabetes Hearing impairment Obstrutive sleep apnea Fatty liver disease Low testosterone in men Periodontal disease Certain aners Fratures Cognitive impairment Depression are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S39

40 Position Statement Obstrutive sleep apnea Age-adjusted rates of obstrutive sleep apnea, a risk fator for CVD, are signifiantly higher (4- to 10-fold) with obesity, espeially with entral obesity, in men and women (390). The prevalene in general populations with type 2 diabetes may be up to 23% (391), and in obese partiipants enrolled in the Look AHEAD trial exeeded 80% (392). Treatment of sleep apnea signifiantly improves quality of life and blood pressure ontrol. The evidene for a treatment effet on glyemi ontrol is mixed (393). Fatty liver disease Unexplained elevation of hepati transaminase onentrations is signifiantly assoiated with higher BMI, waist irumferene, triglyerides, and fasting insulin, and with lower HDL holesterol. Type 2 diabetes and hypertension are independently assoiated with transaminase elevations in women (394). In a prospetive analysis, diabetes was signifiantly assoiated with inident nonaloholi hroni liver disease and with hepatoellular arinoma (395). Interventions that improve metaboli abnormalities in patients with diabetes (weight loss, glyemi ontrol, treatment with speifi drugs for hyperglyemia or dyslipidemia) are also benefiial for fatty liver disease (396). Low testosterone in men Mean levels of testosterone are lower in men with diabetes ompared with agemathed men without diabetes, but obesity is a major onfounder (397). The issue of treatment in asymptomati men is ontroversial. The evidene for effets of testosterone replaement on outomes is mixed, and reent guidelines suggest that sreening and treatment of men without symptoms are not reommended (398). Periodontal disease Periodontal disease is more severe, but not neessarily more prevalent, in patients with diabetes than those without (399). Numerous studies have suggested assoiations with poor glyemi ontrol, nephropathy, and CVD, but most studies are highly onfounded. A omprehensive assessment, and treatment of identified disease, is indiated in patients with diabetes, but the evidene that periodontal disease treatment improves glyemi ontrol is mixed. A meta-analysis reported a signifiant 0.47% improvement in A1C, but noted multiple problems with the quality of the published studies inluded in the analysis (400). Several high-quality RCTs have not shown a signifiant effet (401). Caner Diabetes (possibly only type 2 diabetes) is assoiated with inreased risk of aners of the liver, panreas, endometrium, olon/retum, breast, and bladder (402). The assoiation may result from shared risk fators between type 2 diabetes and aner (obesity, age, and physial inativity) but may also be due to hyperinsulinemia or hyperglyemia (401,403). Patients with diabetes should be enouraged to undergo reommended age- and sexappropriate aner sreenings and to redue their modifiable aner risk fators (obesity, smoking, and physial inativity). Fratures Age-mathed hip frature risk is signifiantly inreased in both type 1 (summary RR 6.3) and type 2 diabetes (summary RR 1.7) in both sexes (404). Type 1 diabetes is assoiated with osteoporosis, but in type 2 diabetes an inreased risk of hip frature is seen despite higher bone mineral density (BMD) (405). One study showed that prevalent vertebral fratures were signifiantly more ommon in men and women with type 2 diabetes, but were not assoiated with BMD (406). In three large observational studies of older adults, femoral nek BMD T-sore and the WHO frature risk algorithm (FRAX) sore were assoiated with hip and nonspine frature, although frature risk was higher in diabeti partiipants ompared with partiipants without diabetes for a given T-sore and age or for a given FRAX sore risk (407). It is appropriate to assess frature history and risk fators in older patients with diabetes and reommend BMD testing if appropriate for the patient s age and sex. For at-risk patients, it is reasonable to onsider standard primary or seondary prevention strategies (redue risk fators for falls, ensure adequate alium and vitamin D intake, avoid use of mediations that lower BMD, suh as gluoortioids), and to onsider pharmaotherapy for high-risk patients. For patients with type 2 diabetes with frature risk fators, avoiding use of thiazolidinediones is warranted. Cognitive impairment Diabetes is assoiated with signifiantly inreased risk of ognitive deline, a greater rate of ognitive deline, and inreased risk of dementia (408,409). In a 15-year prospetive study of a ommunity-dwelling people over the age of 60 years, the presene of diabetes at baseline signifiantly inreased the ageand sex-adjusted inidene of all-ause dementia, Alzheimer disease, and vasular dementia ompared with rates in those with normal gluose tolerane (410). In a substudy of the ACCORD study, there were no differenes in ognitive outomes between intensive and standard glyemi ontrol, although there was signifiantly less of a derement in total brain volume by magneti resonane imaging in partiipants in the intensive arm (411). The effets of hyperglyemia and insulin on the brain are areas of intense researh interest. Depression As disussed in Setion V.H, depression is highly prevalent in people with diabetes and is assoiated with worse outomes. VIII. DIABETES CARE IN SPECIFIC POPULATIONS A. Children and adolesents Reommendations As is the ase for all hildren, hildren with diabetes or prediabetes should be enouraged to engage in at least 60 min of physial ativity eah day. (B) 1. Type 1 diabetes Three-quarters of all ases of type 1 diabetes are diagnosed in individuals,18 years of age. It is appropriate to onsider the unique aspets of are and management of hildren and adolesents with type 1 diabetes. Children with diabetes differ from adults in many respets, inluding hanges in insulin sensitivity related to sexual maturity and physial growth, ability to provide self-are, supervision in hild are and shool, and unique neurologi vulnerability to hypoglyemia and DKA. Attention to suh issues as family dynamis, developmental stages, and physiologial differenes related to sexual maturity are all essential in developing and implementing an optimal diabetes regimen. Although reommendations for hildren and adolesents are less likely to be based on linial trial evidene, expert opinion and a review of available and relevant experimental data are summarized in the ADA statement on are of hildren and adolesents with type 1 diabetes (412). Ideally, the are of a hild or adolesent with type 1 diabetes should be provided by a multidisiplinary team of speialists trained in the are of hildren S40 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

41 with pediatri diabetes. At the very least, eduation of the hild and family should be provided by health are providers trained and experiened in hildhood diabetes and sensitive to the hallenges posed by diabetes in this age-group. It is essential that DSME, MNT, and psyhosoial support be provided at the time of diagnosis and regularly thereafter by individuals experiened with the eduational, nutritional, behavioral, and emotional needs of the growing hild and family. It is expeted that the balane between adult supervision and self-are should be defined and that it will evolve with physial, psyhologial, and emotional maturity. a. Glyemi ontrol Reommendations Consider age when setting glyemi goals in hildren and adolesents with type 1 diabetes. (E) While urrent standards for diabetes management reflet the need to lower gluose as safely possible, speial onsideration should be given to the unique risks of hypoglyemia in young hildren. Glyemi goals may need to be modified to take into aount the fat that most hildren,6 or 7 years of age have a form of hypoglyemi unawareness, inluding immaturity and a relative inability to reognize and respond to hypoglyemi symptoms, plaing them at greater risk for severe hypoglyemia and its sequelae. In addition, and unlike the ase in type 1 diabeti adults, young hildren below the age of 5 years may be at risk for permanent ognitive impairment after episodes of severe hypoglyemia ( ). Furthermore, the DCCT demonstrated that near-normalization of blood gluose levels was more diffiult to ahieve in adolesents than adults. Nevertheless, the inreased frequeny of use of basal-bolus regimens and insulin pumps in youth from infany through adolesene has been assoiated with more hildren reahing ADA blood gluose targets (416,417) in those families in whih both parents and the hild with diabetes partiipate jointly to perform the required diabetes-related tasks. Furthermore, reent studies doumenting neuroognitive sequelae of hyperglyemiainhildrenprovideanotherompelling motivation for ahieving glyemi targets (418,419). In seleting glyemi goals, the benefits on long-term health outomes of ahieving a lower A1C should be balaned against the risks of hypoglyemia and the developmental burdens of intensive regimens in hildren and youth. Age-speifi glyemi and A1C goals are presented in Table 15. b. Sreening and management of hroni ompliations in hildren and adolesents with type 1 diabetes i. Nephropathy Reommendations Annual sreening for miroalbuminuria, with a random spot urine sample for albumin-to-reatinine ratio, should be onsidered one the hild is 10 years of age and has had diabetes for 5 years. (B) Treatment with an ACE inhibitor, titrated to normalization of albumin exretion, should be onsidered when elevated albumin-to-reatinine ratio is subsequently onfirmed on two additional speimens from different days. (E) ii. Hypertension Reommendations Blood pressure should be measured at eah routine visit. Children found to have high-normal blood pressure or hypertension should have blood pressure onfirmed on a separate day. (B) Initial treatment of high-normal blood pressure (systoli or diastoli blood pressure onsistently above the 90th perentile for age, sex, and height) inludes dietary intervention and exerise, aimed at weight ontrol and inreased physial ativity, if appropriate. If target blood pressure is not reahed with 3 6 months of lifestyle intervention, pharmaologial treatment should be onsidered. (E) Pharmaologial treatment of hypertension (systoli or diastoli blood pressure onsistently above the 95th perentile for age, sex, and height or onsistently.130/80 mmhg, if 95% exeeds that value) should be onsidered as soon as the diagnosis is onfirmed. (E) ACE inhibitors should be onsidered for the initial treatment of hypertension, following appropriate reprodutive ounseling due to its potential teratogeni effets. (E) The goal of treatment is a blood pressure onsistently,130/80 or below the 90th perentile for age, sex, and height, whihever is lower. (E) It is important that blood pressure measurements are determined orretly, using the appropriate size uff, and with the hild seated and relaxed. Hypertension should be onfirmed on at least three separate days. Normal blood pressure levels for age, sex, and height and appropriate methods for determinations are available online at health/prof/heart/hbp/hbp_ped.pdf. iii. Dyslipidemia Reommendations Sreening If there is a family history of hyperholesterolemia or a ardiovasular event before age 55 years, or if family history is unknown, then onsider obtaining a fasting lipid profile on hildren.2 years of age soon after diagnosis (after gluose ontrol has been established). If family history is not of onern, then onsider the first lipid sreening at puberty ($10 years of age). For hildren diagnosed with diabetes at or after puberty, onsider obtaining a fasting lipid profile soon after the diagnosis (after gluose ontrol has been established). (E) For both age-groups, if lipids are abnormal, annual monitoring is reasonable. If LDL holesterol values are within the aepted risk levels (,100 mg/dl [2.6 mmol/l]), a lipid profile repeated every 5 years is reasonable. (E) Treatment Initial therapy may onsist of optimization of gluose ontrol and MNT using a Step 2 AHA diet aimed at a derease in the amount of saturated fat Position Statement in the diet. (E) After the age of 10 years, the addition of a statin in patients who, after MNT and lifestyle hanges, have LDL holesterol.160 mg/dl (4.1 mmol/l), or LDL holesterol.130 mg/dl (3.4 mmol/l) and one or more CVD risk fators, is reasonable. (E) The goal of therapy is an LDL holesterol value,100 mg/dl (2.6 mmol/l). (E) People diagnosed with type 1 diabetes in hildhood have a high risk of early sublinial ( ) and linial (423) CVD. Although intervention data are laking, the AHA ategorizes hildren with type 1 diabetes in the highest tier for ardiovasular risk and reommends both lifestyle and pharmaologial treatment for those with elevated LDL holesterol levels (424,425). Initial therapy should be with a Step 2 AHA diet, whih restrits saturated fat to 7% of total alories and restrits dietary holesterol to 200 mg/day. Data from randomized linial trials in hildren as young as 7 months of age indiate that this diet is safe and are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S41

42 Position Statement Table 15dPlasma blood gluose and A1C goals for type 1 diabetes by age-group Values by age (years) Plasma blood gluose goal range (mg/dl) Before meals Bedtime/ overnight A1C Rationale Toddlers and preshoolers (0 6) ,8.5% Vulnerability to hypoglyemia Insulin sensitivity Unpreditability in dietary intake and physial ativity A lower goal (,8.0%) is reasonable if it an be ahieved without exessive hypoglyemia Shool age (6 12) ,8% Vulnerability of hypoglyemia A lower goal (,7.5%) is reasonable if it an be ahieved without exessive hypoglyemia Adolesents and young adults (13 19) ,7.5% A lower goal (,7.0%) is reasonable if it an be ahieved without exessive hypoglyemia Key onepts in setting glyemi goals: Goals should be individualized and lower goals may be reasonable based on benefit-risk assessment. Blood gluose goals should be modified in hildren with frequent hypoglyemia or hypoglyemia unawareness. Postprandial blood gluose values should be measured when there is a disrepany between preprandial blood gluose values and A1C levels and to help assess glyemia in those on basal/bolus regimens. does not interfere with normal growth and development (426,427). Neither long-term safety nor ardiovasular outome effiay of statin therapy has been established for hildren. However, reent studies have shown short-term safety equivalent to that seen in adults and effiay in lowering LDL holesterol levels, improving endothelial funtion and ausing regression of arotid intimal thikening ( ). No statin is approved for use under the age of 10 years, and statin treatment should generally not be used in hildren with type 1 diabetes prior to this age. For postpubertal girls, issues of pregnany prevention are paramount, sine statins are ategory X in pregnany. See Setion VIII.B for more information. iv. Retinopathy Reommendations The first ophthalmologi examination should be obtained one the hild is $10 years of age and has had diabetes for 3 5 years. (B) After the initial examination, annual routine follow-up is generally reommended. Less frequent examinations may be aeptable on the advie of an eye are professional. (E) Although retinopathy (like albuminuria) most ommonly ours after the onset of puberty and after 5 10 years of diabetes duration (431), it has been reported in prepubertal hildren and with diabetes duration of only 1 2 years. Referrals should be made to eye are professionals with expertise in diabeti retinopathy, an understanding of the risk for retinopathy in the pediatri population, and experiene in ounseling the pediatri patient and family on the importane of early prevention/intervention. v. Celia disease Reommendations Consider sreening hildren with type 1 diabetes for elia disease by measuring tissue transglutaminase or antiendomysial antibodies, with doumentation of normal total serum IgA levels, soon after the diagnosis of diabetes. (E) Testing should be onsidered in hildren with growth failure, failure to gain weight, weight loss, diarrhea, flatulene, abdominal pain, or signs of malabsorption or in hildren with frequent unexplained hypoglyemia or deterioration in glyemi ontrol. (E) Consider referral to a gastroenterologist for evaluation with possible endosopy and biopsy for onfirmation of elia disease in asymptomati hildren with positive antibodies. (E) Children with biopsy-onfirmed elia disease should be plaed on a glutenfree diet and have onsultation with a dietitian experiened in managing both diabetes and elia disease. (B) Celia disease is an immune-mediated disorder that ours with inreased frequeny in patients with type 1 diabetes (1 16% of individuals ompared with 0.3 1% in the general population) (432,433). Symptoms of elia disease inlude diarrhea, weight loss or poor weight gain, growth failure, abdominal pain, hroni fatigue, malnutrition due to malabsorption, and other gastrointestinal problems, and unexplained hypoglyemia or errati blood gluose onentrations. Sreening for elia disease inludes measuring serum levels of tissue transglutaminase or antiendomysial antibodies, then small bowel biopsy in antibodypositive hildren. Reent European guidelines on sreening for elia disease in hildren (not speifi to hildren with type 1 diabetes) suggested that biopsy might not be neessary in symptomati hildren with positive antibodies, as long as further testing suh as geneti or HLA testing was supportive, but that asymptomati but atrisk hildren should have biopsies (434). One small study that inluded hildren with and without type 1 diabetes suggested that antibody-positive but biopsy-negative hildren were similar linially to those who were biopsy positive and that biopsy-negative hildren had benefits from a gluten-free diet but worsening on a usual diet (435). Beause this study was small and beause hildren with type 1 diabetes already need to follow a areful diet, it is diffiult to advoate for not onfirming the diagnosis by biopsy before reommending a lifelong gluten-free diet, espeially in asymptomati hildren. In symptomati hildren with type 1 diabetes and elia S42 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

43 disease, gluten-free diets redue symptoms and rates of hypoglyemia (436). vi. Hypothyroidism Reommendations Consider sreening hildren with type 1 diabetes for thyroid peroxidase and thyroglobulin antibodies soon after diagnosis. (E) Measuring thyroid-stimulating hormone (TSH) onentrations soon after diagnosis of type 1 diabetes, after metaboli ontrol has been established, is reasonable. If normal, onsider reheking every 1 2 years, espeially if the patient develops symptoms of thyroid dysfuntion, thyromegaly, or an abnormal growth rate. (E) Autoimmune thyroid disease is the most ommon autoimmune disorder assoiated with diabetes, ourring in 17 30% of patients with type 1 diabetes (437). About one-quarter of type 1 diabeti hildren have thyroid autoantibodies at the time of diagnosis of their diabetes (438), and the presene of thyroid autoantibodies is preditive of thyroid dysfuntion, generally hypothyroidism but less ommonly hyperthyroidism (439). Sublinial hypothyroidism may be assoiated with inreased risk of symptomati hypoglyemia (440) and with redued linear growth (441). Hyperthyroidism alters gluose metabolism, potentially resulting in deterioration of metaboli ontrol.. Self-management No matter how sound the medial regimen, it an only be as good as the ability of the family and/or individual to implement it. Family involvement in diabetes remains an important omponent of optimal diabetes management throughout hildhood and adolesene. Health are providers who are for hildren and adolesents, therefore, must be apable of evaluating the eduational, behavioral, emotional, and psyhosoial fators that impat implementation of a treatment plan and must work with the individual and family to overome barriers or redefine goals as appropriate. d. Shool and day are Sine a sizable portion of a hild s dayis spent in shool, lose ommuniation with and ooperation of shool or day are personnel is essential for optimal diabetes management, safety, and maximal aademi opportunities. See the ADA position statement on diabetes are in the shool and day are setting (442) for further disussion. e. Transition from pediatri to adult are Reommendations As teens transition into emerging adulthood, health are providers and families must reognize their many vulnerabilities (B) and prepare the developing teen, beginning in early to mid adolesene and at least 1 year prior to the transition. (E) Both pediatriians and adult health are providers should assist in providing support and links to resoures for the teen and emerging adult. (B) Care and lose supervision of diabetes management is inreasingly shifted from parents and other older adults throughout hildhood and adolesene. However, the shift from pediatris to adult health are providers often ours very abruptly as the older teen enters the next developmental stage referred to as emerging adulthood (443), a ritial period for young people who have diabetes; during this period of major life transitions, youth begin to move out of their parents home and must beome more fully responsible for their diabetes are inluding the many aspets of self management, making medial appointments, and finaning health are one they are no longer overed under their parents health insurane (444,445). In addition to lapses in health are, this is also a period of deterioration in glyemi ontrol, inreased ourrene of aute ompliations, psyho-soialemotional-behavioral issues, and emergene of hroni ompliations ( ). Though sientifi evidene ontinues to be limited, it is lear that early and ongoing attention be given to omprehensive and oordinated planning for seamless transition of all youth from pediatri to adult health are (444,445). A omprehensive disussion regarding the hallenges faed during this period, inluding speifi reommendations, is foundintheadapositionstatement Diabetes Care for Emerging Adults: Reommendations for Transition From Pediatri to Adult Diabetes Care Systems (445). The National Diabetes Eduation Program (NDEP) has materials available to failitate the transition proess ( and The Endorine Soiety (in ollaborationwiththeada and other organizations has developed transition tools for liniians and youth/ Position Statement families ( linialpratie/transition_of_are.fm). 2. Type 2 diabetes The inidene of type 2 diabetes in adolesents is inreasing, espeially in ethni minority populations (31). Distintion between type 1 and type 2 diabetes in hildren an be diffiult, sine the prevalene of overweight in hildren ontinues to rise and sine autoantigens and ketosis may be present in a substantial number of patients with features of type 2 diabetes (inluding obesity and aanthosis nigrians). Suh a distintion at the time of diagnosis is ritial beause treatment regimens, eduational approahes, and dietary ounsel will differ markedly between the two diagnoses. Type 2 diabetes has a signifiant inidene of omorbidities already present at the time of diagnosis (448). It is reommended that blood pressure measurement, a fasting lipid profile, miroalbuminuria assessment, and dilated eye examination be performed at the time of diagnosis. Thereafter, sreening guidelines and treatment reommendations for hypertension, dyslipidemia, miroalbuminuria, and retinopathy in youth with type 2 diabetes are similar to those for youth with type 1 diabetes. Additional problems that may need to be addressed inlude polyysti ovarian disease and the various omorbidities assoiated with pediatri obesity suh as sleep apnea, hepati steatosis, orthopedi ompliations, and psyhosoial onerns. The ADA onsensus statement on this subjet (33) provides guidane on the prevention, sreening, and treatment of type 2 diabetes and its omorbidities in young people. 3. Monogeni diabetes syndromes Monogeni forms of diabetes (neonatal diabetes or maturity-onset diabetes of the young) represent a small fration of hildren with diabetes (,5%), but the ready availability of ommerial geneti testing is now enabling a true geneti diagnosis with inreasing frequeny. It is important to orretly diagnose one of the monogeni forms of diabetes, as these hildren may be inorretly diagnosed with type 1 or type 2 diabetes, leading to nonoptimal treatment regimens and delays in diagnosing other family members. The diagnosis of monogeni diabetes should be onsidered in the following settings: diabetes diagnosed within the first 6 months of life; in hildren with strong family history of diabetes but without typial features of type 2 diabetes are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S43

44 Position Statement (nonobese, low-risk ethni group); in hildren with mild fasting hyperglyemia ( mg/dl [ mmol]), espeially if young and nonobese; and in hildren with diabetes but with negative autoantibodies without signs of obesity or insulin resistane. A reent international onsensus doument disusses in further detail the diagnosis and management of hildren with monogeni forms of diabetes (449). B. Preoneption are Reommendations A1C levels should be as lose to normal as possible (,7%) in an individual patient before oneption is attempted. (B) Starting at puberty, preoneption ounseling should be inorporated in the routine diabetes lini visit for all women of hildbearing potential. (C) Women with diabetes who are ontemplating pregnany should be evaluated and, if indiated, treated for diabeti retinopathy, nephropathy, neuropathy, and CVD. (B) Mediations used by suh women should be evaluated prior to oneption, sine drugs ommonly used to treat diabetes and its ompliations may be ontraindiated or not reommended in pregnany, inluding statins, ACE inhibitors, ARBs, and most noninsulin therapies. (E) Sine many pregnanies are unplanned, onsider the potential risks and benefits of mediations that are ontraindiated in pregnany in all women of hildbearing potential and ounsel women using suh mediations aordingly. (E) Major ongenital malformations remain the leading ause of mortality and serious morbidity in infants of mothers with type 1 and type 2 diabetes. Observational studies indiate that the risk of malformations inreases ontinuously with inreasing maternal glyemia during the first 6 8 weeks of gestation, as defined by first-trimester A1C onentrations. There is no threshold for A1C values below whih risk disappears entirely. However, malformation rates above the 1 2% bakground rate of nondiabeti pregnanies appear to be limited to pregnanies in whih first-trimester A1C onentrations are.1% above the normal range for a nondiabeti pregnant woman. Preoneption are of diabetes appears to redue the risk of ongenital malformations. Five nonrandomized studies ompared rates of major malformations in infants between women who partiipated in preoneption diabetes are programs and women who initiated intensive diabetes management after they were already pregnant. The preoneption are programs were multidisiplinary and designed to train patients in diabetes self-management with diet, intensified insulin therapy, and SMBG. Goals were set to ahieve normal blood gluose onentrations, and.80% of subjets ahieved normal A1C onentrations before they beame pregnant. In all five studies, the inidene of major ongenital malformations in women who partiipated in preoneption are (range % of infants) was muh lower than the inidene in women who did not partiipate (range % of infants) (106). One limitation of these studies is that partiipation in preoneption are was selfseleted rather than randomized. Thus, it is impossible to be ertain that the lower malformation rates resulted fully from improved diabetes are. Nonetheless, the evidene supports the onept that malformations an be redued or prevented by areful management of diabetes before pregnany. Planned pregnanies greatly failitate preoneption diabetes are. Unfortunately, nearly two-thirds of pregnanies in women with diabetes are unplanned, leading to a persistent exess of malformations in infants of diabeti mothers. To minimize the ourrene of these devastating malformations, standard are for all women with diabetes who have hildbearing potential, beginning at the onset of puberty or at diagnosis, should inlude 1) eduation about the risk of malformations assoiated with unplanned pregnanies and poor metaboli ontrol and 2) use of effetive ontraeption at all times, unless the patient has good metaboli ontrol and is atively trying to oneive. Women ontemplating pregnany need to be seen frequently by a multidisiplinary team experiened in the management of diabetes before and during pregnany. The goals of preoneption are are to 1) involve and empower the patient in the management of her diabetes, 2) ahieve the lowest A1C test results possible without exessive hypoglyemia, 3) assure effetive ontraeption until stable and aeptable glyemia is ahieved, and 4) identify, evaluate, and treat longterm diabetes ompliations suh as retinopathy, nephropathy, neuropathy, hypertension, and CHD (106). Among the drugs ommonly used in the treatment of patients with diabetes, a number may be relatively or absolutely ontraindiated during pregnany. Statins are ategory X (ontraindiated for use in pregnany) and should be disontinued before oneption, as should ACE inhibitors (450). ARBs are ategory C (risk annot be ruled out) in the first trimester but ategory D (positive evidene of risk) in later pregnany and should generally be disontinued before pregnany. Sine many pregnanies are unplanned, health are professionals aring for any woman of hildbearing potential should onsider the potential risks and benefits of mediations that are ontraindiated in pregnany. Women using mediations suh as statins or ACE inhibitors need ongoing family planning ounseling. Among the oral antidiabeti agents, metformin and aarbose are lassified as ategory B (no evidene of risk in humans) and all others as ategory C. Potential risks and benefits of oral antidiabeti agents in the preoneption period must be arefully weighed, reognizing that data are insuffiient to establish the safety of these agents in pregnany. For further disussion of preoneption are, see the ADA s onsensus statement on pre-existing diabetes and pregnany (106) and the position statement (451) on this subjet. C. Older adults Reommendations Olderadultswhoarefuntional,ognitively intat, and have signifiant life expetany should reeive diabetes are with goals similar to those developed for younger adults. (E) Glyemi goals for some older adults might reasonably be relaxed, using individual riteria, but hyperglyemia leading to symptoms or risk of aute hyperglyemi ompliations should be avoided in all patients. (E) Other ardiovasular risk fators should be treated in older adults with onsideration of the time frame of benefit and the individual patient. Treatment of hypertension is indiated in virtually all older adults, and lipid and aspirin therapy may benefit those with life expetany at least equal to the time frame of primary or seondary prevention trials. (E) Sreening for diabetes ompliations should be individualized in older adults, but partiular attention should be paid to ompliations that would lead to funtional impairment. (E) S44 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

45 Diabetes is an important health ondition for the aging population; at least 20% of patients over the age of 65 years have diabetes, and this number an be expeted to grow rapidly in the oming deades. Older individuals with diabetes have higher rates of premature death, funtional disability, and oexisting illnesses suh as hypertension, CHD, and stroke than those without diabetes. Older adults with diabetes are also at greater risk than other older adults for several ommon geriatri syndromes, suh as polypharmay, depression, ognitive impairment, urinary inontinene, injurious falls, and persistent pain. A onsensus report on diabetes and older adults (452) influened the following disussion and reommendations. The are of older adults with diabetes is ompliated by their linial and funtional heterogeneity. Some older individuals developed diabetes years earlier and may have signifiant ompliations; others who are newly diagnosed may have had years of undiagnosed diabetes with resultant ompliations or may have truly reent-onset disease and few or no ompliations. Some older adults with diabetes are frail and have other underlying hroni onditions, substantial diabetesrelated omorbidity, or limited physial or ognitive funtioning. Other older individuals with diabetes have little omorbidity and are ative. Life expetanies are highly variable for this population, but often longer than liniians realize. Providers aring for older adults with diabetes must take this heterogeneity into onsideration when setting and prioritizing treatment goals. There are few long-term studies in older adults demonstrating the benefits of intensive glyemi, blood pressure, and lipid ontrol. Patients who an be expeted to live long enough to reap the benefits of long-term intensive diabetes management, who have good ognitive and funtional funtion, and who hoose to do so via shared deision making may be treated using therapeuti interventions and goals similar to those for younger adults with diabetes. As with all patients, DSME and ongoing DSMS are vital omponents of diabetes are for older adults and their aregivers. For patients with advaned diabetes ompliations, life-limiting omorbid illness, or substantial ognitive or funtional impairment, it is reasonable to set less intensive glyemi target goals. These patients are less likely to benefit from reduing the risk of mirovasular ompliations and more likely to suffer serious adverse effets from hypoglyemia. However, patients with poorly ontrolled diabetes may be subjet to aute ompliations of diabetes, inluding dehydration, poor wound healing, and hyperglyemi hyperosmolar oma. Glyemi goals at a minimum should avoid these onsequenes. Although ontrol of hyperglyemia may be important in older individuals with diabetes, greater redutions in morbidity and mortality may result from ontrol of other ardiovasular risk fators rather than from tight glyemi ontrol alone. There is strong evidene from linial trials of the value of treating hypertension in the elderly (453,454). There is less evidene for lipid-lowering and aspirin therapy, although the benefits of these interventions for primary and seondary prevention are likely to apply to older adults whose life expetanies equal or exeed the time frames seen in linial trials. Speial are is required in presribing and monitoring pharmaologial therapy in older adults. Costs may be a signifiant fator, espeially sine older adults tend to be on many mediations. Metformin may be ontraindiated beause of renal insuffiieny or signifiant heart failure. Thiazolidinediones, if used at all, should be used very autiously in those with, or at risk for, CHF and have also been assoiated with fratures. Sulfonylureas, other insulin seretagogues, and insulin an ause hypoglyemia. Insulin use requires that patients or aregivers have good visual and motor skills and ognitive ability. Dipeptidyl peptidase 4 (DPP-4) inhibitors have few side effets, but their osts may be a barrier to some older patients; the latter is also the ase for GLP-1 agonists. Sreening for diabetes ompliations in older adults also should be individualized. Partiular attention should be paid to ompliations that an develop over short periods of time and/or that would signifiantly impair funtional status, suh as visual and lower-extremity ompliations. D. Cysti fibrosis related diabetes Reommendations Annual sreening for ysti fibrosis related diabetes (CFRD) with OGTT should begin by age 10 years in all patients with ysti fibrosis who do not have CFRD (B). Use of A1C as a sreening test for CFRD is not reommended. (B) During a period of stable health, the diagnosis of CFRD an be made in ysti fibrosis patients aording to usual gluose riteria. (E) Patients with CFRD should be treated with insulin to attain individualized glyemi goals. (A) Annual monitoring for ompliations of diabetes is reommended, beginning 5 years after the diagnosis of CFRD. (E) CFRD is the most ommon omorbidity in persons with ysti fibrosis, ourring in about 20% of adolesents and 40 50% of adults. The additional diagnosis of diabetes in this population is assoiated with worse nutritional status, more severe inflammatory lung disease, and greater mortality from respiratory failure. Insulin insuffiieny related to partial fibroti destrution of the islet mass is the primary defet in CFRD. Genetially determined funtion of the remaining b-ells and insulin resistane assoiated with infetion and inflammation may also play a role. Enouraging new data suggest that early detetion and aggressive insulin therapy have narrowed the gap in mortality between ysti fibrosis patients with and without diabetes and have eliminated the sex differene in mortality (455). Reommendations for the linial management of CFRD an be found in the reent ADA position statement on this topi (456). IX. DIABETES CARE IN SPECIFIC SETTINGS Position Statement A. Diabetes are in the hospital Reommendations All patients with diabetes admitted to the hospital should have their diabetes learly identified in the medial reord. (E) All patients with diabetes should have an order for blood gluose monitoring, with results available to all members of the health are team. (E) Goals for blood gluose levels: Critially ill patients: Insulin therapy should be initiated for treatment of persistent hyperglyemia starting at a threshold of no greater than 180 mg/dl (10 mmol/l). One insulin therapy is started, a gluose range of mg/dl ( mmol/l) is reommended for the majority of ritially ill patients. (A) More stringent goals, suh as mg/dl ( mmol/l) may be are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S45

46 Position Statement appropriate for seleted patients, as long as this an be ahieved without signifiant hypoglyemia. (C) Critially ill patients require an intravenous insulin protool that has demonstrated effiay and safety in ahieving the desired gluose range without inreasing risk for severe hypoglyemia. (E) Non ritially ill patients: There is no lear evidene for speifi blood gluose goals. If treated with insulin, the premeal blood gluose targets generally,140 mg/dl (7.8 mmol/l) with random blood gluose,180 mg/dl (10.0 mmol/l) are reasonable, provided these targets an be safely ahieved. More stringent targets may be appropriate in stable patients with previous tight glyemi ontrol. Less stringent targets may be appropriate in those with severe omorbidities. (E) Sheduled subutaneous insulin with basal, nutritional, and orretion omponents is the preferred method for ahieving and maintaining gluose ontrol in non ritially ill patients. (C) Gluose monitoring should be initiated in any patient not known to be diabeti who reeives therapy assoiated with high risk for hyperglyemia, inluding high-dose gluoortioid therapy, initiation of enteral or parenteral nutrition, or other mediations suh as otreotide or immunosuppressive mediations. (B) If hyperglyemia is doumented and persistent, onsider treating suh patients to the same glyemi goals as patients with known diabetes. (E) A hypoglyemia management protool should be adopted and implemented by eah hospital or hospital system. A plan for preventing and treating hypoglyemia should be established for eah patient. Episodes of hypoglyemia in the hospital should be doumented in the medial reord and traked. (E) Consider obtaining an A1C on patients with diabetes admitted to the hospital if the result of testing in the previous 2 3 months is not available. (E) Consider obtaining an A1C in patients with risk fators for undiagnosed diabetes who exhibit hyperglyemia in the hospital. (E) Patients with hyperglyemia in the hospital who do not have a prior diagnosis of diabetes should have appropriate plans for follow-up testing and are doumented at disharge. (E) Hyperglyemia in the hospital an represent previously known diabetes, previously undiagnosed diabetes, or hospital-related hyperglyemia (fasting blood gluose $126 mg/dl or random blood gluose $200 mg/dl ourring during the hospitalization that reverts to normal after hospital disharge). The diffiulty distinguishing between the seond and third ategories during the hospitalization may be overome by measuring an A1C in undiagnosed patients with hyperglyemia, as long as onditions interfering with A1C utility (hemolysis, blood transfusion) have not ourred. The management of hyperglyemia in the hospital has often been onsidered seondary in importane to the ondition that prompted admission (457). However, a body of literature now supports targeted gluose ontrol in the hospital setting for potential improved linial outomes. Hyperglyemia in the hospital may result from stress, deompensation of type 1 or type 2 or other forms of diabetes, and/or may be iatrogeni due to withholding of antihyperglyemi mediations or administration of hyperglyemia-provoking agents suh as gluoortioids or vasopressors. There is substantial observational evidene linking hyperglyemia in hospitalized patients (with or without diabetes) to poor outomes. Cohort studies as well as a few early RCTs suggested that intensive treatment of hyperglyemia improved hospital outomes ( ). In general, these studies were heterogeneous in terms of patient population, blood gluose targets and insulin protools used, provision of nutritional support, and the proportion of patients reeiving insulin, whih limits the ability to make meaningful omparisons among them. Reent trials in ritially ill patients have failed to show a signifiant improvement in mortality with intensive glyemi ontrol (460,461) or have even shown inreased mortality risk (462). Moreover, these reent RCTs have highlighted the risk of severe hypoglyemia resulting from suh efforts ( ). The largest study to date, NICE- SUGAR (Normoglyaemia in Intensive Care Evaluation and Survival Using Gluose Algorithm Regulation), a multienter, multinational RCT, ompared the effet of intensive glyemi ontrol (target mg/dl, mean blood gluose attained 115 mg/dl) to standard glyemi ontrol (target mg/dl, mean blood gluose attained 144 mg/dl) on outomes among 6,104 ritially ill partiipants, almost all of whom required mehanial ventilation (462). Ninety-day mortality was signifiantly higher in the intensive versus the onventional groupinbothsurgialandmedialpatients, as was mortality from ardiovasular auses. Severe hypoglyemia was also more ommon in the intensively treated group (6.8% vs. 0.5%, P, 0.001). The preise reason for the inreased mortality in the tightly ontrolled group is unknown. The results of this study lie in stark ontrast to a famous 2001 singleenter study that reported a 42% relative redution in intensive are unit (ICU) mortality in ritially ill surgial patients treated to a target blood gluose of mg/dl (458). Importantly, the ontrol group in NICE-SUGAR had reasonably good blood gluose management, maintained at a mean gluose of 144 mg/dl, only 29 mg/dl above the intensively managed patients. Aordingly, this study s findings do not disprove the notion that glyemi ontrol in the ICU is important. However, they do strongly suggest that it may not be neessary to target blood gluose values,140 mg/dl and that a highly stringent target of,110 mg/dl may atually be dangerous. In a reent meta-analysis of 26 trials (N 5 13,567), whih inluded the NICE- SUGAR data, the pooled RR of death with intensive insulin therapy was 0.93 as ompared with onventional therapy (95% CI ) (465). Approximately half of these trials reported hypoglyemia, with a pooled RR of intensive therapy of 6.0 (95% CI ). The speifi ICU setting influened the findings, with patients in surgial ICUs appearing to benefit from intensive insulin therapy (RR 0.63, 95% CI ), whereas those in other medial and mixed ritial are settings did not. It was onluded that, overall, intensive insulin therapy inreased the risk of hypoglyemia but provided no overall benefit on mortality in the ritially ill, although a possible mortality benefit to patients admitted to the surgial ICU was suggested. 1. Glyemi targets in hospitalized patients Definition of gluose abnormalities in the hospital setting Hyperglyemia in the hospital has been defined as any blood gluose.140 mg/dl (7.8 mmol/l). Levels that are signifiantly and persistently above this may require treatment in hospitalized patients. A1C values.6.5% suggest, in undiagnosed S46 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

