Standards of Medical Care in Diabetes 2015

Transcription

1 January 2015 Volume 38, Supplement 1 Standards of Medial Care in Diabetes 2015 S1 S3 S4 S5 S8 Introdution Professional Pratie Committee Standards of Medial Care in Diabetes 2015: Summary of Revisions 1. Strategies for Improving Care Diabetes Care Conepts Care Delivery Systems When Treatment Goals Are Not Met 2. Classifiation and Diagnosis of Diabetes S49 S58 8. Cardiovasular Disease and Risk Management Hypertension/Blood Pressure Control Dyslipidemia/Lipid Management Antiplatelet Agents Coronary Heart Disease 9. Mirovasular Compliations and Foot Care Nephropathy Retinopathy Neuropathy Foot Care S17 S20 S31 S33 S41 Classifiation Diagnosti Tests for Diabetes Categories of Inreased Risk for Diabetes (Prediabetes) Type 1 Diabetes Type 2 Diabetes Gestational Diabetes Mellitus Monogeni Diabetes Syndromes Cysti Fibrosis Related Diabetes 3. Initial Evaluation and Diabetes Management Planning Medial Evaluation Management Plan Common Comorbid Conditions 4. Foundations of Care: Eduation, Nutrition, Physial Ativity, Smoking Cessation, Psyhosoial Care, and Immunization Diabetes Self-management Eduation and Support Medial Nutrition Therapy Physial Ativity Smoking Cessation Psyhosoial Assessment and Care Immunization 5. Prevention or Delay of Type 2 Diabetes Lifestyle Modifiations Pharmaologial Interventions Diabetes Self-management Eduation and Support 6. Glyemi Targets Assessment of Glyemi Control A1C Goals Hypoglyemia Interurrent Illness 7. Approahes to Glyemi Treatment Pharmaologial Therapy for Type 1 Diabetes Pharmaologial Therapy for Type 2 Diabetes Bariatri Surgery S67 S70 S77 S80 S86 S88 S Older Adults Treatment Goals Hypoglyemia Pharmaologial Therapy 11. Children and Adolesents Type 1 Diabetes Type 2 Diabetes Psyhosoial Issues 12. Management of Diabetes in Pregnany Diabetes in Pregnany Preoneption Counseling Glyemi Targets in Pregnany Pregnany and Antihypertensive Drugs Management of Gestational Diabetes Mellitus Management of Pregestational Type 1 Diabetes and Type 2 Diabetes in Pregnany Postpartum Care 13. Diabetes Care in the Hospital, Nursing Home, and Skilled Nursing Faility Hyperglyemia in the Hospital Glyemi Targets in Hospitalized Patients Antihyperglyemi Agents in Hospitalized Patients Preventing Hypoglyemia Diabetes Care Providers in the Hospital Self-management in the Hospital Medial Nutrition Therapy in the Hospital Bedside Blood Gluose Monitoring Disharge Planning Diabetes Self-management Eduation 14. Diabetes Advoay Advoay Position Statements Professional Pratie Committee for the Standards of Medial Care in Diabetes 2015 Index This issue is freely aessible online at are.diabetesjournals.org. Keep up with the latest information for Diabetes Care and other ADA titles via Faebook (/ADAJournals) and Twitter (@ADA_Journals).

2 Diabetes Care Volume 38, Supplement 1, January 2015 S1 Introdution Diabetes Care 2015;38(Suppl. 1):S1 S2 DOI: /d15-S001 INTRODUCTION Diabetes is a omplex, hroni illness requiring ontinuous medial are with multifatorial risk-redution strategies beyond glyemi ontrol. Ongoing patient self-management eduation and support are ritial to preventing aute ompliations and reduing the risk of long-term ompliations. Signifiant evidene exists that supports a range of interventions to improve diabetes outomes. The Amerian Diabetes Assoiation s (ADA s) Standards of Medial Care in Diabetes is 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. The Standards of Care reommendations are not intended to prelude linial judgment and must be applied in the ontext of exellent linial are, with adjustments for individual preferenes, omorbidities, and other patient fators. For more detailed information about management of diabetes, please refer to Medial Management of Type 1 Diabetes (1) and Medial Management of Type 2 Diabetes (2). The reommendations inlude sreening, diagnosti, and therapeuti ations that are known or believed to favorably affet health outomes of patients with diabetes. Many of these interventionshavealsobeenshowntobeosteffetive (3). The ADA strives to improve and update the Standards of Care to ensure that liniians, health plans, and poliy makers an ontinue to rely on them as the most authoritative and urrent guidelines for diabetes are. ADA STANDARDS, STATEMENTS, AND REPORTS The ADA has been atively involved in the development and dissemination of diabetes are standards, guidelines, and related douments for over 20 years. ADA s linial pratie reommendations are viewed as important resoures for health are professionals who are for people with diabetes. ADA s Standards of Medial Care in Diabetes, position statements, and sientifi statements undergo a formal review proess by ADA s Professional Pratie Committee (PPC) and the Exeutive Committee of the Board of Diretors. The Standards and all ADA position statements, sientifi statements, and onsensus reports are available on the Assoiation s Web site at adastatements. Standards of Medial Care in Diabetes Standards of Care: ADA position statement that provides key linial pratie reommendations. The PPC performs an extensive literature searh and updates the Standards annually based on the quality of new evidene. ADA Position Statement A position statement is an offiial ADA point of view or belief that ontains linial or researh reommendations. Position statements are issued on sientifi or medial issues related to diabetes. They are published in ADA journals and other sientifi/medial publiations. ADA position statements are typially based on a systemati review or other review of published literature. Position statements undergo a formal review proess. They are updated annually or as needed. ADA Sientifi Statement A sientifi statement is an offiial ADA point of view or belief that may or may not ontain linial or researh reommendations. Sientifi statements ontain sholarly synopsis of a topi related to diabetes. Workgroup reports fall into this ategory. Sientifi statements are published in the ADA journals and other sientifi/medial publiations, as appropriate. Sientifi statements also undergo a formal review proess. Consensus Report A onsensus report ontains a omprehensive examination by an expert panel (i.e., onsensus panel) of a sientifi or medial issue related to diabetes. A onsensus report is not an ADA position and represents expert opinion only. The ategory may also inlude task fore and expert ommittee reports. The need for a onsensus report arises when liniians or sientists desire guidane on a subjet for whih the evidene is ontraditory or inomplete. A onsensus report is typially developed immediately following a onsensus onferene where the ontroversial issue is extensively disussed. The report represents the panel s olletive analysis, evaluation, and opinion at that point in time based in part on the onferene proeedings. A onsensus report does not undergo a formal ADA review proess. GRADING OF SCIENTIFIC EVIDENCE Sine the ADA first began publishing pratie guidelines, there has been onsiderable evolution in the evaluation of sientifi evidene and in the development of evidene-based guidelines. In 2002, we developed a lassifiation Standards of Medial Care in Diabetes was originally approved in Most reent review/revision: Otober 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.

3 S2 Introdution Diabetes Care Volume 38, Supplement 1, January 2015 Table 1 ADA evidene-grading system for Standards of Medial Care in Diabetes Level of evidene Desription A Clear evidene from well-onduted, generalizable randomized ontrolled trials 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 randomized ontrolled trials 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 B 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 C 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 E Expert onsensus or linial experiene reommendations have the best hane of improving outomes when applied to the population to whih they are appropriate. Reommendations with lower levels of evidene may be equally important but are not as well supported. Of ourse, evidene is only one omponent of linial deision making. Cliniians are for patients, not populations; guidelines must always be interpreted with the individual patient in mind. Individual irumstanes, suh as omorbid and oexisting diseases, age, eduation, disability, and, above all, patients values and preferenes, must 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 nuanes important in diabetes are. For example, although 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. system to grade the quality of sientifi evidene supporting ADA reommendations for all new and revised ADA position statements. A reent analysis of the evidene ited in the Standards of Care found steady improvement in quality over the past 10 years, with last year s Standards for the first time having the majority of bulleted reommendations supported by A- orb-level evidene (4). A grading system (Table 1) developed by ADA and modeled after existing methods was used to larify and odify the evidene that forms the basis for the reommendations. ADA reommendations are assigned ratings of A, B, orc, depending on the quality of evidene. Expert opinion E is a separate ategory for reommendations in whih there is 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 welldone meta-analyses. Generally, these Referenes 1. Kaufman FR (Ed.). Medial Management of Type 1 Diabetes, 6th ed. Alexandria, VA, Amerian Diabetes Assoiation, Burant CF (Ed.). Medial Management of Type 2 Diabetes, 7th ed. 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: Grant RW, Kirkman MS. Trends in the evidene level for the Amerian Diabetes Assoiation s Standards of Medial Care in Diabetes from 2005 to Diabetes Care 2015;38:6 8

4 Diabetes Care Volume 38, Supplement 1, January 2015 Professional Pratie Committee Diabetes Care 2015;38(Suppl. 1):S3 DOI: /d15-S002 The Professional Pratie Committee (PPC) of the Amerian Diabetes Assoiation (ADA) is responsible for the Standards of Medial Care in Diabetes position statement, referred to as the Standards of Care. The PPC is a multidisiplinary expert ommittee omprised of physiians, diabetes eduators, registered dietitians, and others who have expertise in a range of areas, inluding adult and pediatri endorinology, epidemiology, publi health, lipid researh, hypertension, and preoneption and pregnany are. Appointment to the PPC is based on exellene in linial pratie and/or researh. While the primary role of the PPC is to review and update the Standards of Care, it is also responsible for overseeing the review and revisions of ADA s position statements and sientifistatements. All members of the PPC are required to dislose potential onflitsofinterest with industry and/or other relevant organizations. These dislosures are disussed at the onset of eah Standards of Care revision meeting. Members of the ommittee, their employer, and their dislosed onflits of interest are listed in the Professional Pratie Committee for the Standards of Medial Care in Diabetesd2015 table (see p. S88). For the urrent revision, PPC members systematially searhed MEDLINE for human studies related to eah setion and published sine 1 January Reommendations 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 professional.diabetes.org/soc. As for all position statements, the Standards of Care position statement was reviewed andapprovedbytheexeutivecommittee 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 2015 revision of the Standards of Care. Readers who wish to omment on the Standards of Medial Care in Diabetesd2015 are invited to do so at The ADA funds development of the Standards of Care and all ADA position statements out of its general revenues and does not use industry support for these purposes. The PPC would like to thank the following individuals who provided their expertise in reviewing and/or onsulting with the ommittee: Donald R. Coustan, MD; Stephanie Dunbar, MPH, RD; Robert H. Ekel, MD; Henry N. Ginsberg, MD; Edward W. Gregg, PhD; Silvio E. Inzuhi, MD; Mark E. Molith, MD; John M. Morton, MD; Robert E. Ratner, MD; Linda M. Siminerio, RN, PhD, CDE; and Katherine R. Tuttle, MD. Members of the PPC Rihard W. Grant, MD, MPH (Chair)* Thomas W. Donner, MD Judith E. Fradkin, MD Charlotte Hayes, MMS, MS, RD, CDE, ACSM CES William H. Herman, MD, MPH William C. Hsu, MD Eileen Kim, MD Lori Laffel, MD, MPH Rodia Pop-Busui, MD, PhD Neda Rasouli, MD* Desmond Shatz, MD Joseph A. Stankaitis, MD, MPH* Traey H. Taveira, PharmD, CDOE, CVDOE Deborah J. Wexler, MD* *Subgroup leaders ADA Staff Jane L. Chiang, MD Erika Gebel Berg, PhD S3 PROFESSIONAL PRACTICE COMMITTEE 2015 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.

5 S4 Diabetes Care Volume 38, Supplement 1, January 2015 SUMMARY OF REVISIONS Standards of Medial Care in Diabetesd2015: Summary of Revisions Diabetes Care 2015;38(Suppl. 1):S4 DOI: /d15-S003 GENERAL CHANGES Diabetes Care Supplement 1 was previously alled Clinial Pratie Reommendations and inluded the Standards of Medial Care in Diabetes and key Amerian Diabetes Assoiation (ADA) position statements. The supplement has been renamed Standards of Medial Care in Diabetes ( Standards ) and ontains a single ADA position statement that provides evidene-based linial pratie reommendations for diabetes are. Whereas the Standards of Medial Care in Diabetesd2015 should still be viewed as a single doument, it has been divided into 14 setions, eah individually referened, to highlight important topi areas and to failitate navigation. The supplement now inludes an index to help readers find information on partiular topis. SECTION CHANGES Although the levels of evidene for several reommendations have been updated, these hanges are not inluded below as the linial reommendations have remained the same. Changes in evidene level from, for example, C to E are not noted below. The Standards of Medial Care in Diabetesd2015 ontains, in addition to many minor hanges that larify reommendations or reflet new evidene, the following more substantive revisions. Setion 2. Classifiation and Diagnosis of Diabetes The BMI ut point for sreening overweight or obese Asian Amerians for prediabetes and type 2 diabetes was hanged to 23 kg/m 2 (vs. 25 kg/m 2 )toreflet the evidene that this population is at an inreased risk for diabetes at lower BMI levels relative to the general population. Setion 4. Foundations of Care: Eduation, Nutrition, Physial Ativity, Smoking Cessation, Psyhosoial Care, and Immunization The physial ativity setion was revised to reflet evidene that all individuals, inluding those with diabetes, should be enouraged to limit the amount of time they spend being sedentary by breaking up extended amounts of time (.90 min) spent sitting. Due to the inreasing use of e-igarettes, the Standards were updated to make lear that e-igarettes are not supported as an alternative to smoking or to failitate smoking essation. Immunization reommendations were revised to reflet reent Centers for Disease Control and Prevention guidelines regarding PCV13 and PPSV23 vainations in older adults. Setion 6. Glyemi Targets The ADA now reommends a premeal blood gluose target of mg/dl, rather than mg/dl, to better reflet new data omparing atual average gluose levels with A1C targets. To provide additional guidane on the suessful implementation of ontinuous gluose monitoring (CGM), the Standards inlude new reommendations on assessing apatient s readiness for CGM and on providing ongoing CGM support. Setion 7. Approahes to Glyemi Treatment The type 2 diabetes management algorithm was updated to reflet all of the urrently available therapies for diabetes management. Setion 8. Cardiovasular Disease and Risk Management The reommended goal for diastoli blood pressure was hanged from 80 mmhg to 90 mmhg for most people with diabetes and hypertension to better reflet evidene from randomized linial trials. Lower diastoli targets may still be appropriate for ertain individuals. Reommendations for statin treatment and lipid monitoring were revised after onsideration of 2013 Amerian College of Cardiology/Amerian Heart Assoiation guidelines on the treatment of blood holesterol. Treatment initiation (and initial statin dose) is now driven primarily by risk status rather than LDL holesterol level. With onsideration for the new statin treatment reommendations, the Standards now provide the following lipid monitoring guidane: a sreening lipid profile is reasonable at diabetes diagnosis, at an initial medial evaluation and/or at age 40 years, and periodially thereafter. Setion 9. Mirovasular Compliations and Foot Care To better target those at high risk for foot ompliations, the Standards emphasize that all patients with insensate feet, foot deformities, or a history of foot ulers have their feet examined at every visit. Setion 11. Children and Adolesents To reflet new evidene regarding the risks and benefits of tight glyemi ontrol in hildren and adolesents with diabetes, the Standards now reommend a target A1C of,7.5% for all pediatri age-groups; however, individualization is still enouraged. Setion 12. Management of Diabetes in Pregnany This new setion was added to the Standards to provide reommendations related to pregnany and diabetes, inluding reommendations regarding preoneption ounseling, mediations, blood gluose targets, and monitoring 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.