47 patients, that diabetes preeded hospitalization (466). Hypoglyemia has been definedasanybloodgluose,70 mg/dl (3.9 mmol/l). This is the standard definition in outpatients and orrelates with the initial threshold for the release of ounterregulatory hormones. Severe hypoglyemia in hospitalized patients has been defined by many as,40 mg/dl (2.2 mmol/l), although this is lower than the ;50 mg/dl (2.8 mmol/l) level at whih ognitive impairment begins in normal individuals (467). As with hyperglyemia, hypoglyemia among inpatients is also assoiated with adverse short- and long-term outomes. Early reognition and treatment of mild to moderate hypoglyemia (40 69 mg/dl [ mmol/l]) an prevent deterioration to a more severe episode with potential adverse sequelae (468). Critially ill patients Based on the weight of the available evidene, for the majority of ritially ill patients in the ICU setting, insulin infusion should be used to ontrol hyperglyemia, with a starting threshold of no higher than 180 mg/dl (10.0 mmol/l). One intravenous insulin is started, the gluose level should be maintained between 140 and 180 mg/dl (7.8 and 10.0 mmol/l). Greater benefit maybe realized at the lower end of this range. Although strong evidene is laking, somewhat lower gluose targets may be appropriate in seleted patients. One small study suggested that medial intensive are unit (MICU) patients treated to targets of mg/dl had less negative nitrogen balane than those treated to higher targets (469). However, targets,110 mg/dl (6.1 mmol/l) are not reommended. Use of insulin infusion protools with demonstrated safety and effiay, resulting in low rates of hypoglyemia, are highly reommended (468). Non ritially ill patients With no prospetive RCT data to inform speifi glyemi targets in non ritially ill patients, reommendations are based on linial experiene and judgment (470). For the majority of non ritially ill patients treated with insulin, premeal gluose targets should generally be,140 mg/dl (7.8 mmol/l) with random blood gluose,180 mg/dl (10.0 mmol/l), as long as these targets an be safely ahieved. To avoid hypoglyemia, onsideration should be given to reassessing the insulin regimen if blood gluose levels fall below 100 mg/dl (5.6 mmol/l). Modifiation of the regimen is required when blood gluose values are,70 mg/dl (3.9 mmol/l), unless the event is easily explained by other fators (suh as a missed meal). There is some evidene that systemati attention to hyperglyemia in the emergeny room leads to better glyemi ontrol in the hospital for those subsequently admitted (471). Oasional patients with a prior history of suessful tight glyemi ontrol in the outpatient setting who are linially stable may be maintained with a gluose range below the above ut points. Conversely, higher gluose ranges may be aeptable in terminally ill patients or in patients with severe omorbidities, as well as in those in patient are settings where frequent gluose monitoring or lose nursing supervision is not feasible. Clinial judgment, ombined with ongoing assessment of the patient s linial status, inluding hanges in the trajetory of gluose measures, the severity of illness, nutritional status, or onurrent use of mediations that might affet gluose levels (e.g., steroids, otreotide), must be inorporated into the day-today deisions regarding insulin dosing (468). 2. Antihyperglyemi agents in hospitalized patients In the hospital setting, insulin therapy is the preferred method of glyemi ontrol in majority of linial situations (468). In the ICU, intravenous infusion is the preferred route of insulin administration. When the patient is transitioned off intravenous insulin to subutaneous therapy, preautions should be taken to prevent hyperglyemia esape (472,473). Outside of ritial are units, sheduled subutaneous insulin that delivers basal, nutritional, and orretion (supplemental) omponents is preferred. Typial dosing shemes are based on body weight, with some evidene that patients with renal insuffiieny should be treated with lower doses (474). Prolonged therapy with sliding-sale insulin (SSI) as the sole regimen is ineffetive in the majority of patients, inreases risk of both hypoglyemia and hyperglyemia, and has reently been shown in a randomized trial to be assoiated with adverse outomes in general surgery patients with type 2 diabetes (475). SSI is potentially dangerous in type 1 diabetes (468). The reader is referred to several reent publiations and reviews that desribe urrently available insulin preparations and protools and provide guidane in use of insulin therapy in Position Statement speifi linial settings inluding parenteral nutrition (476), enteral tube feedings and with high dose gluoortioid therapy (468). There are no data on the safety and effiay of oral agents and injetable noninsulin therapies suh as GLP-1 analogs and pramlintide in the hospital. They are generally onsidered to have a limited role in the management of hyperglyemia in onjuntion with aute illness. Continuation of these agents may be appropriate in seleted stable patients who are expeted to onsume meals at regular intervals, and they may be initiated or resumed in antiipation of disharge one the patient is linially stable. Speifi aution is required with metformin, due to the possibility that a ontraindiation may develop during the hospitalization, suh as renal insuffiieny, unstable hemodynami status, or need for an imaging study that requires a radio-ontrast dye. 3. Preventing hypoglyemia In the hospital, multiple risk fators for hypoglyemia are present. Patients with or without diabetes may experiene hypoglyemia in the hospital in assoiation with altered nutritional state, heart failure, renal or liver disease, malignany, infetion, or sepsis. Additional triggering events leading to iatrogeni hypoglyemia inlude sudden redution of ortiosteroid dose, altered ability of the patient to report symptoms, redution of oral intake, emesis, new NPO status, inappropriate timing of short- or rapid-ating insulin in relation to meals, redution of rate of administration of intravenous dextrose, and unexpeted interruption of enteral feedings or parenteral nutrition. Despite the preventable nature of many inpatient episodes of hypoglyemia, institutions are more likely to have nursing protools for the treatment of hypoglyemia than for its prevention. Traking suh episodes and analyzing their auses are important quality-improvement ativities (468). 4. Diabetes are providers in the hospital Inpatient diabetes management may be effetively hampioned and/or provided by primary are physiians, endorinologists, intensivists, or hospitalists. Involvement of appropriately trained speialists or speialty teams may redue length of stay, improve glyemi ontrol, and improve outomes (468). In the are of diabetes, implementation of standardized are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S47

48 Position Statement order sets for sheduled and orretiondose insulin may redue reliane on sliding-sale management. As hospitals move to omply with meaningful use regulations for eletroni health reords, as mandated by the Health Information Tehnology At, efforts should be made to assure that all omponents of strutured insulin order sets are inorporated into eletroni insulin order sets (477,478). A team approah is needed to establish hospital pathways. To ahieve glyemi targets assoiated with improved hospital outomes, hospitals will need multidisiplinary support to develop insulin management protools that effetively and safely enable ahievement of glyemi targets (479). 5. Self-management in the hospital Self-management of diabetes in the hospital may be appropriate for ompetent adult patients who have a stable level of onsiousness, have reasonably stable daily insulin requirements, suessfully ondut self-management of diabetes at home, have physial skills needed to suessfully self-administer insulin and perform SMBG, have adequate oral intake, and are profiient in arbohydrate ounting, use of multiple daily insulin injetions or insulin pump therapy, and sik-day management. The patient and physiian, in onsultation with nursing staff, must agree that patient selfmanagement is appropriate under the onditions of hospitalization. Patients who use CSII pump therapy in the outpatient setting an be andidates for diabetes self-management in the hospital, provided that they have the mental and physial apaity to do so (468). A hospital poliy and proedures delineating inpatient guidelines for CSII therapy are advisable, and availability of hospital personnel with expertise in CSII therapy is essential. It is important that nursing personnel doument basal rates and bolus doses taken on a regular basis (at least daily). 6. MNT in the hospital The goals of MNT are to optimize glyemi ontrol, to provide adequate alories to meet metaboli demands, and to reate a disharge plan for follow-up are (457,480). The ADA does not endorse any single meal plan or speified perentages of maronutrients, and the term ADA diet should no longer be used. Current nutrition reommendations advise individualization based on treatment goals, physiologial parameters, and mediation usage. Consistent arbohydrate meal plans are preferred by many hospitals beause they failitate mathing the prandial insulin dose to the amount of arbohydrate onsumed (481). Beause of the omplexity of nutrition issues in the hospital, a registered dietitian, knowledgeable and skilled in MNT, should serve as an inpatient team member. The dietitian is responsible for integrating information about the patient s linial ondition, eating, and lifestyle habits and for establishing treatment goals in order to determine a realisti plan for nutrition therapy (482,483). 7. Bedside blood gluose monitoring POC blood gluose monitoring performed at the bedside is used to guide insulin dosing. In the patient who is reeiving nutrition, the timing of gluose monitoring should math arbohydrate exposure. In the patient who is not reeiving nutrition, gluose monitoring is performed every 4 to 6 h (484,485). More frequent blood gluose testing ranging from every 30 min to every 2 h is required for patients on intravenous insulin infusions. Safety standards should be established for blood gluose monitoring prohibiting sharing of finger-stik laning devies, lanets, needles, and meters to redue the risk of transmission of blood borne diseases. Shared laning devies arry essentially the same risk as is onferred from sharing of syringes and needles (486). Auray of blood gluose measurements using POC meters has limitations that must be onsidered. Although the FDA allows a 1/2 20% error for blood gluose meters, questions about the appropriateness of these riteria have been raised (388). Gluose measures differ signifiantly between plasma and whole blood, terms that are often used interhangeably and an lead to misinterpretation. Most ommerially available apillary blood gluose meters introdue a orretion fator of ;1.12 to report a plasma-adjusted value (487). Signifiant disrepanies between apillary, venous, and arterial plasma samples have been observed in patients with low or high hemoglobin onentrations, hypoperfusion, and the presene of interfering substanes partiularly maltose, as ontained in immunoglobulins (488). Analytial variability has been desribed with several POC meters (489). Inreasingly newer generation POC blood gluose meters orret for variation in hematorit and for interfering substanes. Any gluose result that does not orrelate with the patient s statusshouldbeonfirmed through onventional laboratory sampling of plasma gluose. The FDA has beome inreasingly onerned about the use of POC blood gluose meters in the hospital and is presently reviewing matters related to their use. 8. Disharge planning and DSME Transition from the aute are setting is a high-risk time for all patients, not just those with diabetes or new hyperglyemia. Although there is an extensive literature onerning safe transition within and from the hospital, little of it is speifi to diabetes (490). It is important to remember that diabetes disharge planning is not a separate entity, but is part of an overall disharge plan. As suh, disharge planning begins at admission to the hospital and is updated as projeted patient needs hange. Inpatients may be disharged to varied settings, inluding home (with or without visiting nurse servies), assisted living, rehabilitation, or skilled nursing failities. The latter two sites are generally staffed by health professionals, so diabetes disharge planning will be limited to ommuniation of mediation and diet orders. For the patient who is disharged to assisted living or to home, the optimal program will need to onsider the type and severity of diabetes, the effets of the patient s illness on blood gluose levels, and the apaities and desires of the patient. Smooth transition to outpatient are should be ensured. The Ageny for Healthare Researh and Quality (AHRQ) reommends that at a minimum, disharge plans inlude the following: Mediation reoniliation: The patient s mediations must be rossheked to ensure that no hroni mediations were stopped and to ensure the safety of new presriptions. Whenever possible, presriptions for new or hanged mediation should be filled and reviewed with the patient and family at or before disharge. Strutured disharge ommuniation: Information on mediation hanges, pending tests and studies, and follow-up needs must be aurately and promptly ommuniated to outpatient physiians. Disharge summaries should be transmitted to the primary physiian as soon as possible after disharge. Appointment keeping behavior is enhaned when the inpatient team S48 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

49 shedules outpatient medial followup prior to disharge. Ideally the inpatient are providers or ase managers/ disharge planners will shedule follow-up visit(s) with the appropriate professionals, inluding the primary are provider, endorinologist, and diabetes eduator (491). Teahing diabetes self-management to patients in hospitals is a hallenging task. Patients are ill, under inreased stress related to their hospitalization and diagnosis, and in an environment not onduive to learning. Ideally, people with diabetes should be taught at a time and plae onduive to learning: as an outpatient in a reognized program of diabetes eduation. For the hospitalized patient, diabetes survival skills eduation is generally a feasible approah to provide suffiient information and training to enable safe are at home. Patients hospitalized beause of a risis related to diabetes management or poor are at home need eduation to prevent subsequent episodes of hospitalization. An assessment of the need for a home health referral or referral to an outpatient diabetes eduation program should be part of disharge planning for all patients. DSME annot wait until disharge, espeially in those new to insulin therapy or in whom the diabetes regimen has been substantially altered during the hospitalization. It is reommended that the following areas of knowledge be reviewed and addressed prior to hospital disharge: Identifiation of health are provider who will provide diabetes are after disharge Level of understanding related to the diagnosis of diabetes, SMBG, and explanation of home blood gluose goals Definition, reognition, treatment, and prevention of hyperglyemia and hypoglyemia Information on onsistent eating patterns When and how to take blood gluose lowering mediations inluding insulin administration (if going home on insulin) Sik-day management Proper use and disposal of needles and syringes It is important that patients be provided with appropriate durable medial equipment, mediation, supplies, and presriptions at the time of disharge in order to avoid a potentially dangerous hiatus in are. These supplies/presriptions should inlude the following: Insulin (vials or pens) if needed Syringes or pen needles (if needed) Oral mediations (if needed) Blood gluose meter and strips Lanets and laning devie Urine ketone strips (type 1) Gluagon emergeny kit (insulin-treated) Medial alert appliation/harm More expanded diabetes eduation an be arranged in the ommunity. An outpatient follow-up visit with the primary are provider, endorinologist, or diabetes eduator within 1 month of disharge is advised for all patients having hyperglyemia in the hospital. Clear ommuniation with outpatient providers either diretly or via hospital disharge summaries failitates safe transitions to outpatient are. Providing information regarding the ause or the plan for determining the ause of hyperglyemia, related ompliations and omorbidities, and reommended treatments an assist outpatient providers as they assume ongoing are. B. Diabetes and employment Any person with diabetes, whether insulin treated or noninsulin treated, should be eligible for any employment for whih he/she is otherwise qualified. Employment deisions should never be based on generalizations or stereotypes regarding the effets of diabetes. When questions arise about the medial fitness of a person with diabetes for a partiular job, a health are professional with expertise in treating diabetes should perform an individualized assessment. See the ADA position statement on diabetes and employment (492). C. Diabetes and driving A large perentage of people with diabetes in the U.S. and elsewhere seek a liense to drive, either for personal or employment purposes. There has been onsiderable debate whether, and the extent to whih, diabetes may be a relevant fator in determining the driver ability and eligibility for a liense. People with diabetes are subjet to a great variety of liensing requirements applied by both state and federal jurisditions, whih may lead to loss of employment or signifiant restritions on a person s liense. Presene of a medial ondition that an lead to signifiantly Position Statement impaired onsiousness or ognition may lead to drivers being evaluated for fitness to drive. For diabetes, this typially arises when the person has had a hypoglyemi episode behind the wheel, even if this did not lead to a motor vehile aident. Epidemiologial and simulator data suggest that people with insulin-treated diabetes have a small inrease in risk of motor vehile aidents, primarily due to hypoglyemia and dereased awareness of hypoglyemia. This inrease (RR ) is muh smaller than the risks assoiated with teenage male drivers (RR 42), driving at night (RR 142), driving on rural roads ompared with urban roads (RR 9.2), and obstrutive sleep apnea (RR 2.4), all of whih are aepted for unrestrited liensure. The ADA position statement on diabetes and driving (493) reommends against blanket restritions based on the diagnosis of diabetes and urges individual assessment by a health are professional knowledgeable in diabetes if restritions on liensure are being onsidered. Patients should be evaluated for dereased awareness of hypoglyemia, hypoglyemia episodes while driving, or severe hypoglyemia. Patients with retinopathy or peripheral neuropathy require assessment to determine if those ompliations interfere with operation of a motor vehile. Health are professionals should be ognizant of the potential risk of driving with diabetes and ounsel their patients about deteting and avoiding hypoglyemia while driving. D. Diabetes management in orretional institutions People with diabetes in orretional failities should reeive are that meets national standards. Beause it is estimated that nearly 80,000 inmates have diabetes, orretional institutions should have written poliies and proedures for the management of diabetes and for training of medial and orretional staff in diabetes are praties. See the ADA position statement on diabetes management in orretional institutions (494) for further disussion. X. STRATEGIES FOR IMPROVING DIABETES CARE Reommendations Care should be aligned with omponents of the Chroni Care Model (CCM) to ensure produtive interations between a prepared proative are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S49

50 Position Statement pratie team and an informed ativated patient. (A) When feasible, are systems should support team-based are, ommunity involvement, patient registries, and embedded deision support tools to meet patient needs. (B) Treatment deisions should be timely and based on evidene-based guidelines that are tailored to individual patient preferenes, prognoses, and omorbidities. (B) A patient-entered ommuniation style should be employed that inorporates patient preferenes, assesses literay and numeray, and addresses ultural barriers to are. (B) There has been steady improvement in the proportion of diabeti patients ahieving reommended levels of A1C, blood pressure, and LDL holesterol in the last 10 years, both in primary are settings and in endorinology praties. Mean A1C nationally has delined from 7.82% in to 7.18% in 2004 based on NHANES data (495). This has been aompanied by improvements in lipids and blood pressure ontrol and led to substantial redutions in end-stage mirovasular ompliations in those with diabetes. Nevertheless in some studies only 57.1% of adults with diagnosed diabetes ahieved an A1C of,7%, only 45.5% had a blood pressure,130/80 mmhg, and just 46.5% had a total holesterol,200 mg/dl, with only 12.2% of people with diabetes ahieving all three treatment goals (496). Evidene also suggests that progress in risk fator ontrol may be slowing (497). Certain patient groups, suh as patients with omplex omorbidities, finanial or other soial hardships, and/or limited English profiieny, may present partiular hallenges to goalbased are (498,499). Persistent variation in quality of diabetes are aross providers and aross pratie settings even after adjusting for patient fators indiates that there remains potential for substantial further improvements in diabetes are. Although numerous interventions to improve adherene to the reommended standards have been implemented, a major barrier to optimal are is a delivery system that too often is fragmented, laks linial information apabilities, often dupliates servies, and is poorly designed for the oordinated delivery of hroni are. The CCM has been shown in numerous studies to be an effetive framework for improving the quality of diabetes are (500). The CCM inludes six ore elements for the provision of optimal are of patients with hroni disease: 1) delivery system design (moving from a reative to a proative are delivery system where planned visits are oordinated through a team based approah), 2) self-management support, 3) deision support (basing are on evidene-based, effetive are guidelines), 4) linial information systems (using registries that an provide patient-speifi and populationbased support to the are team), 5) ommunity resoures and poliies (identifying or developing resoures to support healthy lifestyles), and 6) health systems (to reate a quality-oriented ulture). Redefinition of the roles of the lini staff and promoting self-management on the part of the patient are fundamental to the suessful implementation of the CCM (501). Collaborative, multidisiplinary teams are best suited to provide suh are for people with hroni onditions suh as diabetes and to failitate patients performane of appropriate self-management (163,165,220,502). NDEP maintains an online resoure ( to help health are professionals design and implement more effetive health are delivery systems for those with diabetes. Three speifi objetives, with referenes to literature that outlines pratial strategies to ahieve eah, are outlined below. Objetive 1: Optimize provider and team behavior The are team should prioritize timely and appropriate intensifiation of lifestyle and/ or pharmaeutial therapy of patients who have not ahieved benefiial levels of blood pressure, lipid, or gluose ontrol (503). Strategies suh as expliit goal setting with patients (504); identifying and addressing language, numeray, or ultural barriers to are ( ); integrating evidene-based guidelines and linial information tools into the proess of are ( ); and inorporating are management teams inluding nurses, pharmaists, and other providers ( ) have eah been shown to optimize provider and team behavior and thereby atalyze redution in A1C, blood pressure, and LDL holesterol. Objetive 2: Support patient behavior hange Suessful diabetes are requires a systemati approah to supporting patients behavior hange efforts, inluding a) healthy lifestyle hanges (physial ativity, healthy eating, nonuse of tobao, weight management, effetive oping), b) disease self-management (mediation taking and management; self-monitoring of gluose and blood pressure when linially appropriate), and ) prevention of diabetes ompliations (self-monitoring of foot health; ative partiipation in sreening for eye, foot, and renal ompliations; immunizations). High-quality DSME has been shown to improve patient self-management, satisfation, and gluose ontrol (184,516), as has delivery of ongoing DSMS so that gains ahieved during DSME are sustained (134,135,152). National DSME standards all for an integrated approah that inludes linial ontent and skills, behavioral strategies (goal-setting, problem solving), and addressing emotional onerns in eah needed urriulum ontent area. Objetive 3: Change the system of are The most suessful praties have an institutional priority for providing high quality of are (517). Changes that have been shown to inrease quality of diabetes are inlude basing are on evidene-based guidelines (518), expanding the role of teams and staff (501,519), redesigning the proesses of are (520), implementing eletroni health reord tools (521,522), ativating and eduating patients (523,524), and identifying and/or developing and engaging ommunity resoures and publi poliy that support healthy lifestyles (525). Reent initiatives suh as the Patient-Centered Medial Home show promise to improve outomes through oordinated primary are and offer new opportunities for team-based hroni disease are (526). Alterations in reimbursement that reward the provision of appropriate and high-quality are rather than visitbased billing (527) and that an aommodate the need to personalize are goals may provide additional inentives to improve diabetes are (528). It is lear that optimal diabetes management requires an organized, systemati approah and involvement of a oordinated team of dediated health are professionals working in an environment where patient-entered high-quality are is a priority. Referenes 1. Amerian Diabetes Assoiation. Medial Management of Type 1 Diabetes. Alexandria, VA, Amerian Diabetes Assoiation, Amerian Diabetes Assoiation. Medial Management of Type 2 Diabetes. S50 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

51 Alexandria, VA, Amerian Diabetes Assoiation, Amerian Diabetes Assoiation. Therapy for Diabetes Mellitus and Related Disorders. Alexandria, VA, Amerian Diabetes Assoiation, Li R, Zhang P, Barker LE, Chowdhury FM, Zhang X. Cost-effetiveness of interventions to prevent and ontrol diabetes mellitus: a systemati review. Diabetes Care 2010;33: Amerian Diabetes Assoiation. Diagnosis and lassifiation of diabetes mellitus. Diabetes Care 2010;33(Suppl. 1):S62 S69 6. International Expert Committee. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care 2009;32: Ziemer DC, Kolm P, Weintraub WS, et al. Gluose-independent, blak-white differenes in hemoglobin A1 levels: a ross-setional analysis of 2 studies. Ann Intern Med 2010;152: Kumar PR, Bhansali A, Ravikiran M, et al. Utility of glyated hemoglobin in diagnosing type 2 diabetes mellitus: a ommunity-based study. J Clin Endorinol Metab 2010;95: Selvin E, Steffes MW, Ballantyne CM, Hoogeveen RC, Coresh J, Branati FL. Raial differenes in glyemi markers: a ross-setional analysis of ommunitybased data. Ann Intern Med 2011;154: Nowika P, Santoro N, Liu H, et al. Utility of hemoglobin A(1) for diagnosing prediabetes and diabetes in obese hildren and adolesents. Diabetes Care 2011;34: Cowie CC, Rust KF, Byrd-Holt DD, et al. Prevalene of diabetes and high risk for diabetes using A1C riteria in the U.S. population in Diabetes Care 2010;33: Pión MJ, Murri M, Muñoz A, Fernandez-Garıa JC, Gomez-Huelgas R, Tinahones FJ. Hemoglobin A1 versus oral gluose tolerane test in postpartum diabetes sreening. Diabetes Care 2012; 35: Expert Committee on the Diagnosis and Classifiation of Diabetes Mellitus. Report of the Expert Committee on the Diagnosis and Classifiation of Diabetes Mellitus. Diabetes Care 1997;20: Genuth S, Alberti KG, Bennett P, et al.; Expert Committee on the Diagnosis and Classifiation of Diabetes Mellitus. Follow-up report on the diagnosis of diabetes mellitus. Diabetes Care 2003; 26: Zhang X, Gregg EW, Williamson DF, et al. A1C level and future risk of diabetes: a systemati review. Diabetes Care 2010;33: Selvin E, Steffes MW, Zhu H, et al. Glyated hemoglobin, diabetes, and ardiovasular risk in nondiabeti adults. N Engl J Med 2010;362: Akermann RT, Cheng YJ, Williamson DF, Gregg EW. Identifying adults at high risk for diabetes and ardiovasular disease using hemoglobin A1 National Health and Nutrition Examination Survey Am J Prev Med 2011;40: Griffin SJ, Borh-Johnsen K, Davies MJ, et al. Effet of early intensive multifatorial therapy on 5-year ardiovasular outomes in individuals with type 2 diabetes deteted by sreening (ADDI- TION-Europe): a luster-randomised trial. Lanet 2011;378: Kahn R, Alperin P, Eddy D, et al. Age at initiation and frequeny of sreening to detet type 2 diabetes: a osteffetiveness analysis. Lanet 2010;375: Erikson SC, Le L, Zakharyan A, et al. New-onset treatment-dependent diabetes mellitus and hyperlipidemia assoiated with atypial antipsyhoti use in older adults without shizophrenia or bipolar disorder. J Am Geriatr So 2012; 60: Chiu M, Austin PC, Manuel DG, Shah BR, Tu JV. Deriving ethni-speifi BMI utoff points for assessing diabetes risk. Diabetes Care 2011;34: Sheehy A, Pandhi N, Coursin DB, et al. Minority status and diabetes sreening in an ambulatory population. Diabetes Care 2011;34: Knowler WC, Barrett-Connor E, Fowler SE, et al.; Diabetes Prevention Program Researh Group. Redution in the inidene of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346: Tuomilehto J, Lindström J, Eriksson JG, et al.; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by hanges in lifestyle among subjets with impaired gluose tolerane. N Engl J Med 2001;344: Pan XR, Li GW, Hu YH, et al. Effets of diet and exerise in preventing NIDDM in people with impaired gluose tolerane. The Da Qing IGT and Diabetes Study. Diabetes Care 1997;20: Buhanan TA, Xiang AH, Peters RK, et al. Preservation of panreati beta-ell funtion and prevention of type 2 diabetes by pharmaologial treatment of insulin resistane in high-risk Hispani women. Diabetes 2002;51: Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M; STOP- NIDDM Trial Researh Group. Aarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lanet 2002;359: Position Statement 28. Gerstein HC, Yusuf S, Bosh J, et al.; DREAM (Diabetes REdution Assessment with ramipril and rosiglitazone Mediation) Trial Investigators. Effet of rosiglitazone on the frequeny of diabetes in patients with impaired gluose tolerane or impaired fasting gluose: a randomised ontrolled trial. Lanet 2006;368: Ramahandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modifiation and metformin prevent type 2 diabetes in Asian Indian subjets with impaired gluose tolerane (IDPP-1). Diabetologia 2006;49: Johnson SL, Tabaei BP, Herman WH. The effiay and ost of alternative strategies for systemati sreening for type 2 diabetes in the U.S. population years of age. Diabetes Care 2005; 28: Dabelea D, D Agostino RB Jr, Mayer- Davis EJ, et al.; SEARCH for Diabetes in Youth Study Group. Testing the aelerator hypothesis: body size, beta-ell funtion, and age at onset of type 1 (autoimmune) diabetes. Diabetes Care 2006;29: Liese AD, D Agostino RB Jr, Hamman RF, et al.; SEARCH for Diabetes in Youth Study Group. The burden of diabetes mellitus among US youth: prevalene estimates from the SEARCH for Diabetes in Youth Study. Pediatris 2006;118: Amerian Diabetes Assoiation. Type 2 diabetes in hildren and adolesents. Diabetes Care 2000;23: Pesovitz MD, Greenbaum CJ, Krause- Steinrauf H, et al.; Type 1 Diabetes TrialNet Anti-CD20 Study Group. Rituximab, B-lymphoyte depletion, and preservation of beta-ell funtion. N Engl J Med 2009;361: Orban T, Bundy B, Beker DJ, et al.; Type 1 Diabetes TrialNet Abataept Study Group. Co-stimulation modulation with abataept in patients with reentonset type 1 diabetes: a randomised, double-blind, plaebo-ontrolled trial. Lanet 2011;378: Lawrene JM, Contreras R, Chen W, Saks DA. Trends in the prevalene of preexisting diabetes and gestational diabetes mellitus among a raially/ ethnially diverse population of pregnant women, Diabetes Care 2008;31: Metzger BE, Lowe LP, Dyer AR, et al.; HAPO Study Cooperative Researh Group. Hyperglyemia and adverse pregnany outomes. N Engl J Med 2008;358: Metzger BE, Gabbe SG, Persson B, et al.; International Assoiation of Diabetes are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S51