6 Diabetes Care Volume 38, Supplement 1, January 2015 S5 1. Strategies for Improving Care Diabetes Care 2015;38(Suppl. 1):S5 S7 DOI: /d15-S004 Amerian Diabetes Assoiation Reommendations A patient-entered ommuniation style that inorporates patient preferenes, assesses literay and numeray, and addresses ultural barriers to are should be used. B Treatment deisions should be timely and founded on evidene-based guidelines that are tailored to individual patient preferenes, prognoses, and omorbidities. B 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 deision support tools to meet patient needs. B DIABETES CARE CONCEPTS In the following setions, different omponents of the linial management of patients with (or at risk for) diabetes are reviewed. We highlight the following three themes that are woven throughout these setions that liniians, poliymakers, and advoates should keep in mind: POSITION STATEMENT 1. Patient-Centeredness: Pratie reommendations, whether based on evidene or expert opinion, are intended to guide an overall approah to are. The siene and art of mediine ome together when the liniian is faed with making treatment reommendations for a patient who would not have met eligibility riteria for the studies on whih guidelines were based. Reognizing that one size does not fit all, these Standards provide guidane for when and how to adapt reommendations (e.g., see Setion 10. Older Adults and Fig Approah to the Management of Hyperglyemia). Beause patients with diabetes are also at greatly inreased risk of ardiovasular disease, a patient-entered approah should inlude a omprehensive plan to redue ardiovasular risk by addressing blood pressure and lipid ontrol, smoking essation, weight management, and healthy lifestyle hanges that inlude adequate physial ativity. 2. Diabetes Aross the Life Span: An inreasing proportion of patients with type 1 diabetes are adults. Conversely, and for less salutary reasons, the inidene of type 2 diabetes is inreasing in hildren and young adults. Finally, patients both with type 1 diabetes and with type 2 diabetes are living well into older age, a stage of life for whih there is little evidene from linial trials to guide therapy. All these demographi hanges highlight another hallenge to high-quality diabetes are, whih is the need to improve oordination between linial teams as patients pass through different stages of the life span or the stages of pregnany (preoneption, pregnany, and postpartum). 3. Advoay for Patients With Diabetes: Advoay an be defined as ative support and engagement to advane a ause or poliy. Advoay in the ause of improving the lives of patients with (or at risk for) diabetes is an ongoing need. Given the tremendous toll that lifestyle fators suh as obesity, physial inativity, and smoking have on the health of patients with diabetes, ongoing and energeti efforts are needed to address and hange the soietal determinants at the root of these problems. Within the more narrow domain of linial pratie guidelines, the appliation of evidene level grading to pratie reommendations an help identify areas that require more researh investment (1). This topi is explored in more depth in Setion 14. Diabetes Advoay. Suggested itation: Amerian Diabetes Assoiation. Strategies for improving are. Se. 1. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S5 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.

7 S6 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 CARE DELIVERY SYSTEMS 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 (2). The mean A1C nationally has delined from 7.6% in to 7.2% in based on the National Health and Nutrition Examination Survey (NHANES) data (E.W. Gregg, Centers for Disease Control and Prevention, personal ommuniation). This has been aompanied by improvements in lipids and blood pressure ontrol and has led to substantial redutions in end-stage mirovasular ompliations in patients with diabetes. Nevertheless, between 33 and 49% of patients still do not meet targets for glyemi, blood pressure, or holesterol ontrol, and only 14% meet targets for all three measures and nonsmoking status (2). Evidene also suggests that progress in ardiovasular risk fator ontrol (partiularly tobao use) may be slowing (2,3). Certain patient groups, suh as young adults and patients with omplex omorbidities, finanial or other soial hardships, and/or limited English profiieny, may present partiular hallenges to goal-based are (4 6). 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 systemlevelimprovementsindiabetesare. Chroni Care Model 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, dupliates servies, and is poorly designed for the oordinated delivery of hroni are. The CCM has been shown to be an effetive framework for improving the quality of diabetes are (7). 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 patientspeifi and population-based support to the are team), 5) ommunity resoures and poliies (identifying or developing resoures to support healthy lifestyles), and 6)healthsystems(toreateaqualityoriented ulture). Redefining the roles of the lini staff and promoting selfmanagement on the part of the patient are fundamental to the suessful implementation of the CCM (8). Collaborative, multidisiplinary teams are best suited to provide are for people with hroni onditions suh as diabetes and to failitate patients self-management (9 12). Key Objetives The National Diabetes Eduation Program (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 delineated below. Objetive 1: Optimize Provider and Team Behavior The are team should prioritize timely and appropriate intensifiation of lifestyle and/ or pharmaeutial therapy for patients who have not ahieved benefiial levels of blood pressure, lipid, or gluose ontrol (13). Strategies suh as expliit goal setting with patients (14); identifying and addressing language, numeray, or ultural barriers to are (15 18); integrating evidene-based guidelines and linial information tools into the proess of are (19 21); and inorporating are management teams inluding nurses, pharmaists, and other providers (22 24) have eah been shown to optimize provider and team behavior and thereby atalyze redutions in A1C, blood pressure, and LDL holesterol. Objetive 2: Support Patient Behavior Change Suessful diabetes are requires a systemati approah to supporting patients behavior hange efforts, inluding 1) healthy lifestyle hanges (physial ativity, healthy eating, tobao essation, weight management, and effetive oping), 2) disease self-management (taking and managing mediation and, when linially appropriate, self-monitoring of gluose and blood pressure), and 3) prevention of diabetes ompliations (self-monitoring of foot health; ative partiipation in sreening for eye, foot, and renal ompliations; and immunizations). High-quality diabetes self-management eduation (DSME) has been shown to improve patient self-management, satisfation, and gluose ontrol (25,26), as has delivery of ongoing diabetes self-management support (DSMS), so that gains ahieved during DSME are sustained (27 29). National DSME standards all for an integrated approah that inludes linial ontent and skills, behavioral strategies (goal setting, problem solving), and engagement with emotional onerns in eah needed urriulum ontent area. Objetive 3: Change the Care System An institutional priority in most suessful are systems is providing a high quality of are (30). Changes that have been shown to inrease quality of diabetes are inlude basing are on evidene-based guidelines (19); expanding the role of teams and staff and implementing more intensive disease management strategies (6,22,31); redesigning the are proess (32); implementing eletroni health reord tools (33,34); ativating and eduating patients (35,36); removing finanial barriers and reduing patient out-ofpoket osts for diabetes eduation, eye exams, self-monitoring of blood gluose, and neessary mediations (6); and identifying/developing/engaging ommunity resoures and publi poliy that support healthy lifestyles (37). Reent initiatives suh as the Patient-Centered Medial Home show promise for improving outomes through oordinated primary are and offer new opportunities for teambased hroni disease are (38). Additional strategies to improve diabetes are inlude reimbursement strutures that, in ontrast to visit-based billing, reward the provision of appropriate and high-quality are (39), and inentives that aommodate personalized are goals (6,40). It is lear that optimal diabetes management requires an organized, systemati approah and the involvement of a oordinated team of dediated health are professionals workinginanenvironment where patient-entered highquality are is a priority (6). WHEN TREATMENT GOALS ARE NOT MET Some patients and their health are providers may not ahieve the desired treatment goals. Reassessing the treatment regimen may require evaluation of

8 are.diabetesjournals.org Position Statement S7 barriers suh as inome, health literay, diabetes-related distress, depression, poverty, and ompeting demands, inluding those related to family responsibilities and dynamis. Other strategies may inlude ulturally appropriate and enhaned DSME and DSMS, omanagement with a diabetes team, referral to a medial soial worker for assistane with insurane overage, mediationtaking behavior assessment, or hange in pharmaologial therapy. Initiation of or inrease in self-monitoring of blood gluose, ontinuous gluose monitoring, frequent patient ontat, or referral to a mental health professional or physiian with speial expertise in diabetes may be useful. Referenes 1. Grant RW, Kirkman MS. Trends in the evidene level for the Amerian Diabetes Assoiation s Standards of Medial Care in Diabetes from 2005 to Diabetes Care 2015;38: Ali MK, Bullard KM, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Ahievement of goals in U.S. diabetes are, N Engl J Med 2013;368: Wang J, Geiss LS, Cheng YJ, et al. Long-term and reent progress in blood pressure levels among U.S. adults with diagnosed diabetes, Diabetes Care 2011;34: Kerr EA, Heisler M, Krein SL, et al. Beyond omorbidity ounts: how do omorbidity type and severity influene diabetes patients treatment priorities and self-management? J Gen Intern Med 2007;22: Fernandez A, Shillinger D, Warton EM, et al. Language barriers, physiian-patient language onordane, and glyemi ontrol among insured Latinos with diabetes: the Diabetes Study of Northern California (DISTANCE). J Gen Intern Med 2011;26: TRIAD Study Group. Health systems, patients fators, and quality of are for diabetes: a synthesis of findings from the TRIAD study. Diabetes Care 2010;33: Stellefson M, Dipnarine K, Stopka C. The hroni are model and diabetes management in US primary are settings: a systemati review. Prev Chroni Dis 2013;10:E26 8. Coleman K, Austin BT, Brah C, Wagner EH. Evidene on the Chroni Care Model in the new millennium. Health Aff (Millwood) 2009;28: Piatt GA, Anderson RM, Brooks MM, et al. 3- year follow-up of linial and behavioral improvements following a multifaeted diabetes are intervention: results of a randomized ontrolled trial. Diabetes Edu 2010;36: Renders CM, Valk GD, Griffin SJ, Wagner EH, Eijk Van JT, Assendelft WJ. Interventions to improve the management of diabetes in primary are, outpatient, and ommunity settings: a systemati review. Diabetes Care 2001;24: Katon WJ, Lin EHB, Von Korff M, et al. Collaborative are for patients with depression and hroni illnesses. N Engl J Med 2010;363: Parhman ML, Zeber JE, Romero RR, Pugh JA. Risk of oronary artery disease in type 2 diabetes and the delivery of are onsistent with the hroni are model in primary are settings: a STARNet study. Med Care 2007;45: Davidson MB. How our urrent medial are system fails people with diabetes: lak of timely, appropriate linial deisions. Diabetes Care 2009;32: Grant RW, Pabon-Nau L, Ross KM, Youatt EJ, Pandisio JC, Park ER. Diabetes oral mediation initiation and intensifiation: patient views ompared with urrent treatment guidelines. 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 self-management intervention for low-inome Latinos: Latinos en Control. Diabetes Care 2011;34: Osborn CY, Cavanaugh K, Wallston KA, et al. Health literay explains raial 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, Bodkin NL, Fradkin J, et al. Diabetes performane measures: urrent status and future diretions. Diabetes Care 2011;34: 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: Jaffe MG, Lee GA, Young JD, Sidney S, Go AS. Improved blood pressure ontrol assoiated with a large-sale hypertension program. JAMA 2013;310: 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. Diabetes Care 2007;30: Stone RA, Rao RH, Sevik MA, et al. Ative are management supported by home telemonitoring in veterans with type 2 diabetes: the DiaTel randomized ontrolled trial. Diabetes Care 2010;33: Dunan I, Birkmeyer C, Coughlin S, Li QE, Sherr D, Boren S. Assessing the value of diabetes eduation. Diabetes Edu 2009;35: Berikai P, Meyer PM, Kazlauskaite R, Savoy B, Kozik K, Fogelfeld L. Gain in patients knowledge of diabetes management targets is assoiated with better glyemi ontrol. Diabetes Care 2007;30: Funnell MM, Brown TL, Childs BP, et al. National standards for diabetes self-management eduation. Diabetes Care 2007;30: Klein S, Sheard NF, Pi-Sunyer X, et al. Weight management through lifestyle modifiation for the prevention and management of type 2 diabetes: rationale and strategies: a statement of the Amerian Diabetes Assoiation, the North Amerian Assoiation for the Study of Obesity, and the Amerian Soiety for Clinial Nutrition. Diabetes Care 2004;27: Norris SL, Zhang X, Avenell A, et al. Effiay of pharmaotherapy for weight loss in adults with type 2 diabetes mellitus: a meta-analysis. Arh Intern Med 2004;164: Trio AC, Ivers NM, Grimshaw JM, et al. Effetiveness of quality improvement strategies on the management of diabetes: a systemati review and meta-analysis. Lanet 2012;379: Peikes D, Chen A, Shore J, Brown R. Effets of are oordination on hospitalization, quality of are, and health are expenditures among Mediare 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: Reed M, Huang J, Graetz I, et al. Outpatient eletroni health reords and the linial are and outomes of patients with diabetes mellitus. Ann Intern Med 2012;157: Cebul RD, Love TE, Jain AK, Hebert CJ. Eletroni health reords and quality of diabetes are. N Engl J Med 2011;365: 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 ontrolledtrial.arhinternmed2008;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. Patient-entered 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:e6 40. Washington AE, Lipstein SH. The Patient- Centered Outomes Researh Instituted promoting better information, deisions, and health. N Engl J Med 2011;365:e31

9 S8 Diabetes Care Volume 38, Supplement 1, January Classifiation and Diagnosis of Diabetes Amerian Diabetes Assoiation Diabetes Care 2015;38(Suppl. 1):S8 S16 DOI: /d15-S005 CLASSIFICATION Diabetes an be lassified into the following general ategories: POSITION STATEMENT 1. Type 1 diabetes (due to b-ell destrution, usually leading to absolute insulin defiieny) 2. Type 2 diabetes (due to a progressive insulin seretory defet on the bakground of insulin resistane) 3. Gestational diabetes mellitus (GDM) (diabetes diagnosed in the seond or third trimester of pregnany that is not learly overt diabetes) 4. Speifi types of diabetes due to other auses, e.g., monogeni diabetes syndromes (suh as neonatal diabetes and maturity-onset diabetes of the young [MODY]), diseases of the exorine panreas (suh as ysti fibrosis), and drug- or hemial-indued diabetes (suh as in the treatment of HIV/AIDS or after organ transplantation) This setion reviews most ommon forms of diabetes but is not omprehensive. For additional information, see the Amerian Diabetes Assoiation (ADA) position statement Diagnosis and Classifiation of Diabetes Mellitus (1). Assigning a type of diabetes to an individual often depends on the irumstanes present at the time of diagnosis, with individuals not neessarily fitting learly into a single ategory. For example, some patients annot be learly lassified as having type 1 or type 2 diabetes. Clinial presentation and disease progression may vary onsiderably in both types of diabetes. The traditional paradigms of type 2 diabetes ourring only in adults and type 1 diabetes only in hildren are no longer aurate, as both diseases our in both ohorts. Oasionally, patients with type 2 diabetes may present with diabeti ketoaidosis (DKA). Children with type 1 diabetes typially present with the hallmark symptoms of polyuria/polydipsia and oasionally with DKA. The onset of type 1 diabetes may be variable in adults and may not present with the lassi symptoms seen in hildren. However, diffiulties in diagnosis may our in hildren, adolesents, and adults, with the true diagnosis beoming more obvious over time. DIAGNOSTIC TESTS FOR DIABETES Diabetes may be diagnosed based on A1C riteria or plasma gluose riteria, either the fasting plasma gluose (FPG) or the 2-h plasma gluose (2-h PG) value after a 75-g oral gluose tolerane test (OGTT) (1,2) (Table 2.1). The same tests are used to both sreen for and diagnose diabetes. Diabetes may be identified anywhere along the spetrum of linial senarios: in seemingly lowrisk individuals who happen to have gluose testing, in symptomati patients, and in higher-risk individuals whom the provider tests beause of a suspiion of diabetes. The same tests will also detet individuals with prediabetes. A1C The A1C 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 POC assays for diagnosti purposes may be problemati and is not reommended. The A1C has several advantages to the FPG and OGTT, inluding greater onveniene (fasting not required), greater preanalytial stability, and less day-to-day perturbations during stress and illness. These advantages must be balaned by Suggested itation: Amerian Diabetes Assoiation. Classifiation and diagnosis of diabetes. Se. 2. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S8 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.