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62 Position Statement retinopathy. Diabetes Care 2011;34: Fong DS, Aiello L, Gardner TW, et al.; Amerian Diabetes Assoiation. Retinopathy in diabetes. Diabetes Care 2004; 27(Suppl. 1):S84 S Ahmed J, Ward TP, Bursell SE, Aiello LM, Cavallerano JD, Vigersky RA. The sensitivity and speifiity of nonmydriati digital stereosopi retinal imaging in deteting diabeti retinopathy. Diabetes Care 2006;29: Bril V, England J, Franklin GM, et al.; Amerian Aademy of Neurology; Amerian Assoiation of Neuromusular and Eletrodiagnosti Mediine; Amerian Aademy of Physial Mediine and Rehabilitation. Evidene-based guideline: treatment of painful diabeti neuropathy: report of the Amerian Aademy of Neurology, the Amerian Assoiation of Neuromusular and Eletrodiagnosti Mediine, and the Amerian Aademy of Physial Mediine and Rehabilitation. Neurology 2011;76: Boulton AJ, Vinik AI, Arezzo JC, et al.; Amerian Diabetes Assoiation. Diabeti neuropathies: a statement by the Amerian Diabetes Assoiation. 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Peripheral arterial disease in people with diabetes. Diabetes Care 2003;26: Lipsky BA, Berendt AR, Cornia PB, et al.; Infetious Diseases Soiety of Ameria Infetious Diseases Soiety of Ameria linial pratie guideline for the diagnosis and treatment of diabeti foot infetions. Clin Infet Dis 2012;54: e132 e Bainbridge KE, Hoffman HJ, Cowie CC. Diabetes and hearing impairment in the United States: audiometri evidene from the National Health and Nutrition Examination Survey, 1999 to Ann Intern Med 2008;149: Bainbridge KE, Hoffman HJ, Cowie CC. Risk fators for hearing impairment among U.S. adults with diabetes: National Health and Nutrition Examination Survey Diabetes Care 2011; 34: Li C, Ford ES, Zhao G, Croft JB, Balluz LS, Mokdad AH. Prevalene of selfreported linially diagnosed sleep apnea aording to obesity status in men and women: National Health and Nutrition Examination Survey, Prev Med 2010;51: West SD, Nioll DJ, Stradling JR. Prevalene of obstrutive sleep apnoea in men with type 2 diabetes. Thorax 2006;61: Foster GD, Sanders MH, Millman R, et al.; Sleep AHEAD Researh Group. Obstrutive sleep apnea among obese patients with type 2 diabetes. Diabetes Care 2009;32: Shaw JE, Punjabi NM, Wilding JP, Alberti KG, Zimmet PZ. Sleep-disordered breathing and type 2 diabetes: a report from the International Diabetes Federation Taskfore on Epidemiology and Prevention. Diabetes Res Clin Prat 2008;81: Clark JM, Branati FL, Diehl AM. The prevalene and etiology of elevated aminotransferase levels in the United States. Am J Gastroenterol 2003;98: El-Serag HB, Tran T, Everhart JE. Diabetes inreases the risk of hroni liver disease and hepatoellular arinoma. Gastroenterology 2004;126: Amerian Gastroenterologial Assoiation. Amerian Gastroenterologial Assoiation medial position statement: nonaloholi fatty liver disease. Gastroenterology 2002;123: Dhindsa S, Miller MG, MWhirter CL, et al. Testosterone onentrations in diabeti and nondiabeti obese men. Diabetes Care 2010;33: Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in men with androgen defiieny syndromes: an Endorine Soiety linial pratie guideline. J Clin Endorinol Metab 2010;95: Khader YS, Dauod AS, El-Qaderi SS, Alkafajei A, Batayha WQ. Periodontal status of diabetis ompared with nondiabetis: a meta-analysis. J Diabetes Compliations 2006;20: Darré L, Vergnes JN, Gourdy P, Sixou M. Effiay of periodontal treatment on glyaemi ontrol in diabeti patients: a meta-analysis of interventional studies. Diabetes Metab 2008;34: International Diabetes Federation. Oral Health for People with Diabetes.Brussels, International Diabetes Federation, Suh S, Kim KW. Diabetes and aner: is diabetes ausally related to aner? Diabetes Metab J 2011;35: Giovannui E, Harlan DM, Arher MC, et al. Diabetes and aner: a onsensus report. Diabetes Care 2010;33: Janghorbani M, Van Dam RM, Willett WC, Hu FB. Systemati review of type 1 and type 2 diabetes mellitus and risk of frature. Am J Epidemiol 2007;166: Vestergaard P. Disrepanies in bone mineral density and frature risk in patients with type 1 and type 2 diabetesda meta-analysis. Osteoporos Int 2007;18: Yamamoto M, Yamaguhi T, Yamauhi M, Kaji H, Sugimoto T. Diabeti patients have an inreased risk of vertebral fratures independent of BMD or diabeti ompliations. J Bone Miner Res 2009; 24: Shwartz AV, Vittinghoff E, Bauer DC, et al.; Study of Osteoporoti Fratures (SOF) Researh Group; Osteoporoti Fratures in Men (MrOS) Researh Group; Health, Aging, and Body Composition (Health ABC) Researh Group. Assoiation of BMD and FRAX sore with risk of frature in older adults with type 2 diabetes. JAMA 2011;305: Cukierman T, Gerstein HC, Williamson JD. Cognitive deline and dementia in diabetesdsystemati overview of prospetive observational studies. Diabetologia 2005;48: Biessels GJ, Staekenborg S, Brunner E, Brayne C, Sheltens P. 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63 IDDM in hildren 2 years after disease onset. Diabetes Care 1998;21: Rovet J, Alvarez M. Attentional funtioning in hildren and adolesents with IDDM. Diabetes Care 1997;20: Bjørgaas M, Gimse R, Vik T, Sand T. Cognitive funtion in type 1 diabeti hildren with and without episodes of severe hypoglyaemia. Ata Paediatr 1997;86: Nimri R, Weintrob N, Benzaquen H, Ofan R, Fayman G, Phillip M. Insulin pump therapy in youth with type 1 diabetes: a retrospetive paired study. Pediatris 2006;117: Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vinent M, Tamborlane WV. A randomized, prospetive trial omparing the effiay of ontinuous subutaneous insulin infusion with multiple daily injetions using insulin glargine. Diabetes Care 2004;27: Perantie DC, Wu J, Koller JM, et al. Regional brain volume differenes assoiated with hyperglyemia and severe hypoglyemia in youth with type 1 diabetes. Diabetes Care 2007;30: Mäkimattila S, Malmberg-Cèder K, Häkkinen AM, et al. 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64 Position Statement Endorine Soiety, the International Soiety for Pediatri and Adolesent Diabetes, Juvenile Diabetes Researh Foundation International, the National Diabetes Eduation Program, and the Pediatri Endorine Soiety (formerly Lawson Wilkins Pediatri Endorine Soiety). Diabetes Care 2011;34: Bryden KS, Peveler RC, Stein A, Neil A, Mayou RA, Dunger DB. Clinial and psyhologial ourse of diabetes from adolesene to young adulthood: a longitudinal ohort study. Diabetes Care 2001;24: Laing SP, Jones ME, Swerdlow AJ, Burden AC, Gatling W. Psyhosoial and soioeonomi risk fators for premature death in young people with type 1 diabetes. Diabetes Care 2005;28: Eppens MC, Craig ME, Cusumano J, et al. Prevalene of diabetes ompliations in adolesents with type 2 ompared with type 1 diabetes. Diabetes Care 2006;29: Hattersley A, Bruining J, Shield J, Njolstad P, Donaghue KC. The diagnosis and management of monogeni diabetes in hildren and adolesents. 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65 health are institutions. Diabetes Care 2004;27(Suppl. 1):S55 S Curll M, Dinardo M, Noshese M, Korytkowski MT. Menu seletion, glyaemi ontrol and satisfation with standard and patient-ontrolled onsistent arbohydrate meal plans in hospitalised patients with diabetes. Qual Saf Health Care 2010;19: Modi MB, Kozak A, Siedleki SL, et al. Do we know what our patients with diabetes are eating in the hospital? Diabetes Spetrum 2011;24: Bouher JL, Swift CS, Franz MJ, et al. Inpatient management of diabetes and hyperglyemia: impliations for nutrition pratie and the food and nutrition professional. J Am Diet Asso 2007;107: Korytkowski MT, Salata RJ, Koerbel GL, et al. Insulin therapy and glyemi ontrol in hospitalized patients with diabetes during enteral nutrition therapy: a randomized ontrolled linial trial. Diabetes Care 2009;32: Umpierrez GE. Basal versus sliding-sale regular insulin in hospitalized patients with hyperglyemia during enteral nutrition therapy. 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Diabetes Edu 2011;37: Shillinger D, Piette J, Grumbah K, et al. Closing the loop: physiian ommuniation with diabeti patients who have low health literay. Arh Intern Med 2003;163: Rosal MC, Okene IS, Restrepo A, et al. Randomized trial of a literay-sensitive, ulturally tailored diabetes selfmanagement intervention for lowinome Latinos: Latinos en Control. Diabetes Care 2011;34: Osborn CY, Cavanaugh K, Wallston KA, et al. Health literay explains raial Position Statement disparities in diabetes mediation adherene. J Health Commun 2011;16 (Suppl. 3): Rothman R, Malone R, Bryant B, Horlen C, DeWalt D, Pignone M. The relationship between literay and glyemi ontrol in a diabetes disease-management program. Diabetes Edu 2004;30: O Connor PJ, Sperl-Hillen JM, Rush WA, et al. Impat of eletroni health reord linial deision support on diabetes are: a randomized trial. Ann Fam Med 2011;9: Garg AX, Adhikari NK, MDonald H, et al. Effets of omputerized linial deision support systems on pratitioner performane and patient outomes: a systemati review. JAMA 2005;293: Smith SA, Shah ND, Bryant SC, et al.; Evidens Researh Group. Chroni are model and shared are in diabetes: randomized trial of an eletroni deision support system. Mayo Clin Pro 2008; 83: MLean DL, MAlister FA, Johnson JA, et al.; SCRIP-HTN Investigators. A randomized trial of the effet of ommunity pharmaist and nurse are on improving blood pressure management in patients with diabetes mellitus: Study of Cardiovasular Risk Intervention by Pharmaists Hypertension (SCRIP-HTN). Arh Intern Med 2008;168: Wubben DP, Vivian EM. Effets of pharmaist outpatient interventions on adults with diabetes mellitus: a systemati review. Pharmaotherapy 2008;28: Davidson MB, Ansari A, Karlan VJ. Effet of a nurse-direted diabetes disease management program on urgent are/ emergeny room visits and hospitalizations in a minority population. 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66 Position Statement benefiiaries: 15 randomized trials. JAMA 2009;301: Feifer C, Nemeth L, Nietert PJ, et al. Different paths to high-quality are: three arhetypes of top-performing pratie sites. Ann Fam Med 2007;5: Cebul RD, Love TE, Jain AK, Hebert CJ. Eletroni health reords and quality of diabetes are. N Engl J Med 2011;365: Ralston JD, Hirsh IB, Hoath J, Mullen M, Cheadle A, Goldberg HI. Web-based ollaborative are for type 2 diabetes: a pilot randomized trial. Diabetes Care 2009;32: Battersby M, Von Korff M, Shaefer J, et al. Twelve evidene-based priniples for implementing self-management support in primary are. Jt Comm J Qual Patient Saf 2010;36: Grant RW, Wald JS, Shnipper JL, et al. Pratie-linked online personal health reords for type 2 diabetes mellitus: a randomized ontrolled trial. Arh Intern Med 2008;168: Pullen-Smith B, Carter-Edwards L, Leathers KH. Community health ambassadors: a model for engaging ommunity leaders to promote better health in North Carolina. J Publi Health Manag Prat 2008;14(Suppl.):S73 S Bojadzievski T, Gabbay RA. Patiententered medial home and diabetes. Diabetes Care 2011;34: Rosenthal MB, Cutler DM, Feder J. The ACO rulesdstriking the balane between partiipation and transformative potential. N Engl J Med 2011;365:e Washington AE, Lipstein SH. The Patient-Centered Outomes Researh Institutedpromoting better information, deisions, and health. N Engl J Med 2011;365:e31 S66 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

67 P O S I T I O N S T A T E M E N T Diagnosis and Classifiation of Diabetes Mellitus AMERICAN DIABETES ASSOCIATION DEFINITION AND DESCRIPTION OF DIABETES MELLITUSdDiabetes is a group of metaboli diseases haraterized by hyperglyemia resulting from defets in insulin seretion, insulin ation, or both. The hroni hyperglyemia of diabetes is assoiated with long-term damage, dysfuntion, and failure of different organs, espeially the eyes, kidneys, nerves, heart, and blood vessels. Several pathogeni proesses are involved in the development of diabetes. These range from autoimmune destrution of the b-ells of the panreas with onsequent insulin defiieny to abnormalities that result in resistane to insulin ation. The basis of the abnormalities in arbohydrate, fat, and protein metabolism in diabetes is defiient ation of insulin on target tissues. Defiient insulin ation results from inadequate insulin seretion and/or diminished tissue responses to insulin at one or more points in the omplex pathways of hormone ation. Impairment of insulin seretion and defets in insulin ation frequently oexist in the same patient, and it is often unlear whih abnormality, if either alone, is the primary ause of the hyperglyemia. Symptoms of marked hyperglyemia inlude polyuria, polydipsia, weight loss, sometimes with polyphagia, and blurred vision. Impairment of growth and suseptibility to ertain infetions may also aompany hroni hyperglyemia. Aute, life-threatening onsequenes of unontrolled diabetes are hyperglyemia with ketoaidosis or the nonketoti hyperosmolar syndrome. Long-term ompliations of diabetes inlude retinopathy with potential loss of vision; nephropathy leading to renal failure; peripheral neuropathy with risk of foot ulers, amputations, and Charot joints; and autonomi neuropathy ausing gastrointestinal, genitourinary, and ardiovasular symptoms and sexual dysfuntion. Patients with diabetes have an inreased inidene of atherosleroti ardiovasular, peripheral arterial, and erebrovasular disease. Hypertension and abnormalities of lipoprotein metabolism are often found in people with diabetes. The vast majority of ases of diabetes fall into two broad etiopathogeneti ategories (disussed in greater detail below). In one ategory, type 1 diabetes, the ause is an absolute defiieny of insulin seretion. Individuals at inreased risk of developing this type of diabetes an often be identified by serologial evidene of an autoimmune pathologi proess ourring in the panreati islets and by geneti markers. In the other, muh more prevalent ategory, type 2 diabetes, the ause is a ombination of resistane to insulin ation and an inadequate ompensatory insulin seretory response. In the latter ategory, a degree of hyperglyemia suffiient to ause pathologi and funtional hanges in various target tissues, but without linial symptoms, may be present for a long period of time before diabetes is deteted. During this asymptomati period, it is possible to demonstrate an abnormality in arbohydrate metabolism by measurement of plasma gluose in the fasting state or after a hallenge with an oral gluose load or by A1C. The degree of hyperglyemia (if any) may hange over time, depending on the extent of the underlying disease proess (Fig. 1). A disease proess may be present but may not have progressed far enough to ause hyperglyemia. The same disease proess an ause impaired fasting gluose (IFG) and/or impaired gluose tolerane (IGT) without fulfilling the riteria for the diagnosis of diabetes. In some individuals with diabetes, adequate glyemi ontrol an be ahieved with weight redution, exerise, and/or oral gluose-lowering Updated Fall DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. agents. These individuals therefore do not require insulin. Other individuals who have some residual insulin seretion but require exogenous insulin for adequate glyemi ontrol an survive without it. Individuals with extensive b-ell destrution and therefore no residual insulin seretion require insulin for survival. The severity of the metaboli abnormality an progress, regress, or stay the same. Thus, the degree of hyperglyemia reflets the severity of the underlying metaboli proess and its treatment more than the nature of the proess itself. CLASSIFICATION OF DIABETES MELLITUS AND OTHER CATEGORIES OF GLUCOSE REGULATIONdAssigning a type of diabetes to an individual often depends on the irumstanes present at the time of diagnosis, and many diabeti individuals do not easily fit into a single lass. For example, a person diagnosed with gestational diabetes mellitus (GDM) may ontinue to be hyperglyemi after delivery and may be determined to have, in fat, type 2 diabetes. Alternatively, a person who aquires diabetes beause of large doses of exogenous steroids may beome normoglyemi one the gluoortioids are disontinued, but then may develop diabetes many years later after reurrent episodes of panreatitis. Another example would be a person treated with thiazides who develops diabetes years later. Beause thiazides in themselves seldom ause severe hyperglyemia, suh individuals probably have type 2 diabetes that is exaerbated by the drug. Thus, for the liniian and patient, it is less important to label the partiular type of diabetes than it is to understand the pathogenesis of the hyperglyemia and to treat it effetively. Type 1 diabetes (b-ell destrution, usually leading to absolute insulin defiieny) Immune-mediated diabetes. This form of diabetes, whih aounts for only 5 10% of those with diabetes, previously enompassed by the terms insulindependent diabetes or juvenile-onset diabetes, results from a ellular-mediated autoimmune destrution ofthe b-ells of are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S67

68 Position Statement Figure 1dDisorders of glyemia: etiologi types and stages. *Even after presenting in ketoaidosis, these patients an briefly return to normoglyemia without requiring ontinuous therapy (i.e., honeymoon remission); **in rare instanes, patients in these ategories (e.g., Vaor toxiity, type 1 diabetes presenting in pregnany) may require insulin for survival. the panreas. Markers of the immune destrution of the b-ell inlude islet ell autoantibodies, autoantibodies to insulin, autoantibodies to GAD (GAD65), and autoantibodies to the tyrosine phosphatases IA-2 and IA-2b. One and usually more of these autoantibodies are present in 85 90% of individuals when fasting hyperglyemia is initially deteted. Also, the disease has strong HLA assoiations, with linkage to the DQA and DQB genes, and it is influened by the DRB genes. These HLA-DR/DQ alleles an be either predisposing or protetive. In this form of diabetes, the rate of b-ell destrution is quite variable, being rapid in some individuals (mainly infants and hildren) and slow in others (mainly adults). Some patients, partiularly hildren and adolesents, may present with ketoaidosis as the first manifestation of the disease. Others have modest fasting hyperglyemia that an rapidly hange to severe hyperglyemia and/or ketoaidosis in the presene of infetion or other stress. Still others, partiularly adults, may retain residual b-ell funtion suffiient to prevent ketoaidosis for many years; suh individuals eventually beome dependent on insulin for survival and are at risk for ketoaidosis. At this latter stage of the disease, there is little or no insulin seretion, as manifested by low or undetetable levels of plasma C-peptide. Immune-mediated diabetes ommonly ours in hildhood and adolesene, but it an our at any age, even in the 8th and 9th deades of life. Autoimmune destrution of b-ells has multiple geneti predispositions and is also related to environmental fators that are still poorly defined. Although patients are rarely obese when they present with this type of diabetes, the presene of obesity is not inompatible with the diagnosis. These patients are also prone to other autoimmune disorders suh as Graves disease, Hashimoto s thyroiditis, Addison s disease, vitiligo, elia sprue, autoimmune hepatitis, myasthenia gravis, and perniious anemia. Idiopathi diabetes. Some forms of type 1 diabetes have no known etiologies. Some of these patients have permanent insulinopenia and are prone to ketoaidosis, but have no evidene of autoimmunity. Although only a minority of patients with type 1 diabetes fall into this ategory, of those who do, most are of Afrian or Asian anestry. Individuals with this form of diabetes suffer from episodi ketoaidosis and exhibit varying degrees of insulin defiieny between episodes. This form of diabetes is strongly inherited, laks immunologial evidene for b-ell autoimmunity, and is not HLA assoiated. An absolute requirement for insulin replaement therapy in affeted patients may ome and go. Type 2 diabetes (ranging from predominantly insulin resistane with relative insulin defiieny to predominantly an insulin seretory defet with insulin resistane) This form of diabetes, whih aounts for ;90 95% of those with diabetes, previously referred to as non insulin-dependent diabetes, type 2 diabetes, or adultonset diabetes, enompasses individuals who have insulin resistane and usually have relative (rather than absolute) insulin defiieny At least initially, and often throughout their lifetime, these individuals do not need insulin treatment to survive. There are probably many different auses of this form of diabetes. Although the speifi etiologies are not known, autoimmune destrution of b-ells does not our, and patients do not have any of the other auses of diabetes listed above or below. Most patients with this form of diabetes are obese, and obesity itself auses some degree of insulin resistane. Patients who are not obese by traditional weight riteria may have an inreased perentage of body fat distributed predominantly in the abdominal region. Ketoaidosis seldom ours spontaneously in this type of diabetes; when seen, it usually arises in assoiation with the stress of another illness suh as infetion. This form of diabetes frequently goes undiagnosed for many years beause the hyperglyemia S68 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

69 develops gradually and at earlier stages is often not severe enough for the patient to notie any of the lassi symptoms of diabetes. Nevertheless, suh patients are at inreased risk of developing marovasular and mirovasular ompliations. Whereas patients with this form of diabetes may have insulin levels that appear normal or elevated, the higher blood gluose levels in these diabeti patients would be expeted to result in even higher insulin values had their b-ell funtion been normal. Thus, insulin seretion is defetive in these patients and insuffiient to ompensate for insulin resistane. Insulin resistane may improve with weight redution and/or pharmaologial treatment of hyperglyemia but is seldom restored to normal. The risk of developing this form of diabetes inreases with age, obesity, and lak of physial ativity. It ours more frequently in women with prior GDM and in individuals with hypertension or dyslipidemia, and its frequeny varies in different raial/ethni subgroups. It is often assoiated with a strong geneti predisposition, more so than is the autoimmune form of type 1 diabetes. However, the genetis of this form of diabetes are omplex and not fully defined. Other speifi types of diabetes Geneti defets of the b-ell. Several forms of diabetes are assoiated with monogeneti defets in b-ell funtion. These forms of diabetes are frequently haraterized by onset of hyperglyemia at an early age (generally before age 25 years). They are referred to as maturityonset diabetes of the young (MODY) and are haraterized by impaired insulin seretion with minimal or no defets in insulin ation. They are inherited in an autosomal dominant pattern. Abnormalities at six geneti loi on different hromosomes have been identified to date. The most ommon form is assoiated with mutations on hromosome 12 in a hepati transription fator referred to as hepatoyte nulear fator (HNF)-1a. A seond form is assoiated with mutations in the gluokinase gene on hromosome 7p and results in a defetive gluokinase moleule. Gluokinase onverts gluose to gluose-6-phosphate, the metabolism of whih, in turn, stimulates insulin seretion by the b-ell. Thus, gluokinase serves as the gluose sensor for the b-ell. Beause of defets in the gluokinase gene, inreased plasma levels of gluose are neessary to eliit normal levels of insulin seretion. The less ommon forms result from mutations in other transription fators, inluding HNF-4a, HNF-1b, insulin promoter fator (IPF)- 1, and NeuroD1. Diabetes diagnosed in the first 6 months of life has been shown not to be typial autoimmune type 1 diabetes. This so-alled neonatal diabetes an either be transient or permanent. The most ommon geneti defet ausing transient disease is a defet on ZAC/HYAMI imprinting, whereas permanent neonatal diabetes is most ommonly a defet in the gene enoding the Kir6.2 subunit of the b-ell K ATP hannel. Diagnosing the latter has impliations, sine suh hildren an be well managed with sulfonylureas. Point mutations in mitohondrial DNA have been found to be assoiated with diabetes and deafness The most ommon mutation ours at position 3,243 in the trna leuine gene, leading to an A-to-G transition. An idential lesion ours in the MELAS syndrome (mitohondrial myopathy, enephalopathy, lati aidosis, and stroke-like syndrome); however, diabetes is not part of this syndrome, suggesting different phenotypi expressions of this geneti lesion. Geneti abnormalities that result in the inability to onvert proinsulin to insulin have been identified in a few families, and suh traits are inherited in an autosomal dominant pattern. The resultant gluose intolerane is mild. Similarly, the prodution of mutant insulin moleules with resultant impaired reeptor binding has also been identified in a few families and is assoiated with an autosomal inheritane and only mildly impaired or even normal gluose metabolism. Geneti defets in insulin ation. There are unusual auses of diabetes that result from genetially determined abnormalities of insulin ation. The metaboli abnormalities assoiated with mutations of the insulin reeptor may range from hyperinsulinemia and modest hyperglyemia to severe diabetes. Some individuals with these mutations may have aanthosis nigrians. Women may be virilized and have enlarged, ysti ovaries. In the past, this syndrome was termed type A insulin resistane. Leprehaunism and the Rabson- Mendenhall syndrome are two pediatri syndromes that have mutations in the insulin reeptor gene with subsequent alterations in insulin reeptor funtion and extreme insulin resistane. The former has harateristi faial features and is usually fatal in infany, while the latter is Position Statement assoiated with abnormalities of teeth and nails and pineal gland hyperplasia. Alterations in the struture and funtion of the insulin reeptor annot be demonstrated in patients with insulinresistant lipoatrophi diabetes. Therefore, it is assumed that the lesion(s) must reside in the postreeptor signal transdution pathways. Diseases of the exorine panreas. Any proess that diffusely injures the panreas an ause diabetes. Aquired proesses inlude panreatitis, trauma, infetion, panreatetomy, and panreati arinoma. With the exeption of that aused by aner, damage to the panreas must be extensive for diabetes to our; adrenoarinomas that involve only a small portion of the panreas have been assoiated with diabetes. This implies a mehanism other than simple redution in b-ell mass. If extensive enough, ysti fibrosis and hemohromatosis will also damage b-ells and impair insulin seretion. Fibroalulous panreatopathy may be aompanied by abdominal pain radiating to the bak and panreati alifiations identified on X-ray examination. Panreati fibrosis and alium stones in the exorine duts have been found at autopsy. Endorinopathies. Several hormones (e.g., growth hormone, ortisol, gluagon, epinephrine) antagonize insulin ation. Exess amounts of these hormones (e.g., aromegaly, Cushing s syndrome, gluagonoma, pheohromoytoma, respetively) an ause diabetes. This generally ours in individuals with preexisting defets in insulin seretion, and hyperglyemia typially resolves when the hormone exess is resolved. Somatostatinomas, and aldosteronoma-indued hypokalemia, an ause diabetes, at least in part, by inhibiting insulin seretion. Hyperglyemia generally resolves after suessful removal of the tumor. Drug- or hemial-indued diabetes. Many drugs an impair insulin seretion. These drugs may not ause diabetes by themselves, but they may preipitate diabetes in individuals with insulin resistane. In suh ases, the lassifiation is unlear beause the sequene or relative importane of b-ell dysfuntion and insulin resistane is unknown. Certain toxinssuhasvaor(aratpoison)and intravenous pentamidine an permanently destroy panreati b-ells. Suh drug reations fortunately are rare. There are also many drugs and hormones that are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S69

70 Position Statement an impair insulin ation. Examples inlude niotini aid and gluoortioids. Patients reeiving a-interferon have been reported to develop diabetes assoiated with islet ell antibodies and, in ertain instanes, severe insulin defiieny. The list shown in Table 1 is not all-inlusive, but reflets the more ommonly reognized drug-, hormone-, or toxin-indued forms of diabetes. Infetions. Certain viruses have been assoiated with b-ell destrution. Diabetes ours in patients with ongenital rubella, although most of these patients have HLA and immune markers harateristi of type 1 diabetes. In addition, oxsakievirus B, ytomegalovirus, adenovirus, and mumps have been impliated in induing ertain ases of the disease. Unommon forms of immune-mediated diabetes. In this ategory, there are two known onditions, and others are likely to our. The stiff-man syndrome is an autoimmune disorder of the entral nervous system haraterized by stiffness of the axial musles with painful spasms. Patients usually have high titers of the GAD autoantibodies, and approximately one-third will develop diabetes. Anti-insulin reeptor antibodies an ause diabetes by binding to the insulin reeptor, thereby bloking the binding of insulin to its reeptor in target tissues. However, in some ases, these antibodies an at as an insulin agonist after binding to the reeptor and an thereby ause hypoglyemia. Anti-insulin reeptor antibodies are oasionally found in patients with systemi lupus erythematosus and other autoimmune diseases. As in other states of extreme insulin resistane, patients with anti-insulin reeptor antibodies often have aanthosis nigrians. In the past, this syndrome was termed type B insulin resistane. Other geneti syndromes sometimes assoiated with diabetes. Many geneti syndromes are aompanied by an inreased inidene of diabetes. These inlude the hromosomal abnormalities of Down syndrome, Klinefelter syndrome, and Turner syndrome. Wolfram syndrome is an autosomal reessive disorder haraterized by insulin-defiient diabetes and the absene of b-ells at autopsy. Additional manifestations inlude diabetes insipidus, hypogonadism, opti atrophy, and neural deafness. Other syndromes are listed in Table 1. GDM For many years, GDM has been defined as any degree of gluose intolerane with Table 1dEtiologi lassifiation of diabetes mellitus I. Type 1 diabetes (b-ell destrution, usually leading to absolute insulin defiieny) A. Immune mediated B. Idiopathi II. Type 2 diabetes (may range from predominantly insulin resistane with relative insulin defiieny to a predominantly seretory defet with insulin resistane) III. Other speifi types A. Geneti defets of b-ell funtion 1. MODY 3 (Chromosome 12, HNF-1a) 2. MODY 1 (Chromosome 20, HNF-4a) 3. MODY 2 (Chromosome 7, gluokinase) 4. Other very rare forms of MODY (e.g., MODY 4: Chromosome 13, insulin promoter fator-1; MODY 6: Chromosome 2, NeuroD1; MODY 7: Chromosome 9, arboxyl ester lipase) 5. Transient neonatal diabetes (most ommonly ZAC/HYAMI imprinting defet on 6q24) 6. Permanent neonatal diabetes (most ommonly KCNJ11 gene enoding Kir6.2 subunit of b-ell K ATP hannel) 7. Mitohondrial DNA 8. Others B. Geneti defets in insulin ation 1. Type A insulin resistane 2. Leprehaunism 3. Rabson-Mendenhall syndrome 4. Lipoatrophi diabetes 5. Others C. Diseases of the exorine panreas 1. Panreatitis 2. Trauma/panreatetomy 3. Neoplasia 4. Cysti fibrosis 5. Hemohromatosis 6. Fibroalulous panreatopathy 7. Others D. Endorinopathies 1. Aromegaly 2. Cushing s syndrome 3. Gluagonoma 4. Pheohromoytoma 5. Hyperthyroidism 6. Somatostatinoma 7. Aldosteronoma 8. Others E. Drug or hemial indued 1. Vaor 2. Pentamidine 3. Niotini aid 4. Gluoortioids 5. Thyroid hormone 6. Diazoxide 7. b-adrenergi agonists 8. Thiazides 9. Dilantin 10. g-interferon 11. Others F. Infetions 1. Congenital rubella 2. Cytomegalovirus 3. Others G. Unommon forms of immune-mediated diabetes 1. Stiff-man syndrome 2. Anti-insulin reeptor antibodies 3. Others H. Other geneti syndromes sometimes assoiated with diabetes 1. Down syndrome 2. Klinefelter syndrome 3. Turner syndrome 4. Wolfram syndrome 5. Friedreih ataxia 6. Huntington horea 7. Laurene-Moon-Biedl syndrome 8. Myotoni dystrophy 9. Porphyria 10. Prader-Willi syndrome 11. Others IV. Gestational diabetes mellitus Patients with any form of diabetes may require insulin treatment at some stage of their disease. Suh use of insulin does not, of itself, lassify the patient. S70 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

71 onset or first reognition during pregnany. Although most ases resolve with delivery, the definition applied whether or not the ondition persisted after pregnany and did not exlude the possibility that unreognized gluose intolerane may have antedated or begun onomitantly with the pregnany. This definition failitated a uniform strategy for detetion and lassifiation of GDM, but its limitations were reognized for many years. As the ongoing epidemi of obesity and diabetes has led to more type 2 diabetes in women of hildbearing age, the number of pregnant women with undiagnosed type 2 diabetes has inreased. After deliberations in , the International Assoiation of Diabetes and Pregnany Study Groups (IADPSG), an international onsensus group with representatives from multiple obstetrial and diabetes organizations, inluding the Amerian Diabetes Assoiation (ADA), reommended that high-risk women found to have diabetes at their initial prenatal visit, using standard riteria (Table 3), reeive a diagnosis of overt, not gestational, diabetes. Approximately 7% of all pregnanies (ranging from 1 to 14%, depending on the population studied and the diagnosti tests employed) are ompliated by GDM, resulting in more than 200,000 ases annually. CATEGORIES OF INCREASED RISK FOR DIABETESdIn 1997 and 2003, the Expert Committee on Diagnosis and Classifiation of Diabetes Mellitus (1,2) reognized an intermediate group of individuals whose gluose levels do not meet riteria for diabetes, yet are higher than those onsidered normal. These people were defined as having impaired fasting gluose (IFG) [fasting plasma gluose (FPG) levels 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l)], or impaired gluose tolerane (IGT) [2-h values in the oral gluose tolerane test (OGTT) of 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l)]. Individuals with IFG and/or IGT have been referred to as having prediabetes, indiating the relatively high risk for the future development of diabetes. IFG and IGT should not be viewed as linial entities in their own right but rather risk fators for diabetes as well as ardiovasular disease. They an be observed as intermediate stages in any of the disease proesses listed in Table 1. IFG and IGT are assoiated with obesity (espeially abdominal or viseral obesity), dyslipidemia with high triglyerides and/or low HDL holesterol, and hypertension. Strutured lifestyle intervention, aimed at inreasing physial ativity and produing 5 10% loss of body weight, and ertain pharmaologial agents have been demonstrated to prevent or delay the development of diabetes in people with IGT; the potential impat of suh interventions to redue mortality or the inidene of ardiovasular disease has not been demonstrated to date. It should be noted that the 2003 ADA Expert Committee report redued the lower FPG ut point to define IFG from 110 mg/dl (6.1 mmol/l) to 100 mg/dl (5.6 mmol/l), in part to ensure that prevalene of IFG was similar to that of IGT. However, the World Health Organization (WHO) and many other diabetes organizations did not adopt this hange in the definition of IFG. As A1C is used more ommonly to diagnose diabetes in individuals with risk fators, it will also identify those at higher risk for developing diabetes in the future. When reommending the use of the A1C to diagnose diabetes in its 2009 report, the International Expert Committee (3) stressed the ontinuum of risk for diabetes with all glyemi measures and did not formally identify an equivalent intermediate ategory for A1C. The group did note that those with A1C levels above the laboratory normal range but below the diagnosti ut point for diabetes (6.0 to,6.5%) are at very high risk of developing diabetes. Indeed, inidene of diabetes in people with A1C levels in this range is more than 10 times that of people with lower levels (4 7).However,the6.0to,6.5% range fails to identify a substantial number of patients who have IFG and/or IGT. Prospetive studies indiate that people within the A1C range of % have a 5-year umulative inidene of diabetes that ranges from 12 to 25% (4 7), whih is appreiably (three- to eightfold) higher than inidene in the U.S. population as a whole (8). Analyses of nationally representative data from the National Health and Nutrition Examination Survey (NHANES) indiate that the A1C value that most aurately identifies peoplewithifgorigtfallsbetween5.5 and 6.0%. In addition, linear regression analyses of these data indiate that among the nondiabeti adult population, an FPG of 110 mg/dl (6.1 mmol/l) orresponds to an A1C of 5.6%, while an FPG of 100 mg/dl (5.6 mmol/l) orresponds to an A1C of 5.4% (R.T. Akerman, personal ommuniation). Finally, evidene from Position Statement the Diabetes Prevention Program (DPP), wherein the mean A1C was 5.9% (SD 0.5%), indiates that preventive interventions are effetive in groups of people with A1C levels both below and above 5.9% (9). For these reasons, the most appropriate A1C level above whih to initiate preventive interventions is likely to be somewhere in the range of 5.5 6%. As was the ase with FPG and 2-h PG, defining a lower limit of an intermediate ategory of A1C is somewhat arbitrary, as the risk of diabetes with any measure or surrogate of glyemia is a ontinuum, extending well into the normal ranges. To maximize equity and effiieny of preventive interventions, suh an A1C ut point should balane the osts of false negatives (failing to identify those who are going to develop diabetes) against the osts of false positives (falsely identifying and then spending intervention resoures on those who were not going to develop diabetes anyway). As is the ase with the gluose measures, several prospetive studies that used A1C to predit the progression to diabetes demonstrated a strong, ontinuous assoiation between A1C and subsequent diabetes. In a systemati review of 44,203 individuals from 16 ohort studies with a follow-up interval averaging 5.6 years (range years), those with an A1C between 5.5 and 6.0% had a substantially inreased risk of diabetes with 5-year inidenes ranging from 9 to 25%. An A1C range of % had a 5-year risk of developing diabetes between 25 and 50% and relative risk 20 times higher ompared with an A1C of 5.0% (10). In a ommunity-based study of blak and white adults without diabetes, baseline A1C was a stronger preditor of subsequent diabetes and ardiovasular events than was fasting gluose (11). Other analyses suggest that an A1C of 5.7% is assoiated with similar diabetes risk to the high-risk partiipants in the DPP (12). Hene, it is reasonable to onsider an A1C range of % as identifying individuals with high risk for future diabetes, to whom the term prediabetes may be applied. Individuals with an A1C of % should be informed of their inreased risk for diabetes as well as ardiovasular disease and ounseled about effetive strategies, suh as weight loss and physial ativity, to lower their risks. As with gluose measurements, the ontinuum of risk is urvilinear, so that as A1C rises, the risk of diabetes rises disproportionately. are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S71

72 Position Statement Aordingly, interventions should be most intensive and follow-up should be partiularly vigilant for those with A1C levels above 6.0%, who should be onsidered to be at very high risk. However, just as an individual with a fasting gluose of 98 mg/dl (5.4 mmol/l) may not be at negligible risk for diabetes, individuals with A1C levels below 5.7% may still be at risk, depending on level of A1C and presene of other risk fators, suh as obesity and family history. Table 2 summarizes the ategories of inreased risk for diabetes. Evaluation of patients at risk should inorporate a global risk fator assessment for both diabetes and ardiovasular disease. Sreening for and ounseling about risk of diabetes should always be in the pragmati ontext of the patient s omorbidities, life expetany, personal apaity to engage in lifestyle hange, and overall health goals. DIAGNOSTIC CRITERIA FOR DIABETES MELLITUSdFor deades, the diagnosis of diabetes has been based on gluose riteria, either the FPG or the 75-g OGTT. In 1997, the first Expert Committee on the Diagnosis and Classifiation of Diabetes Mellitus revised the diagnosti riteria, using the observed assoiation between FPG levels and presene of retinopathy as the key fator with whih to identify threshold gluose level. The Committee examined data from three ross-setional epidemiologi studies that assessed retinopathy with fundus photography or diret ophthalmosopy and measured glyemia as FPG, 2-h PG, and A1C. These studies demonstrated glyemi levels below whih there was little prevalent retinopathy and above whih the prevalene of retinopathy inreased in an apparently linear fashion. The deiles of the three measures at whih retinopathy began to inrease were the same for eah measure within eah population. Moreover, the glyemi values above Table 2dCategories of inreased risk for diabetes (prediabetes)* FPG 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l) [IFG] 2-h PG in the 75-g OGTT 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l) [IGT] A1C % *For all three tests, risk is ontinuous, extending below the lower limit of the range and beoming disproportionately greater at higher ends of the range. whih retinopathy inreased were similar among the populations. These analyses onfirmed the long-standing diagnosti 2-h PG value of $200mg/dl(11.1mmol/l). However, the older FPG diagnosti ut point of 140 mg/dl (7.8 mmol/l) was noted to identify far fewer individuals with diabetes than the 2-h PG ut point. The FPG diagnosti ut point was redued to $126 mg/dl (7.0 mmol/l). A1C is a widely used marker of hroni glyemia, refleting average blood gluose levels over a 2- to 3-month period of time. The test plays a ritial role in the management of the patient with diabetes, sine it orrelates well with both mirovasular and, to a lesser extent, marovasular ompliations and is widely used as the standard biomarker for the adequay of glyemi management. Prior Expert Committees have not reommended use of the A1C for diagnosis of diabetes, in part due to lak of standardization of the assay. However, A1C assays are now highly standardized so that their results an be uniformly applied both temporally and aross populations. In their reent report (3), an International Expert Committee, after an extensive review of both established and emerging epidemiologial evidene, reommended the use of the A1C test to diagnose diabetes, with a threshold of $6.5%, and ADA affirmsthisdeision. The diagnosti A1C ut point of 6.5% is assoiated with an infletion point for retinopathy prevalene, as are the diagnosti thresholds for FPG and 2-h PG (3). The diagnosti test should be performed using a method that is ertified by the National Glyohemoglobin Standardization Program (NGSP) and standardized or traeable to the Diabetes Control and Compliations Trial referene assay. Point-of-are A1C assays are not suffiiently aurate at this time to use for diagnosti purposes. There is an inherent logi to using a more hroni versus an aute marker of dysglyemia, partiularly sine the A1C is already widely familiar to liniians as a marker of glyemi ontrol. Moreover, the A1C has several advantages to the FPG, inluding greater onveniene, sine fasting is not required, evidene to suggest greater preanalytial stability, and less day-to-day perturbations during periods of stress and illness. These advantages, however, must be balaned by greater ost, the limited availability of A1C testing in ertain regions of the developing world, and the inomplete orrelation between A1C and average gluose in ertain individuals. In addition, the A1C an be misleading in patients with ertain forms of anemia and hemoglobinopathies, whih may also have unique ethni or geographi distributions. For patients with a hemoglobinopathy but normal red ell turnover, suh as sikle ell trait, an A1C assay without interferene from abnormal hemoglobins should be used (an updated list is available at For onditions with abnormal red ell turnover, suh as anemias from hemolysis and iron defiieny, the diagnosis of diabetes must employ gluose riteria exlusively. The established gluose riteria for the diagnosis of diabetes remain valid. These inlude the FPG and 2-h PG. Additionally, patients with severe hyperglyemia suh as those who present with severe lassi hyperglyemi symptoms or hyperglyemi risis an ontinue to be diagnosed when a random (or asual) plasma gluose of $200 mg/dl (11.1 mmol/l) is found. It is likely that in suh ases the health are professional would also measure an A1C test as part of the initial assessment of the severity of the diabetes and that it would (in most ases) be above the diagnosti ut point for diabetes. However, in rapidly evolving diabetes, suh as the development of type 1 diabetes in some hildren, A1C may not be signifiantly elevated despite frank diabetes. Just as there is less than 100% onordane between the FPG and 2-h PG tests, there is not full onordane between A1C and either gluose-based test. Analyses of NHANES data indiate that, assuming universal sreening of the undiagnosed, the A1C ut point of $6.5% identifies one-third fewer ases of undiagnosed diabetes than a fasting gluose ut point of $126 mg/dl (7.0 mmol/l) ( fatsheet11/tables1_2.htm). However, in pratie, a large portion of the population with type 2 diabetes remains unaware of their ondition. Thus, it is oneivable that the lower sensitivity of A1C at the designated ut point will be offset by the test s greater pratiality, and that wider appliation of a more onvenient test (A1C) may atually inrease the number of diagnoses made. Further researh is needed to better haraterize those patients whose glyemi status might be ategorized differently by two different tests (e.g., FPG and S72 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