10 are.diabetesjournals.org Position Statement S9 Table 2.1 Criteria 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 8h.* OR 2-h PG $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, a random plasma gluose $200 mg/dl (11.1 mmol/l). *In the absene of unequivoal hyperglyemia, results should be onfirmed by repeat testing. 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. It is important to take age, rae/ ethniity, and anemia/hemoglobinopathies into onsideration when using the A1C to diagnose diabetes. Age The epidemiologial studies that formed the framework for reommending A1C to diagnose diabetes only inluded adult populations. Therefore, it remains unlear if A1C and the same A1C ut point should be used to diagnose diabetes in hildren and adolesents (3 5). Rae/Ethniity A1C levels may vary with patients rae/ ethniity (6,7). For example, Afrian Amerians may have higher A1C levels than non-hispani whites despite similar fasting and postgluose load gluose levels. A reent epidemiologial study found that, when mathed for FPG, Afrian Amerians (with and without diabetes) had higher A1C levels than non- Hispani 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 (8). Hemoglobinopathies/Anemias Interpreting A1C levels in the presene of ertain hemoglobinopathies and anemia may be problemati. For patients with an abnormal hemoglobin but normal red ell turnover, suh as those with the sikle ell trait, an A1C assay without interferene from abnormal hemoglobins should be used. An updated list of interferenes is available at In onditions assoiated with inreased red ell turnover, suh as pregnany (seond and third trimesters), reent blood loss or transfusion, erythropoietin therapy, or hemolysis, only blood gluose riteria should be used to diagnose diabetes. Fasting and 2-Hour Plasma Gluose In addition to the A1C test, the FPG and 2-h PG may also be used to diagnose diabetes (Table 2.1). The onordane between the FPG and 2-h PG tests is imperfet, as is the onordane between A1C and either gluose-based test. National Health and Nutrition Examination Survey (NHANES) data indiate that an 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) (9). Numerous studies have onfirmed that, ompared with these A1C and FPG ut points, the 2-h PG value diagnoses more people with diabetes. Of note, the lower sensitivity of A1C at the designated ut point may be offset by the test s ease of use and failitation of more widespread testing. Unless there is a lear linial diagnosis (e.g., a patient in a hyperglyemi risis or with lassi symptoms of hyperglyemia and a random plasma gluose $200 mg/dl), it is reommended that the same test be repeated immediately using a new blood sample for onfirmation beause there will be a greater likelihood of onurrene. For example, if the A1C is 7.0% and a repeat result is 6.8%, the diagnosis of diabetes is onfirmed. If two different tests (suh as A1C and FPG) are both above the diagnosti threshold, this also onfirms the diagnosis. On the other hand, if a patient has disordant results from two different tests, then the test result that is above the diagnosti ut point should be repeated. The diagnosis is made on the basis of the onfirmed test. For example, if a patient meets the diabetes riterion of the A1C (two results $6.5%), but not FPG (,126 mg/dl [7.0 mmol/l]), that person should nevertheless be onsidered to have diabetes. Sine all the tests have preanalyti and analyti variability, it is possible that an abnormal result (i.e., above the diagnosti threshold), when repeated, will produe a value below the diagnosti ut point. This senario is least likely for A1C, more likely for FPG, and most likely for the 2-h PG, espeially if the gluose samples are olleted at room temperature and not entrifuged promptly. Barring laboratory error, suh patients will likely have test results near the margins of the diagnosti threshold. The health are professional should follow the patient losely and repeat the test in 3 6 months. CATEGORIES OF INCREASED RISK FOR DIABETES (PREDIABETES) Reommendations Testing to assess risk for future diabetes in asymptomati people should be onsidered in adults of any age who are overweight or obese (BMI $25 kg/m 2 or $23 kg/m 2 in Asian Amerians) and who have one or more additional risk fators for diabetes. For all patients, partiularly those who are overweight or obese, testing should begin at age 45 years. B If tests are normal, repeat testing arried out at a minimum of 3- year intervals is reasonable. C To test for prediabetes, the A1C, FPG, and 2-h PG after 75-g OGTT are appropriate. B In patients with prediabetes, identify and, if appropriate, treat other ardiovasular disease (CVD) risk fators. B Testing to detet prediabetes should be onsidered in hildren and adolesents who are overweight or obese and who have two or more additional risk fators for diabetes. E Desription In 1997 and 2003, the Expert CommitteeonDiagnosisandClassifiation of Diabetes Mellitus (10,11) reognized a group of individuals whose gluose levels did not meet the riteria for diabetes but were too high to be onsidered

11 S10 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Table 2.2 Criteria for testing for diabetes or prediabetes in asymptomati adults 1. Testing should be onsidered in all adults who are overweight (BMI $25 kg/m 2 or $23 kg/m 2 in Asian Amerians) 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. For all patients, partiularly those who are overweight or obese, testing should begin at age 45 years. 3. If results are normal, testing should be repeated at a minimum of 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. normal. Prediabetes is the term used for individuals with impaired fasting gluose (IFG) and/or impaired gluose tolerane (IGT) and indiates an inreased 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 (Table 2.2) andcvd.ifg and IGT are assoiated with obesity (espeially abdominal or viseral obesity), dyslipidemia with high triglyerides and/or low HDL holesterol, and hypertension. Diagnosis In 1997 and 2003, the Expert Committee on Diagnosis and Classifiation of Diabetes Mellitus (10,11) defined IFG as FPG levels mg/dl ( mmol/l) and IGT as 2-h PG after 75-g OGTT levels mg/dl ( mmol/l). It should be noted that the WorldHealthOrganization(WHO)and numerous diabetes organizations define the IFG utoff at 110 mg/dl (6.1 mmol/l). As 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 % had a substantially inreased risk of diabetes (5-year inidene from 9to25%).AnA1Crangeof % had a 5-year risk of developing diabetes between 25 50% and a relative risk 20 times higher ompared with an A1C of 5.0% (12). In a ommunity-based study of Afrian Amerian and non- Hispani white adults without diabetes, baseline A1C was a stronger preditor of subsequent diabetes and ardiovasular events than fasting gluose (13). Other analyses suggest that an A1C of 5.7% is assoiated with a diabetes risk similar to that of the high-risk partiipants in the Diabetes Prevention Program (DPP) (14). Hene, it is reasonable to onsider an A1C range of % as identifying individuals with prediabetes. As with those with IFG and/or IGT, individuals with an A1C of % should be informed of their inreased risk for diabetes and CVD and ounseled about effetive strategies to lower their risks (see Setion 5. Prevention or Delay of Type 2 Diabetes). Similar to gluose measurements, the ontinuum of risk is urvilinear, so as A1C rises, the diabetes risk rises disproportionately (12). Aggressive interventions and vigilant follow-up should be pursued for those onsidered at very high risk (e.g., those with A1C.6.0%). Table 2.3 summarizes the ategories of prediabetes. For reommendations regarding risk fators and sreening for prediabetes, see p. S12 ( Testing for Type 2 Diabetes and Prediabetes in Asymptomati Adults and Testing for Type 2 Diabetes and Prediabetes in Children and Adolesents ). TYPE 1 DIABETES Reommendation Inform the relatives of patients with type 1 diabetes of the opportunity to be tested for type 1 diabetes risk, but only in the setting of a linial researh study. E Immune-Mediated Diabetes This form, previously alled insulindependent diabetes or juvenile-onset diabetes, aounts for 5 10% of diabetes and is due to ellular-mediated autoimmune destrution of the panreati b-ells. Autoimmune markers inlude islet ell autoantibodies, autoantibodies to insulin, autoantibodies to GAD (GAD65), autoantibodies to the tyrosine phosphatases IA-2 and IA-2b, and autoantibodies to zin transporter 8 (ZnT8). Type 1 diabetes is defined by the presene of one or more of these autoimmune markers. The disease has strong HLA assoiations, with linkage to the DQA and DQB genes. These HLA-DR/DQ alleles an be either predisposing or protetive. Therateofb-ell destrution is quite variable, being rapid in some individuals (mainly infants and hildren) and slow in others (mainly adults). Children 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 with infetion or other stress. Adults may retain suffiient b-ell funtion 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 Table 2.3 Categories 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 PG 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.

12 are.diabetesjournals.org Position Statement S11 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 not typially obese when they present with type 1 diabetes, obesity should not prelude the diagnosis. These patients are also prone to other autoimmune disorders suh as Graves disease, Hashimoto s thyroiditis, Addison s disease, vitiligo, elia disease, autoimmune hepatitis, myasthenia gravis, and perniious anemia. Idiopathi Diabetes Some forms of type 1 diabetes have no known etiologies. 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. Testing for Type 1 Diabetes The inidene and prevalene of type 1 diabetes is inreasing (15). Type 1 diabeti patients often present with aute symptoms of diabetes and markedly elevated blood gluose levels, and some are diagnosedwithlife-threateningketoaidosis. Several studies suggest that measuring islet autoantibodies in relatives of those with type 1 diabetes may identify individuals who are at risk for developing type 1 diabetes. Suh testing, oupled with eduation about diabetes symptoms and lose follow-up in an observational linial study, may enable earlier identifiation of type 1 diabetes onset. There is evidene to suggest that early diagnosis may limit aute ompliations (16) and extend long-term endogenous insulin prodution (17). A reent study reported the risk of progression to type 1 diabetes from the time of seroonversion to autoantibody positivity in three pediatri ohorts from Finland, Germany, and the U.S. Of the 585 hildren who developed more than two autoantibodies, nearly 70% developed type 1 diabetes within 10 years and 84% within 15 years (16,18). These findings are highly signifiant beause, while the German group was reruited from offspring of parents with type 1 diabetes, the Finnish and Amerian groups were reruited from the general population. Remarkably, the findings in all three groups were the same, suggesting that the same sequene of events led to linial disease in both sporadi and geneti ases of type 1 diabetes. While there is urrently a lak of aepted sreening programs, one should onsider referring relatives of those with type 1 diabetes for antibody testing for risk assessment in the setting of a linial researh study ( Widespread linial testing of asymptomati low-risk individuals is not urrently reommended due to lak of approved therapeuti interventions. Higher-risk individuals may be tested, but only in the ontext of a linial researh setting. Individuals who test positive will be ounseled about the risk of developing diabetes, diabetes symptoms, and DKA prevention. Numerous linial studies are being onduted to test various methods of preventing type 1 diabetes in those with evidene of autoimmunity ( TYPE 2 DIABETES Reommendations Testing to detet type 2 diabetes in asymptomati people should be onsidered in adults of any age who are overweight or obese (BMI $25 kg/m 2 or $23 kg/m 2 in Asian Amerians) and who have one or more additional risk fators for diabetes. For all patients, partiularly those who are overweight or obese, testing should begin at age 45 years. B If tests are normal, repeat testing arried out at a minimum of 3-year intervals is reasonable. C To test for diabetes, the A1C, FPG, and 2-h PG after 75-g OGTT are appropriate. B In patients with diabetes, identify and, if appropriate, treat other CVD risk fators. B Testing to detet type 2 diabetes should be onsidered in hildren andadolesentswhoareoverweight or obese and who have two or more additional risk fators for diabetes. E Desription This form, previously referred to as noninsulin-dependent diabetes or adultonset diabetes, aounts for ;90 95% of all diabetes. Type 2 diabetes enompasses individuals who have insulin resistane and usually relative (rather than absolute) insulin defiieny. At least initially, and often throughout their lifetime, these individuals may not need insulin treatment to survive. There are various auses of type 2 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 known auses of diabetes. Most, but not all, patients with type 2 diabetes are obese. 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 type 2 diabetes; when seen, it usually arises in assoiation with the stress of another illness suh as infetion. Type 2 diabetes frequently goes undiagnosed for many years beause hyperglyemia develops gradually and at earlier stages is often not severe enough for the patient to notie the lassi diabetes symptoms. Nevertheless, suh patients are at an inreased risk of developing marovasular and mirovasular ompliations. Whereaspatientswithtype2diabetes may have insulin levels that appear normal or elevated, the higher blood gluose levels in these 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 type 2 diabetes inreases with age, obesity, and lak of physial ativity. It ours more frequently

13 S12 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 in women with prior GDM, in those with hypertension or dyslipidemia, and in ertain raial/ethni subgroups (Afrian Amerian, Amerian Indian, Hispani/ Latino, and Asian Amerian). It is often assoiated with a strong geneti predisposition, more so than type 1 diabetes. However, the genetis of type 2 diabetes is poorly understood. Testing for Type 2 Diabetes and Prediabetes in Asymptomati Adults Prediabetes and diabetes meet riteria for onditions in whih early detetion is appropriate. Both onditions are ommon and impose signifiant linial and publi health burdens. There is often a long presymptomati phase before the diagnosis of type 2 diabetes. Simple tests to detet prelinial disease are readily available. The duration of glyemi burden is a strong preditor of adverse outomes. There are effetive interventions that prevent progression from prediabetes to diabetes (see Setion 5. Prevention or Delay of Type 2 Diabetes) and redue the risk of diabetes ompliations (see Setion 8. Cardiovasular Disease and Risk Management and Setion 9. Mirovasular Compliations and Foot Care). Approximately one-quarter of people with diabetes in the U.S. are undiagnosed. Although sreening of asymptomati individuals to identify those with prediabetes or diabetes might seem reasonable, rigorous linial trials to prove the effetiveness of suh sreening have not been onduted and are unlikely to our. A large European randomized ontrolled trial ompared the impat of sreening for diabetes and intensive multifatorial intervention with that of sreening and routine are (19). General pratie patients between the ages of years were sreened for diabetes and randomized by pratie to intensive treatment of multiple risk fators or routine diabetes are. After 5.3 years of follow-up, CVD risk fators were modestly but signifiantly improved with intensive treatment ompared with routine are, but the inidene of first CVD events or mortality was not signifiantly different between the groups (19). The exellent are provided to patients in the routine are group and the lak of an unsreened ontrol arm limit our ability to prove that sreening and early intensive treatment impat outomes. Mathematial modeling studies suggest that sreening, beginning at age 30 or 45 years and independent of risk fators, may be ost-effetive (,$11,000 per qualityadjusted life-year gained) (20). Additional onsiderations regarding testing for type 2 diabetes and prediabetes in asymptomati patients inlude the following: Age Testing reommendations for diabetes in asymptomati adults are listed in Table 2.2. Age is a major risk fator for diabetes. Testing should begin at age 45 years for all patients, partiularly those who are overweight or obese. BMI and Ethniity Testingshouldbeonsideredinadults of any age with BMI $25 kg/m 2 and one or more additional risk fators for diabetes. However, reent data (21) and evidene from the ADA position statement BMI Cut Points to Identify At-Risk Asian Amerians for Type 2 Diabetes Sreening (22)suggestthattheBMI ut point should be lower for the Asian Amerian population. For diabetes sreening purposes, the BMI ut points fall onsistently between kg/m 2 (sensitivity of 80%) for nearly all Asian Amerian subgroups (with levels slightly lower for Japanese Amerians). This makes a rounded ut point of 23 kg/m 2 pratial. In determining a single BMI ut point, it is important to balane sensitivity and speifiity so as to provide a valuable sreening tool without numerous false positives. An argument an be made to push the BMI ut point to lower than 23 kg/m 2 in favor of inreased sensitivity; however, this would lead to an unaeptably low speifiity (13.1%). Data from the WHO also suggest that a BMI $23 kg/m 2 should be used to define inreased risk in Asian Amerians (23). Evidene also suggests that other populations may benefit fromlower BMI ut points. For example, in a large multiethni ohort study, for an equivalent inidene rate of diabetes, a BMI of 30 kg/m 2 in non-hispani whites was equivalent to a BMI of 26 kg/m 2 in Afrian Amerians (24). Mediations Certain mediations, suh as gluoortioids, thiazide diuretis, and atypial antipsyhotis (25), are known to inrease the risk of diabetes and should be onsidered when asertaining a diagnosis. Diagnosti Tests The A1C, FPG, and 2-h PG after 75-g 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 (26 32) has primarily been demonstrated among individuals with IGT, not for individuals with isolated IFG or for those with prediabetes defined by A1C riteria. Testing Interval The appropriate interval between tests is not known (33). The rationale for the 3-year interval is that with this interval, the number of false-positive tests that require onfirmatory testing will be redued and individuals with false-negative tests will be retested before substantial time elapses and ompliations develop (33). Community Sreening Ideally, testing should be arried out within a health are setting beause of the need for follow-up and treatment. Community testing outside a health are setting is not reommended beause people with positive tests may not seek, or have aess to, appropriate follow-up testing and are. Community testing may also be poorly targeted; i.e., it may fail to reah the groups most at risk and inappropriately test those at very low risk or even those who have already been diagnosed. Testing for Type 2 Diabetes and Prediabetes in Children and Adolesents In the last deade, the inidene and prevalene of type 2 diabetes in adolesents has inreased dramatially, espeially in ethni populations (15). Reent studies question the validity of A1C in the pediatri population, espeially among ertain ethniities, and suggest OGTT or FPG as more suitable diagnosti tests (34). However, many of these studies do not reognize that diabetes diagnosti riteria are based on longterm health outomes, and validations are not urrently available in the pediatri population (35). The ADA aknowledges the limited data supporting A1C for diagnosing diabetes in hildren and adolesents. However, aside from rare instanes, suh as ysti fibrosis and hemoglobinopathies, the ADA ontinues to reommend A1C in this ohort (36,37). The modified reommendations of the ADA onsensus report Type 2 Diabetes in Children and Adolesents are summarized in Table 2.4.

14 are.diabetesjournals.org Position Statement S13 Table 2.4 Testing for type 2 diabetes or prediabetes 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 smallfor-gestational-age 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. GESTATIONAL DIABETES MELLITUS Reommendations Test for undiagnosed type 2 diabetes at the first prenatal visit in those with risk fators, using standard diagnosti riteria. B Test for GDM at weeks of gestation in pregnant women not previously known to have diabetes. A Sreen women with GDM for persistent diabetes at 6 12 weeks postpartum, using the OGTT and linially appropriate nonpregnany diagnosti riteria. E WomenwithahistoryofGDM should have lifelong sreening for the development of diabetes or prediabetes at least every 3 years. B WomenwithahistoryofGDM found to have prediabetes should reeive lifestyle interventions or metformin to prevent diabetes. A Definition For many years, GDM was defined as any degree of gluose intolerane that was first reognized during pregnany (10), regardless of whether the ondition may have predated the pregnany or persisted after the pregnany. This definition failitated a uniform strategy for detetion and lassifiation of GDM, but it was limited by impreision. The ongoing epidemi of obesity and diabetes has led to more type 2 diabetes in women of hildbearing age, resulting in an inrease in the number of pregnant women with undiagnosed type 2 diabetes (38). Beause of the number of pregnant women with undiagnosed type 2 diabetes, it is reasonable to test women with risk fators for type 2 diabetes (Table 2.2) at their initial prenatal visit, using standard diagnosti riteria (Table 2.1). Women with diabetes in the first trimester would be lassified as having type 2 diabetes. GDM is diabetes diagnosed in the seond or third trimester of pregnany that is not learly overt diabetes. Diagnosis GDM arries risks for the mother and neonate. Not all adverse outomes are of equal linial importane. The Hyperglyemia and Adverse Pregnany Outome (HAPO) study (39), a large-sale (;25,000 pregnant women) multinational ohort 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. GDM diagnosis (Table 2.5) an be aomplished with either of two strategies: 1. One-step 75-g OGTT or 2. Two-step approah with a 50-g (nonfasting) sreen followed by a 100-g OGTT for those who sreen positive Different diagnosti riteria will identify different degrees of maternal hyperglyemia and maternal/fetal risk, leading some experts to debate, and disagree on, optimal strategies for the diagnosis of GDM. One-Step Strategy In the 2011 Standards of Care (40), the ADA for the first time reommended that all pregnant women not known to have prior diabetes undergo a 75-g OGTT at weeks of gestation, basedonareommendationoftheinternational Assoiation of the Diabetes and Pregnany Study Groups (IADPSG) (41). The IADPSG defined diagnosti ut points for GDM as the average gluose values (fasting, 1-h, and 2-h PG) in the HAPO study at whih odds for adverse outomes reahed 1.75 times the estimated odds of these outomes at the mean gluose levels of the study population. This one-step strategy was antiipated to signifiantly inrease the inidene of GDM (from 5 6% to ;15 20%), primarily beause only one abnormal value, not two, beame suffiient to make the diagnosis. The ADA reognized that the antiipated inrease in the inidene of GDM would have signifiant impat on the osts, medial infrastruture apaity, and potential for inreased medialization of pregnanies previously ategorized as normal, but reommended these diagnosti riteria hanges in the ontext of worrisome worldwide inreases in obesity and diabetes rates with the intent of optimizing gestational outomes for women and their offspring. The expeted benefits to these pregnanies and offspring are inferred from intervention trials that foused on women with lower levels of hyperglyemia than identified using older GDM diagnosti riteria and that found modest benefits inluding redued rates of largefor-gestational-age births and preelampsia (42,43). It is important to note that 80 90% of women being treated for mild GDM in two randomized ontrolled trials (whose gluose values overlapped with the thresholds reommended by the IADPSG) ould be managed with lifestyle therapy alone. Data are laking on how the treatment of lower levels of hyperglyemia affets a mother s risk for the development of type 2 diabetes in the future and her offspring s riskfor obesity, diabetes, and other metaboli dysfuntion. Additional well-designed linial studies are needed to determine the optimal intensity of monitoring and treatment of women with GDM diagnosed by the one-step strategy. Two-Step Strategy In 2013, the National Institutes of Health (NIH) onvened a onsensus development onferene on diagnosing GDM. The 15-member panel had representatives from obstetris/gyneology, maternalfetal mediine, pediatris, diabetes researh, biostatistis, and other related fields to onsider diagnosti riteria (44). The panel reommended the two-step approah of sreening with a 1-h 50-g

15 S14 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Table 2.5 Sreening for and diagnosis of GDM One-step strategy Perform a 75-g OGTT, with plasma gluose measurement when patient is fasting and at 1 and 2h,at24 28 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 met or exeeded: Fasting: 92 mg/dl (5.1 mmol/l) 1 h: 180 mg/dl (10.0 mmol/l) 2 h: 153 mg/dl (8.5 mmol/l) Two-step strategy Step 1: Perform a 50-g GLT (nonfasting), with plasma gluose measurement at 1 h, at weeks of gestation in women not previously diagnosed with overt diabetes. If the plasma gluose level measured 1 h after the load is $140 mg/dl* (7.8 mmol/l), proeed to a 100-g OGTT. Step 2: The 100-g OGTT should be performed when the patient is fasting. The diagnosis of GDM is made if at least two of the following four plasma gluose levels (measured fasting and 1 h, 2 h, 3 h after the OGTT) are met or exeeded: Carpenter/Coustan (56) or NDDG (57) Fasting 95 mg/dl (5.3 mmol/l) 105 mg/dl (5.8 mmol/l) 1 h 180 mg/dl (10.0 mmol/l) 190 mg/dl (10.6 mmol/l) 2 h 155 mg/dl (8.6 mmol/l) 165 mg/dl (9.2 mmol/l) 3 h 140 mg/dl (7.8 mmol/l) 145 mg/dl (8.0 mmol/l) NDDG, National Diabetes Data Group. *The ACOG reommends a lower threshold of 135 mg/dl (7.5 mmol/l) in high-risk ethni populations with higher prevalene of GDM; some experts also reommend 130 mg/dl (7.2 mmol/l). gluose load test (GLT) followed by a 3-h 100-g OGTT for those who sreen positive, a strategy ommonly used in the U.S. Key fators reported in the NIH panel s deision-making proess were the lak of linial trial interventions demonstrating the benefits of the one-step strategy and the potential negative onsequenes of identifying a large new group of women with GDM, inluding medialization of pregnany with inreased interventions and osts. Moreover, sreening with a 50-g GLT does not require fasting and is therefore easier to aomplish for many women. Treatment of higher threshold maternal hyperglyemia, as identified by the two-step approah, redues rates of neonatal marosomia, large-for-gestational-age births, and shoulder dystoia, without inreasing small-for-gestational-age births (45). The Amerian College of Obstetriians and Gyneologists (ACOG) updated its guidelines in 2013 and supported the two-step approah (46). Future Considerations The onfliting reommendations from expert groups undersore the fat that there are data to support eah strategy. The deision of whih strategy to implement must therefore be made based on the relative values plaed on fators thathaveyettobemeasured(e.g.,ostbenefit estimation, willingness to hange pratie based on orrelation studies rather than linial intervention trial results, relative role of ost onsiderations, and available infrastruture loally, nationally, and internationally). As the IADPSG riteria have been adopted internationally, further evidene has emerged to support improved pregnany outomes with ost savings (47) and may be the preferred approah. In addition, pregnanies ompliated by GDM per IADPSG riteria, but not reognized as suh, have omparable outomes to pregnanies diagnosed as GDM by the more stringent two-step riteria (48). There remains strong onsensus that establishing a uniform approah to diagnosing GDM will benefit patients, aregivers, and poliymakers. Longer-term outome studies are urrently underway. MONOGENIC DIABETES SYNDROMES Monogeni defets that ause b-ell dysfuntion, suh as neonatal diabetes and MODY, represent a small fration of patients with diabetes (,5%). These forms of diabetes are frequently haraterized by onset of hyperglyemia at an early age (generally before age 25 years). Neonatal Diabetes 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. Maturity-Onset Diabetes of the Young MODY is haraterized by impaired insulin seretion with minimal or no defets in insulin ation. It is 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. The less ommon forms of MODY result from mutations in other transription fators, inluding HNF-4a,HNF-1b, insulin promoter fator (IPF)-1, and NeuroD1. Diagnosis Readily available ommerial geneti testing now enables a true geneti diagnosis. It is important to orretly diagnose one of the monogeni forms of diabetes beause these hildren may be inorretly diagnosed with type 1 or type 2 diabetes, leading to suboptimal treatment regimens and delays in diagnosing other family members (49). The diagnosis of monogeni diabetes should be onsidered in hildren with the following findings: Diabetes diagnosed within the first 6 months of life Strong family history of diabetes but without typial features of type 2 diabetes (nonobese, low-risk ethni group)

16 are.diabetesjournals.org Position Statement S15 Mild fasting hyperglyemia ( mg/dl [ mmol/l]), espeially if young and nonobese Diabetes with negative autoantibodies and without signs of obesity or insulin resistane CYSTIC 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 A1C as a sreening test for CFRD is not reommended. B Patients with CFRD should be treated with insulin to attain individualized glyemi goals. A In patients with ysti fibrosis and IGT without onfirmed diabetes, prandial insulin therapy should be onsidered to maintain weight. B Annual monitoring for ompliations of diabetes is reommended, beginning 5 years after the diagnosis of CFRD. E CFRD is the most ommon omorbidity in people with ysti fibrosis, ourring in about 20% of adolesents and 40 50% of adults. 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. While sreening for diabetes before the age of 10 years an identify risk for progression to CFRD in those with abnormal gluose tolerane, there appears to be no benefit withrespet to weight, height, BMI, or lung funtion ompared with those with normal gluose tolerane,10 years of age. The use of ontinuous gluose monitoring may be more sensitive than OGTT to detet risk for progression to CFRD, but this likely needs more evidene. Enouraging data suggest that improved sreening (50,51) and aggressive insulin therapy have narrowed the gap in mortality between ysti fibrosis patients with and without diabetes and have eliminatedthesexdiffereneinmortality(52). Reent trials omparing insulin with oral repaglinide showed no signifiant differene between the groups. However, another study ompared three different groups: premeal insulin aspart, repaglinide, or oral plaebo in ysti fibrosis patients with abnormal gluose tolerane. Patients all had weight loss; however, in the insulin-treated group, this pattern was reversed, and they gained 0.39 (6 0.21) BMI units (P ). Patients in the repaglinide-treated group had initial weight gain, but this was not sustained by 6 months. The plaebo group ontinued to lose weight (53). Insulin remains the most widely used therapy for CFRD (54). Reommendations for the linial management of CFRD an be found in the ADA position statement 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 (55). Referenes 1. Amerian Diabetes Assoiation. Diagnosis and lassifiation of diabetes mellitus. Diabetes Care 2014;37(Suppl. 1):S81 S90 2. The International Expert Committee. International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care 2009;32: 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: Garía de Guadiana Romualdo L, González Morales M, Albaladejo Otón MD, et al. 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17 S16 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 assessing diabetes risk. Diabetes Care 2011;34: Erikson SC, Le L, Zakharyan A, et al. Newonset 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: 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 X-R, Li G-W, Hu Y-H, 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 b-ell funtion and prevention of type 2 diabetes by pharmaologial treatment of insulin resistane in high-risk Hispani women. Diabetes 2002;51: Chiasson J-L, 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: 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: JohnsonSL,TabaeiBP,HermanWH.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: Buse JB, Kaufman FR, Linder B, Hirst K, El Ghormli L, Willi S; HEALTHY Study Group. Diabetes sreening with hemoglobin A(1) versus fasting plasma gluose in a multiethni middle-shool ohort. Diabetes Care 2013;36: Kapadia C, Zeitler P; Drugs and Therapeutis Committee of the Pediatri Endorine Soiety. Hemoglobin A1 measurement for the diagnosis of type 2 diabetes in hildren. Int J Pediatr Endorinol 2012;2012: Kester LM, Hey H, Hannon TS. Using hemoglobin A1 for prediabetes and diabetes diagnosis in adolesents: an adult reommendations be upheld for pediatri use? J Adoles Health 2012;50: Wu E-L, Kazzi NG, Lee JM. Cost-effetiveness of sreening strategies for identifying pediatri diabetes mellitus and dysglyemia. JAMA Pediatr 2013;167: Lawrene JM, Contreras R, Chen W, Saks DA. 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Diabetes Care 2014;37: Ethridge JK Jr, Catalano PM, Waters TP. Perinatal outomes assoiated with the diagnosis of gestational diabetes made by the International Assoiation of the Diabetes and Pregnany Study Groups riteria. Obstet Gyneol 2014;124: Hattersley A, Bruining J, Shield J, Njolstad P, Donaghue KC. The diagnosis and management of monogeni diabetes in hildren and adolesents. Pediatr Diabetes 2009;10(Suppl. 12): Kern AS, Prestridge AL. Improving sreening for ysti fibrosis-related diabetes at a pediatri ysti fibrosis program. Pediatris 2013;132: e512 e Waugh N, Royle P, Craigie I, et al. Sreening for ysti fibrosis-related diabetes: a systemati review. Health Tehnol Assess 2012; 16:iii iv, Moran A, Dunitz J, Nathan B, Saeed A, Holme B, Thomas W. Cysti fibrosis-related diabetes: urrent trends in prevalene, inidene, and mortality. Diabetes Care 2009;32: MoranA,PekowP,GroverP,etal.;Cysti Fibrosis Related Diabetes Therapy Study Group. Insulin therapy to improve BMI in ysti fibrosisrelated diabetes without fasting hyperglyemia: results of the ysti fibrosis related diabetes therapy trial. Diabetes Care 2009;32: Onady GM, Stolfi A. Insulin and oral agents for managing ysti fibrosis-related diabetes. Cohrane Database Syst Rev 2013;7: CD Moran A, Brunzell C, Cohen RC, et al.; CFRD Guidelines Committee. Clinial are guidelines for ysti fibrosis-related diabetes: a position statement of the Amerian Diabetes Assoiation and a linial pratie guideline of the Cysti Fibrosis Foundation, endorsed by the Pediatri Endorine Soiety. Diabetes Care 2010;33: Carpenter MW, Coustan DR. Criteria for sreening tests for gestational diabetes. Am J Obstet Gyneol 1982;144: National Diabetes Data Group. Classifiation and diagnosis of diabetes mellitus and other ategories of gluose intolerane. Diabetes 1979;28:

18 Diabetes Care Volume 38, Supplement 1, January 2015 S17 3. Initial Evaluation and Diabetes Management Planning Amerian Diabetes Assoiation Diabetes Care 2015;38(Suppl. 1):S17 S19 DOI: /d15-S006 MEDICAL EVALUATION Reommendation Consider sreening those with type 1 diabetes for autoimmune diseases (e.g., thyroid dysfuntion, elia disease) as appropriate. E A omplete medial evaluation should be performed at the initial visit to 1. Classify diabetes 2. Detet diabetes ompliations 3. Review previous treatment and risk fator ontrol in patients with established diabetes 4. Assist in formulating a management plan 5. Provide a basis for ontinuing are Laboratory tests appropriate to the evaluation of eah patient s medial ondition should be ompleted. A fous on the omponents of omprehensive are (Table 3.1) will enable the health are team to optimally manage the patient with diabetes. Adults who develop type 1 diabetes an develop additional autoimmune disorders, although their risk is lower than that in hildren and adolesents with type 1 diabetes. For additional details on autoimmune onditions, see Setion 11. Children and Adolesents. POSITION STATEMENT MANAGEMENT PLAN People with diabetes should reeive medial are from a ollaborative, integrated team with expertise in diabetes. This team may inlude physiians, nurse pratitioners, physiian s assistants, nurses, dietitians, pharmaists, and mental health professionals. Individuals with diabetes must also assume an ative role in their are. The management plan should be written with input from the patient and family, the physiian, and other members of the health are team. Diabetes self-management eduation (DSME) and ongoing diabetes support should be integral omponents of the management plan. Various strategies and tehniques should be used to enable patients to self-manage diabetes, inluding providing eduation on problem-solving skills for all aspets of diabetes management. Treatment goals and plans should be individualized and take patient preferenes into aount. In developing the plan, onsideration should be given to the patient s age, shool/work shedule and onditions, physial ativity, eating patterns, soial situation, ultural fators, presene of diabetes ompliations, health priorities, and other medial onditions. COMMON COMORBID CONDITIONS Reommendation Consider assessing for and addressing ommon omorbid onditions (e.g., depression, obstrutive sleep apnea) that may ompliate diabetes management. B Improved disease prevention and treatment effiay means that patients with diabetes are living longer, often with multiple omorbidities requiring ompliated medial regimens (1). Obesity, hypertension, and dyslipidemia are the most ommonly appreiated omorbidities. However, onurrent onditions, suh as heart Suggested itation: Amerian Diabetes Assoiation. Initial evaluation and diabetes management planning. Se. 3. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38 (Suppl. 1):S17 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.

19 S18 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Table 3.1 Components 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 Presene of ommon omorbidities, psyhosoial problems, and dental disease 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: oronary heart disease, erebrovasular disease, and peripheral arterial 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 3 months If not performed/available within past year Fasting lipid profile, inluding total, LDL, and HDL holesterol and triglyerides, as needed Liver funtion tests Test for urine albumin exretion with spot urine albumin-to-reatinine ratio Serum reatinine and alulated glomerular filtration rate 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 medial nutrition therapy DSME/DSMS Dentist for omprehensive periodontal examination Mental health professional, if needed DKA, diabeti ketoaidosis; DSMS, diabetes self-management support; TSH, thyroid-stimulating hormone. failure, depression, anxiety, and arthritis, are found at higher rates in people with diabetes than in age-mathed people without diabetes and often ompliate diabetes management. These onurrent onditions present linial hallenges relatedtopolypharmay,prevalent symptoms, and omplexity of are (2 5). Depression As disussed in Setion 4. Foundations of Care, depression, anxiety, and other mental health symptoms are highly prevalent in people with diabetes and are assoiated with worse outomes. Obstrutive Sleep Apnea Age-adjusted rates of obstrutive sleep apnea, a risk fator for ardiovasular disease, are signifiantly higher (4- to 10-fold) with obesity, espeially with entral obesity, in men and women (6). The prevalene in general populations with type 2 diabetes may be up to 23% (7) and in obese partiipants enrolled in the Look AHEAD trial exeeded 80% (8). Treatment of sleep apnea signifiantly improves quality of life and blood pressure ontrol. The evidene for a treatment effet on glyemi ontrol is mixed (9). Fatty Liver Disease Unexplained elevations of hepati transaminase onentrations are signifiantly assoiated with higher BMI, waist irumferene, triglyerides, and fasting insulin and with lower HDL holesterol. In a prospetive analysis, diabetes was signifiantly assoiated with inident nonaloholi hroni liver disease and with hepatoellular arinoma (10). Interventions that improve metaboli abnormalities in patients with diabetes (weight loss, glyemi ontrol, and treatment with speifi drugs for hyperglyemia or dyslipidemia) are also benefiial for fatty liver disease (11). Caner Diabetes (possibly only type 2 diabetes) is assoiated with inreased risk of aners of the liver, panreas, endometrium, olon/retum, breast, and bladder (12). The assoiation may result from shared risk fators between type 2 diabetes and aner (obesity, older age, and physial inativity), but may also be due to hyperinsulinemia or hyperglyemia (13). Patients with diabetes should be enouraged to undergo reommended age- and sex-appropriate aner sreenings and to redue their modifiable aner risk fators (obesity, smoking, and physial inativity). Fratures Age-mathed hip frature risk is signifiantlyinreasedinbothtype1(summary relative risk [RR] 6.3) and type 2 diabetes (summary RR 1.7) in both sexes (14). 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) (15). 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 partiipants with diabetes ompared with those without diabetes for a given T sore and age or for a given FRAX sore (16). 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. Prevention strategies are the same as for the general population. For type 2 diabeti patients with frature risk fators, avoiding thiazolidinediones is warranted.

20 are.diabetesjournals.org Position Statement S19 Cognitive Impairment Diabetes is assoiated with a signifiantly inreased risk, and rate, of ognitive deline and with inreased risk of dementia (17,18). In a 15-year prospetive study of ommunity-dwelling people over the age of 60 years, the presene of diabetes at baseline signifiantly inreased the age- and sexadjusted inidene of all-ause dementia, Alzheimer disease, and vasular dementiaomparedwithratesinthosewith normal gluose tolerane (19). In a substudy of the Ation to Control Cardiovasular Risk in Diabetes (ACCORD) linial trial, 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, as measured by MRI, in partiipants in the intensive arm (20). The effets of hyperglyemia and insulin on the brain are areas of intense researh interest. Low Testosterone in Men Mean levels of testosterone are lower in menwithdiabetesomparedwithagemathed men without diabetes, but obesity is a major onfounder (21). Treatment in asymptomati men is ontroversial. The evidene that testosterone replaement affets outomes is mixed, and reent guidelines suggest that testing and treating men without symptoms are not reommended (22). Periodontal Disease Periodontal disease is more severe, but not neessarily more prevalent, in patients with diabetes than in those without (23). Current evidene suggests that periodontal disease adversely affets diabetes outomes, although evidene for treatment benefits remains ontroversial (5). Hearing Impairment Hearing impairment, both in high frequeny and low/mid frequeny ranges, is more ommon in people with diabetes than in those without, perhaps due to neuropathy and/or vasular disease. In a National Health and Nutrition Examination Survey (NHANES) analysis, hearing impairment was about twie as prevalent in people with diabetes ompared with those without, after adjusting for age and other risk fators for hearing impairment (24). Referenes 1. Selvin E, Coresh J, Branati FL. The burden and treatment of diabetes in elderly individuals in the U.S. Diabetes Care 2006;29: Grant RW, Ashburner JM, Hong CS, Chang Y, Barry MJ, Atlas SJ. Defining patient omplexity from the primary are physiian s perspetive: a ohort study. Ann Intern Med 2011;155: Tinetti ME, Fried TR, Boyd CM. Designing health are for the most ommon hroni onditiondmultimorbidity. JAMA 2012;307: Sudore RL, Karter AJ, Huang ES, et al. Symptom burden of adults with type 2 diabetes aross the disease ourse: Diabetes & Aging Study. J Gen Intern Med 2012;27: Borgnakke WS, Ylöstalo PV, Taylor GW, Geno RJ. Effet of periodontal disease on diabetes: systemati review of epidemiologi observational evidene. J Periodontol 2013; 84(Suppl.):S135 S Li C, Ford ES, Zhao G, Croft JB, Balluz LS, Mokdad AH. Prevalene of self-reported 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 KGMM, Zimmet PZ; International Diabetes Federation Taskfore on Epidemiology and Prevention. 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: 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: 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: 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 diabetesd systemati overview of prospetive observational studies. Diabetologia 2005;48: Biessels GJ, Staekenborg S, Brunner E, Brayne C, Sheltens P. Risk of dementia in diabetes mellitus: a systemati review. Lanet Neurol 2006;5: Ohara T, Doi Y, Ninomiya T, et al. Gluose tolerane status and risk of dementia in the ommunity: the Hisayama study. Neurology 2011;77: Launer LJ, Miller ME, Williamson JD, et al.; ACCORD MIND investigators. Effets of intensive gluose lowering on brain struture and funtion in people with type 2 diabetes (ACCORD MIND): a randomised open-label substudy. Lanet Neurol 2011;10: 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 metaanalysis. J Diabetes Compliations 2006;20: 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;149:1 10

21 S20 Diabetes Care Volume 38, Supplement 1, January Foundations of Care: Eduation, Nutrition, Physial Ativity, Smoking Cessation, Psyhosoial Care, and Immunization Diabetes Care 2015;38(Suppl. 1):S20 S30 DOI: /d15-S007 Amerian Diabetes Assoiation POSITION STATEMENT DIABETES SELF-MANAGEMENT EDUCATION AND SUPPORT Reommendations People with diabetes should reeive diabetes self-management eduation (DSME) and diabetes self-management support (DSMS) aording to the national standards for DSME and DSMS 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, as 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 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 (1). DSME and DSMS are essential elements of diabetes are (2,3), and the urrent national standards for DSME and DSMS (1) are based on evidene of their 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 as treatment advanes beome available. DSME enables patients (inluding youth) to optimize metaboli ontrol, prevent and manage ompliations, and maximize quality of life in a ost-effetive manner (2,4). Current best pratie of DSME is a skill-based approah that fouses on helping those with diabetes make informed self-management hoies (1,2). DSME has hanged from a didati approah fousing on providing information to empowerment models that fous on helping those with diabetes make informed selfmanagement deisions (2). Diabetes are 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. Patient-entered are is respetful of and responsive to individual patient preferenes, needs, and values and ensures that patient values guide all deision making (5). Evidene for the Benefits Multiple studies have found that DSME is assoiated with improved diabetes knowledge, improved self-are behavior (1), improved linial outomes, suh as lower Suggested itation: Amerian Diabetes Assoiation. Foundations of are: eduation, nutrition, physial ativity, smoking essation, psyhosoial are, and immunization. Se. 4. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S20 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.

22 are.diabetesjournals.org Position Statement S21 A1C (3,6 8), lower self-reported weight (9,10), improved quality of life (8,11), healthy oping (12,13), and lower osts (14,15). Better outomes were reported for DSME interventions that were longer and inluded follow-up support (DSMS) (16 18), that were ulturally (19,20) and age appropriate (21,22), that were tailoredtoindividualneedsandpreferenes, and that addressed psyhosoial issues and inorporated behavioral strategies (2,12,23,24). Both individual and group approahes have been found effetive (10,25). There is growing evidene for the role of ommunity health workers (26), as well as peer (27 30) and lay leaders (31), in delivering DSME and DSMS (32). Diabetes eduation is assoiated with inreased use of primary and preventive servies (14,33,34) and lower use of aute, inpatient hospital servies (14). 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 insurane laim osts (15,33). National Standards The national standards for DSME and DSMSaredesignedtodefine quality and to assist diabetes eduators in a variety of settings to provide evidenebased eduation and self-management support (1). The standards are reviewed and updated every 5 years by a task fore representing key organizations involved in diabetes eduation and are. Reimbursement DSME, when provided by a program that meets national standards for DSME and is reognized by the Amerian Diabetes Assoiation (ADA) or other approval bodies, is reimbursed as part of the Mediare program as overseen by the Centers for Mediare & Mediaid Servies. DSME is also overed by most health insurane plans. Although DSMS has been shown to be instrumental for improving outomes and an be provided via phone alls and telehealth, it urrently has limited reimbursement as in-person follow-up to DSME. MEDICAL NUTRITION THERAPY For many individuals with diabetes, the most hallenging part of the treatment plan is determining what to eat. It is the position of the ADA that there is not a one-size-fits-all eating pattern for individuals with diabetes. The ADA also reognizes the integral role of nutrition therapy in overall diabetes management and reommends that eah personwithdiabetesbeativelyengaged in self-management, eduation, and treatment planning with his or her health are provider, whih inludes the ollaborative development of an individualized eating plan (35,36). Therefore, it is important that all members of the health are team be knowledgeable about diabetes nutrition therapy and support its implementation. See Table 4.1 for speifi nutrition reommendations. Goals of Nutrition Therapy for Adults With Diabetes 1. To promote and support healthful eating patterns, emphasizing a variety of nutrient-dense foods in appropriate portion sizes, in order to improve overall health and speifially to Attain individualized glyemi, blood pressure, and lipid goals Ahieve and maintain body weight goals Delay or prevent ompliations of diabetes 2. To address individual nutrition needs based on personal and ultural preferenes, health literay and numeray, aess to healthful food hoies, willingness and ability to make behavioral hanges, and barriers to hange. 3. To maintain the pleasure of eating by providing positive messages about food hoies while limiting food hoies only when indiated by sientifi evidene. 4. To provide the individual with diabetes with pratial tools for day-to-day meal planning rather than fousing on individual maronutrients, mironutrients, or single foods. Nutrition therapy is an integral omponent of diabetes prevention, management, and self-management eduation. All individuals with diabetes should reeive individualized medial nutrition therapy (MNT), preferably provided by a registered dietitian who is knowledgeable and skilled in providing diabetes MNT. Comprehensive group diabetes eduation programs inluding nutrition therapy or individualized eduation sessions have reported A1C dereases of 0.3 1% for type 1 diabetes (37 41) and 0.5 2% for type 2 diabetes (42 49). Carbohydrate Management Individuals with type 1 diabetes should be offered intensive insulin therapy eduation using the arbohydrateounting meal planning approah (37,39,40,43,50), whih has been shown to improve glyemi ontrol (50,51). Consistent arbohydrate intake with respet to time and amount an result in improved glyemi ontrol for individuals using fixed daily insulin doses (36). A simple diabetes meal planning approah, suh as portion ontrol or healthful food hoies, may be better suited for individuals with health literay and numeray onerns (36 40,42). Weight Loss Intensive lifestyle programs with frequent follow-up are required to ahieve signifiant redutions in exess body weight and improve linial indiators (52,53). Weight loss of 2 8 kg may provide linial benefits in those with type 2 diabetes, espeially early in the disease proess (52,53). Although several studies resulted in improvements in A1C at 1 year (52,54 56), not all weight-loss interventions led to 1-year A1C improvements (45,57 60). The most onsistently identified hanges in ardiovasular risk fators were an inrease in HDL holesterol (52,54,56,59,61), derease in triglyerides (52,61 63), and derease in blood pressure (52,54,57,59,61). Weight-loss studies have used a variety of energy-restrited eating patterns, with no lear evidene that one eating pattern or optimal maronutrient distribution was ideal, suggesting that maronutrient proportions should be individualized (64). Studies show that people with diabetes eat on average about 45% of their alories from arbohydrates, ;36 40% of alories from fat, and ;16 18% from protein (57 59). A variety of eating patterns have been showntobeeffetiveinmanagingdiabetes, inluding Mediterranean-style (53,65), Dietary Approahes to Stop Hypertension (DASH)-style (66), and plant-based (vegan or vegetarian) (67), lower-fat (68), and lower-arbohydrate patterns (68).