73 A1C), obtained in lose temporal approximation. Suh disordane may arise from measurement variability, hange over time, or beause A1C, FPG, and posthallenge gluose eah measure different physiologial proesses. In the setting of an elevated A1C but nondiabeti FPG, the likelihood of greater postprandial gluose levels or inreased glyation rates for a given degree of hyperglyemia may be present. In the opposite senario (high FPG yet A1C below the diabetes ut point), augmented hepati gluose prodution or redued glyation rates may be present. As with most diagnosti tests, a test result diagnosti of diabetes should be repeated to rule out laboratory error, unless the diagnosis is lear on linial grounds, suh as a patient with lassi symptoms of hyperglyemia or hyperglyemi risis. It is preferable that the same test be repeated for onfirmation, sine there will be a greater likelihood of onurrene in this ase. For example, if the A1C is 7.0% and a repeat result is 6.8%, the diagnosis of diabetes is onfirmed. However, there are senarios in whih results of two different tests (e.g., FPG and A1C) are available for the same patient. In this situation, if the two different tests are both above the diagnosti thresholds, the diagnosis of diabetes is onfirmed. On the other hand, when two different tests are available in an individual and the results are disordant, the test whose result is above the diagnosti ut point should be repeated, and the diagnosis is made on the basis of the onfirmed test. That is, if a patient meets the diabetes riterion of the A1C (two results $6.5%) but not the FPG (,126 mg/dl or 7.0 mmol/l), or vie versa, that person should be onsidered to have diabetes. Admittedly, in most irumstane the nondiabeti test is likely to be in a range very lose to the threshold that defines diabetes. Sine there is preanalyti and analyti variability of all the tests, it is also possible that when a test whose result was above the diagnosti threshold is repeated, the seond value will be below the diagnosti ut point. This is least likely for A1C, somewhat more likely for FPG, and most likely for the 2-h PG. Barring a laboratory error, suh patients are likely to have test results near the margins of the threshold for a diagnosis. The healthare professional might opt to follow the patient losely and repeat the testing in 3 6 months. The deision about whih test to use to assess a speifi patient for diabetes should be at the disretion of the health are professional, taking into aount the availability and pratiality of testing an individual patient or groups of patients. Perhaps more important than whih diagnosti test is used, is that the testing for diabetes be performed when indiated. There is disouraging evidene indiating that many at-risk patients still do not reeive adequate testing and ounseling for this inreasingly ommon disease, or for its frequently aompanying ardiovasular risk fators. The urrent diagnosti riteria for diabetes are summarized in Table 3. Diagnosis of GDM GDM arries risks for the mother and neonate. The Hyperglyemia and Adverse Pregnany Outomes (HAPO) study (13), a large-sale (;25,000 pregnant women) multinational epidemiologi study, demonstrated that risk of adverse maternal, fetal, and neonatal outomes ontinuously inreased as a funtion of maternal glyemia at weeks, even within ranges previously onsidered Position Statement normal for pregnany. For most ompliations, there was no threshold for risk. These results have led to areful reonsideration of the diagnosti riteria for GDM. After deliberations in , the IADPSG, an international onsensus group with representatives from multiple obstetrial and diabetes organizations, inluding ADA, developed revised reommendations for diagnosing GDM. The group reommended that all women not known to have diabetes undergo a 75-g OGTT at weeks of gestation. Additionally, the group developed diagnosti ut points for the fasting, 1-h, and 2-h plasma gluose measurements that onveyed an odds ratio for adverse outomes of at least 1.75 ompared with women with mean gluose levels in the HAPO study. Current sreening and diagnosti strategies, based on the IADPSG statement (14), are outlined in Table 4. These new riteria will signifiantly inrease the prevalene of GDM, primarily beause only one abnormal value, not two, is suffiient to make the diagnosis. The ADA reognizes the antiipated signifiant inrease in the inidene of GDM to be diagnosed by these riteria and is sensitive to onerns about the medialization of pregnanies previously ategorized as normal. These diagnosti riteria hanges are being made in the ontext of worrisome worldwide inreases in obesity and diabetes rates, with the intent of optimizing gestational outomes for women and their babies. Admittedly, there are few data from randomized linial trials regarding therapeuti interventions in women who will now be diagnosed with GDM based on only one blood gluose value above the speified ut points (in ontrast to the older riteria that stipulated at least two Table 3dCriteria for the diagnosis of diabetes A1C $6.5%. The test should be performed in a laboratory using a method that is NGSP ertified and standardized to the DCCT assay.* OR FPG $126 mg/dl (7.0 mmol/l). Fasting is defined as no alori intake for at least 8 h.* OR 2-h plasma gluose $200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as desribed by the World Health Organization, using a gluose load ontaining the equivalent of 75 g anhydrous gluose dissolved in water.* OR In a patient with lassi symptoms of hyperglyemia or hyperglyemi risis, a random plasma gluose $200 mg/dl (11.1 mmol/l). *In the absene of unequivoal hyperglyemia, riteria 1 3 should be onfirmed by repeat testing. Table 4dSreening for and diagnosis of GDM Perform a 75-g OGTT, with plasma gluose measurement fasting and at 1 and 2 h, at weeks of gestation in women not previously diagnosed with overt diabetes. The OGTT should be performed in the morning after an overnight fast of at least 8h. The diagnosis of GDM is made when any of the following plasma gluose values are exeeded: Fasting: $92 mg/dl (5.1 mmol/l) 1h:$180 mg/dl (10.0 mmol/l) 2h:$153 mg/dl (8.5 mmol/l) are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S73

74 Position Statement abnormal values). Expeted benefits to their pregnanies and offspring is inferred from intervention trials that foused on women with more mild hyperglyemia than identified using older GDM diagnosti riteria and that found modest benefits (15,16). The frequeny of their follow-up and blood gluose monitoring is not yet lear but likely to be less intensive than women diagnosed by the older riteria. Additional well-designed linial studies are needed to determine the optimal intensity of monitoring and treatment of women with GDM diagnosed by the new riteria (that would not have met the prior definition of GDM). It is important to note that 80 90% of women in both of the mild GDM studies (whose gluose values overlapped with the thresholds reommended herein) ould be managed with lifestyle therapy alone. Referenes 1. Expert Committee on the Diagnosis and Classifiation of Diabetes Mellitus. Report of the Expert Committee on the Diagnosis and Classifiation of Diabetes Mellitus. Diabetes Care 1997;20: Genuth S, Alberti KG, Bennett P, Buse J, DeFronzo R, Kahn R, Kitzmiller J, Knowler WC, Lebovitz H, Lernmark A, Nathan D, Palmer J, Rizza R, Saudek C, Shaw J, Steffes M, Stern M, Tuomilehto J, Zimmet P, Expert Committee on the Diagnosis and Classifiation of Diabetes Mellitus. Followup report on the diagnosis of diabetes mellitus. Diabetes Care 2003;26: International Expert Committee. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care 2009;32: Edelman D, Olsen MK, Dudley TK, Harris AC, Oddone EZ. Utility of hemoglobin A1 in prediting diabetes risk. J Gen Intern Med 2004;19: Pradhan AD, Rifai N, Buring JE, Ridker PM. Hemoglobin A1 predits diabetes but not ardiovasular disease in nondiabeti women. Am J Med 2007;120: Sato KK, Hayashi T, Harita N, Yoneda T, Nakamura Y, Endo G, Kambe H. Combined measurement of fasting plasma gluose and A1C is effetive for the predition of type 2 diabetes: the Kansai Healthare Study. Diabetes Care 2009;32: Shimazaki T, Kadowaki T, Ohyama Y, Ohe K, Kubota K. Hemoglobin A1 (HbA1) predits future drug treatment for diabetes mellitus: a follow-up study using routine linial data in a Japanese university hospital. Translational Researh 2007;149: Geiss LS, Pan L, Cadwell B, Gregg EW, Benjamin SM, Engelgau MM. Changes in inidene of diabetes in U.S. adults, Am J Prev Med 2006;30: Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lahin JM, Walker EA, Nathan DM, Diabetes Prevention Program Researh Group. Redution in the inidene of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346: Zhang X, Gregg EW, Williamson DF, Barker LE, Thomas W, Bullard KW, Imperatore G, Williams DE, Albright AL. A1C level and future risk of diabetes: a systemati review. Diabetes Care 2010; 33: Selvin E, Steffes MW, Zhu H, Matsushita K, Wagenkneht L, Pankow J, Coresh J, Branati FL. Glyated hemoglobin, diabetes, and ardiovasular risk in nondiabeti adults. N Engl J Med 2010;362: Akermann RT, Cheng YJ, Williamson DF, Gregg EW. Identifying adults at high risk for diabetes and ardiovasular disease using hemoglobin A1 National Health and Nutrition Examination Survey Am J Prev Med 2011;40: Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, MCane DR, Hod M, MIntyre HD, Oats JJ, Persson B, Rogers MS, Saks DA. Hyperglyemia and adverse pregnany outomes. N Engl J Med 2008;358: Metzger BE, Gabbe SG, Persson B, Buhanan TA, Catalano PA, Damm P, Dyer AR, Leiva A, Hod M, Kitzmiler JL, Lowe LP, MIntyre HD, Oats JJ, Omori Y, Shmidt MI. International Assoiation of Diabetes and Pregnany Study Groups reommendations on the diagnosis and lassifiation of hyperglyemia in pregnany. Diabetes Care 2010;33: Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM, Jr., Sisione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaeman AM, Tolosa JE, Anderson GB. A multienter, randomized trial of treatment for mild gestational diabetes. N Engl J Med 2009;361: Crowther CA, Hiller JE, Moss JR, MPhee AJ, Jeffries WS, Robinson JS. Effet of treatment of gestational diabetes mellitus on pregnany outomes. N Engl J Med 2005;352: S74 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

75 P O S I T I O N S T A T E M E N T ]Diabetes Care in the Shool and Day Care Setting AMERICAN DIABETES ASSOCIATION D iabetes is one of the most ommon hroni diseases of hildhood (1). There are ;215,000 individuals,20 years of age with diabetes in the U.S. (2). The majority of these young people attend shool and/or some type of day are and need knowledgeable staff to provide a safe shool environment. Both parents and the health are team should work together to provide shool systems and day are providers with the information neessary to allow hildren with diabetes to partiipate fully and safely in the shool experiene (3,4). DIABETES AND THE LAWdFederal laws that protet hildren with diabetes inlude Setion 504 of the Rehabilitation At of 1973 (5), the Individuals with Disabilities Eduation At (originally the Eduation for All Handiapped Children At of 1975) (6), and the Amerians with Disabilities At (7). Under these laws, diabetes has been onsidered to be a disability, and it is illegal for shools and/or day are enters to disriminate against hildren with disabilities. In addition, any shool that reeives federal funding or any faility onsidered open to the publi must reasonably aommodate the speial needs of hildren with diabetes. Indeed, federal law requires an individualized assessment of any hild with diabetes. The required aommodations should be doumented in a written plan developed under the appliable federal law suh as a Setion 504 Plan or Individualized Eduation Program (IEP). The needs of a student with diabetes should be provided for within the hild s usual shool setting with as little disruption to the shool s andthe hild s routine as possible and allowing the hild full partiipation in all shool ativities (8,9). Despite these protetions, hildren in the shool and day are setting still fae disrimination. For example, some day are enters may refuse admission to hildren with diabetes, and hildren in the lassroom may not be provided the assistane neessary to monitor blood gluose and administer insulin and may be prohibited from eating needed snaks. The Amerian Diabetes Assoiation works to ensure the safe and fair treatment of hildren with diabetes in the shool and day are setting (10 15) ( org/shooldisrimination). Diabetes are in shools Appropriatediabetesareintheshooland day are setting is neessary for the hild s immediate safety, long-term well-being, and optimal aademi performane. The Diabetes Control and Compliations Trial showed a signifiant link between blood gluose ontrol and later development of diabetes ompliations, with improved glyemi ontrol dereasing the risk of these ompliations (16,17). To ahieve glyemi ontrol, a hild must hek blood gluose frequently, monitor food intake, take mediations, and engage in regular physial ativity. Insulin is usually taken in multiple daily injetions or through an infusion pump. Cruial to ahieving glyemi ontrol is an understanding of the effets of physial ativity, nutrition therapy, and insulin on blood gluose levels. To failitate the appropriate are of the student with diabetes, the shool nurse as well as other shool and day are personnel must have an understanding of diabetes and must be trained in its management and in the treatment of diabetes emergenies (3,18,19,20,34,36). Originally approved Revised DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. Knowledgeable trained personnel are essential if the student is to avoid the immediate health risks of low blood gluose and to ahieve the metaboli ontrol required to derease risks for later development of diabetes ompliations (3,20). Studies have shown that the majority of shool personnel have an inadequate understanding of diabetes (21,22). Consequently, diabetes eduation must be targeted toward day are providers, teahers, and other shool personnel who interat with the hild, inluding shool administrators, shool nurses, oahes, health aides, bus drivers, seretaries, et. (3,20). Current reommendations and up-to-date resoures regarding appropriate are for hildren with diabetes in the shool are universally available to all shool personnel (3,23). The purpose of this position statement is to provide reommendations for the management of hildren with diabetes in the shool and day are setting. GENERAL GUIDELINES FOR THE CARE OF THE CHILD IN THE SCHOOL AND DAY CARE SETTING I. Diabetes Medial Management Plan An individualized Diabetes Medial Management Plan (DMMP) should be developed by the student s personal diabetes health are team with input from the parent/guardian. Inherent in this proess are delineated responsibilities assumed by all parties, inluding the parent/guardian, the shool personnel, and the student (3,24,25). These responsibilities are outlined in this position statement. In addition, the DMMP should be used as the basis for the development of written eduation plans suh as the Setion 504 Plan or the IEP. The DMMP should address the speifi needs of the hild and provide speifi instrutions for eah of the following: are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S75

76 Position Statement 1. Blood gluose monitoring, inluding the frequeny and irumstanes requiring blood gluose heks, and use of ontinuous gluose monitoring if utilized. 2. Insulin administration (if neessary), inluding doses/injetion times presribed for speifi blood gluose values and for arbohydrate intake, the storage of insulin, and, when appropriate, physiian authorization of parent/guardian adjustments to insulin dosage. 3. Meals and snaks, inluding food ontent, amounts, and timing. 4. Symptoms and treatment of hypoglyemia (low blood gluose), inluding the administration of gluagon if reommended by the student s treating physiian. 5. Symptoms and treatment of hyperglyemia (high blood gluose). 6. Cheking for ketones and appropriate ations to take for abnormal ketone levels, if requested by the student s health are provider. 7. Partiipation in physial ativity. 8. Emergeny evauation/shool lokdown instrutions. A sample DMMP ( diabetes.org/dmmp) may be aessed online and ustomized for eah individual student. For detailed information on the symptoms and treatment of hypoglyemia and hyperglyemia, refer to Medial Management of Type 1 Diabetes (26). A brief desription of diabetes targeted to shool and day are personnel is inluded in the APPENDIX; it may be helpful to inlude this information as an introdution to the DMMP. II. Responsibilities of the various are providers A. The parent/guardian should provide the shool or day are provider with the following: 1. All materials, equipment, insulin, and other mediation neessary for diabetes are tasks, inluding blood gluose monitoring, insulin administration (if needed), and urine or blood ketone monitoring. The parent/guardian is responsible for the maintenane of the blood gluose monitoring equipment (i.e., leaning and performing ontrolled testing per the manufaturer s instrutions) and must provide materials neessary to ensure proper disposal of materials. A separate logbook should be kept at shool with the diabetes supplies for the staff or student to reord blood gluose and ketone results; blood gluose values should be transmitted to the parent/guardian for review as often as requested. Some students maintain a reord of blood gluose results in meter memory rather than reording in a logbook, espeially if the same meter is used at home and at shool. 2. The DMMP ompleted and signed by the student s personal diabetes health are team. 3. Supplies to treat hypoglyemia, inluding a soure of gluose and a gluagon emergeny kit, if indiated in the DMMP. 4. Information about diabetes and the performane of diabetes-related tasks. 5. Emergeny phone numbers for the parent/guardian and the diabetes health are team so that the shool an ontat these individuals with diabetes-related questions and/or during emergenies. 6. Information about the student s meal/ snak shedule. The parent should work with the shool during the teaher preparation period before the beginning of the shool year or before the student returns to shool after diagnosis to oordinate this shedule with that of the other students as losely as possible. For young hildren, instrutions should be given for when food is provided during shool parties and other ativities. 7. In most loations, and inreasingly, a signed release of onfidentiality from the legal guardian will be required so that the health are team an ommuniate with the shool. Copies should be retained both at the shool and in the health are professionals offies. B. The shool or day are provider should provide the following: 1. Opportunities for the appropriate level of ongoing training and diabetes eduation for the shool nurse. 2. Training for shool personnel as follows: level 1 training for all shool staff members, whih inludes a basi overview of diabetes, typial needs of a student with diabetes, reognition of hypoglyemia and hyperglyemia, and who to ontat for help; level 2 training for shool staff members who have responsibility for a student or students with diabetes, whih inludes all ontent from level 1 plus reognition and treatment of hypoglyemia and hyperglyemia and required aommodations for those students; and level 3 training for a small group of shool staff members who will perform student-speifi routine and emergeny are tasks suh as blood gluose monitoring, insulin administration, and gluagon administration when a shool nurse is not available to perform these tasks and whih will inlude level 1 and 2 training as well. 3. Immediate aessibility to the treatment of hypoglyemia by a knowledgeable adult. The student should remain supervised until appropriate treatment has been administered, and the treatment should be available as lose to where the student is as possible. 4. Aessibility to sheduled insulin at times set out in the student s DMMP as well as immediate aessibility to treatment for hyperglyemia inluding insulin administration as set out by the student s DMMP. 5. A loation in the shool that provides privay during blood gluose monitoring and insulin administration, if desired by the student and family, or permission for the student to hek his or her blood gluose level and take appropriate ation to treat hypoglyemia in the lassroom or anywhere the student is in onjuntion with a shool ativity, if indiated in the student s DMMP. 6. Shool nurse and bak-up trained shool personnel who an hek blood gluose and ketones and administer insulin, gluagon, and other mediations as indiated by the student s DMMP. 7. Shool nurse and bak-up trained shool personnel responsible for the student who will know the shedule of the student s meals and snaks and work with the parent/guardian to oordinate this shedule with that of the other students as losely as possible. This individual will also notify the parent/guardian in advane of any expeted hanges in the shool shedule that affet the student s meal times or exerise routine and will remind young hildren of snak times. S76 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

77 Position Statement Table 1dResoures for teahers, hild are providers, parents, and health professionals Helping the Student with Diabetes Sueed: A Guide for Shool Personnel. National Diabetes Eduation Program, Available at Diabetes Care Tasks at Shool: What Key Personnel Need to Know. Alexandria, VA, Amerian Diabetes Assoiation, Available at Your Shool & Your Rights: Proteting Children with Diabetes Against Disrimination in Shools and Day Care Centers. Alexandria, VA, Amerian Diabetes Assoiation, 2005 (brohure). Available at Children with Diabetes: Information for Shool and Child Care Providers. Alexandria, VA, Amerian Diabetes Assoiation, 2004 (brohure). Available at ADA s Safe at Shool ampaign and information on how to keep hildren with diabetes safe at shool. Call DIABETES and go to parents-and-kids/diabetes-are-at-shool/ Amerian Diabetes Assoiation: Complete Guide to Diabetes. Alexandria, VA, Amerian Diabetes Assoiation, Available at Assoiation-Complete-Guide-to-Diabetes-5th-Edition.aspx Amerian Diabetes Assoiation: Guide to Raising a Child With Diabetes, 3rd ed. Alexandria, VA, Amerian Diabetes Assoiation, Available at Guide-to-Raising-a-Child-with-Diabetes-3rd-Edition.aspx Clarke W: Advoating for the hild with diabetes. Diabetes Spetrum 12: , 1999 Shool Disrimination Resoures. Alexandria, VA, Amerian Diabetes Assoiation, Available at Every Day Wisdom: A Kit for Kids with Diabetes (and their parents). Alexandria, VA, Amerian Diabetes Assoiation, Available at ADA s Planet D, online information for hildren and youth with diabetes. Available at *Available in the Amerian Diabetes Assoiation s Eduation Disrimination Paket by alling DIABETES. 8. Permission for self-suffiient and apable students to arry equipment, supplies, mediation, and snaks; to perform diabetes management tasks; and to have ell phone aess to reah parent/guardian and health are provider. 9. Permission for the student to see the shool nurse and other trained shool personnel upon request. 10. Permission for the student to eat a snak anywhere, inluding the lassroom or the shool bus, if neessary to prevent or treat hypoglyemia. 11. Permission to miss shool without onsequenes for illness and required medial appointments to monitor the student s diabetes management. This should be an exused absene with a dotor s note, if required by usual shool poliy. 12. Permission for the student to use the restroom and have aess to fluids (i.e., water) as neessary. 13. An appropriate loation for insulin and/or gluagon storage, if neessary. 14. A plan for the disposal of sharps based upon an agreement with the student s family, loal ordinanes, and Universal Preaution Standards. 15. Information on serving size and alori, arbohydrate, and fat ontent of foods served in the shool (27). The shool nurse should be the key oordinator and provider of are and should oordinate the training of an adequate number of shool personnel as speified above and ensure that if the shool nurse is not present at least one adult is present who is trained to perform these proedures in a timely manner while the student is at shool, on field trips, partiipating in shool-sponsored extraurriular ativities, and on transportation provided by the shool or day are faility. This is needed in order to enable full partiipation in shool ativities (3,18,20). These shool personnel need not be health are professionals (3,9,20,28,33,35). It is the shool s responsibility to provide appropriate training of an adequate number of shool staff on diabetes-related tasks and in the treatment of diabetes emergenies. This training should be provided by the shool nurse or another qualified health are professional with expertise in diabetes. Members of the student s diabetes health are team should provide shool personnel and parents/ guardians with eduational materials from the Amerian Diabetes Assoiation and other soures targeted to shool personnel and/or parents. Table 1 inludes a listing of appropriate resoures. III. Expetations of the student in diabetes are Children and youth should be allowed to provide their own diabetes are at shool to the extent that is appropriate based on the student s development and his or her experiene with diabetes. The extent of the student s ability to partiipate in diabetes are should be agreed upon by the shool personnel, the parent/guardian, and the health are team, as neessary. The ages at whih hildren are able to perform self-are tasks are variable and depend on the individual, and a hild s apabilities and willingness to provide self-are should be respeted (18). 1. Toddlers and preshool-aged hildren: unable to perform diabetes tasks independently and will need an adult to provide all aspets of diabetes are. Many of these younger hildren will have diffiulty in reognizing hypoglyemia, so it is important that shool personnel are able to reognize and provide prompt treatment. However, hildren in this age range an usually determine whih finger to prik, an hoose an injetion site, and are generally ooperative. 2. Elementary shool aged hildren: depending on the length of diagnosis and level of maturity, may be able to perform their own blood gluose heks, but usually will require supervision. Older elementary shool aged hildren are generally beginning to self-administer insulin with supervision and understand the effet of insulin, physial ativity, and nutrition on blood gluose levels. Unless the hild has hypoglyemi unawareness, he or she should usually be able to let an adult know when experiening hypoglyemia. 3. Middle shool and high shool aged hildren: usually able to provide selfare depending on the length of are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S77

78 Position Statement diagnosis and level of maturity but will always need help when experiening severe hypoglyemia. Independene in older hildren should be enouraged to enable the hild to make his or her deisions about his or her own are. Students ompetene and apability for performing diabetes-related tasks are set out in the DMMP and then adapted to the shool setting by the shool health team and the parent/guardian. At all ages, individuals with diabetes may require help to perform a blood gluose hek when the blood gluose is low. In addition, many individuals require a reminder to eat or drink during hypoglyemia and should not be left unsupervised until suh treatment has taken plae and the blood gluose value has returned to the normal range. Ultimately, eah person with diabetes beomes responsible for all aspets of routine are, and it is important for shool personnel to failitate a student in reahing this goal. However, regardless of a student s ability to provide self-are, help will always be needed in the event of a diabetes emergeny. MONITORING BLOOD GLUCOSE IN THE CLASSROOMdIt is best for a student with diabetes to monitor blood gluose levels and respond to the results as quikly and onveniently as possible. This is important to avoid medial problems being worsened by a delay in monitoring and treatment and to minimize eduational problems aused by missing instrution in the lassroom. Aordingly, as stated earlier, a student should be permitted to monitor his or her blood gluose level and take appropriate ation to treat hypoglyemia and hyperglyemia in the lassroom or anywhere the student is in onjuntion with a shool ativity, if preferred by the student and indiated in the student s DMMP (3,24). However, some students desire privay for blood gluose monitoring and other diabetes are tasks, and this preferene should also be aommodated. In summary, with proper planning and the eduation and training of shool personnel, hildren and youth with diabetes an fully partiipate in the shool experiene. To this end, the family, the health are team, and the shool should work together to ensure a safe learning environment. APPENDIX Bakground information on diabetes for shool personnel Diabetes is a serious, hroni disease that impairs the body s ability to use food. Insulin, a hormone produed by the panreas, helps the body onvert food into energy. In people with diabetes, either the panreas does not make insulin or the body annot use insulin properly. Without insulin, the body s main energy souredgluosedannot be used as fuel. Rather, gluose builds up in the blood. Over many years, high blood gluose levels an ause damage to the eyes, kidneys, nerves, heart, and blood vessels. The majority of shool-aged youth with diabetes have type 1 diabetes. People with type 1 diabetes do not produe insulin and must reeive insulin through either injetions or an insulin pump. Insulin taken in this manner does not ure diabetes and may ause the student s blood gluose level to beome dangerously low. Type 2 diabetes, the most ommon form of the disease, typially affliting obese adults, has been shown to be inreasing in youth. This may be due to the inrease in obesity and derease in physial ativity in young people. Students with type 2 diabetes may be able to ontrol their disease through diet and exerise alone or may require oral mediations and/or insulin injetions. All people with type 1 and type 2 diabetes must arefully balane food, mediations, and ativity level to keep blood gluose levels as lose to normal as possible. Low blood gluose (hypoglyemia) is the most ommon immediate health problem for students with diabetes. It ours when the body gets too muh insulin, too little food, a delayed meal, or more than the usual amount of exerise. Symptoms of mild to moderate hypoglyemia inlude tremors, sweating, lightheadedness, irritability, onfusion, and drowsiness. In younger hildren other symptoms may inlude inattention, falling asleep at inappropriate times, unexplained behavior, and temper tantrums. A student with this degree of hypoglyemia will need to ingest arbohydrates promptly and may require assistane. Severe hypoglyemia, whih is rare, may lead to unonsiousness and onvulsions and an be life-threatening if not treated promptly with gluagon as per the student s DMMP (18,24,29,30,31). High blood gluose (hyperglyemia) ours when the body gets too little insulin, too muh food, or too little exerise; it may also be aused by stress or an illness suh as a old. The most ommon symptoms of hyperglyemia are thirst, frequent urination, and blurry vision. If untreated over a period of days, hyperglyemia and insuffiient insulin an lead to a serious ondition alled diabeti ketoaidosis (DKA), whih is haraterized by nausea, vomiting, and a high level of ketones in the blood and urine. For students using insulin infusion pumps, lak of insulin supply may lead to DKA more rapidly. DKA an be lifethreatening and thus requires immediate medial attention (32). AknowledgmentsdThe Amerian Diabetes Assoiation thanks the members of the Health Care Professional Volunteer Writing Group for this updated statement: William Clarke, MD; Larry C. Deeb, MD; Paula Jameson, MSN, ARNP, CDE; Franine Kaufman, MD; Georgeanna Klingensmith, MD; Desmond Shatz, MD; Janet H. Silverstein, MD; and Linda M. Siminerio, RN, PhD, CDE. Referenes 1. Amerian Diabetes Assoiation: Amerian Diabetes Assoiation Complete Guide to Diabetes. 5th ed. Alexandria, VA, Amerian Diabetes Assoiation, Centers for Disease Control and Prevention: National Diabetes Fat Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United States, Atlanta, GA, U.S. Department of Health and Human Servies, Centers for Disease Control and Prevention, National Institutes of Health: Helping the Student with Diabetes Sueed: A Guide for Shool Personnel. Bethesda, MD, National Diabetes Eduation Program (NIH publiation no , revised September 2010) 4. Nabors L, Troillett A, Nash T, Masiulis B: Shool nurse pereptions of barriers and supports for hildren with diabetes. JSh Health 75: , of the Rehabilitation At of 1973, 29 U.S.C. 794, implementing regulations at 35 CFR Part Individuals with Disabilities Eduation At, 20 U.S.C et seq., implementing regulations at 34 CRF Part Title II of the Amerians with Disabilities At of 1990, 42 U.S.C et seq., implementing regulations at 28 CFR Part Rapp J: Students with diabetes in shools. In Inquiry & Analysis. Alexandria, VA, National Shool Boards Assoiation Counil of Shool Attorneys, June 2005 S78 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

79 9. Arent S, Kaufman F: Federal laws and diabetes management at shool. Shool Nurse News, November Jesi Stuthard and ADA v. Kinderare Learning Centers, In. Case no. C (USCD South Ohio 8/96) 11. Calvin Davis and ADA v. LaPetite Aademy, In. Case no. CIV PHX-SMM (USCD Arizona 1997) 12. Agreement, Loudoun County Publi Shools (VA) and the Offie for Civil Rights, United States Department of Eduation (Complaint nos , , , 1999) 13. Henderson County (NC) Pub. Shls., Complaint no , 34 IDLER 43 (OCR 2000) 14. Rapp J, Arent S, Dimmik B, Jakson C: Legal Rights of Students with Diabetes. 2nd ed. Alexandria, VA, Amerian Diabetes Assoiation, Otober 2005, updated Otober Available from org/living-with-diabetes/know-your-rights/ for-lawyers/eduation-materials-for-lawyers/ legal-rights-of-students-with-diabetes. html 15. Greene MA: Diabetes legal advoay omes of age. Diabetes Spetr 19: , Diabetes Control and Compliations Trial Researh Group: Effet of intensive diabetes treatment on the development and progression of long-term ompliations in insulin-dependent diabetes mellitus. N Engl J Med 329: , Diabetes Control and Compliations Trial Researh Group: Effet of intensive diabetes treatment on the development and progression of long-term ompliations in adolesents with insulin-dependent diabetes mellitus. JPediatr125: , Amerian Diabetes Assoiation: Care of hildren and adolesents with type 1 diabetes (Position Statement). Diabetes Care 28: , Barrett JC, Goodwin DK, Kendrik O: Nursing, food servie, and the hild with diabetes. JShNurs18: , Jameson P: Developing diabetes training programs for shool personnel. Shool Nurse News, September Wysoki T, Meinhold P, Cox DJ, Clarke WL: Survey of diabetes professionals regarding developmental harges in diabetes self-are. Diabetes Care 13: 65 68, Lindsey R, Jarrett L, Hillman K: Elementary shoolteahers understanding of diabetes. Diabetes Edu 13: , Amerian Diabetes Assoiation: Diabetes Care Tasks at Shool: What Key Personnel Need to Know. Alexandria, VA, Amerian Diabetes Assoiation, Available from shools/forward2008.pdf 24. Jameson P: Helping students with diabetes thrive in shool. In On the Cutting Edge, Amerian Dieteti Assoiation s Diabetes Care and Eduation Pratie Group Newsletter. Summer 2006, p Owen S: Pediatri pumpsdbarriers and breakthroughs. Pediatri Pumps 32 (Suppl. 1), January/February Amerian Diabetes Assoiation: Medial Management of Type 1 Diabetes. 6th ed. Kaufman F, Ed. Alexandria, VA, Amerian Diabetes Assoiation, Aommodating Children with Speial Dietary Needs in the Shool Nutrition Program: Guidane for Shool Food Servie Staff. Washington, DC, U.S. Department of Agriulture Food and Nutrition Servie, Amerian Diabetes Assoiation: Safe at Shool Campaign Statement of Priniples endorsed by Amerian Aademy of Pediatris, Amerian Assoiation of Clinial Endorinologists, Amerian Assoiation of Diabetes Eduators, Amerian Diabetes Assoiation, Amerian Dieteti Position Statement Assoiation, Children with Diabetes, Disability Rights Eduation Defense Fund, Juvenile Diabetes Researh Foundation, Lawson Wilkins Pediatri Endorine Soiety, Pediatri Endorine Nursing Soiety, Endorine Soiety [artile online]. Available from Evert A: Managing hypoglyemia in the shool setting. Shool Nurse News, November Bulsara MD, Holman CD, David EA, Jones TW: The impat of a deade of hanging treatment on rates of severe hypoglyemia in a population-based ohort of hildren with type 1 diabetes. Diabetes Care 27: , Nabors L, Lehmkuhl H, Christos N, Andreone TF: Children with diabetes: pereptions of supports for self-management at shool. J Sh Health 73: , Kaufman FR: Diabetes mellitus. Pediatr Rev 18: , Pediatri Endorine Nursing Soiety: Children With Diabetes at Shool. September Available from the Pediatri Endorinology Nursing Soiety, 7794 Grow Dr., Pensaola, FL Committee on Shool Health, Amerian Aademy of Pediatris Poliy Statement: Guidane for the administration of mediation in shool. Pediatris 124: , Hellems MA, Clarke WL: Safe at shool: a Virginia experiene. Diabetes Care 30: , Amerian Medial Assoiation: Report 4 of the Counil on Siene and Publi Health (A-08): Ensuring the Best In-Shool Care for Children with Diabetes [artile online], June Available from saph4a08.pdf are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S79