23 S22 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Table 4.1 Nutrition therapy reommendations Topi Reommendations Evidene rating Effetiveness of nutrition therapy Nutrition therapy is reommended for all people with type 1 and type 2 A diabetes as an effetive omponent of the overall treatment plan. Individuals who have diabetes should reeive individualized MNT to A ahieve treatment goals, preferably provided by a registered dietitian familiar with the omponents of diabetes MNT. For individuals with type 1 diabetes, partiipation in an intensive, flexible A insulin therapy eduation program using the arbohydrate-ounting meal planning approah an result in improved glyemi ontrol. For individuals using fixed daily insulin doses, onsistent arbohydrate B intake with respet to time and amount an result in improved glyemi ontrol and redue hypoglyemia risk. A simple diabetes meal planning approah, suh as portion ontrol or C healthful food hoies, may be better suited to individuals with type 2 diabetes with health and numeray literay onerns. This strategy also may be effetive for older adults. Beause diabetes nutrition therapy an result in ost savings B and improved outomes (e.g., A1C redution) A, MNT should be adequately reimbursed by insurane and other payers. E B, A, E Energy balane Eating patterns and maronutrient distribution Protein For overweight or obese adults with type 2 diabetes or at risk for diabetes, reduing energy intake while maintaining a healthful eating pattern is reommended to promote weight loss. Modest weight loss may provide linial benefits in some individuals with diabetes, espeially those early in the disease proess. To ahieve modest weight loss, intensive lifestyle interventions with ongoing support are reommended. Evidene suggests that there is not an ideal perentage of alories from arbohydrate, protein, and fat for all people with diabetes B; therefore, maronutrient distribution should be based on individualized assessment of urrent eating patterns, preferenes, and metaboli goals. E Carbohydrate amount and available insulin may be the most important fators influening glyemi response after eating and should be onsidered when developing the eating plan. Monitoring arbohydrate intake, whether by arbohydrate ounting or experiene-based estimation, remains ritial in ahieving glyemi ontrol. Carbohydrate intake from vegetables, fruits, whole grains, legumes, and dairy produts should be advised over intake from other arbohydrate soures, espeially those that ontain added fats, sugars, or sodium. Substituting low glyemi2load foods for higher glyemi2load foods may modestly improve glyemi ontrol. Individuals at high risk for type 2 diabetes should be enouraged to ahieve the U.S. Department of Agriulture reommendation for dietary fiber (14 g fiber/1,000 kal) and to onsume foods ontaining whole grains (one-half of grain intake). While substituting surose-ontaining foods for isoalori amounts of other arbohydrates may have similar blood gluose effets, onsumption should be minimized to avoid displaing nutrient-dense food hoies. People with diabetes and those at risk should limit or avoid intake of sugar-sweetened beverages to redue risk for weight gain and worsening of ardiometaboli risk profile. In individuals with type 2 diabetes, ingested protein appears to inrease insulin response without inreasing plasma gluose onentrations. Therefore, arbohydrate soures high in protein should not be used to treat or prevent hypoglyemia. Evidene is inonlusive regarding an ideal amount of total fat for people with diabetes; therefore, goals should be individualized. C Fat quality appears to be far more important than quantity. B A Mediterranean-style eating pattern, rih in monounsaturated fatty aids, may benefit glyemi ontrol and CVD risk fators and an therefore be reommended as an effetive alternative to a lower-fat, higher-arbohydrate eating pattern. A A B, E A B B C B A B B C, B B Continued on p. S23

24 are.diabetesjournals.org Position Statement S23 Table 4.1 Continued Topi Reommendations Evidene rating Dietary fat Inreased onsumption of foods ontaining long-hain omega-3 fatty aids B (EPA and DHA), suh as fatty fish, and omega-3 linoleni aid (ALA) is reommended. The onsumption of fish (partiularly fatty fish) at least two times (two B servings) per week is reommended. The amount of dietary saturated fat, holesterol, and trans fat reommended C for people with diabetes is the same as that reommended for the general population. Evidene does not support reommending omega-3 supplements for people A with diabetes for the prevention or treatment of ardiovasular events. Mironutrients and herbalsupplements There is no lear evidene of benefit from vitamin or mineral C supplementation in people with diabetes who do not have underlying defiienies. Routine supplementation with antioxidants, suh as vitamins E and C and C arotene, is not advised due to insuffiient evidene of effiay and onerns related to long-term safety. There is insuffiient evidene to support the routine use of C mironutrients suh as hromium, magnesium, and vitamin D to improve glyemi ontrol in people with diabetes. There is insuffiient evidene to support the use of innamon or other E herbs/supplements for the treatment of diabetes. It is reommended that individualized meal planning inlude optimization of food hoies to meet reommended dietary allowane/dietary referene intake for all mironutrients. E Alohol Sodium If adults with diabetes hoose to drink alohol, they should be advised to do so in moderation (no more than one drink per day for adult women and no more than two drinks per day for adult men). Alohol onsumption may plae people with diabetes at an inreased risk for delayed hypoglyemia, espeially if taking insulin or insulin seretagogues. Eduation and awareness regarding the reognition and management of delayed hypoglyemia are warranted. The reommendation for the general population to redue sodium to less than 2,300 mg/day is also appropriate for people with diabetes. For individuals with both diabetes and hypertension, further redution in sodium intake should be individualized. C B B B Maronutrients Carbohydrates Studies examining the ideal amount of arbohydrate intake for people with diabetes are inonlusive, although monitoring arbohydrate intake and onsidering the available insulin are key strategies for improving postprandial gluose ontrol (37,69). The literature onerning glyemi index and glyemi load in individuals with diabetesisomplex,althoughredutionsin A1C of 20.2% to 20.5% have been demonstrated in some studies (64,70). A systemati review (64) found onsumption of whole grains was not assoiated with improvements in glyemi ontrol in people with type 2 diabetes, although it may redue systemi inflammation. One study did find a potential benefit of whole-grain intake in reduing mortality and ardiovasular disease (CVD) (71). Proteins For people with diabetes and no evidene of diabeti kidney disease, the evidene is inonlusive about reommending an ideal amount of protein for optimizing glyemi ontrol or for improving one or more CVD risk measures (64). Therefore, these goals should be individualized. For people with diabetes and diabeti kidney disease (with albuminuria), reduing the amount of dietary protein below usual intake is not reommended beause it does not alter glyemi measures, ardiovasular risk measures, or the ourse of glomerular filtration rate deline (72,73). In individuals with type 2 diabetes, ingested protein appears to inrease insulin response without inreasing plasma gluose onentrations (74). Therefore, arbohydrate soures high in protein should not be used to treat or prevent hypoglyemia. Protein s effet on blood gluose levels in type 1 diabetes is less lear. Fats Limited researh exists onerning the ideal amount of fat for individuals with diabetes. The Institute of Mediine has defined an aeptable maronutrient distribution range for all adults for total fat of 20 35%ofenergywithnotolerable upper intake level defined (75). The type of fatty aids onsumed is more important than total amount of fat when looking at metaboli goals and risk of CVD (53,76,77). Multiple randomized ontrolled trials inluding patients with type 2 diabetes have reported improved glyemi ontrol and/or blood lipids when a Mediterranean-style eating pattern, rih in monounsaturated fatty aid, was onsumed (53,57,78,79). A systemati review (64) onluded that

25 S24 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 supplementation with omega-3 fatty aids did not improve glyemi ontrol but that higher dose supplementation dereased triglyerides in individuals with type 2 diabetes. Randomized ontrolled trials also do not support reommending omega-3 supplements for primary or seondary prevention of CVD (80 85). People with diabetes should be advised to follow the guidelines for the general population for the reommended intakes of saturated fat, dietary holesterol, and trans fat (86). Sodium A review found that dereasing sodium intake redues blood pressure in those with diabetes (87). Inrementally lowering sodium intake (i.e., to 1,500 mg/day) has shown benefiial effets on blood pressure (87 89). The Amerian Heart Assoiation reommends 1,500 mg/day for Afrian Amerians, people diagnosed with hypertension, diabetes, or hroni kidney disease, and those over 51 years of age (90). However, other studies (88,89) have warranted aution for universal sodium restrition to 1,500 mg in this population. For individuals with diabetes and hypertension, setting a sodium intake goal of,2,300 mg/day should be onsidered on an individual basis. Sodium intake reommendations should take into aount palatability, availability, additional ost of speialty low-sodium produts, and the diffiulty of ahieving both lowsodium reommendations and a nutritionally adequate diet (86). For omplete disussion and referenes of all reommendations, see the ADA position statement Nutrition Therapy Reommendations for the Management of Adults With Diabetes (36). PHYSICAL ACTIVITY Reommendations Children with diabetes or prediabetes should be enouraged to engage in at least 60 min of physial ativity eah day. B 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 Evidene supports that all individuals, inluding those with diabetes, should be enouraged to redue sedentary time, partiularlybybreakingupextended amounts of time (.90 min) spent sitting. B 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 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 (91 93). Strutured exerise interventions of at least 8 weeks duration have been showntolowera1cbyanaverageof 0.66% in people with type 2 diabetes, even with no signifiant hange in BMI (94). There are onsiderable data for the health benefits (e.g., inreased ardiovasular fitness, musle strength, improved insulin sensitivity, et.) of regular physial ativity for those with type 1 diabetes (95). Higher levels of exerise intensity are assoiated with greater improvements in A1C and in fitness (96). Other benefits inlude slowing the deline in mobility among overweight patients with diabetes (97). Exerise and Type 2 Diabetes: The Amerian College of Sports Mediine and the Amerian Diabetes Assoiation: Joint Position Statement Exeutive Summary reviews the evidene for the benefits of exerise in people with type 2 diabetes (98). Exerise and Children As is reommended for all hildren, hildren with diabetes or prediabetes should be enouraged to engage in at least 60 min of physial ativity eah day. Inluded in the 60 min eah day, hildren should engage in vigorous-intensity aerobi ativity, musle-strengthening ativities, and bone-strengthening ativities at least 3 of those days (99). Frequeny and Type of Exerise The U.S. Department of Health and Human Servies physial ativity guidelines for Amerians (100) suggest that adults over age 18 years do 150 min/week of moderate-intensity or 75 min/week of vigorous-intensity 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 or more 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. Reent evidene supports that all individuals, inluding those with diabetes, should be enouraged to redue the amount of time spent being sedentary (e.g., working at a omputer, wathing TV)partiularlybybreakingupextended amounts of time (.90 min) spent sitting (101). Exerise and Glyemi Control Based on physial ativity studies that inlude people with diabetes, it seems reasonable to reommend that people with diabetes follow the physial ativity guidelines as for the general population. For example, studies inluded in the metaanalysis of effets of exerise interventions on glyemi ontrol (94) had a mean of 3.4 sessions/week, with a mean of 49 min/ session. Also, the Diabetes Prevention Program (DPP) lifestyle intervention inluded 150 min/week of moderate-intensity exerise and showed benefiial effet on glyemia in those with prediabetes (91). Clinial trials have provided strong evidene for the A1C-lowering value of resistane training in older adults with type 2 diabetes (98) and for an additive benefit of ombined aerobi and resistane exerise in adults with type 2 diabetes (102,103). If not ontraindiated, 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 (98). Pre-exerise Evaluation As disussed more fully in Setion 8. Cardiovasular Disease and Risk Management, the best protool for sreening asymptomati diabeti patients for oronary artery disease (CAD) remains unlear. The ADA onsensus report Sreening for Coronary Artery Disease in Patients With Diabetes (104) on this issue onluded that routine sreening is not reommended. Providers should use linial judgment in

26 are.diabetesjournals.org Position Statement S25 this area. Certainly, high-risk patients should be enouraged to start with short periods of low-intensity exerise and slowly inrease the intensity and duration. 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, a history of foot lesions, and unstable proliferative retinopathy. The patient s age and previous physial ativity level should be onsidered. For type 1 diabeti patients, the provider should ustomize the exerise regimen to the individual s needs. Those with ompliations may require a more thorough evaluation (95). Exerise in the Presene of Nonoptimal Glyemi Control Hyperglyemia When individuals with type 1 diabetes are deprived of insulin for h and are ketoti, exerise an worsen hyperglyemia and ketosis (105); therefore, vigorous ativity should be avoided with 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 less ommon in diabeti patients 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 Compliations of Diabetes Retinopathy If proliferative diabeti retinopathy or severe nonproliferative diabeti retinopathy is present, then vigorous aerobi or resistane exerise may be ontraindiated beause of the risk of triggering vitreous hemorrhage or retinal detahment (106). Peripheral Neuropathy Dereased pain sensation and a higher pain threshold in the extremities result in an inreased risk of skin breakdown and infetion and of Charot joint destrution with some forms of exerise. However, studies have shown that moderate-intensity walking may not lead to an inreased risk of foot ulers or reuleration in those with peripheral neuropathy (107). In addition, 150 min/ week of moderate exerise was reported to improve outomes in patients with milder forms of neuropathy (106). 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 exerise-indued injury or adverse event through dereased ardia responsiveness to exerise, postural hypotension, impaired thermoregulation, impaired night vision due to impaired papillary reation, and higher suseptibility to hypoglyemia (108). Cardiovasular autonomi neuropathy is also an independent risk fator for ardiovasular death and silent myoardial ishemia (109). Therefore, individuals 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 appears to be no need for speifi exerise restritions for people with diabeti kidney disease (106). SMOKING CESSATION 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 Results from epidemiologial, aseontrol, and ohort studies provide onvining evidene to support the ausal link between igarette smoking and health risks. Muh of the work doumenting the effet of smoking on health does not separately disuss results on subsets of individuals with diabetes, but it does suggest 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 (and people exposed to seondhand smoke) have a heightened risk of CVD, premature death, and the mirovasular ompliations of diabetes. Smoking may have a role in the development of type 2 diabetes (110). 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 (111). The routine and thorough assessment of tobao use is essential to prevent smoking or enourage essation. Numerous large randomized linial trials have demonstrated the effiay and ost-effetiveness of brief ounseling in smoking essation, inluding the use of quit lines, in reduing 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 (112). Although some patients may gain weight in the period shortly after smoking essation, reent researh has demonstrated that this weight gain does not diminish the substantial CVD risk benefit realized from smoking essation (113). There is no evidene that e-igarettes are a healthier alternative to smoking or that e-igarettes an failitate smoking essation. Rigorous study of their shortand long-term effets is needed in determining their safety and effiay and their ardiopulmonary effets in omparison with smoking and standard approahes to smoking essation (114). PSYCHOSOCIAL ASSESSMENT AND CARE Reommendations Inlude assessment of the patient s psyhologial and soial situation as an ongoing part of the medial management of diabetes. B Psyhosoial sreening and followup may inlude, but are not limited

27 S26 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 to, attitudes about the illness, expetations for medial management and outomes, affet/ mood, general and diabetesrelated quality of life, resoures (finanial, soial, and emotional), and psyhiatri history. E Routinely sreen for psyhosoial problems suh as depression, diabetes-related distress, anxiety, eating disorders, and ognitive impairment. B Older adults (aged $65 years) with diabetes should be onsidered a high-priority population for depression sreening and treatment. B Patients with omorbid diabetes and depression should reeive a stepwise ollaborative are approah for the management of depression. A Emotional well-being is an important part of diabetes are and self-management. Psyhologial and soial problems an impair the individual s ( ) or family s (118) ability to arry out diabetes are tasks and therefore ompromise health status. There are opportunities for the liniian to routinely 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 onboth outomes (119). Sreening Key opportunities for routine sreening of psyhosoial status our at diagnosis, during regularly sheduled management visits, during hospitalizations, with new-onset ompliations, or when problems with gluose ontrol, quality of life, or self-management are identified. Patients are likely to exhibit psyhologial vulnerability at diagnosis, when their medial status hanges (e.g., end of the honeymoon period), when the need for intensified treatment is evident, and when ompliations are disovered. Depression affets about 20 25% of people with diabetes (120) and inreases the risk for myoardial infartion and postmyoardial infartion (121) and all-ause mortality (122). There appears to be a bidiretional relationship between depression and both diabetes (123) and metaboli syndrome (124). Diabetes-related distress is distint from linial depression and is very ommon ( ) among people with diabetes and their family members (118). Prevalene is reported as 18 45%, with an inidene of 38 48% over 18 months. High levels of distress are signifiantly linked to A1C, self-effiay, dietary and exerise behaviors (13,126), and mediation adherene (128). 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, anxiety, general and diabetesrelated quality of life, resoures (finanial, soial, and emotional) (129), and psyhiatri history (130). Sreening tools are available for a number of these areas (23,131,132). Referral to Mental Health Speialist Indiations for referral to a mental health speialist familiar with diabetes management may inlude gross disregard for the medial regimen (by self or others) (133), depression, overall stress related to work-life balane, possibility of self-harm, debilitating anxiety (alone or with depression), indiations of an eating disorder (134), or ognitive funtioning that signifiantly impairs judgment. It is preferable to inorporate psyhologial assessment and treatment into routine are rather than waiting for a speifi problem or deterioration in metaboli or psyhologial status (23,125). In the Seond Diabetes Attitudes, Wishes and Needs (DAWN2) study, signifiant diabetes-related distress was reported by 44.6% of the partiipants, but only 23.7% reported that their health are team asked them how diabetes impated their life (125). Although the liniian may not feel qualified to treat psyhologial problems (135), optimizing the patientprovider relationship as a foundation an inrease the likelihood that the patient will aept referral for other servies. Collaborative are interventions and use of a team approah have demonstrated effiay in diabetes and depression (136,137). Interventions to enhane self-management and address severe distress have demonstrated effiay in diabetes-related distress (13). IMMUNIZATION Reommendations Provide routine vainations for hildren and adults with diabetes as for the general population. C Annually provide an influenza vaine to all patients with diabetes $6 monthsofage.c Administer pneumooal polysaharide vaine 23 (PPSV23) to all patients with diabetes $2 years of age. C Adults $65 years of age, if not previously vainated, should reeive pneumooal onjugate vaine 13 (PCV13), followed by PPSV months after initial vaination. C Adults $65 years of age, if previously vainated with PPSV23, should reeive a follow-up $12 months with PCV13. C Administer hepatitis B vaination to unvainated adults with diabetes who are aged years. C Consider administering hepatitis B vaination to unvainated adults with diabetes who are aged $60 years. C As for the general population, all hildren and adults with diabetes should reeive routine vainations (138,139). Influenza and pneumonia are ommon, preventable infetious diseases assoiated with high mortality and morbidity in vulnerable populations, suh as the young and the elderly, and in people with hroni diseases. Although 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 andits ompliations. People with diabetes may be at an inreased risk of the bateremi form of pneumooal infetion and have been reported to have a high risk of nosoomial bateremia, with a mortality rate as high as 50% (140). In a ase-ontrol series,

28 are.diabetesjournals.org Position Statement S27 influenza vaine was shown to redue diabetes-related hospital admission by as muh as 79% during flu epidemis (141). There is suffiient evidene to support that people with diabetes have appropriate serologi 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 ( Pneumooal Vaines in Older Adults The ADA endorses a reent CDC advisory panel that reommends that both PCV13 and PPSV23 should be administered routinely in series to all adults 65 years of age or older (142). Pneumooal Vaine-Naïve People Adults 65 years of age or older who have not previously reeived pneumooal vaine or whose previous vaination history is unknown should reeive a dose of PCV13 first, followed by PPSV23. A dose of PPSV23 should be given 6 12 months following a dose of PCV13. If PPSV23 annot be given within this time period, a dose of PPSV23 should be given during the next visit. The two vaines should not be oadministered, and the minimum interval between vaine dosing should be 8 weeks. Previous Vaination With PPSV23 Adults 65 years of age or older who previously have reeived one or more doses of PPSV23 should also reeive PCV13 if they have not yet reeived it. PCV13 should be given no sooner than 12 months after reeipt of the most reent PPSV23 dose. For those for whom an additional dose of PPSV23 is indiated, this subsequent PPSV23 dose should be given 6 12 months after PCV13 and at least 5 years sine the most reent dose of PPSV23. Referenes 1. Haas L, Maryniuk M, Bek J, et al. National standards for diabetes self-management eduation and support. Diabetes Care 2013;37(Suppl. 1):S144 S Marrero DG, Ard J, Delamater AM, et al. Twenty-first entury behavioral mediine: a ontext for empowering liniians and patients with diabetes: a onsensus report. Diabetes Care 2013;36: Norris SL, Lau J, Smith SJ, Shmid CH, Engelgau MM. Self-management eduation for adults with type 2 diabetes: a meta-analysis of the effet on glyemi ontrol. Diabetes Care 2002;25: Martin D, Lange K, Sima A, et al.; SWEET group. Reommendations for age-appropriate eduation of hildren and adolesents with diabetes and their parents in the European Union. Pediatr Diabetes 2012;13(Suppl. 16): Committee on Quality of Health Care in Ameria. Institute of Mediine. Crossing the Quality Chasm: A New Health System for the 21st Century [Internet], Washington, DC: National Aademies Press, Available from Reports/2001/Crossing-the-Quality-Chasm-A- New-Health-System-for-the-21st-Century.aspx. Aessed 1 Otober Barker JM, Goehrig SH, Barriga K, et al.; DAISY Study. Clinial harateristis of hildren diagnosed with type 1 diabetes through intensive sreening and follow-up. Diabetes Care 2004;27: Frosh DL, Uy V, Ohoa S, Mangione CM. Evaluation of a behavior support intervention for patients with poorly ontrolled diabetes. Arh Intern Med 2011;171: Cooke D, Bond R, Lawton J, et al.; U.K. NIHR DAFNE Study Group. Strutured type 1 diabetes eduation delivered within routine are: impat on glyemi ontrol and diabetes-speifi quality of life. Diabetes Care 2013;36: Steinsbekk A, Rygg LØ, Lisulo M, Rise MB, Fretheim A. Group based diabetes selfmanagement eduation ompared to routine treatment for people with type 2 diabetes mellitus. A systemati review with meta-analysis. BMC Health Serv Res 2012;12: Deakin TA, MShane CE, Cade JE, Williams R. Group based training for self-management strategies in people with type 2 diabetes mellitus. Cohrane Database Syst Rev 2005;2:CD Cohran J, Conn VS. Meta-analysis of quality of life outomes following diabetes selfmanagement training. Diabetes Edu 2008;34: Thorpe CT, Fahey LE, Johnson H, Deshpande M, Thorpe JM, Fisher EB. Failitating healthy oping in patients with diabetes: a systemati review. Diabetes Edu 2013;39: Fisher L, Hessler D, Glasgow RE, et al. REDEEM: a pragmati trial to redue diabetes distress. Diabetes Care 2013;36: Robbins JM, Thather GE, Webb DA, Valdmanis VG. Nutritionist visits, diabetes lasses, and hospitalization rates and harges: the Urban Diabetes Study. Diabetes Care 2008;31: Dunan I, Ahmed T, Li QE, et al. Assessing the value of the diabetes eduator. Diabetes Edu 2011;37: Piatt GA, Anderson RM, Brooks MM, et al. 3-year follow-up of linial and behavioral improvements following a multifaeted diabetes are intervention: results of a randomized ontrolled trial. Diabetes Edu 2010;36: Tang TS, Funnell MM, Brown MB, Kurlander JE. Self-management support in real-world settings: an empowerment-based intervention. Patient Edu Couns 2010;79: Renders CM, Valk GD, Griffin SJ, Wagner EH, Eijk Van JT, Assendelft WJ. Interventions to improve the management of diabetes in primary are, outpatient, and ommunity settings: a systemati review. Diabetes Care 2001;24: Glazier RH, Bajar J, Kennie NR, Willson K. A systemati review of interventions to improve diabetes are in soially disadvantaged populations. Diabetes Care 2006;29: Hawthorne K, Robles Y, Cannings-John R, Edwards AG. Culturally appropriate health eduation for type 2 diabetes mellitus in ethni minority groups. Cohrane Database Syst Rev 2008;3:CD Sarkisian CA, Brown AF, Norris KC, Wintz RL, Mangione CM. A systemati review of diabetes self-are interventions for older, Afrian Amerian, or Latino adults. Diabetes Edu 2003;29: Chodosh J, Morton SC, Mojia W, et al. Metaanalysis: hroni disease self-management programs for older adults. Ann Intern Med 2005; 143: Peyrot M, Rubin RR. Behavioral and psyhosoial interventions in diabetes: a oneptual review. Diabetes Care 2007;30: Naik AD, Palmer N, Petersen NJ, et al. Comparative effetiveness of goal setting in diabetes mellitus group linis: randomized linial trial. Arh Intern Med 2011;171: Duke S-AS, Colagiuri S, Colagiuri R. Individual patient eduation for people with type 2 diabetes mellitus. Cohrane Database Syst Rev 2009;1:CD Shah M, Kaselitz E, Heisler M. The role of ommunity health workers in diabetes: update on urrent literature. Curr Diab Rep 2013;13: Heisler M, Vijan S, Makki F, Piette JD. Diabetes ontrol with reiproal peer support versus nurse are management: a randomized trial. Ann Intern Med 2010;153: Heisler M. Overview of peer support models to improve diabetes self-management and linial outomes. Diabetes Spetrum 2007;20: 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: Moskowitz D, Thom DH, Hessler D, Ghorob A, Bodenheimer T. Peer oahing to improve diabetes self-management: whih patients benefit most? J Gen Intern Med 2013;28: Foster G, Taylor SJC, Eldridge SE, Ramsay J, Griffiths CJ. Self-management eduation programmes by lay leaders for people with hroni onditions. Cohrane Database Syst Rev : CD Siminerio L, Ruppert KM, Gabbay RA. Who an provide diabetes self-management support in primary are? Findings from a randomized ontrolled trial. Diabetes Edu 2013;39: Dunan I, Birkmeyer C, Coughlin S, Li QE, Sherr D, Boren S. Assessing the value of diabetes eduation. Diabetes Edu 2009;35: Johnson TM, Murray MR, Huang Y. Assoiations between self-management eduation and omprehensive diabetes linial are. Diabetes Spetrum 2010;23: Inzuhi SE, Bergenstal RM, Buse JB, et al.; Amerian Diabetes Assoiation (ADA); European Assoiation for the Study of Diabetes (EASD). Management of hyperglyemia in type 2 diabetes: a patient-entered approah.

29 S28 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Position statement of the Amerian Diabetes Assoiation (ADA) and the European Assoiation for the Study of Diabetes (EASD). Diabetes Care 2012;35: Evert AB, Bouher JL, Cypress M, et al. Nutrition therapy reommendations for the management of adults with diabetes. Diabetes Care 2014;37(Suppl. 1):S120 S DAFNE Study Group. Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: Dose Adjustment For Normal Eating (DAFNE) randomised ontrolled trial. BMJ 2002;325: Kulkarni K, Castle G, Gregory R, et al.; The Diabetes Care and Eduation Dieteti Pratie Group. Nutrition pratie guidelines for type 1 diabetes mellitus positively affet dietitian praties and patient outomes. J Am Diet Asso 1998;98:62 70; quiz Rossi MCE, Niolui A, Di Bartolo P, et al. Diabetes Interative Diary: a new telemediine system enabling flexible diet and insulin therapy while improving quality of life: an open-label, international, multienter, randomized study. Diabetes Care 2010;33: Laurenzi A, Bolla AM, Panigoni G, et al. Effets of arbohydrate ounting on gluose ontrol and quality of life over 24 weeks in adult patients with type 1 diabetes on ontinuous subutaneous insulin infusion: a randomized, prospetive linial trial (GIOCAR). Diabetes Care 2011;34: Savone G, Manto A, Pitoo D, et al. Effet of arbohydrate ounting and medial nutritional therapy on glyaemi ontrol in type 1 diabeti subjets: a pilot study. Diabet Med 2010;27: UK Prospetive Diabetes Study (UKPDS) Group. Effet of intensive blood-gluose ontrol with metformin on ompliations in overweight patients with type 2 diabetes (UKPDS 34). Lanet 1998;352: Rikheim PL, Weaver TW, Flader JL, Kendall DM. Assessment of group versus individual diabetes eduation: a randomized study. Diabetes Care 2002;25: Ziemer DC, Berkowitz KJ, Panayioto RM, et al. A simple meal plan emphasizing healthy food hoies is as effetive as an exhangebasedmealplanforurbanafrianamerians with type 2 diabetes. Diabetes Care 2003;26: Wolf AM, Conaway MR, Crowther JQ, et al.; Improving Control with Ativity and Nutrition (ICAN) Study. Translating lifestyle intervention to pratie in obese patients with type 2 diabetes: Improving Control with Ativity and Nutrition (ICAN) study. Diabetes Care 2004;27: Nield L, Moore H, Hooper L, et al. Dietary advie for treatment of type 2 diabetes mellitus in adults. Cohrane Database Syst Rev 2007;3: CD Davis RM, Hith AD, Salaam MM, Herman WH, Zimmer-Galler IE, Mayer-Davis EJ. Telehealth improves diabetes self-management in an underserved ommunity: diabetes Teleare. Diabetes Care 2010;33: Coppell KJ, Kataoka M, Williams SM, Chisholm AW, Vorgers SM, Mann JI. Nutritional intervention in patients with type 2 diabetes who are hyperglyaemi despite optimised drug treatment Lifestyle Over and Above Drugs in Diabetes (LOADD) study: randomised ontrolled trial. BMJ 2010;341: Franz MJ, Monk A, Barry B, et al. Effetiveness of medial nutrition therapy provided by dietitians in the management of non-insulindependent diabetes mellitus: a randomized, ontrolled linial trial. J Am Diet Asso 1995; 95: Sämann A, Mühlhauser I, Bender R, Kloos Ch, Müller UA. Glyaemi ontrol and severe hypoglyaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes: a prospetive implementation study. Diabetologia 2005;48: MIntyre HD, Knight BA, Harvey DM, Noud MN, Hagger VL, Gilshenan KS. Dose Adjustment For Normal Eating (DAFNE) - an audit of outomes in Australia. Med J Aust 2010;192: Pi-Sunyer X, Blakburn G, Branati FL, et al.; Look AHEAD Researh Group. Redution in weight and ardiovasular disease risk fators in individuals with type 2 diabetes: one-year results of the Look AHEAD trial. Diabetes Care 2007;30: Estruh R, Ros E, Salas-Salvadó J,etal.; PREDIMED Study Investigators. Primary prevention of ardiovasular disease with a Mediterranean diet. N Engl J Med 2013;368: Metz JA, Stern JS, Kris-Etherton P, et al. A randomized trial of improved weight loss with a prepared meal plan in overweight and obese patients: impat on ardiovasular risk redution. Arh Intern Med 2000;160: West DS, DiLillo V, Bursa Z, Gore SA, Greene PG. Motivational interviewing improves weight loss in women with type 2 diabetes. Diabetes Care 2007;30: Larsen RN, Mann NJ, Malean E, Shaw JE. The effet of high-protein, low-arbohydrate diets in the treatment of type 2 diabetes: a 12 month randomised ontrolled trial. Diabetologia 2011;54: Brehm BJ, Lattin BL, Summer SS, et al. Oneyear omparison of a high-monounsaturated fat diet with a high-arbohydrate diet in type 2 diabetes. Diabetes Care 2009;32: Davis NJ, Tomuta N, Shehter C, et al. Comparative study of the effets of a 1-year dietary intervention of a low-arbohydrate diet versus a low-fat diet on weight and glyemi ontrol in type 2 diabetes. Diabetes Care 2009;32: Guldbrand H, Dizdar B, Bunjaku B, et al. In type 2 diabetes, randomisation to advie to follow a low-arbohydrate diet transiently improves glyaemi ontrol ompared with advie to follow a low-fat diet produing a similar weight loss. Diabetologia 2012;55: Krebs JD, Elley CR, Parry-Strong A, et al. The Diabetes Exess Weight Loss (DEWL) Trial: a randomised ontrolled trial of high-protein versus high-arbohydrate diets over 2 years in type 2 diabetes. Diabetologia 2012;55: Wing RR, Bolin P, Branati FL, et al.; Look AHEAD Researh Group. Cardiovasular effets of intensive lifestyle intervention in type 2 diabetes. N Engl J Med 2013;369: Esposito K, Maiorino MI, Ciotola M, et al. Effets of a Mediterranean-style diet on the need for antihyperglyemi drug therapy in patients with newly diagnosed type 2 diabetes: a randomized trial. Ann Intern Med 2009;151: Li TY, Brennan AM, Wedik NM, Mantzoros C, Rifai N, Hu FB. Regular onsumption of nuts is assoiated with a lower risk of ardiovasular disease in women with type 2 diabetes. J Nutr 2009;139: Wheeler ML, Dunbar SA, Jaaks LM, et al. Maronutrients, food groups, and eating patterns in the management of diabetes: a systemati review of the literature, Diabetes Care 2012;35: Elhayany A, Lustman A, Abel R, Attal-Singer J, Vinker S. A low arbohydrate Mediterranean diet improves ardiovasular risk fators and diabetes ontrol among overweight patients with type 2 diabetes mellitus: a 1-year prospetive randomized intervention study. Diabetes Obes Metab 2010;12: Azadbakht L, Fard NRP, Karimi M, et al. Effets of the Dietary Approahes to Stop Hypertension (DASH) eating plan on ardiovasular risks among type 2 diabeti patients: a randomized rossover linial trial. Diabetes Care 2011; 34: Turner-MGrievy GM, Barnard ND, Cohen J, Jenkins DJA, Gloede L, Green AA. Changes in nutrient intake and dietary quality among partiipants with type 2 diabetes following a lowfat vegan diet or a onventional diabetes diet for 22 weeks. J Am Diet Asso 2008;108: Stern L, Iqbal N, Seshadri P, et al. The effets of low-arbohydrate versus onventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial. Ann Intern Med 2004;140: Delahanty LM, Nathan DM, Lahin JM, et al.; Diabetes Control and Compliations Trial/Epidemiology of Diabetes. Assoiation of diet with glyated hemoglobin during intensive treatment of type 1 diabetes in the Diabetes Control and Compliations Trial. Am J Clin Nutr 2009;89: Thomas D, Elliott EJ. Low glyaemi index, or low glyaemi load, diets for diabetes mellitus. Cohrane Database Syst Rev 2009;1:CD He M, van Dam RM, Rimm E, Hu FB, Qi L. Whole-grain, ereal fiber, bran, and germ intake and the risks of all-ause and ardiovasular disease-speifi mortality among women with type 2 diabetes mellitus. Cirulation 2010;121: Pan Y, Guo LL, Jin HM. Low-protein diet for diabeti nephropathy: a meta-analysis of randomized ontrolled trials. Am J Clin Nutr 2008; 88: Robertson L, Waugh N, Robertson A. Protein restrition for diabeti renal disease. Cohrane Database Syst Rev 2007;4:CD Layman DK, Clifton P, Gannon MC, Krauss RM, Nuttall FQ. Protein in optimal health: heart disease and type 2 diabetes. Am J Clin Nutr 2008;87:1571S 1575S 75. Institute of Mediine. Dietary Referene Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Aids, Cholesterol, Protein, and Amino Aids [Internet], Available from edu/reports/2002/dietary-referene-intakes- for-energy-carbohydrate-fiber-fat-fatty-aids-