80 P O S I T I O N S T A T E M E N T Diabetes and Driving AMERICAN DIABETES ASSOCIATION O f the nearly 19 million people in the U.S. with diagnosed diabetes (1), a large perentage will seek or urrently hold a liense to drive. For many, a driver s liense is essential to work; taking are of family; seuring aess to publi and private failities, servies, and institutions; interating with friends; attending lasses; and/or performing many other funtions of daily life. Indeed, in many ommunities and areas of the U.S. the use of an automobile is the only (or the only feasible or affordable) means of transportation available. There has been onsiderable debate whether, and the extent to whih, diabetes may be a relevant fator in determining driver ability and eligibility for a liense. This position statement addresses suh issues in light of urrent sientifi and medial evidene. Sometimes people with a strong interest in road safety, inluding motor vehile administrators, pedestrians, drivers, other road users, and employers, assoiate all diabetes with unsafe driving when in fat most people with diabetes safely operate motor vehiles without reating any meaningful risk of injury to themselves or others. When legitimate questions arise about the medial fitness of a person with diabetes to drive, an individual assessment of that person s diabetes managementdwith partiular emphasis on demonstrated ability to detet and appropriately treat potential hypoglyemiadis neessary in order to determine any appropriate restritions. The diagnosis of diabetes is not suffiient to make any judgments about individual driver apaity. This doument provides an overview of existing liensing rules for people with diabetes, addresses the fators that impat driving for this population, and identifies general guidelines for assessing driver fitness and determining appropriate liensing restritions. LICENSING REQUIREMENTSdPeople with diabetes are urrently subjet to a great variety of liensing requirements and restritions. These liensing deisions our at several points and involve different levels and types of review, depending on the type of driving. Some states and loal jurisditions impose no speial requirements for people with diabetes. Other jurisditions ask drivers with diabetes various questions about their ondition, inluding their management regimen and whether they have experiened any diabetes-related problems that ould affet their ability to safely operate a motor vehile. In some instanes, answers to these questions result in restritions being plaed on a person s liense, inluding restritions on the type of vehile they may operate and/or where they may operate that vehile. In addition, the rules for operating a ommerial motor vehile, and for obtaining related liense endorsements (suh as rules restriting operation of a shool bus or transport of passengers or hazardous materials) are quite different and in many ways more umbersome for people with diabetes, espeially those who use insulin. With the exeption of ommerial driving in interstate ommere (Interstate ommerial driving is defined as trade, traffi or transportation in the United States between a plae in a state and a plae outside of suh a state, between two plaes in a state through another state or a plae outside of the United States, or between two plaes in a state as part of trade, traffi or transportation originating or terminating outside the state or the United States [2]), whih is subjet to uniform federal regulation, both private and ommerial driving are subjet to rules determined by individual states. These rules vary widely, with eah state taking its own approah to determining medial fitness to drive and the issuane of lienses. How diabetes is Peer reviewed by the Professional Pratie Committee, September 2011, and approved by the Exeutive Committee of the Amerian Diabetes Assoiation, November DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. identified, whih people are medially evaluated, and what restritions are plaed on people who have experiened hypoglyemia or other problems related to diabetes all vary from state to state. States identify drivers with diabetes in a number of ways. In at least 23 states, drivers are either asked diretly if they have diabetes or are otherwise required to self-identify if they have diabetes. In other states drivers are asked some variation of a question about whether they have a ondition that is likely to ause altered pereption or loss of onsiousness while driving. In most states, when the answer to either question is yes, the driver is required to submit to a medial evaluation before he or she will be issued a liense. Medial evaluation Drivers whose medial onditions an lead to signifiantly impaired onsiousness are evaluated for their fitness to ontinue to drive. For people with diabetes, this typially ours when a person has experiened hypoglyemia (3) behind the wheel, even if this did not result in a motor vehile aident. In some states this ours as a result of a poliy to evaluate all people with diabetes, even if there has been no triggering event. It an also our when a person experienes severe hypoglyemia while not driving and a physiian reports the episode to the liensing authority. In a handful of states, suh reporting by physiians is mandatory. In most other states physiians are permitted to make reports but are given disretion to determine when suh reports are neessary. Some states speify that physiians may voluntarily report those patients who pose an imminent threat to publi safety beause they are driving against medial advie. Physiians and others required to make reports to the liensing authority are usually provided with immunity from ivil and riminal ations resulting from the report. When liensing authorities learn that a driver has experiened an episode of hypoglyemia that potentially affeted the ability to drive, that driver is referred for a medial evaluation and in many ases will lose driving privileges for a period of time until leared by the liensing authority. This period an range from 3 to 6 months or longer. Some state laws allow for waiversoftheruleswhentheepisodeisa one-time event not likely to reur, for S80 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

81 example beause of a hange in mediation or episodes that our only during sleep. Medial evaluation proedures vary and range from a simple onfirmation of the person s diabetes from a physiian to a more elaborate proess involving a state medial advisory board, hearings, and presentation and assessment of medial evidene. Some states onvene medial advisory boards with nurses and physiians of different speialties who review and make reommendations onerning the liensing of people with diabetes and other medial onditions. In other states, liensing deisions are made by administrative staff with little or no medial training and with little or no review by a medial review board or by a physiian or physiians with any relevant expertise onerning medial onditions presented by individual appliants. The medial evaluation proess for ommerial drivers ours at predetermined intervals, typially every 2 years. Unlike nonommerial lienses, these regular evaluations are not linked to episodes of severe hypoglyemia but are part of an ongoing fitness evaluation for jobs requiring ommerial driving. The federal government has no diabetes-speifi restritions for individuals who manage their disease with diet, exerise, and/or oral mediation. It offers an exemption program for insulin-using interstate ommerial drivers and issues medial ertifiates to qualified drivers. Fators in the federal ommerial driving medial evaluation inlude a review of diabetes history, mediations, hospitalizations, blood gluose history, and tests for various ompliations and an assessment of driver understanding of diabetes and willingness to monitor their ondition. SCIENCE OF DIABETES AND DRIVINGdHypoglyemia indiating an impaired ability to drive, retinopathy or atarat formation impairing the vision needed to operate a motor vehile, and neuropathy affeting the ability to feel foot pedals an eah impat driving safety (4). However, the inidene of these onditions is not suffiiently extensive to justify restrition of driving privileges for all drivers with diabetes. Driving mishaps related to diabetes are relatively infrequent for most drivers with diabetes and our at a lower rate than mishaps of many other drivers with onditions that affet driving performane and that are tolerated by soiety. However, just as there are some patients with onditions that inrease their risk of inurring driving mishaps, suh as unstable oronary heart disease, obstrutive sleep apnea, epilepsy, Parkinson s disease, or alohol and substane abuse, there are also some drivers with diabetes that have a higher risk for driving mishaps. The hallenges are to identify highrisk individuals and develop measures to assist them to lower their risk for driving mishaps. Understanding the risk of diabetes and driving In a reent Sottish study, only 62% of health are professionals suggested that insulin-treated drivers should test their blood gluose before driving; 13% of health are professionals thought it safe to drive with blood gluose,72 mg/dl (4 mmol/l), and 8% did not know that impaired awareness of hypoglyemia might be a ontraindiation to driving (5). It is important that health are professionals be knowledgeable and take the lead in disussing risk redution for their patients at risk for hypoglyemia. In a large international study, nearly half of drivers with type 1 diabetes and three-quarters of those with type 2 diabetes had never disussed driving guidelines with their physiian (8). A meta-analysis of 15 studies suggested that the relative risk of having a motor vehile aident for people with diabetes as a whole, i.e., without differentiating those with a signifiant risk from those with little or no risk, as ompared with the general population ranges between and 1.19, a 12 19% inreased risk (6). Some published studies indiated that drivers with type 1 diabetes have a slightly higher risk, with a relative risk ratio of ;2 (7,8,9), but this was not onfirmed by other studies (10). Two studies even suggested that there is no inreased risk assoiated with insulin-treated diabetes (11,12), but the methodologies used have been ritiized (13). This inreased risk of ollisions must be interpreted in the light of soiety stolerane of other and muh higher risk onditions. For example, 16-year-old males have 42 times more ollisions than 35- to 45-year-old women. If the heaviest ar ollides with the lightest ar, the driver of the latter is 20 times more likely to be killed than the driver of the former. The most dangerous rural highways are 9.2 times more dangerous than the safest urban highways. Driving at 1:00 A.M. on Sunday is 142 times more dangerous than driving at 11:00 A.M. (7). Drivers with attention defiit/ hyperativity disorder have a relative risk Position Statement ratio of ;4 (14), whereas those with sleep apnea have a relative risk of ;2.4 (15). If soiety tolerates these onditions, it would be unjustified to restrit the driving privileges of an entire lass of individuals who are at muh lower risk, suh as drivers with diabetes. The most signifiant subgroup of persons with diabetes for whom a greater degree of restritions is often applied is drivers managing their diabetes with insulin. Yet, when the type of diabetes is ontrolled for, insulin therapy per se has not been found to be assoiated with inreased driving risk (3,16,17). While impaired awareness of hypoglyemia has been found to relate to inreased inidene of motor vehile rashes in some studies (12), it has not been found to be a relevant variable in other studies (4,7,23). The single most signifiant fator assoiated with driving ollisions for drivers with diabetes appears to be a reent history of severe hypoglyemia, regardless of the type of diabetes or the treatment used (1,3,18 21). The Amerian Diabetes Assoiation Workgroup on Hypoglyemia defined severe hypoglyemia as low blood gluose resulting in neuroglyopenia that disrupts ognitive motor funtion and requires the assistane of another to atively administer arbohydrate, gluagon, or other resusitative ations (22). In a prospetive multienter study of 452 drivers with type 1 diabetes followed monthly for 12 months, 185 partiipants (41%) reported a total of 503 episodes of moderate hypoglyemia (where the driver ould still treat him/herself but ould no longer drive safely) and 23 partiipants (5%) reported 31 episodes of severe hypoglyemia (where the driver was unable to treat him/herself) while driving (21). Conversely, the Diabetes Control and Compliations Trial (DCCT) group reported 11 motor vehile aidents in 714 episodes of severe hypoglyemia, a rate of 1.5% (23). The signifiant impat of moderate hypoglyemia while driving is supported by multiple studies demonstrating that moderate hypoglyemia signifiantly and onsistently impairs driving safety (24 26) and judgment (27,28) as to whether to ontinue to drive or to self-treat (29,30) under suh metaboli onditions. In one study, 25% of respondents thought it was safe to drive even when blood gluose was,70 mg/dl (3.9 mmol/l) (31). While signifiant hyperglyemia may impair ognitive, motor, and pereptual funtioning (32 35), there is only one report suggesting extreme hyperglyemia an impat driving safety (36). Thus, are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S81

82 Position Statement efforts to equate hyperglyemia with driving impairment are urrently not sientifially justified. Individual differenes Eighty perent of episodes of severe hypoglyemia affet about 20% of people with type 1 diabetes (37 39). Available data suggest that a small subgroup of drivers with type 1 diabetes aount for the majority of hypoglyemia-related ollisions (9,30,40). When 452 drivers with type 1 diabetes were followed prospetively for a year, baseline reports of prior episodes of mild symptomati hypoglyemia while driving or severe hypoglyemia while driving, hypoglyemia-related driving mishaps, or hypoglyemia-related ollisions were assoiated with a higher risk of driving mishaps in the following 12 months by 3, 6, 6, and 20%, respetively. Risk inreased exponentially with additional reported episodes: If individuals had two episodes of severe hypoglyemia in the preeding 12 months their risk inreased to 12%, and two ollisions in the previous 2 years inreased their risk by 40%. The strongest preditors involved a history of hypoglyemia while driving (21). Laboratory studies that ompared drivers with type 1 diabetes who had no history of hypoglyemia-related driving mishap in the past year to those who had more than one mishap found that those with a history of mishaps: 1) drove signifiantly worse during progressive mild hypoglyemia (70 50 mg/dl, mmol/l) but drove equally well when blood gluose was normal (euglyemia); 2) had a lower epinephrine response while driving during hypoglyemia, 3) were more insulin sensitive, and 4) demonstrated greater diffiulties with working memory and information proessing speed during euglyemia and hypoglyemia (24,40,41). Thus, a history of mishaps should be used as a basis for identifying insulin-managed drivers with elevated risk of future mishaps. Suh individuals are appropriately subjeted to additional sreening requirements. Four studies have demonstrated that Blood Gluose Awareness Training (BGAT) redues the ourrene of ollisions and moving vehile violations while improving judgment about whether to drive while hypoglyemi (42 45). BGAT is an 8-week psyho-eduational training program designed to assist individuals with type 1 diabetes to better antiipate, prevent, reognize, and treat extreme blood gluose events. This intervention an be effetively delivered over the internet (46). Diabetes Driving (diabetesdriving.om), a program funded by the National Institutes of Health, is another internet-based tool to help assess the risk of driving mishaps and assist highrisk drivers to avoid hypoglyemia while driving and to better detet and manage hypoglyemia if it ours while driving. RECOMMENDATIONS Identifying and evaluating diabetes in drivers Individuals whose diabetes poses a signifiantly elevated risk to safe driving must be identified and evaluated prior to getting behind the wheel. Beause people with diabetes are diverse in terms of the nature of their ondition, the symptoms they experiene, and the measures they take to manage their diabetes, it is important that identifiation and evaluation proesses be appropriate, individualized, and based not solely on a diagnosis of diabetes but rather on onrete evidene of atual risk. Laws that require all people with diabetes (or all people with insulin-treated diabetes) to be medially evaluated as a ondition of liensure are ill advised beause they ombine people with diabetes into one group rather than identifying those drivers who may be at inreased risk due to potential diffiulties in avoiding hypoglyemia or the presene of ompliations. In addition, the logistis of registering and evaluating millions of people with diabetes who wish to drive presents an enormous administrative and fisal burden to liensing agenies. States that require drivers to identify diabetes should limit the identifiation to reports of diabetesrelated problems. To identify potentially at-risk drivers, a short questionnaire an be used to find those drivers who may require further evaluation. The questionnaire should ask whether the driver has, within the past 12 months, lost onsiousness due to hypoglyemia, experiened hypoglyemia that required intervention from another person to treat or that interfered with driving, or experiened hypoglyemia that developed without warning. The questionnaire should also query about loss of visual auity or peripheral vision and loss of feeling in the right foot. Inasmuh as obstrutive sleep apnea is more ommon in people with type 2 diabetes than in the nondiabeti population, patients should be queried about falling asleep during the day. Any positive answer should trigger an evaluation to determine whether restritions on the liense or mehanial modifiations to the vehile (e.g., hand ontrols for people with an insensate foot) are neessary to ensure publi safety. It is ill-advised to determine risk for driving mishaps based on a driver s glyosylated hemoglobin beause episodi transitions into hypoglyemia, not average blood gluose, inreases risk of driving mishaps. Evaluation of drivers with diabetes must inlude an assessment by the treating physiian or another diabetes speialist who an review reent diabetes history and provide to the liensing ageny a reommendation about whether the driver has a ondition that impairs his or her ability to safely operate a motor vehile. The treating physiian or another physiian who is knowledgeable about diabetes is the best soure of information onerning the driver s diabetes management and history. The input of suh a physiian is essential to assess a person s diabetes management and determine whether operation of a motor vehile is safe and pratiable. If questions arise onerning the safe driving ability of a person with hroni ompliations of diabetes (e.g., retinopathy or neuropathy), the individual should be referred to a speialist with expertise in evaluating the diabetes-related problem for speifi reommendations. Physiians should be requested to provide the following information: 1) whether the driver has had an episode of severe hypoglyemia requiring intervention from another person within the previous 2 years (and when this happened); 2) whether there was an explanation for the hypoglyemia; 3) whether the driver is at inreased risk of severe hypoglyemia; 4) whether the driver has the ability to reognize inipient hypoglyemia and knows how to take appropriate orretive ation; 5) whether the driver provides evidene of suffiient self-monitoring of blood gluose; 6) whether the driver has any diabetes-related ompliations affeting safe driving that need further assessment; and 7) whether the driver has a good understanding of diabetes and its treatment, has been eduated on the avoidane of hypoglyemia while driving, and is willing to follow a suggested treatment plan. When evaluating a driver with a history of severe hypoglyemia, impaired hypoglyemia awareness, or a diabetes-related motor vehile aident, it is neessary to S82 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

83 investigate the reasons for the hypoglyemia and to determine whether it is a funtion of the driver s treatment regimen or lifestyle, a psyhologial reation to the management of their diabetes, or the normal ourse of diabetes. Appropriate linial interventions should be instituted. Liensing deisions following evaluation Drivers with diabetes should only have a liense suspended or restrited if doing so is the only pratial way to address an established safety risk. Liensing deisions should reflet deferene to the professional judgment of the evaluating physiian with regard to diabetes, while also balaning the liensing ageny s need to keep the roads and the publi safe. States should have medial advisory boards whose role is to assess potential driving risks based on ontinually updated medial information, to ensure that liensing ageny staff is prepared to handle diabetes liensing issues, and to make reommendations relevant to individual drivers. State medial advisory boards should have representation by health are professionals with expertise in treating diabetes, in addition to the information provided by the driver s treating physiian, prior to making liensing deisions for people with diabetes. Where the medial advisory board does not have a permanent member with expertise in diabetes, suh an expert should be onsulted in ases involving restritions on a driver with diabetes. As disussed above, a history of hypoglyemia does not mean an individual annot be a safe driver. Rather, when there is evidene of a history of severe hypoglyemia, an appropriate evaluation should be undertaken to determine the ause of the low blood gluose, the irumstanes of the episode, whether it was an isolated inident, whether adjustment to the insulin regimen may mitigate the risk, and the likelihood of suh an episode reurring. It is important that liensing deisions take into onsideration ontributory fators that may mitigate a potential risk, and that liensing agenies do not adopt a one strike approah to liensing people with diabetes. Drivers with diabetes must be individually assessed to determine whether their diabetes poses a safety risk. The mere fat that a person s diabetes has ome to the attention of the liensing agenydwhether by a report or beause of an aidentdshould not itself predetermine a liensing deision. Generally, severe hypoglyemia that ours during sleep should not disqualify a person from driving. Hypoglyemia that ours while the person is not driving should be examined to determine if it is indiative of a larger problem or an event that is not likely to reur while the person is behind the wheel of a ar (e.g., hypoglyemia that ours during an intense bout of exerise). Some episodes of severe hypoglyemia an be explained and orreted with the assistane of a diabetes health are professional, e.g., episodes that our beause of a hange in mediation. However, reurrent episodes of severe hypoglyemia, defined as two or more episodes in a year, may indiate that a person is not able to safely operate a motor vehile. States whose liensing rules lead to a suspension of a driver s liense following an episode of hypoglyemia should allow for waiver of these rules when the hypoglyemia an be explained and addressed by the treating physiian and is not likely to reur. For example, waivers may be appropriate following hypoglyemia that happens as a result of a hange in mediation or during or onurrent with illness or pregnany. Liensing agenies may request doumentation from the physiian attesting that the patient meets the onditions for a waiver (whih may inlude, among other requirements, eduation on diabetes management and avoidane of hypoglyemia). Drivers with a suspended liense beause of fators related to diabetes should be eligible to have their driver s liense reinstated following a suffiient period of time (usually no more than 6 months) upon advie from the treating physiian that the driver has made appropriate adjustments and is adhering to a regimen that has resulted in orretion of the problems that led to the liense suspension. Following reinstatement of driving privileges, periodi follow-up evaluation is neessary to ensure that the person remains safely able to operate a motor vehile. People who experiene progressive impairment of their awareness of hypoglyemia should onsult a health are provider to determine whether it is safe to ontinue driving with proper measures to avoid disruptive hypoglyemia (suh as testing blood gluose before driving and at regular intervals in the ourse of a journey lasting more than min). If the driver is able to make adjustments to improve awareness or prevent disruptive hypoglyemia while driving, there should not be liense restritions. Continuous Position Statement gluose monitoring may also be benefiial, partiularly when noting the diretion of the gluose trend. If this tehnology is used, the person using the devie needs to appreiate that any ation taken (e.g., additional arbohydrate onsumption) needs to be based on a blood gluose measurement. The determination of whih disqualified drivers should be reevaluated and when this should be done should be made on an individual basis onsidering fators suh as the irumstanes of the disqualifying event and hanges in mediation and behavior that have been implemented by the driver. When an assessment determines that the driver should be evaluated at some point in the future, the driver s physiian should be onsulted to determine the length of the reevaluation period. A driver with diabetes should not be kept in an endless yle of reevaluation if there is no longer a signifiantly elevated safety risk. The determination of medial fitness to drive should be a linial one, weighing the various fators noted above. Deisions about whether liensing restritions are neessary to ensure safety of the traveling publi are ultimately determined by the liensing ageny, taking into aount the linial determination of medial fitness. Physiian reporting Although the onept behind mandatory physiian reporting laws is to keep roads safe by eliminating unaeptable risk from impaired driving, suh laws have the unintended onsequene of disouraging people with diabetes from disussing their ondition frankly with a physiian when there is a problem that needs orretion due to fear of losing their liense. Patients who are not andid with their physiians are likely to reeive inferior treatment and therefore may experiene ompliations that present a driving risk. In addition to the negative effet that mandatory reporting has on the physiian-patient relationship, there is no evidene that mandatory physiian reporting redues the rash rate or improves publi safety (47). Physiians should be permitted to exerise professional judgment in deiding whether and when to report a patient to the liensing ageny for review of driving privileges. States that allow physiians to make suh reports should fous on whether the driver s mental or physial ondition impairs the patient s ability to exerise safe ontrol over a motor vehile. are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S83

84 Position Statement Reports based solely on a diagnosis of diabetes, or tied to a haraterization that the driver has a ondition involving lapses of onsiousness, are too broad and do not adequately measure individual risk. Ultimately, reports must be left to the disretion of the physiian, using professional judgment about whether the patient poses a safety risk. Further, in order to protet the physiian-patient relationship and ensure the open and honest ommuniation that ultimately promotes safety, it is important that physiians be immunized from liability, both for making reports and not making reports. Patient eduation and linial interventions It is important that health are professionals be knowledgeable and take the lead in disussing risk redution for their patients at risk for disruptive hypoglyemia. This starts with health are professionals being onversant with safe praties, partiularly for those patients at inreased risk for diabetes-related inidents. Perhaps the most important aspet of enouraging people with diabetes to be safe drivers is for health are professionals who treat diabeti drivers to provide eduation about driving with diabetes and potential risks assoiated with patients treatment regimens. When that regimen inludes the possibility of hypoglyemia, eduation should inlude instrution on avoiding and responding to hypoglyemia, disussion about the patient s vulnerability for driving mishaps, and ongoing learning to ensure that patients have knowledge of when it is and is not safe for them to drive. For example, the risks of driving under the influene of alohol are well known, but the delayed hypoglyemi effets of even moderate alohol intake are not, and alohol exaerbates the ognitive impairment assoiated with hypoglyemia (48). Inasmuh as hypoglyemia an be mistaken for intoxiation, and both inrease the risk of motor vehile aidents, patients should be ounseled to test gluose more frequently for several hours after moderate alohol intake. When a patient has ompliations of diabetes, it is important for the physiian to disuss with the driver the effet of those ompliations, if any, on driving ability. Physiians and other health are professionals who treat people with diabetes should regularly disuss the risk of driving with low blood gluose with their patients. Clinial visits should inlude review of blood gluose logs and questions to the patient about symptoms assoiated with high or low blood gluose levels and what the patient did to treat those levels. Allowing health are professionals to exerise professional judgment about the information they learn in these patient onversations will enourage andid sharing of information and lead to improved patient health and road safety. Clinial interventions in response to hypoglyemia vary by individual but may inlude strategies for the frequeny and timing of blood gluose monitoring, mediation dosage hanges, and establishing more onservative gluose targets if there is a history of severe hypoglyemia. Certain people who have a history of severe hypoglyemia may be enouraged by their health are provider to use ontinuous gluose monitoring systems that enable them to detet a trend toward hypoglyemia before gluose levels fall to a level that will affet safe driving. Of note, speial are should be taken to prevent hypoglyemia while operating any vehile in drivers with type 1 diabetes and in those with type 2 diabetes who are at risk for developing hypoglyemia. They should be instruted to always hek blood gluose before getting behind the wheel and at regular intervals while driving for periods of 1 h or greater. Consideration should be given to fators that may predit a fall in blood gluose, inluding time of insulin administration, timing of the last meal or food ingestion, and exerise type, duration, intensity, and timing. Low blood gluose values should be treated immediately and appropriately, and the driver should not drive until blood gluose is in a safely aeptable range, usually after min beause of delayed reovery of ognitive funtion. People with diabetes who are at risk for disruptive hypoglyemia should be ounseled to: 1) always arrya blood gluose meter and appropriate snaks, inluding a quik-ating soure of sugar (suh as juie, nondiet soda, hard andy, or dextrose tablets) as well as snaks with omplex arbohydrate, fat, and protein (e.g., heese rakers), in their vehile; 2) never begin an extended drive with low normal blood gluose (e.g., mg/dl) without prophylati arbohydrate onsumption to avoid a fall in blood gluose during the drive; 3) stop the vehile as soon any of the symptoms of low blood gluose are experiened and measure and treat the blood gluose level; and 4) not resume driving until their blood gluose and ognition have reovered. CONCLUSIONdIn summary, people with diabetes should be assessed individually, taking into aount eah individual s medial history as well as the potential related risks assoiated with driving. AknowledgmentsdThe Amerian Diabetes Assoiation thanks the members of the writing group for developing this statement: Daniel Lorber, MD, FACP, CDE (Chair); John Anderson, MD; Shereen Arent, JD; Daniel J. Cox, PhD, ABPP; Brian M. Frier, BS, MD, FRCPE, FRCPG; Mihael A. Greene, JD; John W. Griffin, Jr., JD; Gary Gross, JD; Katie Hathaway, JD; Irl Hirsh, MD; Daniel B. Kohrman, JD; David G. Marrero, PhD; Thomas J. Songer, PhD; and Alan L. Yatvin, JD. Referenes 1. Centers for Disease Control and Prevention. National Diabetes Fat Sheet: National Estimates and General Information on Diabetes and Prediabetes in the U.S., Atlanta, GA, U.S. Department of Health and Human Servies, Centers for Disease Control and Prevention, Code of Federal Regulation. Title 49: Transportation. Subpart A: General Appliability and Definitions. x Amerian Diabetes Assoiation. Standards of medial are in diabetesd2013 (Position Statement). Diabetes Care 2013;36 (Suppl. 1):S11 S66 4. Cox DJ, Kovathev BK, Vandear K, Gonder-Frederik L, Ritterband L, Clarke W. Hypoglyemia preeding fatal ar ollisions. Diabetes Care 2006;29: Watson WA, Currie T, Lemon JS, Gold AE. Driving and insulin-treated diabetes: who knows the rules and reommendations? Prat Diabetes Int 2004;24: ECRI. Diabetes and Commerial Motor Vehile Safety (Federal Motor Carrier Safety Administration). June 2011 Update. Plymouth Meeting, Pennsylvania, ECRI, Lave LB, Songer TJ, LaPorte RE. Should persons with diabetes be liensed to drive truks? Risk management. Risk Anal 1993;13: Harsh IA, Stoker S, Radespiel-Tröger M, et al. Traffi hypoglyaemias and aidents in patients with diabetes mellitus treated with different antidiabeti regimens. J Intern Med 2002;252: Cox DJ, Penberthy JK, Zrebie J, et al. Diabetes and driving mishaps: frequeny and orrelations from a multinational survey. Diabetes Care 2003;26: Stork ADM, van Haeften TW, Veneman TF. Diabetes and driving: desired data, researh methods and their pitfalls, urrent knowledge, and future researh. Diabetes Care 2006;29: Lonnen KF, Powell RJ, Taylor D, Shore AC, MaLeod KM. Road traffi aidents and S84 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

85 diabetes: insulin use does not determine risk. Diabet Med 2008;25: Eadington DW, Frier BM. Type 1 diabetes and driving experiene: an eight-year ohort study. Diabet Med 1989;6: Major HG, Rees SDR, Frier BM. Driving and diabetes: DVLA response to Lonnen et al. Diabet Med 2009;26: Jerome L, Habinski L, Segal A. Attentiondefiit/hyperativity disorder (ADHD) and driving risk: a review of the literature and a methodologial ritique. Curr Psyhiatry Rep 2006;8: Tregear S, Reston J, Shoelles K, Phillips B. Obstrutive sleep apnea and risk of motor vehile rash: systemati review and meta-analysis. J Clin Sleep Med 2009; 5: Laberge-Nadeau C, Dionne G, Ekoé JM, et al. Impat of diabetes on rash risks of truk-permit holders and ommerial drivers. Diabetes Care 2000;23: Tregear SJ, Rizzo M, Tiller M, et al. Diabetes and motor vehile rashes: a systemati evidene-based review and meta-analysis. In Proeedings of the Fourth International Driving Symposium on Human Fators in Driver Assessment, Training and Vehile Design. Iowa City, Iowa, The University of Iowa, 2007, p Songer TJ. Low blood sugar and motor vehile rashes in persons with type 1 diabetes. Annu Pro Asso Adv Automot Med 2002;46: Songer TJ, Dorsey RR. High risk harateristis for motor vehile rashes in persons with diabetes by age. Annu Pro Asso Adv Automot Med 2006;50: Redelmeier DA, Kenshole AB, Ray JG. Motor vehile rashes in diabeti patients with tight glyemi ontrol: a populationbased ase ontrol analysis. PLoS Med 2009;6:e Cox DJ, Ford D, Gonder-Frederik LG, et al. Driving mishaps among individuals with type 1 diabetes: a prospetive study. Diabetes Care 2009;32: Amerian Diabetes Assoiation. Defining and reporting hypoglyemia in diabetes: a report from the Amerian Diabetes Assoiation Workgroup on Hypoglyemia. Diabetes Care 2005;28: The DCCT Researh Group. Epidemiology of severe hypoglyemia in the diabetes ontrol and ompliations trial. Am J Med 1991;90: Cox DJ, Gonder-Frederik LA, Clarke WL. Driving derements in type I diabetes during moderate hypoglyemia. Diabetes 1993;42: Quillian WC, Cox DJ, Gonder-Frederik LA, Driesen NR, Clarke WL. Reliability of driving performane during moderate hypoglyemia in adults with IDDM. Diabetes Care 1994;17: Cox DJ, Gonder-Frederik LA, Kovathev BP, Julian DM, Clarke WL. Progressive hypoglyemia s impat on driving simulation performane: ourrene, awareness and orretion. Diabetes Care 2000;23: Weinger K, Kinsley BT, Levy CJ, et al. The pereption of safe driving ability during hypoglyemia in patients with type 1 diabetes mellitus. Am J Med 1999;107: Clarke WL, Cox DJ, Gonder-Frederik LA, Kovathev BP. Hypoglyemia and the deision to drive a motor vehile by persons with diabetes. JAMA 1999;282: Cox DJ, Gonder-Frederik LA, Kovathev BP, Clarke WL. Self-treatment of hypoglyemia while driving. Diabetes Res Clin Prat 2001;54: Cox DJ, Kovathev BP, Anderson SM, Clarke WL, Gonder-Frederik LA. Type 1 diabeti drivers with and without a history of reurrent hypoglyemia-related driving mishaps: physiologial and performane differenes during euglyemia and the indution of hypoglyemia. Diabetes Care 2010;33: Graveling AJ, Warren RE, Frier BM. Hypoglyaemia and driving in people with insulin-treated diabetes: adherene to reommendations for avoidane. Diabet Med 2004;21: Kovathev BP, Cox DJ, Summers KH, Gonder-Frederik LA, Clarke WL. Postprandial gluose dynamis and assoiated symptoms in type 2 diabetes mellitus. J Appl Res 2003;3: Sommerfield AJ,Deary IJ,Frier BM.Aute hyperglyemia alters mood state and impairs ognitive performane in people with type 2 diabetes. Diabetes Care 2004; 27: Cox DJ, MCall A, Kovathev BP, Sarwat S, Ilag LL, Tan MH. Effets of blood gluose rate of hanges on pereived mood and ognitive symptoms in insulin-treated type 2 diabetes. Diabetes Care 2007;30: Gonder-Frederik LA, Zrebie JF, Bauhowitz AU, et al. Cognitive funtion is disrupted by both hypo- and hyperglyemia in shool-aged hildren with type 1 diabetes: a field study. Diabetes Care 2009;32: Cox D, Ford D, Ritterband L, Singh H, Gonder-Frederik L. Disruptive effets of hyperglyemia on driving in adults with type 1 and 2 diabetes (Abstrat). Diabetes 2011;60(Suppl. 1):A223 Position Statement 37. Pedersen-Bjergaard U, Pramming S, Heller SR, et al. Severe hypoglyaemia in 1076 adult patients with type 1 diabetes: influene of risk markers and seletion. Diabetes Metab Res Rev 2004;20: Bognetti F, Brunelli A, Meshi F, Visardi M, Bonfanti R, Chiumello G. Frequeny and orrelates of severe hypoglyaemia in hildren and adolesents with diabetes mellitus. Eur J Pediatr 1997;156: Rewers A, Chase HP, Makenzie T, et al. Preditors of aute ompliations in hildren with type 1 diabetes. JAMA 2002; 287: Campbell LK, Gonder-Frederik LA, Broshek DK, et al. Neuroognitive differenes between drivers with type 1 diabetes with and without a reent history of reurrent driving mishaps. Int J Diabetes Mellit 2010;2: Cox DJ, Kovathev BP, Gonder-Frederik LA, Clarke WL. Physiologial and performane differenes between drivers with Type 1 Diabetes Mellitus (T1DM) with and without a reent history of driving mishaps: An exploratory study. Can J Diabetes 2003; 27: Cox DJ, Gonder-Frederik LA, Julian DM, Clarke W. Long-term follow-up evaluation of blood gluose awareness training. Diabetes Care 1994;17: Cox DJ, Gonder-Frederik LA, Polonsky W, Shlundt D, Julian D, Clarke W. A multienter evaluation of blood gluose awareness training-ii. Diabetes Care 1995; 18: Cox DJ, Gonder-Frederik LA, Polonsky W, Shlundt D, Kovathev B, Clarke W. Blood gluose awareness training (BGAT- 2): long-term benefits. Diabetes Care 2001;24: Broers S, le Cessie S, van Vliet KP, Spinhoven P, van der Ven NC, Radder JK. Blood gluose awareness training in Duth Type 1 diabetes patients. Shortterm evaluation of individual and group training. Diabet Med 2002;19: Cox DJ, Ritterband L, Magee J, Clarke W, Gonder-Frederik L. Blood gluose awareness training delivered over the Internet. Diabetes Care 2008;31: MLahlan RS, Starreveld E, Lee MA. Impat of mandatory physiian reporting on aident risk in epilepsy. Epilepsia 2007;48: Cheyne EH, Sherwin RS, Lunt MJ, Cavan DA, Thomas PW, Kerr D. Influene of alohol on ognitive performane during mild hypoglyaemia: impliations for Type 1 diabetes. Diabet Med 2004;21: are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S85

86 P O S I T I O N S T A T E M E N T Diabetes Management in Corretional Institutions AMERICAN DIABETES ASSOCIATION A t any given time, over 2 million people are inarerated in prisons and jails in the U.S (1). It is estimated that nearly 80,000 of these inmates have diabetes, a prevalene of 4.8% (2). In addition, many more people pass through the orretions system in a given year. In 1998 alone, over 11 million people were released from prison to the ommunity (1). The urrent estimated prevalene of diabetes in orretional institutions is somewhat lower than the overall U.S. prevalene of diabetes, perhaps beause the inarerated population is younger than the general population. The prevalene of diabetes and its related omorbidities and ompliations, however, will ontinue to inrease in the prison population as urrent sentening guidelines ontinue to inrease the number of aging prisoners and the inidene of diabetes in young people ontinues to inrease. People with diabetes in orretional failities should reeive are that meets national standards. Corretional institutions have unique irumstanes that need to be onsidered so that all standards of are may be ahieved (3). Corretional institutions should have written poliies and proedures for the management of diabetes and for training of medial and orretional staff in diabetes are praties. These poliies must take into onsideration issues suh as seurity needs, transfer from one faility to another, and aess to medial personnel and equipment, so that all appropriate levels of are are provided. Ideally, these poliies should enourage or at least allow patients to self-manage their diabetes. Ultimately, diabetes management is dependent upon having aess to needed medial personnel and equipment. Ongoing diabetes therapy is important in order to redue the risk of later ompliations, inluding ardiovasular events, visual loss, renal failure, and amputation. Early identifiation and intervention for people with diabetes is also likely to redue short-term risks for aute ompliations requiring transfer out of the faility, thus improving seurity. This doument provides a general set of guidelines for diabetes are in orretional institutions. It is not designed to be a diabetes management manual. More detailed information on the management of diabetes and related disorders an be found in the Amerian Diabetes Assoiation (ADA) Clinial Pratie Reommendations, published eah year in January as the first supplement to Diabetes Care,aswell asthe Standards of Medial Care in Diabetes (4) ontained therein. This disussion will fous on those areas where the are of people with diabetes in orretional failities may differ, and speifi reommendations are made at the end of eah setion. INTAKE MEDICAL ASSESSMENT Reeption sreening Reeption sreening should emphasize patient safety. In partiular, rapid identifiation of all insulin-treated persons with diabetes is essential in order to identify those at highest risk for hypo- and hyperglyemia and diabeti ketoaidosis (DKA). All insulin-treated patients should have a apillary blood gluose (CBG) determination within 1 2 h of arrival. Signs and symptoms of hypo- or hyperglyemia an often be onfused with intoxiation or withdrawal from drugs or alohol. Individuals with diabetes exhibiting signs and symptoms onsistent with hypoglyemia, partiularly altered mental status, agitation, ombativeness, and diaphoresis, should have finger-stik blood gluose levels measured immediately. Intake sreening Patients with a diagnosis of diabetes should have a omplete medial history Originally approved Most reent revision, DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. and physial examination by a liensed health are provider with presriptive authority in a timely manner. If one is not available on site, one should be onsulted by those performing reeption sreening. The purposes of this history and physial examination are to determine the type of diabetes, urrent therapy, alohol use, and behavioral health issues, as well as to sreen for the presene of diabetes-related ompliations. The evaluation should review the previous treatment and the past history of both glyemi ontrol and diabetes ompliations. It is essential that mediation and medial nutrition therapy (MNT) be ontinued without interruption upon entry into the orretional system, as a hiatus in either mediation or appropriate nutrition may lead to either severe hypo- or hyperglyemia that an rapidly progress to irreversible ompliations, even death. Intake physial examination and laboratory All potential elements of the initial medial evaluation are inluded in Table 7 of the ADA s Standards of Medial Care in Diabetes, referred to hereafter as the Standards of Care (4). The essential omponents of the initial history and physial examination are detailed in Fig. 1. Referrals should be made immediately if the patient with diabetes is pregnant. Reommendations Patients with a diagnosis of diabetes should have a omplete medial history and undergo an intake physial examination by a liensed health professional in a timely manner. (E) Insulin-treated patients should have a CBG determination within 1 2 hof arrival. (E) Mediations and MNT should be ontinued without interruption upon entry into the orretional environment. (E) SCREENING FOR DIABETESd Consistent with the ADA Standards of Care, patients should be evaluated for diabetes risk fators at the intake physial and at appropriate times thereafter. Those who are at high risk should be onsidered for blood gluose sreening. If pregnant, a risk assessment for gestational diabetes S86 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

87 Position Statement Figure 1dEssential omponents of the initial history and physial examination. Alb/Cr ratio, albumin-to-reatinine ratio; ALT, alanine aminotransferase; AST, aspartate aminotransferase. mellitus (GDM) should be undertaken at the first prenatal visit. Patients with linial harateristis onsistent with a high risk for GDM should undergo gluose testing as soon as possible. High-risk women not found to have GDM at the initial sreening and average-risk women should be tested between 24 and 28 weeks of gestation. For more detailed informationonsreeningforbothtype2 and gestational diabetes, see the ADA Position Statement Sreening for Type 2Diabetes (5) and the Standards of Care (4). MANAGEMENT PLANdGlyemi ontrol is fundamental to the management of diabetes. A management plan to ahieve normal or near-normal glyemia with an A1C goal of,7% should be developed for diabetes management at the time of initial medial evaluation. Goals should be individualized (4), and less stringent treatment goals may be appropriate for patients with a history of severe hypoglyemia, patients with limited life expetanies, elderly adults, and individuals with omorbid onditions (4). This plan should be doumented in the patient s reord and ommuniated to all persons involved in his/her are, inluding seurity staff. Table 1, taken from the ADA Standards of Care, provides a summary of reommendations for setting glyemi ontrol goals for adults with diabetes. People with diabetes should ideally reeive medial are from a physiianoordinated team. Suh teams inlude, but are not limited to, physiians, nurses, dietitians, and mental health professionals with expertise and a speial interest in diabetes. It is essential in this ollaborative and integrated team approah that individuals with diabetes assume as ative a role in their are as possible. Diabetes self-management eduation is an integral omponent of are. Patient selfmanagement should be emphasized, and the plan should enourage the involvement of the patient in problem solving as muh as possible. It is helpful to house insulin-treated patients in a ommon unit, if this is possible, safe, and onsistent with providing aess to other programs at the orretional institution. Common housing not only an failitate mealtimes and mediation administration, but also potentially provides an opportunity for diabetes self-management eduation to be reinfored by fellow patients. NUTRITION AND FOOD SERVICESdNutrition ounseling and menu planning are an integral part of the multidisiplinary approah to diabetes management in orretional failities. A ombination of eduation, interdisiplinary ommuniation, and monitoring food intake aids patients in understanding their medial nutritional needs and an failitate diabetes ontrol during and after inareration. Nutrition ounseling for patients with diabetes is onsidered an essential omponent of diabetes self-management. People with diabetes should reeive individualized MNT as needed to ahieve treatment goals, preferably provided by a registered dietitian familiar with the omponents of MNT for persons with diabetes. Eduating the patient, individually or in a group setting, about how arbohydrates and food hoies diretly affet diabetes ontrol is the first step in failitating self-management. This eduation enables the patient to identify better food are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S87

88 Position Statement Table 1dSummary of reommendations for glyemi, blood pressure, and lipid ontrol for most adults with diabetes A1C,7.0%* Blood pressure,140/80 mmhg Lipids LDL holesterol,100 mg/dl (,2.6 mmol/l) *More or less stringent glyemi goals may be appropriate for individual patients. Goals should be individualized based on duration of diabetes, age/life expetany, omorbid onditions, known CVD or advaned mirovasular ompliations, hypoglyemia unawareness, individual and patient onsiderations. Based on patient harateristis and response to therapy, lower SBP targets may be appropriate. In individuals with overt CVD, a lower LDL holesterol goal of,70 mg/dl (1.8 mmol/l), using a high dose of a statin, is an option. seletions from those available in the dining hall and ommissary. Suh an approah is more realisti in a faility where the patient has the opportunity to make food hoies. The easiest and most ost-effetive means to failitate good outomes in patients with diabetes is instituting a hearthealthy diet as the master menu (6). There should be onsistent arbohydrate ontent at eah meal, as well as a means to identify the arbohydrate ontent of eah food seletion. Providing arbohydrate ontent of food seletions and/or providing eduation in assessing arbohydrate ontent enables patients to meet the requirements of their individual MNT goals. Commissaries should also help in dietary management by offering healthy hoies and listing the arbohydrate ontent of foods. The use of insulin or oral mediations may neessitate snaks in order to avoid hypoglyemia. These snaks are a part of suh patients medial treatment plans and should be presribed by medial staff. Timing of meals and snaks must be oordinated with mediation administration as needed to minimize the risk of hypoglyemia, as disussed more fully in the MEDICATION setion of this doument. For further information, see the ADA Position Statement Nutrition Reommendations and Interventions for Diabetes (7). URGENT AND EMERGENCY ISSUESdAll patients must have aess to prompt treatment of hypo- and hyperglyemia. Corretional staff should be trained in the reognition and treatment of hypo- and hyperglyemia, and appropriate staff should be trained to administer gluagon. After suh emergeny are, patients should be referred for appropriate medial are to minimize risk of future deompensation. Institutions should implement a poliy requiring staff to notify a physiian of all CBG results outside of a speified range, as determined by the treating physiian (e.g.,,50 or.350 mg/dl). Hyperglyemia Severe hyperglyemia in a person with diabetes may be the result of interurrent illness, missed or inadequate mediation, or ortiosteroid therapy. Corretional institutions should have systems in plae to identify and refer to medial staff all patients with onsistently elevated blood gluose as well as interurrent illness. The stress of illness in those with type 1 diabetes frequently aggravates glyemi ontrol and neessitates more frequent monitoring of blood gluose (e.g., every 4 6 h). Marked hyperglyemia requires temporary adjustment of the treatment program and, if aompanied by ketosis, interation with the diabetes are team. Adequate fluid and alori intake must be ensured. Nausea or vomiting aompanied with hyperglyemia may indiate DKA, a life-threatening ondition that requires immediate medial are to prevent ompliations and death. Corretional institutions should identify patients with type 1 diabetes who are at risk for DKA, partiularly those with a prior history of frequent episodes of DKA. For further information see Hyperglyemi Crisis in Diabetes (8). Hypoglyemia Hypoglyemia is defined as a blood gluose level,70 mg/dl. Severe hypoglyemia is a medial emergeny defined as hypoglyemia requiring assistane of a third party and is often assoiated with mental status hanges that may inlude onfusion, inoherene, ombativeness, somnolene, lethargy, seizures, or oma. Signs and symptoms of severe hypoglyemia an be onfused with intoxiation or withdrawal. Individuals with diabetes exhibiting signs and symptoms onsistent with hypoglyemia, partiularly altered mental status, agitation, and diaphoresis, should have their CBG levels heked immediately. Seurity staff who supervise patients at risk for hypoglyemia (i.e., those on insulin or oral hypoglyemi agents) should be eduated in the emergeny response protool for reognition and treatment of hypoglyemia. Every attempt should be made to doument CBG before treatment. Patients must have immediate aess to gluose tablets or other gluoseontaining foods. Hypoglyemia an generally be treated by the patient with oral arbohydrates. If the patient annot be relied on to keep hypoglyemia treatment on his/her person, staff members should have ready aess to gluose tablets or equivalent. In general, g oral gluose will be adequate to treat hypoglyemi events. CBG and treatment should be repeated at 15-min intervals until blood gluose levels return to normal (.70 mg/ dl). Staff should have gluagon for intramusular injetion or gluose for intravenous infusion available to treat severe hypoglyemia without requiring transport of the hypoglyemi patient to an outside faility. Any episode of severe hypoglyemia or reurrent episodes of mild to moderate hypoglyemia require reevaluation of the diabetes management plan by the medial staff. In ertain ases of unexplained or reurrent severe hypoglyemia, it may be appropriate to admit the patient to the medial unit for observation and stabilization of diabetes management. Corretional institutions should have systems in plae to identify the patients at greater risk for hypoglyemia (i.e., those on insulin or sulfonylurea therapy) and to ensure the early detetion and treatment of hypoglyemia. If possible, patients at greater risk of severe hypoglyemia (e.g., those with a prior episode of severe hypoglyemia) may be housed in units loser to the medial unit in order to minimize delay in treatment. Reommendations Train orretional staff in the reognition, treatment, and appropriate referral for hypo- and hyperglyemia. (E) Train appropriate staff to administer gluagon. (E) Train staff to reognize symptoms and signs of serious metaboli deompensation, and immediately refer the patient for appropriate medial are. (E) Institutions should implement a poliy requiringstafftonotifyaphysiianof all CBG results outside of a speified range, as determined by the treating physiian (e.g.,,50 or.350 mg/dl). (E) Identify patients with type 1 diabetes who are at high risk for DKA. (E) MEDICATIONdFormularies should provide aess to usual and ustomary S88 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

89 oral mediations and insulins neessary to treat diabetes and related onditions. While not every brand name of insulin and oral mediation needs to be available, individual patient are requires aess to short-, medium-, and long-ating insulins and the various lasses of oral mediations (e.g., insulin seretagogues, biguanides, a-gluosidase inhibitors, and thiazolidinediones) neessary for urrent diabetes management. Patients at all levels of ustody should have aess to mediation at dosing frequenies that are onsistent with their treatment plan and medial diretion. If feasible and onsistent with seurity onerns, patients on multiple doses of shortating oral mediations should be plaed in a keep on person program. In other situations, patients should be permitted to self-injet insulin when onsistent with seurity needs. Medial department nurses should determine whether patients have the neessary skill and responsible behavior to be allowed self-administration and the degree of supervision neessary. When needed, this skill should be a part of patient eduation. Reasonable syringe ontrol systems should be established. In the past, the reommendation that regular insulin be injeted min before meals presented a signifiant problem when lok downs or other disruptions to the normal shedule of meals and mediations ourred. The use of multiple-dose insulin regimens using rapid-ating analogs an derease the disruption aused by suh hanges in shedule. Corretional institutions should have systems in plae to ensure that rapid-ating insulin analogs and oral agents are given immediately before meals if this is part of the patient smedial plan. It should be noted however that even modest delays in meal onsumption with these agents an be assoiated with hypoglyemia. If onsistent aess to food within 10 min annot be ensured, rapidating insulin analogs and oral agents are approved for administration during or immediately after meals. Should irumstanes arise that delay patient aess to regular meals following mediation administration, poliies and proedures must be implemented to ensure the patient reeives appropriate nutrition to prevent hypoglyemia. Both ontinuous subutaneous insulin infusion and multiple daily insulin injetion therapy (onsisting of three or more injetions a day) an be effetive means of implementing intensive diabetes management with the goal of ahieving near-normal levels of blood gluose (9). While the use of these modalities may be diffiult in orretional institutions, every effort should be made to ontinue multiple daily insulin injetion or ontinuous subutaneous insulin infusion in people who were using this therapy before inareration or to institute these therapies as indiated in order to ahieve blood gluose targets. It is essential that transport of patients from jails or prisons to off-site appointments, suh as medial visits or ourt appearanes, does not ause signifiant disruption in mediation or meal timing. Corretional institutions and polie lokups should implement poliies and proedures to diminish the risk of hypo- and hyperglyemia by, for example, providing arry-along meals and mediation for patients traveling to off-site appointments or hanging the insulin regimen for that day. The availability of prefilled insulin pens provides an alternative for off-site insulin delivery. Reommendations Formularies should provide aess to usual and ustomary oral mediations and insulins to treat diabetes and related onditions. (E) Patients should have aess to mediation at dosing frequenies that are onsistent with their treatment plan and medial diretion. (E) Corretional institutions and polie lok-ups should implement poliies and proedures to diminish the risk of hypo- and hyperglyemia during offsite travel (e.g., ourt appearanes). (E) ROUTINE SCREENING FOR AND MANAGEMENT OF DIABETES COMPLICATIONSdAll patients with a diagnosis of diabetes should reeive routine sreening for diabetes-related ompliations, as detailed in the ADA Standards of Care (4). Interval hroni disease linis for persons with diabetes provide an effiient mehanism to monitor patients for ompliations of diabetes. In this way, appropriate referrals to onsultant speialists, suh as optometrists/ ophthalmologists, nephrologists, and ardiologists, an be made on an as-needed basis and interval laboratory testing an be done. The following ompliations should be onsidered: Position Statement Foot are: Reommendations for foot are for patients with diabetes and no history of an open foot lesion are desribed in the ADA Standards of Care. A omprehensive foot examination is reommended annually for all patients with diabetes to identify risk fators preditive of ulers and amputations. Persons with an insensate foot, an open foot lesion, or a history of suh a lesion should be referred for evaluation by an appropriate liensed health professional (e.g., podiatrist or vasular surgeon). Speial shoes should be provided as reommended by liensed health professionals to aid healing of foot lesions and to prevent development of new lesions. Retinopathy: Annual retinal examinations by a liensed eye are professional should be performed for all patients with diabetes, as reommended in the ADA Standards of Care. Visual hanges that annot be aounted for by aute hanges in glyemi ontrol require prompt evaluation by an eye are professional. Nephropathy: An annual spot urine test for determination of miroalbuminto-reatinine ratio should be performed. The use of ACE inhibitors or angiotensin reeptor blokers is reommended for all patients with albuminuria. Blood pressure should be ontrolled to,140/ 80 mmhg. Cardia: People with type 2 diabetes are at a partiularly high risk of oronary artery disease. Cardiovasular disease (CVD) risk fator management is of demonstrated benefit inreduing this ompliation in patients with diabetes. Blood pressure should be measured at every routine diabetes visit. In adult patients, test for lipid disorders at least annually and as needed to ahieve goals with treatment. Use aspirin therapy ( mg/day) in all adult patients with diabetes and ardiovasular risk fators or known marovasular disease. Current national standards for adults with diabetes all for treatment of lipids to goals of LDL #100, HDL.40, triglyerides,150 mg/dl, and blood pressure to a level of,140/80 mmhg. MONITORING/TESTS OF GLYCEMIAdMonitoring of CBG is a strategy that allows aregivers and people with diabetes to evaluate diabetes management regimens. The frequeny of monitoring will vary by patients glyemi ontrol and diabetes regimens. Patients are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S89

90 Position Statement with type 1 diabetes are at risk for hypoglyemia and should have their CBG monitored three or more times daily. Patients with type 2 diabetes on insulin need to monitor at least one daily and more frequently based on their medial plan. Patients treated with oral agents should have CBG monitored with suffiient frequeny to failitate the goals of glyemi ontrol, assuming that there is a program for medial review of these data on an ongoing basis to drive hanges in mediations. Patients whose diabetes is poorly ontrolled or whose therapy is hanging should have more frequent monitoring. Unexplained hyperglyemia in a patient with type 1 diabetes may suggest impending DKA, and monitoring of ketones should therefore be performed. Glyated hemoglobin (A1C) is a measure of long-term (2- to 3-month) glyemi ontrol. Perform the A1C test at least two times a year in patients who are meeting treatment goals (and who have stable glyemi ontrol) and quarterly in patients whose therapy has hanged or who are not meeting glyemi goals. Disrepanies between CBG monitoring results and A1C may indiate a hemoglobinopathy, hemolysis, or need for evaluation of CBG monitoring tehnique and equipment or initiation of more frequent CBG monitoring to identify when glyemi exursions are ourring and whih faet of the diabetes regimen is hanging. In the orretional setting, poliies and proedures need to be developed and implemented regarding CBG monitoring that address the following: infetion ontrol eduation of staff and patients proper hoie of meter disposal of testing lanets quality ontrol programs aess to health servies size of the blood sample patient performane skills doumentation and interpretation of test results availability of test results for the health are provider (10) Reommendations In the orretional setting, poliies and proedures need to be developed and implemented to enable CBG monitoring to our at the frequeny neessitated by the individual patient s glyemi ontrol and diabetes regimen. (E) A1C should be heked every 3 6 months. (E) SELF-MANAGEMENT EDUCATIONdSelf-management eduation is the ornerstone of treatment for all people with diabetes. The health staff must advoate for patients to partiipate in self-management as muh as possible. Individuals with diabetes who learn self-management skills and make lifestyle hanges an more effetively manage their diabetes and avoid or delay ompliations assoiated with diabetes. In the development of a diabetes selfmanagement eduation program in the orretional environment, the unique irumstanes of the patient should be onsidered while still providing, to the greatest extent possible, the elements of the National Standards for Diabetes Self-Management Eduation and Support (11). A staged approah may be used depending on the needs assessment and the length of inareration. Table 2 sets out the major omponents of diabetes self-management eduation. Survival skills should be addressed as soon as possible; other aspets of eduationmaybeprovidedaspartofanongoing eduation program. Ideally, self-management eduation is oordinated by a ertified diabetes eduator who works with the faility to develop polies, proedures, and protools to ensure that nationally reognized eduation guidelines are implemented. The eduator is also able to identify patients who need diabetes self-management eduation, inluding an assessment of the patients medial, soial, and diabetes histories; diabetes knowledge, skills, and behaviors; and readiness to hange. STAFF EDUCATIONdPoliies and proedures should be implemented to ensure that the health are staff has adequate knowledge and skills to diret the management and eduation of persons with diabetes. The health are staff needs to be involved in the development of the orretional offiers training program. The staff eduation program should be at a lay level. Training should be offered at least biannually, and the urriulum should over the following: what diabetes is signs and symptoms of diabetes risk fators signs and symptoms of, and emergeny response to, hypo- and hyperglyemia gluose monitoring mediations exerise nutrition issues inluding timing of meals and aess to snaks Reommendations Inlude diabetes in orretional staff eduation programs. (E) ALCOHOL AND DRUGSdPatients with diabetes who are withdrawing from drugs and alohol need speial onsideration. This issue partiularly affets initial polie ustody and jails. At an intake faility, proper initial identifiation and assessment of these patients are ritial. The presene of diabetes may ompliate detoxifiation. Patients in need of ompliated detoxifiation should be referred to a faility equipped to deal with highrisk detoxifiation. Patients with diabetes should be eduated in the risks involved with smoking. All inmates should be advised not to smoke. Assistane in smoking essation should be provided as pratial. TRANSFER AND DISCHARGEdPatients in jails may be housed for a short period of time before being transferred or released, and it is not unusual for patients in prison to be transferred within the system several times during their inareration. One of the many hallenges that health are providers fae working in the orretional system is how to best ollet and ommuniate important health are information in a timely manner when a patient is in initial polie ustody, is jailed short term, or is transferred from faility to faility. The importane of this ommuniation beomes ritial when the patient has a hroni illness suh as diabetes. Transferring a patient with diabetes from one orretional faility to another requires a oordinated effort. To failitate a thorough review of medial information and ompletion of a transfer summary, it is ritial for ustody personnel to provide medial staff with suffiient notie before movement of the patient. Before the transfer, the health are staff should review the patient s medial reord and omplete a medial transfer summary that inludes the patient s S90 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

91 Position Statement Table 2dMajor omponents of diabetes self-management eduation Survival skills hypo-/hyperglyemia sik day management mediation monitoring foot are urrent health are issues. At a minimum, the summary should inlude the following: the patient s urrent mediation shedule and dosages the date and time of the last mediation administration any reent monitoring results (e.g., CBG and A1C) other fators that indiate a need for immediate treatment or management at the reeiving faility (e.g., reent episodes of hypoglyemia, history of severe hypoglyemia or frequent DKA, onurrent illnesses, presene of diabetes ompliations) information on sheduled treatment/ appointments if the reeiving faility is responsible for transporting the patient to that appointment name and telephone/fax number of a ontat person at the transferring faility who an provide additional information, if needed The medial transfer summary, whih ats as a quik medial referene for the reeiving faility, should be transferred along with the patient. To supplement the flow of information and to inrease the probability that mediations are orretly identified at the reeiving institution, sending institutions are enouraged to provide eah patient with a mediation ard to be arried by the patient that ontains information onerning diagnoses, mediation names, dosages, and frequeny. Diabetes supplies, inluding diabetes mediation, should aompany the patient. The sending faility must be mindful of the transfer time in order to provide the patient with mediation and food if needed. The transfer summary or medial reord should be reviewed by a health Daily management issues disease proess nutritional management physial ativity mediations monitoring aute ompliations risk redution goal setting/problem solving psyhosoial adjustment preoneption are/pregnany/gestational diabetes management are provider upon arrival at the reeiving institution. Planning for patients disharge from prisons should inlude instrution in the long-term ompliations of diabetes, the neessary lifestyle hanges and examinations required to prevent these ompliations, and, if possible, where patients may obtain regular follow-up medial are. A quarterly meeting to eduate patients with upoming disharges about ommunity resoures an be valuable. Inviting ommunity agenies to speak at these meetings and/or provide written materials an help strengthen the ommunity link for patients disharging from orretional failities. Disharge planning for the patients with diabetes should begin 1 month before disharge. During this time, appliation for appropriate entitlements should be initiated. Any gaps in the patient s knowledge of diabetes are need to be identified and addressed. It is helpful if the patient is given a diretory or list of ommunity resoures and if an appointment for follow-up are with a ommunity provider is made. A supply of mediation adequate to last until the first postrelease medial appointment should be provided to the patient upon release. The patient should be provided with a written summary of his/her urrent health are issues, inluding mediations and doses, reent A1C values, et. Reommendations For all interinstitutional transfers, omplete a medial transfer summary to be transferred with the patient. (E) Diabetes supplies and mediation should aompany the patient during transfer. (E) Begin disharge planning with adequate lead time to insure ontinuity of are and failitate entry into ommunity diabetes are. (E) SHARING OF MEDICAL INFORMATION AND RECORDSdPratial onsiderations may prohibit obtaining medial reords from providers who treated the patient before arrest. Intake failities should implement poliies that 1) define the irumstanes under whih prior medial reords are obtained (e.g., for patients who have an extensive history of treatment for ompliations); 2) identify person(s) responsible for ontating the prior provider; and 3) establish proedures for traking requests. Failities that use outside medial providers should implement poliies and proedures for ensuring that key information (e.g., test results, diagnoses, physiians orders, appointment dates) is reeived from the provider and inorporated into the patient s medial hart after eah outside appointment. The proedure should inlude, at a minimum, a means to highlight when key information has not been reeived and designation of a person responsible for ontating the outside provider for this information. All medial harts should ontain CBG test results in a speified, readily aessible setion and should be reviewed on a regular basis. CHILDREN AND ADOLESCENTS WITH DIABETESdChildren and adolesents with diabetes present speial problems in disease management, even outside the setting of a orretional institution. Children and adolesents with diabetes should have initial and follow-up are with physiians who are experiened in their are. Confinement inreases the diffiulty in managing diabetes in hildren and adolesents, as it does in adults with diabetes. Corretional authorities also have different legal obligations for hildren and adolesents. Nutrition and ativity Growing hildren and adolesents have greater alori/nutritional needs than adults. The provision of an adequate amount of alories and nutrients for adolesents is ritial to maintaining good nutritional status. Physial ativity should be provided at the same time eah day. If inreased physial ativity ours, additional CBG monitoring is neessary and additional arbohydrate snaks may be required. are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S91

92 Position Statement Medial management and follow-up Children and adolesents who are inarerated for extended periods should have follow-up visits at least every 3 months with individuals who are experiened in the are of hildren and adolesents with diabetes. Thyroid funtion tests and fasting lipid and miroalbumin measurements should be performed aording to reognized standards for hildren and adolesents (12) in order to monitor for autoimmune thyroid disease and ompliations and omorbidities of diabetes. Children and adolesents with diabetes exhibiting unusual behavior should have their CBG heked at that time. Beause hildren and adolesents are reported to have higher rates of noturnal hypoglyemia (13), onsideration should be given regarding the use of episodi overnight blood gluose monitoring in these patients. In partiular, this should be onsidered in hildren and adolesents who have reently had their overnight insulin dose hanged. PREGNANCYdPregnany in a woman with diabetes is by definition a high-risk pregnany. Every effort should be made to ensure that treatment of the pregnant woman with diabetes meets aepted standards (14,15). It should be noted that glyemi standards are more stringent, the details of dietary management are more omplex and exating, insulin is the only antidiabeti agent approved for use in pregnany, and a number of mediations used in the management of diabeti omorbidities are known to be teratogeni and must be disontinued in the setting of pregnany. SUMMARY AND KEY POINTSdPeople with diabetes should reeive are that meets national standards. Being inarerated does not hange these standards. Patients must have aess to mediation and nutrition needed to manage their disease. In patients who do not meet treatment targets, medial and behavioral plans should be adjusted by health are professionals in ollaboration with the prison staff. It is ritial for orretional institutions to identify partiularly high-risk patients in need of more intensive evaluation and therapy, inluding pregnant women, patients with advaned ompliations, a history of repeated severe hypoglyemia, or reurrent DKA. A omprehensive, multidisiplinary approah to the are of people with diabetes an be an effetive mehanism to improve overall health and delay or prevent the aute and hroni ompliations of this disease. AknowledgmentsdThe following members of the Amerian Diabetes Assoiation/National Commission on Corretional Health Care Joint Working Group on Diabetes Guidelines for Corretional Institutions ontributed to the revision of this doument: Daniel L. Lorber, MD, FACP, CDE (hair); R. Sott Chavez, MPA, PA-C; Joanne Dorman, RN, CDE, CCHP-A; Lynda K. Fisher, MD; Stephanie Guerken, RD, CDE; Linda B. Haas, CDE, RN; Joan V. Hill, CDE, RD; David Kendall, MD; Mihael Puisis, DO; Kathy Salomone, CDE, MSW, APRN; Ronald M. Shansky, MD, MPH; and Barbara Wakeen, RD, LD. Referenes 1. National Commission on Corretional Health Care: The Health Status of Soon-to- Be Released Inmates: A Report to Congress. Vol. 1. Chiago, NCCHC, Hornung CA, Greifinger RB, Gadre S: A Projetion Model of the Prevalene of Seleted Chroni Diseases in the Inmate Population. Vol. 2. Chiago, NCCHC, 2002, p Puisis M: Challenges of improving quality in the orretional setting. In Clinial Pratie in Corretional Mediine. St. Louis, MO, Mosby-Yearbook, 1998, p Amerian Diabetes Assoiation: Standards of medial are in diabetesd2013 (Position Statement). Diabetes Care 36 (Suppl. 1): S11 S66, Amerian Diabetes Assoiation: Sreening for type 2 diabetes (Position Statement). Diabetes Care 27 (Suppl. 1):S11 S14, Krauss RM, Ekel RH, Howard B, Appel LJ, Daniels SR, Dekelbaum RJ, Erdman JW Jr, Kris-Etherton P, Goldberg IJ, Kothen TA, Lihtenstein AH, Mith WE, Mullis R, Robinson K, Wylie-Rosett J, St Jeor S, Suttie J, Tribble DL, Bazzarre TL: Amerian Heart Assoiation Dietary Guidelines: revision 2000: a statement for healthare professionals from the Nutrition Committee of the Amerian Heart Assoiation. Stroke 31: , Amerian Diabetes Assoiation: Nutrition reommendations and interventions for diabetes (Position Statement). Diabetes Care 31 (Suppl. 1):S61 S78, Amerian Diabetes Assoiation: Hyperglyemi risis in diabetes (Position Statement). Diabetes Care 27 (Suppl. 1): S94 S102, Amerian Diabetes Assoiation: Continuous subutaneous insulin infusion (Position Statement). Diabetes Care 27 (Suppl. 1):S110, Amerian Diabetes Assoiation: Tests of glyemia in diabetes (Position Statement). Diabetes Care 27 (Suppl. 1):S91 S93, HaasL,MaryniukM,BekJ,CoxCE, Duker P, Edwards L, Fisher EB, Hanson L, Kent D, Kolb L, MLaughlin S, Orzek E, Piette JD, Rhinehart AS, Rothman R, Sklaroff S, Tomky D, Youssef G, on behalf of the 2012 Standards Revision Task Fore: National standards for diabetes self-management eduation and support. Diabetes Care 36 (Suppl. 1):S100 S108, International Soiety for Pediatri and Adolesent Diabetes: Consensus Guidelines 2000: ISPAD Consensus Guidelines for the Management of Type 1 Diabetes Mellitus in Children and Adolesents. Zeist,Netherlands, Medial Forum International, 2000, p. 116, Kaufman FR, Austin J, Neinstein A, Jeng L, Halyorson M, Devoe DJ, Pitukheewanont P: Noturnal hypoglyemia deteted with the ontinuous gluose monitoring system in pediatri patients with type 1 diabetes. J Pediatr 141: , Amerian Diabetes Assoiation: Gestational diabetes mellitus (Position Statement). Diabetes Care 27 (Suppl. 1):S88 S90, Jovanovi L (Ed.): Medial Management of Pregnany Compliated by Diabetes.4thed. Alexandria, VA, Amerian Diabetes Assoiation, 2009 S92 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

93 P O S I T I O N S T A T E M E N T Diabetes and Employment AMERICAN DIABETES ASSOCIATION A s of 2010, nearly 26 million Amerians have diabetes (1), most of whom are or wish to be partiipating members of the workfore. Diabetes usually has no impat on an individual s ability to do a partiular job, and indeed an employer may not even know that a given employee has diabetes. In 1984, the Amerian Diabetes Assoiation adopted the following position on employment: Any person with diabetes, whether insulin [treated] or non insulin [treated], should be eligible for any employment for whih he/she is otherwise qualified. Questions are sometimes raised by employers about the safety and effetiveness of individuals with diabetes in a given job. When suh questions are legitimately raised, a person with diabetes should be individually assessed to determine whether or not that person an safely and effetively perform the partiular duties of the job in question. This doument provides a general set of guidelines for evaluating individuals with diabetes for employment, inluding how an assessment should be performed and what hanges (aommodations) in the workplae may be needed for an individual with diabetes. I. EVALUATING INDIVIDUALS WITH DIABETES FOR EMPLOYMENTdIt was one ommon pratie to restrit individuals with diabetes from ertain jobs or lasses of employment solely beause of the diagnosis of diabetes or the use of insulin, without regard to an individual s abilities or irumstanes. Suh blanket bans are medially inappropriate and ignore the many advanements in diabetes management that range from the types of mediations used to the tools used to administer them and to monitor blood gluose levels. Employment deisions should not be based on generalizations or stereotypes regarding the effets of diabetes. The impat of diabetes and its management varies widely among individuals. Therefore, a proper assessment of individual andidates for employment or urrent employees must take this variability into aount. In addition, federal and state laws require employers to make deisions that are based on assessment of the irumstanes and apabilities of the individual with diabetes for the partiular job in question (2,3). Appliation of blanket poliies to individuals with diabetes results in people with diabetes being denied employment for whih they are well qualified and fully apable of performing effetively and safely. It should be noted that, as a result of amendments to the Amerians with Disabilities At, whih beame effetive on 1 January 2009, all persons with diabetes are onsidered to have a disability within the meaning of that law. This is beause, among other reasons, diabetes onstitutes a substantial limitation on endorine system funtioningdthe At was amended to extend its overage to persons with a substantial limitation in, among other things, a major bodily funtion, suh as the endorine system. Therefore, persons with diabetes are proteted from disrimination in employment and other areas. The amendments overturned a series of Supreme Court deisions that had severely narrowed who was overed by the law and resulted in many people with diabetes and other hroni illnesses being denied protetion from disrimination. This setion provides an overview of the fators relevant to a medially appropriate Revised Fall DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. individualized assessment of the andidate or employee with diabetes. Role of diabetes health are professionals When questions arise about the medial fitness of a person with diabetes for a partiular job, a health are professional with expertise in treating diabetes should perform an individualized assessment. The involvement of the diabetes health are professional should our before any adverse employment deision, suh as failure to hire or promote or termination. A health professional who is familiar with thepersonwithdiabetesandwhohas expertise in treating diabetes is best able to perform suh an assessment. In some situations and in omplex ases, an endorinologist or a physiian who speializes in treating diabetes or its ompliations is the best qualified health professional to assume this responsibility (4). The individual s treating physiian is generally the health are professional with the best knowledge of an individual s diabetes. Thus, even when the employer utilizes its own physiian to perform the evaluation, the opinions of the treating physiian and other health are professionals with linial expertise in diabetes should be sought out and arefully onsidered. In situations where there is disagreement between the opinion of the employee s treating physiian and that of the employer s physiian, the evaluation should be handed over to an independent health are professional with signifiant linial expertise in diabetes. Individual assessment A medial evaluation of an individual with diabetes may our only in limited irumstanes (3). Employers may not inquire about an individual s health statusd diretly or indiretly and regardless of the type of jobdbefore making a job offer, but may require a medial examination or make a medial inquiry one an offer of employment has been extended and before the individual begins the job. are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S93

94 Position Statement The job offer may be onditioned on the results of the medial inquiry or examination. An employer may withdraw an offer from an appliant with diabetes only if it beomes lear that he or she annot do the essential funtions of the job or would pose a diret threat (i.e., a signifiant risk of substantial harm) to health or safety and suh threat ould not be eliminated with an aommodation (a workplae hange that enables a worker with a disability to safely and effetively perform job duties). Another situation in whih a medial evaluation is permissible is when a problem potentially related to the employee s diabetesarisesonthejob and suh problem ould affet job performane and/or safety. In this situation, a physiian may be asked to evaluate the employee s fitness to remain on the job and/or his or her ability to safely perform the job. Employers also may obtain medial information about an employee when the employee has requested an aomodation and his or her disability or need for aommodation is not obvious. An employer should not rely on a medial evaluation to deny an employment opportunity to an individual with diabetes unless it is onduted by a health are professional with expertise in diabetes and based on suffiient and appropriate medial data. The information sought and assessed must be properly limited to data relevant to the individual s diabetes and job performane (3). The data needed will vary depending on the type of job and the reason for the evaluation, but an evaluation should never be made based only on one piee of data, suh as a single blood gluose result or A1C result. Sine diabetes is a hroni disease in whih health status and management requirements naturally hange over time, it is inappropriated and medially unneessarydfor examiners to ollet all past laboratory values or information regarding offie visits whether or not related to diabetes. Only medial information relevant to evaluating an individual s urrent apaity for safe performane of the partiular job at issue should be olleted. For example, in some irumstanes a review of an individual s hypoglyemia history may be relevant to the evaluation and should be olleted. Information about the individual s diabetes management (suh as the urrent treatment regimen, mediations, and blood gluose logs), job duties, and work environment are all relevant fators to be onsidered. Only health are professionals tasked with suh evaluations should have aess to employee medial information, and this information must be kept separate from personnel reords (3). Sreening guidelines A number of sreening guidelines for evaluating individuals with diabetes in various types of high risk jobs have been developed in reent years. Examples inlude the Amerian College of Oupational and Environmental Mediine s National Consensus Guideline for the Medial Evaluation of Law Enforement Offiers, the National Fire Protetion Assoiation s Standard on Comprehensive Oupational Medial Program for Fire Departments, the U.S. Department of Transportation s Federal Motor Carrier Safety Administration s Diabetes Exemption Program, and the U.S. Marshall Servie and Federal Oupational Health Law Enforement Program Diabetes Protool. Suh guidelines and protools an be useful tools in making deisions about individual andidates or employees if they are used in an objetive way and based on the latest sientifi knowledge about diabetes and its management. These protools should be regularly reevaluated and updated to reflet hanges in diabetes knowledge and evidene and should be developed and reviewed by health are professionals with signifiant experiene in diabetes and its treatment. Individuals who do not meet the standards set forth in suh protools should be given the opportunity to demonstrate exeptional irumstanes that would justify deviating from the guidelines. Suh guidelines or protools are not absolute riteria but rather the framework for a thorough individualized assessment. Reommendations People with diabetes should be individually onsidered for employment based on the requirements of the speifi job and the individual smedial ondition, treatment regimen, and medial history. (E) When questions arise about the medial fitness of a person with diabetes for a partiular job, a health are professional with expertise in treating diabetes should perform an individualized assessment; input from the treating physiian should always be inluded. (E) Employment evaluations should be based on suffiient and appropriate medial data and should never be made based solely on one piee of data. (E) Sreening guidelines and protools an be useful tools in making deisions about employment if they are used in an objetive way and based on the latest sientifi knowledge about diabetes and its management. (E) II. EVALUATING THE SAFETY RISK OF EMPLOYEES WITH DIABETESdEmployers who deny job opportunities beause they pereive all people with diabetes to be a safety risk do so based on misoneptions, misinformation, or a lak of urrent information about diabetes. The following guidelines provide information for evaluating an individual with diabetes who works or seeks to work in what may be onsidered a safetysensitive position. Safety onerns The first step in evaluating safety onerns is to determine whether the onerns are reasonable in light of the job duties the individual must perform. For most types of employment (suh as jobs in an offie, retail, or food servie environment) there is no reason to believe that the individual s diabetes will put employees or the publi at risk. In other types of employment (suh as jobs where the individual must arry a firearm or operate dangerous mahinery) the safety onern is whether the employee will beome suddenly disoriented or inapaitated. Suh episodes, whih are usually due to severely low blood gluose (hypoglyemia), our only in people reeiving ertain treatments suh as insulin or seretagogues suh as sulfonylureas and even then our infrequently. Workplae aommodations an be made that are minimal yet effetive in helping the individual to manage his or her diabetes on the job and avoid severe hypoglyemia. Hypoglyemia Hypoglyemia is defined as a blood gluose level,70 mg/dl (4,6). It is a potential side effet of some diabetes treatments, inluding insulin and sulfonlyureas. It an usually be effetively self-treated by ingestion of gluose (arbohydrate) and is not often assoiated with loss of onsiousness or a seizure. Severe hypoglyemia, requiring the assistane of another person, is a medial emergeny. S94 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

95 Symptoms of severe hypoglyemia may inlude onfusion or, rarely, seizure or loss of onsiousness (6). Most individuals with diabetes never experiene an episode of severe hypoglyemia beause either they are not on mediation that auses it or they reognize the early warning signs and an quikly self-treat the problem by drinking or eating. Also, with self-monitoring of blood gluose levels, most people with diabetes an manage their ondition in suh a manner that there is minimal risk of inapaitation from hypoglyemia beause mildly low gluose levels an be easily deteted and treated (4,7). A single episode of severe hypoglyemia should not per se disqualify an individual from employment. Rather, an appropriate evaluation should be undertaken by a health are professional with expertise in diabetes to determine the ause of the low blood gluose, the irumstanes of the episode, whether it was an isolated inident, whether adjustment to the insulin regimen may mitigate this risk, and the likelihood of suh an episode happening again. Some episodes of severe hypoglyemia an be explained and orreted with the assistane of a diabetes health are professional. However, reurrent episodes of severe hypoglyemia may indiate that an individual may in fat not be able to safely perform a job, partiularly jobs or tasks involving signifiant risk of harm to employees or the publi, espeially when these episodes annot be explained. The person s medial history and details of any history of severe hypoglyemia should be examined losely to determine whether it is likely that suh episodes will reur on the job. In all ases, job duties should be arefully examined to determine whether there are ways to minimize the risk of severe hypoglyemia (suh as adjustment of the insulin regimen or providing additional breaks to hek blood gluose levels). Hyperglyemia In ontrast to hypoglyemia, high blood gluose levels (hyperglyemia) an ause long-term ompliations over years or deades but does not normally lead to any adverse effet on job performane. The symptoms of hyperglyemia generally develop over hours or days and do not our suddenly. Therefore, hyperglyemia does not pose an immediate risk of sudden inapaitation. While over years or deades, high blood gluose may ause long-term ompliations to the nerves (neuropathy), eyes (retinopathy), kidneys (nephropathy), or heart, not all individuals with diabetes develop these long-term ompliations. Suh ompliations beome relevant in employment deisions only when they are established and interfere with the performane of the atual job being onsidered. Evaluations should not be based on speulation as to what might our in the future. Job evaluations should take high blood gluose levels into aount only if they have already aused long-term ompliations suh as visual impairment that interfere with performane of the speifi job. Aspets of a safety assessment When an individual with diabetes is assessed for safety risk there are several aspets that must be onsidered. Blood gluose test results. A single blood gluose test result only gives information about an individual s blood gluose level at one partiular point in time. Beause blood gluose levels flutuate throughout the day (this is also true for people without diabetes), one test result is of no use in assessing the overall health of a person with diabetes. The results of a series of self-monitored blood gluose measurements over a period of time, however, an give valuable information about an individual s diabetes health. Blood gluose reords should be assessed by a health are professional with expertise in diabetes (7). History of severe hypoglyemia. Often, a key fator in assessing employment safety and risk is doumentation of inidents of severe hypoglyemia. An individual who has managed his or her diabetes over an extended period of time without experiening severe hypoglyemia is unlikely to experiene this ondition in the future. Conversely, multiple inidents of severe hypoglyemia may in some situations be disqualifying for high-risk oupations. However, the irumstanes of eah inident should be examined, as some inidents an be explained due to hanges in insulin dosage, illness, or other fators and thus will be unlikely to reur or have already been addressed by the individual through hanges to his or her diabetes treatment regimen or eduation. Hypoglyemia unawareness. Some individuals over time lose the ability to reognize the early warning signs of hypoglyemia. These individuals are at inreased risk for a sudden episode of severe hypoglyemia. Some of these individuals may Position Statement be able to lessen this risk with areful hanges to their diabetes management regimen (for example, more frequent blood gluose testing or frequent meals). Presene of diabetes-related ompliations. Chroni ompliations that may result from long-term diabetes involve the blood vessels and nerves. These ompliations may involve nerve (neuropathy), eye (retinopathy), kidney (nephropathy), and heart disease. In turn, these problems an lead to amputation, blindness or other vision problems, inluding vision loss, kidney failure, stroke, or heart attak. As these ompliations ould potentially affet job performane and safety, suh ompliations should be evaluated by a speialist in the speifi area related to the ompliation. If ompliations are not present, their possible future development should not be addressed, both beause of laws prohibiting suh onsideration and beause with medial monitoring and therapies, long-term ompliations an now often be avoided or delayed. Thus, many people with diabetes never develop any of these ompliations, and those that do generally develop them over a period of years. Inappropriate assessments The following tools and terms do not aurately reflet the urrent state of diabetes treatment and should be avoided in an assessment of whether an individual with diabetes is able to safely and effetively perform a partiular job. Urine gluose tests. Urine gluose results are no longer onsidered to be an appropriate and aurate methodology for assessing diabetes ontrol (8). Before the mid-1970s, urine gluose tests were the best available method of monitoring blood gluose levels. However, the urine test is not a reliable or aurate indiator of blood gluose levels and is a poor measure of the individual s urrent health status. Blood gluose monitoring is a more aurate and timely means to measure glyemi ontrol. Urine gluose tests should never be used to evaluate the employability of a person with diabetes. A1C and estimated average gluose. Hemoglobin A1C (A1C) test results reflet average glyemia over several months and orrelate with mean plasma gluose levels (4). Estimated average gluose (eag) is diretly related to A1C and also provides an individual with an estimate of average blood gluose over a period of time, but it uses the same values and units that are observed when using a are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S95

96 Position Statement gluose meter or reording a fasting gluose value on a lab report (5). A1C/eAG values provide health are providers with important information about the effetiveness of an individual s treatment regimen (4) but are often misused in assessing whether an individual an safely perform a job. Beause they identify only averages and not whether the person had severe extreme blood gluose readings, A1C/eAG results are of no value in prediting short-term ompliations of diabetes and thus have no use in evaluating individuals in employment situations. The Amerian Diabetes Assoiation reommends that in most patients A1C levels be kept below 7% (4), or eag below 154 mg/dl. This reommendation sets a target in order to lessen the hanes of long-term ompliations of high blood gluose levels but does not provide useful information on whether the individual is at signifiant risk for hypoglyemia or suboptimal job performane and is not a measure of ompliane with therapy. An A1C or eag ut off sore is not mediallyjustified in employment evaluations and should never be a determinative fator in employment. Unontrolled or brittle diabetes. Sometimes an individual s diabetesisdesribed as unontrolled, poorly ontrolled, or brittle. These terms are not well defined and are not relevant to job evaluations. As suh, giving an opinion on the level of ontrol an individual hasoverdiabetesisnotthesameasassessing whether that individual is qualified to perform a partiular job and an do so safely. Suh an individual assessment is the only relevant evaluation. Reommendations Evaluating the safety risk of employees with diabetes inludes determining whether the onerns are reasonable in light of the job duties the individual must perform. (E) Most people with diabetes an manage their ondition in suh a manner that there is no or minimal risk of inapaitation from hypoglyemia at work. A single episode of severe hypoglyemia should not per se disqualify an individual from employment, but an individual with reurrent episodes of severe hypoglyemia may be unable to safely perform ertain jobs, espeially when those episodes annot be explained. (E) Hyperglyemia does not pose an immediate risk of sudden inapaitation on the job, and long-term ompliations are relevant in employment deisions only when they are established and interfere with the performane of the atual job being onsidered. (E) Proper safety assessments should inlude review of blood gluose test results, history of severe hypoglyemia, presene of hypoglyemia unawareness, and presene of diabetes-related ompliations and should not inlude urine gluose or AIC/eAG tests or be based on a general assessment of level of ontrol. (E) III. ACCOMMODATING EMPLOYEES WITH DIABETESdIndividuals with diabetes may need ertain hanges or aommodations on the job in order to perform their work responsibilities effetively and safely. Federal and state laws require the provision of reasonable aommodations to help an employee with diabetes to perform the essential funtions of the job (3). Additional laws provide for leave for an employee to deal with his or her medial needs or those of a family member (9). Although there are some typial aommodations that many people with diabetes use, the need for aommodations must be assessed on an individualized basis (2). Aommodating daily diabetes management needs Many of the aommodations that employees with diabetes need on a day-today basis are those that allow them to manage their diabetes in the workplae as they would elsewhere. They are usually simple aommodations, an be provided without any ost to the employer, and should ause little or no disruption in the workplae. Most employers are required to provide aommodations unless those aommodations would reate an undue burden (3). Some aommodations that may be needed inlude the following. Testing blood gluose. Breaks may be needed to allow an individual to test blood gluose levels when needed. Suh heks only take minutes to omplete. Some individuals use ontinuous gluose monitors but will still need an opportunity to hek blood gluose with a meter. Blood gluose an be heked wherever the employee is without putting other employees at risk, and employers should not limit where employees with diabetes are permitted to manage their diabetes. Some employees may prefer to have a private loation for testing or other diabetes are tasks that should be provided whenever feasible. Administering insulin. Employees may need short breaks during the workday to administer insulin when it is needed. Insulin an be safely administered wherever the employee happens to be. The employee may also need a plae to store insulin and other supplies if work onditions (suh as extreme temperatures) prevent the supplies from being arried on the person (10). Food and drink. Employees may need aess to food and/or beverages during the workday. This is partiularly important in the event that the employee needs to quikly respond to low blood gluose levels or maintain hydration if gluose levels are high. Employees should be permitted to onsume food or beverages as needed at their desk or work station (exept in an extremely rare situation in whih this would pose a hazard and reate a safety issue, and if this is the ase, an alternative site should be provided). Leave. Employees may need leave or a flexible work shedule to aommodate medial appointments or other diabetes are needs. Oasionally, employees may need to miss work due to unantiipated events (severe hypoglyemi episode) or illness. Work shedules. Certain types of work shedules, suh as rotating or split shifts, an make it espeially diffiult for some individuals to manage diabetes effetively. Aommodating ompliations of diabetes In addition to aommodating the day-today management of diabetes in the workplae, for some individuals it is also neessary to seek modifiations for longterm diabetes-related ompliations. Suh people an remain produtive employees if appropriate aommodations are implemented. For example, an employee with diabeti retinopathy or other vision impairments may benefit from using a big sreen omputer or other visual aids, while an employee with nerve pain may benefit from redued walking distanes or having the ability to sit down on the job. Individuals with kidney problems may need to have flexibility to take time off work for dialysis treatment. It is impossible to provide an exhaustive list of potential aommodations. The key message in aommodating an employee with diabetes is to ensure that S96 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

97 aommodations are tailored to the individual and effetive in helping the individual perform his or her job. Input from health are professionals who speialize in the partiular ompliation, or from voational rehabilitation speialists or organizations, may help identify appropriate aommodations. Reommendations Individuals with diabetes may need aommodations on the job in order to perform their work responsibilities effetively and safely; these inlude aommodating daily diabetes needs and, when present, the ompliations of diabetes. All suh aommodations must be tailored to the individual and effetive in helping the individual perform his or her job. (E) CONCLUSIONdIndividuals with diabetes an and do serve as highly produtive members of the workfore. While not every individual with diabetes will be qualified for, nor an perform, every available job, reasonable aommodations an readily be made that allow the vast majority of people with diabetes to effetively perform the vast majority of jobs. The therapies for, and effets of, diabetes vary greatly from person to person, so employers must onsider eah person s apaities and needs on an individual basis. People with diabetes should always be evaluated individually with the assistane of experiened diabetes health are professionals. The requirements of the speifi jobandthe individual s ability to perform that job, with or without reasonable aommodations, always need to be onsidered. AknowledgmentsdThe Amerian Diabetes Assoiation thanks the members of the volunteer writing group for this updated statement: John E. Anderson, MD; Mihael A. Greene, JD; John W. Griffin, Jr., JD; Daniel B. Kohrman, JD; Daniel Lorber, MD, FACP, CDE; Christopher D. Saudek, MD; Desmond Shatz, MD; and Linda Siminerio, RN, PhD, CDE. Referenes 1. Centers for Disease Control and Prevention: National Diabetes Fat Sheet: General Information and National Estimates on Diabetes and Prediabetes in the U.S., Atlanta, GA, U.S. Department of Health and Human Servies, Centers for Disease Control and Prevention, 2011 Position Statement 2. Equal Employment Opportunity Commission: Questions and Answers About Diabetes in the Workplae and the Amerians with Disabilities At (ADA), Ot. 29, Available from Aessed 26 May Amerians with Disabilities At of 1990, 42 U.S.C. x12101 et seq. 4. Amerian Diabetes Assoiation: Standards of medial are in diabetesd2013 (Position Statement). Diabetes Care 2013;36 (Suppl. 1): S11 S66 5. Nathan DM, Kuenen J, Borg R, Zheng H, Shoenfeld D, Heine R: Translating the A1C assay into estimated average gluose values. Diabetes Care 31: , Amerian Diabetes Assoiation: Defining and reporting hypoglyemia in diabetes, a report from the Amerian Diabetes Assoiation Workgroup on Hypoglyemia. Diabetes Care 28: , Amerian Diabetes Assoiation: Selfmonitoring of blood gluose (Consensus Statement). Diabetes Care 17: 81 86, Amerian Diabetes Assoiation: Tests of glyemia in diabetes (Position Statement). Diabetes Care 27 (Suppl. 1): S91 S93, Family Medial Leave At of 1993, 29 U.S.C. x2601 et seq. 10. Amerian Diabetes Assoiation: Insulin administration (Position Statement). Diabetes Care 27 (Suppl. 1): S106 S109, 2004 are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S97

98 P O S I T I O N S T A T E M E N T Third-Party Reimbursement for Diabetes Care, Self-Management Eduation, and Supplies AMERICAN DIABETES ASSOCIATION D iabetes is a hroni disease that affets nearly 26 million Amerians (1) and is haraterized by serious, ostly, and often fatal ompliations. The total ost of diagnosed diabetes in the U.S. in 2007 was estimated to be $174 billion (2). To prevent or delay ostly diabetes ompliations and to enable people with diabetes to lead healthy, produtive lives, appropriate medial are based on urrent standards of pratie, self-management eduation, and mediation and supplies must be available to everyone with diabetes. This artile is based on tehnial reviews titled Diabetes Self-Management Eduation (3) and National Standards for Diabetes Self-Management Eduation Programs (4). The goal of medial are for people with diabetes is to optimize glyemi ontrol and minimize ompliations. The Diabetes Control and Compliations Trial (DCCT) demonstrated that treatment that maintains blood gluose levels near normal in type 1 diabetes delays the onset and redues the progression of mirovasular ompliations. The UK Prospetive Diabetes Study (UKPDS) doumented that optimal glyemi ontrol an also benefit most individuals with type 2 diabetes. To ahieve optimal gluose ontrol, the person with diabetes must be able to aess health are providers who have expertise in the field of diabetes. Treatment plans must also inlude self-management training and tools, regular and timely laboratory evaluations, medial nutrition therapy, appropriately presribed mediation(s), and regular self-monitoring of blood gluose levels. The Amerian Diabetes Assoiation position statement Standards of Medial Care in Diabetes outlines appropriate medial are for people with diabetes (5). An integral omponent of diabetes are is self-management eduation (inpatient and/or outpatient) delivered by an interdisiplinary team. Self-management training helps people with diabetes adjust their daily regimen to improve glyemi ontrol. Diabetes self-management eduation teahes individuals with diabetes to assess the interplay among medial nutrition therapy, physial ativity, emotional/physial stress, and mediations, and then to respond appropriately and ontinually to those fators to ahieve and maintain optimal gluose ontrol. Today, self-management eduation is understood to be suh a ritial part of diabetes are that medial treatment of diabetes without systemati self-management eduation is regarded as inadequate. The National Standards for Diabetes Self- Management Eduation and Support establish speifi riteria against whih diabetes eduation programs an be measured, and a quality assurane program has been developed and subsequently revised (6). Treatments and therapies that improve glyemi ontrol and redue the ompliations of diabetes will also signifiantly redue health are osts (7,8). Numerous studies have demonstrated that self-management eduation leads to redutions in the osts assoiated with all types of diabetes. Partiipants in selfmanagement eduation programs have been found to have dereased lowerextremity amputation rates, redued mediation osts, and fewer emergeny room visits and hospitalizations. To ahieve optimal glyemi ontrol, thus ahieving long-term redution in The reommendations in this artile are based on the evidene reviewed in the following publiations: Diabetes self-management eduation (Tehnial Review). Diabetes Care 18: , 1995, and National standards for diabetes self-management eduation and support. Diabetes Care 35: , Approved Revised DOI: /d13-S by the Amerian Diabetes Assoiation. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See lienses/by-n-nd/3.0/ for details. health are osts, individuals with diabetes must have aess to the integral omponents of diabetes are, suh as health are visits, diabetes supplies, selfmanagement eduation, and diabetes mediations. As suh, insurers must reimburse for diabetes-related medial treatment as well as for self-management eduation programs that have met aepted standards, suh as the Amerian Diabetes Assoiation s National Standards for Diabetes Self-Management Eduation and Support. Furthermore, third-party payers must also reimburse for mediations and supplies related to the daily are of diabetes. These same standards should also apply to organizations that purhase health are benefits for their members or employees, as well as managed are organizations that provide servies to partiipants. It is reognized that the use of formularies, prior authorization, ompetitive bidding, and related provisions (hereafter referred to as ontrols ) an manage provider praties and osts to the potential benefit of payors and patients. Soial Seurity At Title XIX, setion 1927, states that exluded mediations should not have a signifiant linially meaningful therapeuti advantage in terms of safety, effetiveness or linial outomes of suh treatment of suh population. A variety of laws, regulations, and exeutive orders also provide guidane on the use of suh ontrols to oversee the purhase and use of durable medial equipment (hereafter referred to as equipment ) and singleuse medial supplies (hereafter referred to as supplies ) assoiated with the management of diabetes. Certain priniples should guide the reation and enforement of ontrols in ordertoinsurethattheymeettheomprehensive medial needs of people living with diabetes. A wide array of mediations and supplies are orrelated with improved glyemi outomes and a redution in the risk of diabetes-related ompliations. Beause no single diabetes treatment regimen is appropriate for all people with diabetes, providers and patients should have aess to a broad array of mediations and supplies to develop an effetive treatment modality. S98 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

99 However, the Assoiation also reognizes that there may be a number of mediations and/or supplies within any given lass. As suh, any ontrols should ensure that all lasses of antidiabeti agents with unique mehanisms of ation are available to failitate ahieving glyemi goals to redue the risk of ompliations. Similar issues operate in the management of lipid disorders, hypertension, and other ardiovasular risk fators, as well as for other diabetes ompliations. Furthermore, any ontrols should ensure that all lasses of equipment and supplies designed for use with suh equipment are available to failitate ahieving glyemi goals to redue the risk of ompliations. It is important to note that medial advanes are rapidly hanging the landsape of diabetes mediations and supplies. To ensure that patients with diabetes have aess to benefiial updates in treatment modalities, systems of ontrols must employ effiient mehanisms through whih to introdue and approve new produts. Though it an seem appropriate for ontrols to restrit ertain items in hroni disease management, partiularly with a omplex disorder suh as diabetes, it should be reognized that adherene is a major barrier to ahieving targets. Any ontrols should take into aount the huge mental and physial burden that intensive disease management exerts upon patients with diabetes. Protetions should ensure that patients with diabetes an readily omply with therapy in the widely variable irumstanes enountered in daily life. These protetions should guarantee aess to an aeptable range and all lasses of antidiabeti mediations, equipment, and supplies. Furthermore, fair and reasonable appeals proesses should ensure that diabeti patients and their medial are pratitioners an obtain mediations, equipment, and supplies that are not ontained within existent ontrols. Diabetes management needs individualization in order for patients to reah glyemi targets. Beause there is diversity in the manifestations of the disease and in the impat of other medial onditions upon diabetes, it is ommon that pratitioners will need to uniquely tailor treatment for their patients. To reah diabetes treatment goals, pratitioners should have aess to all lasses of antidiabeti mediations, equipment, and supplies without undue ontrols. Without appropriate safeguards, these ontrols ould onstitute an obstrution of effetive are. The value of self-management eduation and provision of diabetes supplies has been aknowledged by the passage of the Balaned Budget At of 1997 (9) and by stated medial poliy on both diabetes eduation and medial nutrition therapy. Referenes 1. Centers for Disease Control and Prevention: National estimates and general Position Statement information on diabetes and prediabetes in the U.S., Atlanta, GA, U.S. Department of Health and Human Servies, Centers for Disease Control and Prevention, Amerian Diabetes Assoiation: Eonomi osts of diabetes in the U.S. in Diabetes Care 31: , Clement S: Diabetes self-management eduation (Tehnial Review). Diabetes Care 18: , Funnell MM, Haas LB: National standards for diabetes self-management eduation programs (Tehnial Review). Diabetes Care 18: , Amerian Diabetes Assoiation: Standards of medial are in diabetesd2013 (Position Statement). Diabetes Care 36 (Suppl. 1): S11 S66, Haas L, Maryniuk M, Bek J, Cox CE, Duker P, Edwards L, Fisher EB, Hanson L, Kent D, Kolb L, MLaughlin S, Orzek E, Piette JD, Rhinehart AS, Rothman R, Sklaroff S, Tomky D, Youssef G, on behalf of the 2012 Standards Revision Task Fore: National standards for diabetes self-management eduation and support. Diabetes Care 35: , Herman WH, Dasbah DJ, Songer TJ, Thompson DE, Crofford OB: Assessing the impat of intensive insulin therapy on the health are system. Diabetes Rev 2: , Wagner EH, Sandu N, Newton KM, MCullok DK, Ramsey SD, Grothaus LC: Effets of improved glyemi ontrol on health are osts and utilization. JAMA 285: , Balaned Budget At of U.S. Govt. Printing Offie, 1997, p (publ. no ) are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S99

100 N A T I O N A L S T A N D A R D S National Standards for Diabetes Self-Management Eduation and Support LINDA HAAS, PHC, RN, CDE (CHAIR) 1 MELINDA MARYNIUK, MED, RD, CDE (CHAIR) 2 JONI BECK, PHARMD, CDE, BC-ADM 3 CARLA E. COX, PHD, RD, CDE, CSSD 4 PAULINA DUKER, MPH, RN, BC-ADM, CDE 5 LAURA EDWARDS, RN, MPA 6 EDWIN B. FISHER, PHD 7 LENITA HANSON, MD, CDE, FACE, FACP 8 DANIEL KENT, PHARMD, BS, CDE 9 LESLIE KOLB, RN, BSN, MBA 10 B y the most reent estimates, 18.8 million people in the U.S. have been diagnosed with diabetes and an additional 7 million are believed to be living with undiagnosed diabetes. At the same time, 79 million people are estimated to have blood gluose levels in the range of prediabetes or ategories of inreased risk for diabetes. Thus, more than 100 million Amerians are at risk for developing the devastating ompliations of diabetes (1). Diabetes self-management eduation (DSME) is a ritial element of are for all people with diabetes and those at risk for developing the disease. It is neessary in order to prevent or delay the ompliations of diabetes (2 6) and has elements related to lifestyle hanges that are also essential for individuals with prediabetes as part of efforts to prevent the disease (7,8). SUE MCLAUGHLIN, BS, RD, CDE, CPT 11 ERIC ORZECK, MD, FACE, CDE 12 JOHN D. PIETTE, PHD 13 ANDREW S. RHINEHART, MD, FACP, CDE 14 RUSSELL ROTHMAN, MD, MPP 15 SARA SKLAROFF 16 DONNA TOMKY, MSN, RN, C-NP, CDE, FAADE 17 GRETCHEN YOUSSEF, MS, RD, CDE 18 ON BEHALF OF THE 2012 STANDARDS REVISION TASK FORCE The National Standards for Diabetes Self- Management Eduation are designed to define quality DSME and support and to assist diabetes eduators in providing evidene-based eduation and selfmanagement support. The Standards are appliable to eduators in solo pratie as well as those in large multienter programsdand everyone in between. There are many good models for the provision of diabetes eduation and support. The Standards do not endorse any one approah, but rather seek to delineate the ommonalities among effetive and exellent self-management eduation strategies. These are the standards used in the field for reognition and areditation. They also serve as a guide for nonaredited and nonreognized providers and programs. From the 1 VA Puget Sound Health Care System Hospital and Speialty Mediine, Seattle, Washington; the 2 Joslin Diabetes Center, Boston, Massahusetts; 3 Pediatri Diabetes and Endorinology, The University of Oklahoma Health Sienes Center College of Mediine, Edmond, Oklahoma; the 4 Western Montana Clini, Missoula, Montana; the 5 Diabetes Eduation/Clinial Programs, Amerian Diabetes Assoiation, Alexandria, Virginia; the 6 Center for Healthy North Carolina, Apex, North Carolina; 7 Peers for Progress, Amerian Aademy of Family Physiians Foundation and Department of Health Behavior, Gillings Shool of Global Publi Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; 8 Ultraare Endorine and Diabetes Consultants, Venie, Florida; the 9 Group Health Central Speialty Clini, Seattle, Washington; the 10 Diabetes Eduation Areditation Program, Amerian Assoiation of Diabetes Eduators, Chiago, Illinois; 11 On Site Health and Wellness, LLC, Omaha, Nebraska; 12 Endorinology Assoiates, Main Medial Plaza, Houston, Texas; the 13 VA Center for Clinial Management Researh and the University of Mihigan Health System, Ann Arbor, Mihigan; 14 Johnston Memorial Diabetes Care Center, Abingdon, Virginia; the 15 Center for Health Servies Researh, Vanderbilt University Medial Center, Nashville, Tennessee; 16 Tehnial Writer, Washington, DC; the 17 Department of Endorinology and Diabetes, ABQ Health Partners, Albuquerque, New Mexio; and 18 MedStar Diabetes Institute/MedStar Health, Washington, DC. Corresponding authors: Linda Haas, [email protected], and Melinda Maryniuk, [email protected]. DOI: /d13-S100 The previous version of this artile National Standards for Diabetes Self-Management Eduation was published in Diabetes Care 2007;30: This version reeived final approval in July by the Amerian Diabetes Assoiation and the Amerian Assoiation of Diabetes Eduators. Readers may use this artile as long as the work is properly ited, the use is eduational and not for profit, and the work is not altered. See for details. Beause of the dynami nature of health are and diabetes-related researh, the Standards are reviewed and revised approximately every 5 years by key stakeholders and experts within the diabetes eduation ommunity. In the fall of 2011, a Task Fore was jointly onvened by the Amerian Assoiation of Diabetes Eduators (AADE) and the Amerian Diabetes Assoiation (ADA). Members of the Task Fore inluded experts from the areas of publi health, underserved populations inluding rural primary are and other rural health servies, individual praties, large urban speialty praties, and urban hospitals. They also inluded individuals with diabetes, diabetes researhers, ertified diabetes eduators, registered nurses, registered dietitians, physiians, pharmaists, and a psyhologist. The Task Fore was harged with reviewing the urrent National Standards for Diabetes Self-Management Eduation for their appropriateness, relevane, and sientifibasis andupdatingthembasedontheavailable evidene and expert onsensus. The Task Fore made the deision to hange the name of the Standards from the National Standards for Diabetes Self- Management Eduation to the National Standards for Diabetes Self-Management Eduation and Support. This name hange is intended to odify the signifiane of ongoing support for people with diabetes and those at risk for developing the disease, partiularly to enourage behavior hange, the maintenane of healthy diabetes-related behaviors, and to address psyhosoial onerns. Given that self-management does not stop when a patient leaves the eduator s offie, self-management support must be an ongoing proess. Although the term diabetes is used predominantly, the Standards should also be understood to apply to the eduation and support of people with prediabetes. Currently, there are signifiant barriers to the provision of eduation and support to those with prediabetes. And yet, the strategies for supporting suessful behavior hange and the healthy behaviors reommended for people with prediabetes are largely idential to those for S100 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

101 individuals with diabetes. As barriers to are are overome, providers of DSME and diabetes self-management support (DSMS), given their training and experiene, are partiularly well equipped to assist individuals with prediabetes in developing and maintaining behaviors that an prevent or delay the onset of diabetes. Many people with diabetes have or are at risk for developing omorbidities, inluding both diabetes-related ompliations and onditions (e.g., heart disease, lipid abnormalities, nerve damage, hypertension, and depression) and other medial problems that may interfere with self-are (e.g., emphysema, arthritis, and aloholism). In addition, the diagnosis, progression, and daily work of managing the disease an take a major emotional toll on people with diabetes that makes selfare even more diffiult (9). The Standards enourage providers of DSME and DSMS to address the entire panorama of eah partiipant slinialprofile. Regular ommuniation among the members of partiipant s health are teams is essential to ensure high-quality, effetive eduation and support for people with diabetes and prediabetes. In the ourse of its work on the Standards, the Task Fore identified areas in whih there is urrently an insuffiient amount of researh. In partiular, there are three areas in whih the Task Fore reommends additional researh: 1. Whatisthe influene of organizational struture on the effetiveness of the provision of DSME and DSMS? 2. What is the impat of using a strutured urriulum in DSME? 3. What training should be required for those ommunity, lay, or peer workers without training in health or diabetes who are to partiipate in the provision of DSME and to provide DSMS? Finally, the Standards emphasize that the person with diabetes is at the enter of the entire diabetes eduation and support proess. It is the individuals with diabetes who do the hard work of managing their ondition, day in and day out. The eduator s role,first and foremost, is to make that work easier (10). DEFINITIONS DSME: The ongoing proess of failitating the knowledge, skill, and ability neessary for prediabetes and diabetes self-are. This proess inorporates the needs, goals, and life experienes of the person with diabetes or prediabetes and is guided by evidene-based standards. The overall objetives of DSME are to support informed deision making, self-are behaviors, problem solving, and ative ollaboration with the health are team and to improve linial outomes, health status, and quality of life. DSMS: Ativities that assist the person with prediabetes or diabetes in implementing and sustaining the behaviors needed to manage his or her ondition on an ongoing basis beyond or outside of formal self-management training. The type of support provided an be behavioral, eduational, psyhosoial, or linial (11 15). STANDARD 1 Internal struture The provider(s) of DSME will doument an organizational struture, mission statement, and goals. For those providers working within a larger organization, that organization will reognize and support quality DSME as an integral omponent of diabetes are. Doumentation of an organizational struture, mission statement, and goals an lead to effiient and effetive provision of DSME and DSMS. In the business literature, ase studies and ase report investigations of suessful management strategies emphasize the importane of lear goals and objetives, defined relationships and roles, and managerial support. Business and health poliy experts and organizations emphasize written ommitments, poliies, support, and the importane of outomes reporting to maintain ongoing support or ommitment (16,17). Doumentation of an organizational struture that delineates hannels of ommuniation and represents institutional ommitment to the eduational entity is ritial for suess. Aording to The Joint Commission, this type of doumentation is equally important for both small and large health are organizations (18). Health are and business experts overwhelmingly agree that doumentation of the proess of providing servies is a ritial fator in lear ommuniation and provides a solid basis from whih to deliver quality diabetes eduation. In 2010, The Joint Commission published the Disease-Speifi CareCertifiation Manual, whih outlines standards and performane measurements for hroni are programs and disease management servies, inluding Supporting Self- Management (18). STANDARD 2 External input The provider(s) of DSME will seek ongoing input from external stakeholders and experts in order to promote program quality. For both individual and group providers of DSME and DSMS, external input is vital to maintaining an up-to-date, effetive program. Broad partiipation of ommunity stakeholders, inluding individuals with diabetes, health professionals, and ommunity interest groups, will inrease the program s knowledge of the loal population and allow the provider to better serve the ommunity. Often, but not always, this external input is best ahieved by the establishment of a formal advisory board. The DSME and DSMS provider(s) must have a doumented plan for seeking outside input and ating on it. The goal of external input and disussion in the program planning proess is to foster ideas that will enhane the quality of the DSME and/or DSMS being provided, while building bridges to key stakeholders (19). The result is effetive, dynami DSME that is patient entered, more responsive to onsumer-identified needs and the needs of the ommunity, more ulturally relevant, and more appealing to onsumers (17,19,20). STANDARD 3 Aess The provider(s) of DSME will determine who to serve, how best to deliver diabetes eduation to that population, and what resoures an provide ongoing support for that population. Currently, the majority of people with diabetes and prediabetes do not reeive any strutured diabetes eduation (19,20). While there are many barriers to DSME, one ruial issue is aess (21). Providers of DSME an help address this issue by: National Standards Clarifying the speifi populationtobe served. Understanding the ommunity, servie area, or regional demographis is ruial to ensuring that as many people as possible are being reahed, inluding those who do not frequently attend linial appointments (9,17,22 24). Determining that population s selfmanagement eduation and support are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S101

102 National Standards needs. Different individuals, their families, and ommunities need different types of eduation and support (25). The provider(s) of DSME and DSMS needs to work to ensure that the neessary eduation alternatives are available (25 27). This means understanding the population s demographi harateristis, suh as ethni/ ultural bakground, sex, and age, as well as levels of formal eduation, literay, and numeray (28 31). It may also entail identifying resoures outside of the provider spratiethatan assist in the ongoing support of the partiipant. Identifying aess issues and working to overome them. It is essential to determine fators that prevent individuals with diabetes from reeiving self-management eduation and support. The assessment proess inludes the identifiation of these barriers to aess (32 34). These barriers may inlude the soioeonomi or ultural fators mentioned above, as well as, for example, health insurane shortfalls and the lak of enouragement from other health providers to seek diabetes eduation (35,36). STANDARD 4 Program oordination A oordinator will be designated to oversee the DSME program. The oordinator will have oversight responsibility for the planning, implementation, and evaluation of eduation servies. Coordination is essential to ensure that quality diabetes self-management eduation and support is delivered through an organized, systemati proess (37,38). As the field of DSME ontinues to evolve, the oordinator plays a pivotal role in ensuring aountability and ontinuity in the eduation program (39 41). The oordinator s role may be viewed as that of oordinating the program (or eduation proess) and/or as supporting the oordination of the many aspets of selfmanagement in the ontinuum of diabetes and related onditions when feasible (42 49). This oversight inludes designing an eduation program or servie that helps the partiipant aess needed resoures and assists him or her in navigating the health are system (37,50 55). The individual serving as the oordinator will have knowledge of the lifelong proess of managing a hroni disease and failitating behavior hange, in addition to experiene with program and/or linial management (56 59). In some ases, partiularly in solo or other small praties, the oordinator may also provide DSME and/ or DSMS. STANDARD 5 Instrutional staff One or more instrutors will provide DSME and, when appliable, DSMS. At least one of the instrutors responsible for designing and planning DSME and DSMS will be a registered nurse, registered dietitian, or pharmaist with training and experiene pertinent to DSME, or another professional with ertifiation in diabetes are and eduation, suh as a CDE or BC-ADM. Other health workers an ontribute to DSME and provide DSMS with appropriate training in diabetes and with supervision and support. Historially, nurses and dietitians were the main providers of diabetes eduation (3,4,60 64). In reent years, the role of the diabetes eduator has expanded to other disiplines, partiularly pharmaists (65 67). Reviews omparing the effetiveness of different disiplines for eduation have not identified lear differenes in the quality of servies delivered by different professionals (3 5). However, the literature favors the registered nurse, registered dietitian, and pharmaist serving both as the key primary instrutors for diabetes eduation and as members of the multidisiplinary team responsible for designing the urriulum and assisting in the delivery of DSME (1 7,68). Expert onsensus supports the need for speialized diabetes and eduational training beyond aademi preparation for the primary instrutors on the diabetes team (69 72). Professionals serving as instrutors must doument appropriate ontinuing eduation or omparable ativities to ensure their ontinuing ompetene to serve in their instrutional, training, and oversight roles (73). Refleting the evolving health are environment, a number of studies have endorsed a multidisiplinary team approah to diabetes are, eduation, and support. The disiplines that may be involved inlude, but are not limited to, physiians, psyhologists and other mental health speialists, physial ativity speialists (inluding physial therapists, oupational therapists, and exerise physiologists), optometrists, and podiatrists (68,74,75). More reently, health eduators (e.g., Certified Health Eduation Speialists and Certified Medial Assistants), ase managers, lay health and ommunity workers (76 83), and peer ounselors or eduators (84,85) have been shown to ontribute effetivelyaspartofthedsmeteamandin providing DSMS. While DSME and DSMS are often provided within the framework of a ollaborative and integrated team approah, it is ruial that the individual with diabetes is viewed as entral to the team and that he or she takes an ative role. Certifiation as a diabetes eduator (CDE) by the National Certifiation Board for Diabetes Eduators (NCBDE) is one way a health professional an demonstrate mastery of a speifi body of knowledge, and this ertifiation has beome an aepted redential in the diabetes ommunity (86). An additional redential that indiates speialized training beyond basi preparation is board ertifiation in Advaned Diabetes Management (BC-ADM) offered by the AADE, whih is available for nurses, dietitians, pharmaists, physiians, and physiian assistants (68,74,87). Individuals who serve as lay health and ommunity workers and peer ounselors or eduators may ontribute to the provision of DSME instrution and provide DSMS if they have reeived training in diabetes management, the teahing of selfmanagement skills, group failitation, and emotional support. For these individuals, a system must be in plae that ensures supervision of the servies they provide by a diabetes eduator or other health are professional and professional bak-up to address linial problems or questions beyond their training (88 90). For servies outside the expertise of any provider(s) of DSME and DSMS, a mehanism must be in plae to ensure that the individual with diabetes is onneted with appropriately trained and redentialed providers. STANDARD 6 Curriulum A written urriulum refleting urrent evidene and pratie guidelines, with riteria for evaluating outomes, will serve as the framework for the provision of DSME. The needs of the individual partiipant will determine whih parts of the urriulum will be provided to that individual. Individuals with prediabetes and diabetes and their families and aregivers have muh to learn to beome effetive self-managers of their ondition. DSME S102 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

103 an provide this eduation via an up-todate, evidene-based, and flexible urriulum (8,91). The urriulum is a oordinated set of ourses and eduational experienes. It also speifies learning outomes and effetive teahing strategies (92,93). The urriulum must be dynami and reflet urrent evidene and pratie guidelines (93 97). Reent eduation researh endorses the inlusion of pratial problemsolving approahes, ollaborative are, psyhosoial issues, behavior hange, and strategies to sustain self-management efforts (12,13,19,74,86,98 101). The following ore topis are ommonly part of the urriulum taught in omprehensive programs that have demonstrated suessful outomes (2,3,5,91, ): Desribing the diabetes disease proess and treatment options Inorporating nutritional management into lifestyle Inorporating physial ativity into lifestyle Using mediation(s) safely and for maximum therapeuti effetiveness Monitoring blood gluose and other parameters and interpreting and using the results for self-management deision making Preventing, deteting, and treating aute ompliations Preventing, deteting, and treating hroni ompliations Developing personal strategies to address psyhosoial issues and onerns Developing personal strategies to promote health and behavior hange While the ontent areas listed above provide a solid outline for a diabetes eduation and support urriulum, it is ruial that the ontent be tailored to matheahindividual s needsandbe adapted as neessary for age, type of diabetes (inluding prediabetes and diabetes in pregnany), ultural fators, health literay and numeray, and omorbidities (14, ). The ontent areas will be able to be adapted for all pratie settings. Approahes to eduation that are interative and patient entered have been shown to be effetive (12,13, ). Also ruial is the development of ation-oriented behavioral goals and objetives (12 14,113). Creative, patient-entered, experiene-based delivery methodsdbeyond the mere aquisition of knowledgedare effetive for supporting informed deision making and meaningful behavior hange and addressing psyhosoial onerns (114,115). STANDARD 7 Individualization The diabetes self-management, eduation, and support needs of eah partiipant will be assessed by one or more instrutors. The partiipant and instrutor(s) will then together develop an individualized eduation and support plan foused on behavior hange. Researh has demonstrated the importane of individualizing diabetes eduation to eah partiipant s needs (116). The assessment proess is used to identify what those needs are and to failitate the seletion of appropriate eduational and behavioral interventions and selfmanagement support strategies, guided by evidene (2,63, ). The assessment must garner information about the individual s medial history, age, ultural influenes, health beliefs and attitudes, diabetes knowledge, diabetes self-management skills and behaviors, emotional response to diabetes, readiness to learn, literay level (inluding health literay and numeray), physial limitations, family support, and finanial status (11,106,108,117, ). The eduation and support plan that the partiipant and instrutor(s) develop will be rooted in evidene-based approahes to effetive health ommuniation and eduation while taking into onsideration partiipant barriers, abilities, and expetations. The instrutor will use lear health ommuniation priniples, avoiding jargon, making information ulturally relevant, using language- and literayappropriate eduation materials, and using interpreter servies when indiated (107, ). Evidene-based ommuniation strategies suh as ollaborative goal setting, motivational interviewing, ognitive behavior hange strategies, problem solving, self-effiay enhanement, and relapse prevention strategies are also effetive (101, ). Periodi reassessment an determine whether there is need for additional or different interventions and future reassessment (6,72, ). A variety of assessment modalities, inluding telephone follow-up and other information tehnologies (e.g., Web based, text messaging, or automated phone alls), may augment fae-to-fae assessments (72,87, ). The assessment and eduation plan, intervention, and outomes will be doumented in the eduation/health reord. Doumentation of partiipant enounters will guide the eduation proess, provide evidene of ommuniation among instrutional staff and other members of the partiipant s health are team, prevent dupliation of servies, and demonstrate adherene to guidelines (117,135,142,143). Providing information to other members of the partiipant s health are team through doumentation of eduational objetives and personal behavioral goals inreases the likelihood that all the members will work in ollaboration (86,143). Evidene suggests that the development of standardized proedures for doumentation, training health professionals to doument appropriately, and the use of strutured standardized forms based on urrent pratie guidelines an improve doumentation and may ultimately improve quality of are (135, ). STANDARD 8 National Standards Ongoing support The partiipant and instrutor(s) will together develop a personalized follow-up plan for ongoing self-management support. The partiipant s outomes and goals and the plan for ongoing self-management support will be ommuniated to other members of the health are team. While DSME is neessary and effetive, it does not in itself guarantee a lifetime of effetive diabetes self-are (113). Initial improvements in partiipants metaboli and other outomes have been found to diminish after approximately 6 months (3). To sustain the level of self-management needed to effetively manage prediabetes and diabetes over the long term, most partiipants need ongoing DSMS (15). The type of support provided an be behavioral, eduational, psyhosoial, or linial (11 14). A variety of strategies are available for providing DSMS both within and outside the DSME organization. Some patients benefitfromworkingwithanurse ase manager (6,86,146). Case management for DSMS an inlude reminders about needed follow-up are and tests, mediation management, eduation, behavioral goal setting, psyhosoial support, and onnetion to ommunity resoures. The effetiveness of providing DSMS through disease management programs, trained peers and ommunity health workers, ommunity-based programs, information tehnology, ongoing eduation, support groups, and medial nutrition are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S103

104 National Standards therapy has also been established (7 11,86,88 90,142, ). While the primary responsibility for diabetes eduation belongs to the provider(s) of DSME, partiipants benefit by reeiving reinforement of ontent and behavioral goals from their entire health are team (135). Additionally, many patients reeive DSMS through their primary are provider. Thus, ommuniation among the team regarding the patient s eduational outomes, goals, and DSMS plan is essential to ensure that people with diabetes reeive support that meets their needs and is reinfored and onsistent among the health are team members. Beause self-management takes plae in partiipants daily lives and not in linial or eduational settings, patients will be assisted to formulate a plan to find ommunity-based resoures that may support their ongoing diabetes selfmanagement. Ideally, DSME and DSMS providers will work with partiipants to identify suh servies and, when possible, trak those that have been effetive with patients, while ommuniating with providers of ommunity-based resoures inordertobetterintegratetheminto patients overall are and ongoing support. STANDARD 9 Patient progress The provider(s) of DSME and DSMS will monitor whether partiipants are ahieving their personal diabetes self-management goals and other outome(s) as a way to evaluate the effetiveness of the eduational intervention(s), using appropriate measurement tehniques. Effetive diabetes self-management an be a signifiant ontributor to long-term, positive health outomes. The provider(s) of DSME and DSMS will assess eah partiipant s personal self-management goals and his or her progress toward those goals (151,152). The AADE Outome Standards for Diabetes Eduation speify behavior hange as the key outome and provide a useful framework for assessment and doumentation. The AADE7 lists seven essential fators: physial ativity, healthy eating, taking mediation, monitoring blood gluose, diabetes self-are related problem solving, reduing risks of aute and hroni ompliations, and psyhosoial aspets of living with diabetes (93,153,154). Differenes in behaviors, health beliefs, and ulture as well as their emotional response to diabetes an have a signifiant impat on how partiipants understand their illness and engage in self-management. DSME providers who aount for these differenes when ollaborating with partiipants on the design of personalized DSME or DSMS programs an improve partiipant outomes (147,148). Assessments of partiipant outomes must our at appropriate intervals. The interval depends on the nature of the outome itself and the time frame speified based on the partiipant s personal goals. For some areas, the indiators, measures, and time frames will be based on guidelines from professional organizations or government agenies. STANDARD 10 Quality improvement The provider(s) of DSME will measure the effetiveness of the eduation and support and look for ways to improve any identified gaps in servies or servie quality using a systemati review of proess and outome data. Diabetes eduation must be responsive to advanes in knowledge, treatment strategies, eduation strategies, and psyhosoial interventions, as well as onsumer trends and the hanging health are environment. By measuring and monitoring both proess and outome data on an ongoing basis, providers of DSME an identify areas of improvement and make adjustments in partiipant engagement strategies and program offerings aordingly. The Institute for Healthare Improvement suggests three fundamental questions that should be answered by an improvement proess (149): What are we trying to aomplish? How will we know a hange is an improvement? What hanges an we make that will result in an improvement? One areas for improvement are identified, the DSME provider must designate timelines and important milestones inluding data olletion, analysis, and presentation of results (150). Measuring both proesses and outomes helps to ensure that hange is suessful without ausing additional problems in the system. Outome measures indiate the result of a proess (i.e., whether hanges are atually leading to improvement), while proessmeasuresprovideinformation about what aused those results (144,150). Proess measures are often targeted to those proesses that typially impat the most important outomes. AknowledgmentsdNo potential onflits of interest relevant to this artile were reported. The Task Fore aknowledges Paulina Duker, ADA Staff Failitator; Leslie Kolb, AADE Staff Failitator; Karen Fitzner, PhD, meeting failitator (FH Consultants, Chiago, Illinois); and Sara Sklaroff for tehnial writing assistane. Referenes 1. Centers for Disease Control and Prevention. 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107 Models for Suess. Oakland, CA, California Health Care Foundation, Long JA, Jahnle EC, Rihardson DM, Loewenstein G, Volpp KG. Peer mentoring and finanial inentives to improve gluose ontrol in Afrian Amerian veterans: a randomized trial. Ann Intern Med 2012;156: Amerian Assoiation of Diabetes Eduators. The Sope of Pratie, Standards of Pratie, and Standards of Professional Performane for Diabetes Eduators [Internet], Available from diabeteseduator.org/diabeteseduation/ position/sope_x_standards.html. Aessed 26 June Valentine V, Kulkarni K, Hinnen D. Evolving roles: from diabetes eduators to advaned diabetes managers. Diabetes Edu 2003;29: , 604, Amerian Assoiation of Diabetes Eduators. AADE guidelines for the pratie of diabetes self-management eduation and training (DSME/T). Diabetes Edu 2009;35(Suppl. 3):85S 107S 89. Amerian Assoiation of Diabetes Eduators. Competenies for diabetes eduators: a ompanion doument to the guidelines for the pratie of diabetes eduation [Internet], Available from diabeteseduator.org/professionalresoures/ position/ompetenies.html. Aessed 26 June Amerian Assoiation of Diabetes Eduators. A sustainable model of diabetes self-management eduation/training involves a multi-level team that an inlude ommunity health workers [Internet], Available from org/diabeteseduation/position/white_ Papers.html. Aessed 26 June Gillett M, Dallosso HM, Dixon S, et al. Delivering the diabetes eduation and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: ost effetiveness analysis. BMJ 2010;341: Redman BK. The Pratie of Patient Eduation. 10th ed. St. Louis, MO, Mosby, Mulahy K, Maryniuk M, Peeples M, et al. Diabetes self-management eduation ore outomes measures. Diabetes Edu 2003;29: , , ReaderD,SplettP,GundersonEP;Diabetes Care and Eduation Dieteti Pratie Group. 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108 National Standards 123. Chodosh J, Morton SC, Mojia W, et al. Meta-analysis: hroni disease selfmanagement programs for older adults. Ann Intern Med 2005;143: Anderson-Loftin W, Barnett S, Bunn P, Sullivan P, Hussey J, Tavakoli A. Soul food light: ulturally ompetent diabetes eduation. Diabetes Edu 2005;31: Mensing CR, Norris SL. Group eduation in diabetes: effetiveness and implementation. Diabetes Spetrum 2003; 16: Brown SA, Blozis SA, Kouzekanani K, Garia AA, Winhell M, Hanis CL. Dosage effets of diabetes self-management eduation for Mexian Amerians: the Starr County Border Health Initiative. Diabetes Care 2005;28: Hosey GM, Freeman WL, Straqualursi F, Gohdes D. Designing and evaluating diabetes eduation material for Amerian Indians. Diabetes Edu 1990;16: Thomson FJ, Masson EA. Can elderly patients o-operate with routine foot are? Diabetes Spetrum 1995;8: Hawthorne K, Robles Y, Cannings-John R, Edwards AG. 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109 Professional Pratie Committee for the 2013 Clinial Pratie Reommendations Committee members dislosed the following finanial or other onflits of interest overing the period 1 November Otober Member Employment Researh grant Other researh support Roger Austin, MS, RPH, CDE Henry Ford Health System, None None Sterling Heights, MI Nathaniel G. Clark, MD, RD Diabetes Center of Cape Cod, None None Hyannis, MA Cyrus V. Desouza, MD University of Nebraska REATA Researh Trial#, None Medial Center and Omaha VA Medial Center, Omaha, NE Novo Nordisk# Martha Funnell, MSN, University of Mihigan, Ann None None RN, CDE Arbor, MI Allison B. Goldfine, MD Joslin Diabetes Center, Boston, MA NIDDK#, NHLBI# Researh supplies from Carao Pharmaeutials#, LifeSan#, Merodia#, Nestle#, Amneal# Rihard Grant, MD, MPH Division of Researh, Kaiser AHRQ#, NIDDK# None Permanente, Oakland, CA James Lenhard, MD Christiana Care Health System, NIH# None Jennifer B. Marks, MD Anthony L. MCall, MD, PhD Wilmington, DE VA Diabetes Management Team, Miami, FL, and Diabetes Researh Institute, University of Miami Shool of Mediine, Miami, FL Janis R. MWilliams, RN, MSN, CDE, BC-ADM R. Harsha Rao, MD University of Pittsburgh Medial Center, Pittsburgh, PA, and VA Pittsburgh Healthare System, Pittsburgh, PA Andrew Rhinehart, MD, CDE, BC-ADM, FACP Henry Rodriguez, MD Debra L. Simmons, MD, MS Lilly#, NIH#, Leona M. and Harry B. Helmsley Charitable Trust (T1D Exhange Clini Registry)# Aventis#, Eli Lilly#, NIDDK NIDDK University of Virginia, None Charlottesville, VA Consultant, Pittsburgh, PA None None Mountain States Health Alliane, Abingdon, VA University of South Florida, Tampa, FL University of Utah, VA Salt Lake City, Salt Lake City, UT, and University of Arkansas for Medial Sienes and Central Arkansas Veterans Healthare System, Little Rok, AR None Diabetes Impat Grant#, Health Wagon Grant# NIH#, Bristol-Myers Squibb#, Daiihi Sankyo#, Novartis#, Merk#, Leona M. and Harry B. Helmsley Charitable Trust (T1D Exhange Clini Registry)# NHLBI#, Novo Nordisk# Patriia Urbanski, MEd, RD, LD, CDE Carol Wysham, MD (Chair) Rokwood Clini, Spokane, WA NIH#, Leona M. and Harry B. Helmsley Charitable Trust (T1D Exhange Clini Registry)# None None None None Consultant, Cloquet, MN None None None Judy Fradkin, MD (Ex offiio) Stephanie Dunbar, RD, MPH (Staff) Sue Kirkman, MD (Staff) NIDDK, Bethesda, MD None None Amerian Diabetes Assoiation, Alexandria, VA Amerian Diabetes Assoiation, Alexandria, VA None None None None *$$10,000 per year from ompany to individual; #grant or ontrat is to university or other employer. are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S109

110 Professional Pratie Committee Member Speakers bureau/honoraria Ownership interest Consultant/advisory board Other R.A. Johnson & Johnson None None None Diabetes Institute (wife Mary Austin) N.G.C. Novo Nordisk, Amylin None None Clinial Diabetes, Editorial Board C.V.D. None None Novo Nordisk, Takeda None M.F. None None Eli Lilly, Boehringer Ingelheim, None Halozyme Therapeutis, Merk Pharmaeutial, Bristol-Myers Squibb/ AstraZenea, UCLA Center for Health Poliy Researh, Animas/LifeSan Gluose Meter, Bristol- Myers Squibb Nurse Pratitioner, Bayer Health Care Diabetes Care, Novo Nordisk Pen Devies A.B.G. None Pending patents: JDP 106 (SAZ T2D), JDP 109 (SAZ CUD), JDP 129 (SRF) None Speial Government Employee, FDA (invited partiipant for Endorine and Metaboli Advisory Committee) R.G. None None None None J.L. Boehringer Ingelheim, sanofi-aventis None None Expert witness for variety of legal firms. No ases involved in the last 12 months onerned drugs, devies, or pharmaeutial ompanies J.B.M. ADA, Diabetes Researh None Amgen None Institute Foundation A.L.M. None None None Clinial Siene Chair, The Endorine Soiety Annual Meeting & Expo 2012 J.R.M. Rohe (Creative Coahing Workshop), VMS (Steady Start Eduator Network), Healthy Interations None None None R.H.R. None Co-inventor of GENIE. No ommerial agreements or ollaborations. (U.S. patent appliation number filed by VA Tehnology Transfer Program, DC01- # v Automated System and Method of Diabetes Control (Rao RH, Perreiah PL, Cunningham CA, Inventors) A.R. Forest Laboratories*, Abbott Laboratories, Eli Lilly, Novo Nordisk*, sanofiaventis*, Boehringer Ingelheim, Amylin None None None sanofi-aventis*, Amylin Board Member and President, Appalahian Diabetes Foundation H.R. Eli Lilly* None Eli Lilly*, Rohe Diagnostis Diabetes Foreast, Assoiate Editor D.L.S. None None None None P.U. Eli Lilly None Eli Lilly, sanofi-aventis, Halozyme Therapeutis, Medtroni Clinial Diabetes, Editorial Board C.W. Amylin Pharmaeutials*, Eli Lilly*, Merk, Novo Nordisk*, sanofiaventis*, Boehringer Ingelheim None Amylin Pharmaeutials*, Boehringer Ingelheim, Johnson & Johnson, sanofi-aventis* J.F. None None None None S.D. None None None None S.K. None None None None None S110 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

111 Systemati Reviews A systemati review provides a sientifi rationale for a position statement and undergoes ritial peer review before submission to the Professional Pratie Committee for approval. Effetive January 2010, tehnial reports were replaed with systemati reviews, for whih a priori searh and inlusion/ exlusion riteria are developed and published. Listed below are reent reviews. Maronutrients, Food Groups, and Eating Patterns in the Management of Diabetes: A Systemati Review of the Literature, 2010 Madelyn L. Wheeler, Stephanie A. Dunbar, Lindsay M. Jaaks, Wahida Karmally, Elizabeth J. Mayer-Davis, Judith Wylie-Rosett, and William S. Yany Jr. Diabetes Care 35: , 2012 Cost-Effetiveness of Interventions to Prevent and Control Diabetes Mellitus: A Systemati Review Rui Li, Ping Zhang, Lawrene E. Barker, Farah M. Chowdhury, and Xuanping Zhang Diabetes Care 33: , 2010 are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 e1

112 Consensus Reports Effetive January 2010, priorreports ofthe types listedbelow were renamed onsensus reports. Listed below are reent onsensus reports. EXPERT COMMITTEE REPORTS International Expert Committee Report on the Role of the A1C Assay in the Diagnosis of Diabetes International Expert Committee Diabetes Care 32: , 2009 CONSENSUS REPORTS Diabetes in Older Adults M. Sue Kirkman, Vanessa Jones Brisoe, Nathaniel Clark, Hermes Florez, Linda B. Haas, Jeffrey B. Halter, Elbert S. Huang, Mary T. Korytkowski, Medha N. Munshi, Peggy Soule Odegard, Rihard E. Pratley, and Carrie S. Swift Diabetes Care 35: , 2012 The Charot Foot in Diabetes Lee C. Rogers, Robert G. Frykberg, David G. Armstrong, Andrew J.M. Boulton, Mihael Edmonds, Georges Ha Van, Agnes Hartemann, Franes Game, William Jeffoate, Alexandra Jirkovska, Edward Jude, Stephan Morbah, William B. Morrison, Mihael Pinzur, Dario Pitoo, Lee Sanders, Dane K. Wukih, and Luigi Uioli Diabetes Care 34: , 2011 Diabetes and Caner Edward Giovannui, David M. Harlan, Mihael C. Arher, Rihard M. Bergenstal, Susan M. Gapstur, Laurel A. Habel, Mihael Pollak, Judith G. Regensteiner, and Douglas Yee Diabetes Care 33: , 2010 Amerian Assoiation of Clinial Endorinologists and Amerian Diabetes Assoiation Consensus Statement on Inpatient Glyemi Control Etie S. Moghissi, Mary T. Korytkowski, Monia DiNardo, Daniel Einhorn, Rihard Hellman, Irl B. Hirsh, Silvio E. Inzuhi, Faramarz Ismail-Beigi, M. Sue Kirkman, and Guillermo E. Umpierrez Diabetes Care 32: , 2009 Hyperglyemi Crises in Adult Patients With Diabetes Abbas E. Kitabhi, Guillermo E. Umpierrez, John M. Miles, and Joseph N. Fisher Diabetes Care 32: , 2009 How Do We Define Cure of Diabetes? John B. Buse, Sonia Caprio, William T. Cefalu, Antonio Ceriello, Stefano Del Prato, Silvio E. Inzuhi, Sue MLaughlin, Gordon L. Phillips II, R. Paul Robertson, Franeso Rubino, Rihard Kahn, and M. Sue Kirkman Diabetes Care 32: , 2009 Lipoprotein Management in Patients With Cardiometaboli Risk: Consensus Statement From the Amerian Diabetes Assoiation and the Amerian College of Cardiology Foundation John D. Brunzell, Mihael Davidson, Curt D. Furberg, Ronald B. Goldberg, Barbara V. Howard, James H. Stein, and Joseph L. Witztum Diabetes Care 31: , 2008 Managing Preexisting Diabetes for Pregnany: Summary of Evidene and Consensus Reommendations for Care John L. Kitzmiller, Jennifer M. Blok, Florene M. Brown, Patrik M. Catalano, Deborah L. Conway, Donald R. Coustan, Eria P. Gunderson, William H. Herman, Lisa D. Hoffman, Maribeth Inturrisi, Lois B. Jovanovi, Siri I. Kjos, Robert H. Knopp, Martin N. Montoro, Edward S. Ogata, Pathmaja Paramsothy, Diane M. Reader, Barak M. Rosenn, Alye M. Thomas, and M. Sue Kirkman Diabetes Care 31: , 2008 Influene of Rae, Ethniity, and Culture on Childhood Obesity: Impliations for Prevention and Treatment: A Consensus Statement of Shaping Ameria s Health and the Obesity Soiety Sonia Caprio, Stephen R. Daniels, Adam Drewnowski, Franine R. Kaufman, Lawrene A. Palinkas, Arlan L. Rosenbloom, and Jeffrey B. Shwimmer Diabetes Care 31: , 2008 Sreening for Coronary Artery Disease in Patients With Diabetes Jeroen J. Bax, Lawrene H. Young, Robert L. Frye, Robert O. Bonow, Helmut O. Steinberg, and Eugene J. Barrett Diabetes Care 30: , 2007 e2 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org

113 Position Statements A position statement is an offiial point of view or belief of the ADA. Position statements are issued on sientifi or medial issues related to diabetes. They may be authored or unauthored and are published in ADA journals and other sientifi/medial publiations as appropriate. Position statements must be reviewed and approved by the Professional Pratie Committee and, subsequently, by the Exeutive Committee of the Board of Diretors. ADA position statements are typially based on a tehnial review or other review of published literature. They are reviewed on an annual basis and updatedasneeded.inadditiontothosepublished in this supplement, listed below are reent position statements. Diabetes Management at Camps for Children With Diabetes Amerian Diabetes Assoiation Diabetes Care 35 (Suppl. 1):S72 S75, 2012 Management of Hyperglyemia in Type 2 Diabetes: A Patient-Centered Approah. Position Statement of the Amerian Diabetes Assoiation (ADA) and the European Assoiation for the Study of Diabetes (EASD) Silvio E. Inzuhi, Rihard M. Bergenstal, John B. Buse, Mihaela Diamant, Ele Ferrannini, Mihael Nauk, Anne L. Peters, Apostolos Tsapas, Rihard Wender, and David R. Matthews Diabetes Care 35: , 2012 Guidelines and Reommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus DavidB.Saks,MarkArnold,GeorgeL. Bakris, David E. Bruns, Andrea Rita Horvath, M. Sue Kirkman, Ake Lernmark, Boyd E. Metzger, and David M. Nathan Diabetes Care 34:e61 e99, 2011 Diabetes Care for Emerging Adults: Reommendations for Transition From Pediatri to Adult Diabetes Care Systems. A Position Statement of the Amerian Diabetes Assoiation, With Representation by the Amerian College of Osteopathi Family Physiians, the Amerian Aademy of Pediatris, the Amerian Assoiation of Clinial Endorinologists, the Amerian Osteopathi Assoiation, the Centers for Disease Control and Prevention,ChildrenwithDiabetes, The Endorine Soiety, the International Soiety for Pediatri and Adolesent Diabetes, Juvenile Diabetes Researh Foundation International, the National Diabetes Eduation Program, and the Pediatri Endorine Soiety (formerly Lawson Wilkins Pediatri Endorine Soiety) Anne Peters, Lori Laffel, and the Amerian Diabetes Assoiation Transitions Working Group Diabetes Care 34: , 2011 Aspirin for Primary Prevention of Cardiovasular Events in People With Diabetes: A Position Statement of the Amerian Diabetes Assoiation, a Sientifi Statement of the Amerian Heart Assoiation, and an Expert Consensus Doument of the Amerian College of Cardiology Foundation Mihael Pignone, Mark J. Alberts, John A. Colwell, Mary Cushman, Silvio E. Inzuhi, Debabrata Mukherjee, Robert S. Rosenson, Craig D. Williams, Peter W. Wilson, and M. Sue Kirkman Diabetes Care 33: , 2010 Exerise and Type 2 Diabetes. The Amerian College of Sports Mediine and the Amerian Diabetes Assoiation: Joint Position Statement Sheri R. Colberg, Ronald J. Sigal, Bo Fernhall, Judith G. Regensteiner, Bryan J. Blissmer, Rihard R. Rubin, Lisa Chasan- Taber, Ann L. Albright, and Barry Braun Diabetes Care 33:e147 e167, 2010 Clinial Care Guidelines for Cysti Fibrosis Related Diabetes: A Position Statement of the Amerian Diabetes Assoiation and a Clinial Pratie Guideline of the Cysti Fibrosis Foundation, Endorsed by the Pediatri Endorine Soiety Antoinette Moran, Carol Brunzell, Rihard C. Cohen, Maria Katz, Brue C. Marshall, Gary Onady, Karen A. Robinson, Kathryn A. Sabadosa, Arlene Steenko, Bonnie Slovis, and the CFRD Guidelines Committee Diabetes Care 33: , 2010 Intensive Glyemi Control and the Prevention of Cardiovasular Events: Impliations of the ACCORD, ADVANCE, and VA Diabetes Trials. A Position Statement of the Amerian Diabetes Assoiation and a Sientifi Statement of the Amerian College of Cardiology Foundation and the Amerian Heart Assoiation Jay S. Skyler, Rihard Bergenstal, Robert O. Bonow, John Buse, Prakash Deedwania, Edwin A.M. Gale, Barbara V. Howard, M. Sue Kirkman, Mikhail Kosiborod, Peter Reaven, and Robert S. Sherwin Diabetes Care 32: , 2009 Nutrition Reommendations and Interventions for Diabetes: A Position Statement of the Amerian Diabetes Assoiation Amerian Diabetes Assoiation Diabetes Care 31 (Suppl. 1):S61 S78, 2008 are.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 e3

114 Sientifi Statements A sientifi statement is a sholarly synopsis of a topi related to diabetes, whih may or may not ontain linial or researh reommendations. Any reommendations inluded represent the offiial point of view or belief of the ADA. Work Group Reports and Task Fore Reports fall into this ategory. Sientifi statements must be reviewed and approved by the Professional Pratie Committee and, subsequently, by the Exeutive Committee of the Board of Diretors. Listed below are reent sientifi statements. Nonnutritive Sweeteners: Current Use and Health Perspetives. A Sientifi Statement From the Amerian Heart Assoiation and the Amerian Diabetes Assoiation Christopher Gardner, Judith Wylie- Rosett,SamuelS.Gidding,LynM.Steffen, Rahel K. Johnson, Diane Reader, and Alie H. Lihtenstein, on behalf of the Amerian Heart Assoiation Nutrition Committee of the Counil on Nutrition, Physial Ativity and Metabolism, Counil on Arterioslerosis, Thrombosis and Vasular Biology, Counil on Cardiovasular Disease in the Young, and the Amerian Diabetes Assoiation Diabetes Care 35: , 2012 Comprehensive Foot Examination and Risk Assessment: A Report of the Task Fore of the Foot Care Interest Group of the Amerian Diabetes Assoiation, With Endorsement by the Amerian Assoiation of Clinial Endorinologists Andrew J.M. Boulton, David G. Armstrong, Stephen F. Albert, Robert G. Frykberg, Rihard Hellman, M. Sue Kirkman, Lawrene A. Lavery, Joseph W. LeMaster, Joseph L. Mills, Sr., Mihael J. Mueller, Peter Sheehan, and Dane K. Wukih Diabetes Care 31: , 2008 Amerian Diabetes Assoiation Statement on Emergeny and Disaster Preparedness: A Report of the Disaster Response Task Fore The Disaster Response Task Fore Diabetes Care 30: , 2007 e4 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 are.diabetesjournals.org