30 are.diabetesjournals.org Position Statement S29 Cholesterol-Protein-and-Amino-Aids.aspx. Aessed 1 Otober Offie of Disease Prevention and Health Promotion, U.S. Department of Health and Human Servies. Dietary Guidelines for Amerians [Internet], Available from Aessed 1 Otober Ros E. Dietary is-monounsaturated fatty aids and metaboli ontrol in type 2 diabetes. Am J Clin Nutr 2003;78(Suppl.):617S 625S 78. Shai I, Shwarzfuhs D, Henkin Y, et al.; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a lowarbohydrate, Mediterranean, or low-fat diet. N Engl J Med 2008;359: Brunerova L, Smejkalova V, Potokova J, Andel M. A omparison of the influene of a high-fat diet enrihed in monounsaturated fatty aids and onventional diet on weight loss and metaboli parameters in obese non-diabeti and type 2 diabeti patients. Diabet Med 2007;24: Harris WS, Mozaffarian D, Rimm E, et al. Omega-6 fatty aids and risk for ardiovasular disease: a siene advisory from the Amerian Heart Assoiation Nutrition Subommittee of the Counil on Nutrition, Physial Ativity, and Metabolism; Counil on Cardiovasular Nursing; and Counil on Epidemiology and Prevention. Cirulation 2009;119: Crohemore ICC, Souza AFP, de Souza ACF, Rosado EL. v-3 polyunsaturated fatty aid supplementation does not influene body omposition, insulin resistane, and lipemia in women with type 2 diabetes and obesity. Nutr Clin Prat 2012;27: Bot M, Pouwer F, Assies J, Jansen EHJM, Beekman ATF, de Jonge P. Supplementation with eiosapentaenoi omega-3 fatty aid does not influene serum brain-derived neurotrophi fator in diabetes mellitus patients with major depression: a randomized ontrolled pilot study. Neuropsyhobiology 2011;63: Holman RR, Paul S, Farmer A, Tuker L, Stratton IM, Neil HA; Atorvastatin in Fatorial with Omega-3 EE90 Risk Redution in Diabetes Study Group. Atorvastatin in Fatorial with Omega-3EE90RiskRedution in Diabetes (AFORRD): a randomised ontrolled trial. Diabetologia 2009;52: Kromhout D, Geleijnse JM, de Goede J, et al. n-3 fatty aids, ventriular arrhythmia-related events, and fatal myoardial infartion in postmyoardial infartion patients with diabetes. Diabetes Care 2011;34: Bosh J, Gerstein HC, Dagenais GR, et al.; ORIGIN Trial Investigators. n-3 fatty aids and ardiovasular outomes in patients with dysglyemia. N Engl J Med 2012;367: Maillot M, Drewnowski A. A onflit between nutritionally adequate diets and meeting the 2010 dietary guidelines for sodium. Am J Prev Med 2012;42: Bray GA, Vollmer WM, Saks FM, Obarzanek E, Svetkey LP, Appel LJ; DASH Collaborative Researh Group. A further subgroup analysis of the effets of the DASH diet and three dietary sodium levels on blood pressure: results of the DASH-Sodium Trial. Am J Cardiol 2004;94: Thomas MC, Moran J, Forsblom C, et al.; FinnDiane Study Group. The assoiation between dietary sodium intake, ESRD, and allause mortality in patients with type 1 diabetes. Diabetes Care 2011;34: Ekini EI, Clarke S, Thomas MC, et al. Dietary salt intake and mortality in patients with type 2 diabetes. Diabetes Care 2011;34: Whelton PK, Appel LJ, Sao RL, et al. Sodium, blood pressure, and ardiovasular disease: further evidene supporting the Amerian Heart Assoiation sodium redution reommendations. Cirulation 2012;126: 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 X-R, Li G-W, Hu Y-H, 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: Boulé NG, Haddad E, Kenny GP, Wells GA, Sigal RJ. Effets of exerise on glyemi ontrol and body mass in type 2 diabetes mellitus: a meta-analysis of ontrolled linial trials. JAMA 2001;286: Colberg SR, Riddell MC. Physial ativity: regulation of gluose metabolism, liniial management strategies, and weight ontrol. In Type 1 Diabetes Sourebook. Peters AL, Laffel LM, Eds. Alexandria, VA, Amerian Diabetes Assoiation, Boulé NG, Kenny GP, Haddad E, Wells GA, Sigal RJ. Meta-analysis of the effet of strutured exerise training on ardiorespiratory fitness in type 2 diabetes mellitus. Diabetologia 2003;46: Rejeski WJ, Ip EH, Bertoni AG, et al.; Look AHEAD Researh Group. Lifestyle hange and mobility in obese adults with type 2 diabetes. N Engl J Med 2012;366: ColbergSR,SigalRJ,FernhallB,etal. Exerise and type 2 diabetes: the Amerian College of Sports Mediine and the Amerian Diabetes Assoiation: joint position statement exeutive summary. Diabetes Care 2010;33: Janssen I, Leblan AG. Systemati review of the health benefits of physial ativity and fitness in shool-aged hildren and youth. Int J Behav Nutr Phys At 2010;7: Offie of Disease Prevention and Health Promotion; U.S. Department of Health and Human Servies Physial Ativity Guidelines for Amerians [Internet], Available from guidelines/default.aspx. Aessed 1 Otober Katzmarzyk PT, Churh TS, Craig CL, Bouhard C. Sitting time and mortality from all auses, ardiovasular disease, and aner. Med Si Sports Exer 2009;41: Sigal RJ, Kenny GP, Wasserman DH, Castaneda-Seppa C. Physial ativity/exerise and type 2 diabetes. Diabetes Care 2004;27: Churh TS, Blair SN, Coreham S, et al. Effets of aerobi and resistane training on hemoglobin A1 levels in patients with type 2 diabetes: a randomized ontrolled trial. JAMA 2010;304: Bax JJ, Young LH, Frye RL, Bonow RO, Steinberg HO, Barrett EJ. Sreening for oronary artery disease in patients with diabetes. Diabetes Care 2007;30: Chu L, Hamilton J, Riddell MC. Clinial management of the physially ative patient with type 1 diabetes. Phys Sportsmed 2011;39: Colberg SR. Exerise and Diabetes: A Cliniian s Guide to Presribing Physial Ativity, 1st ed. Alexandria, VA, Amerian Diabetes Assoiation, Lemaster JW, Reiber GE, Smith DG, Heagerty PJ, Wallae C. Daily weight-bearing ativity does not inrease the risk of diabeti foot ulers. Med Si Sports Exer 2003;35: Spallone V, Ziegler D, Freeman R, et al.; Toronto Consensus Panel on Diabeti Neuropathy. Cardiovasular autonomi neuropathy in diabetes: linial impat, assessment, diagnosis, and management. Diabetes Metab Res Rev 2011;27: Pop-Busui R, Evans GW, Gerstein HC, et al.; Ation to Control Cardiovasular Risk in Diabetes Study Group. Effets of ardia autonomi dysfuntion on mortality risk in the Ation to Control Cardiovasular Risk in Diabetes (ACCORD) trial. Diabetes Care 2010;33: Jankowih M, Choudhary G, Taveira TH, Wu W-C. Age-, rae-, and gender-speifi prevalene of diabetes among smokers. Diabetes Res Clin Prat 2011;93:e101 e Voulgari C, Katsilambros N, Tentolouris N. Smoking essation predits amelioration of miroalbuminuria in newly diagnosed type 2 diabetes mellitus: a 1-year prospetive study. Metabolism 2011;60: Ranney L, Melvin C, Lux L, MClain E, Lohr KN. Systemati review: smoking essation intervention strategies for adults and adults in speial populations. Ann Intern Med 2006;145: Clair C, Rigotti NA, Porneala B, et al. Assoiation of smoking essation and weight hange with ardiovasular disease among adults with and without diabetes. JAMA 2013;309: Palazzolo DL. Eletroni igarettes and vaping: a new hallenge in linial mediine and publi health. A literature review. Front Publi Health 2013;1: Anderson RJ, Grigsby AB, Freedland KE, et al. Anxiety and poor glyemi ontrol: a meta-analyti review of the literature. Int J Psyhiatry Med 2002;32: Delahanty LM, Grant RW, Wittenberg E, et al. Assoiation of diabetes-related emotional distress with diabetes treatment in primary are patients with type 2 diabetes. Diabet Med 2007; 24: Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalene of omorbid depression in adults with diabetes: a meta-analysis. Diabetes Care 2001;24:

31 S30 Position Statement Diabetes Care Volume 38, Supplement 1, January Kovas Burns K, Niolui A, Holt RIG, et al.; DAWN2 Study Group. Diabetes Attitudes, Wishes and Needs seond study (DAWN2Ô): ross-national benhmarking indiators for family members living with people with diabetes. Diabet Med 2013;30: Harkness E, Madonald W, Valderas J, Coventry P, Gask L, Bower P. Identifying psyhosoial interventions that improve both physial andmentalhealthinpatientswithdiabetes: a systemati review and meta-analysis. Diabetes Care 2010;33: Bot M, Pouwer F, Zuidersma M, van Melle JP, de Jonge P. Assoiation of oexisting diabetes and depression with mortality after myoardial infartion. Diabetes Care 2012;35: Sherrer JF, Garfield LD, Chrusiel T, et al. Inreased risk of myoardial infartion in depressed patients with type 2 diabetes. Diabetes Care 2011;34: Sullivan MD, O Connor P, Feeney P, et al. Depression predits all-ause mortality: epidemiologial evaluation from the ACCORD HRQL substudy. Diabetes Care 2012;35: Chen P-C, Chan Y-T, Chen H-F, Ko M-C, Li C-Y. Population-based ohort analyses of the bidiretional relationship between type 2 diabetes and depression. Diabetes Care 2013;36: Pan A, Keum N, Okereke OI, et al. Bidiretional assoiation between depression and metaboli syndrome: a systemati review and metaanalysis of epidemiologial studies. Diabetes Care 2012;35: Niolui A, Kovas Burns K, Holt RIG, et al.; DAWN2 Study Group. Diabetes Attitudes, Wishes and Needs seond study (DAWN2Ô): ross-national benhmarking of diabetesrelated psyhosoial outomes for people with diabetes. Diabet Med 2013;30: Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress linially meaningful? Establishing ut points for the Diabetes Distress Sale. Diabetes Care 2012;35: Fisher L, Glasgow RE, Stryker LA. The relationship between diabetes distress and linial depression with glyemi ontrol among patients with type 2 diabetes. Diabetes Care 2010;33: Aikens JE. Prospetive assoiations between emotional distress and poor outomes in type 2 diabetes. Diabetes Care 2012;35: Gary TL, Safford MM, Gerzoff RB, et al. Pereption of neighborhood problems, health behaviors, and diabetes outomes among adults with diabetes in managed are: the TranslatingResearhIntoAtionforDiabetes (TRIAD) study. Diabetes Care 2008;31: Zhang X, Norris SL, Gregg EW, Cheng YJ, Bekles G, Kahn HS. Depressive symptoms and mortality among persons with and without diabetes. Am J Epidemiol 2005;161: Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress sreening instrument. Ann Fam Med 2008;6: MGuire BE, Morrison TG, Hermanns N, et al. Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Sale (PAID)-5 and PAID-1. Diabetologia 2010;53: Rubin RR, Peyrot M. Psyhologial issues and treatments for people with diabetes. J Clin Psyhol 2001;57: Young-Hyman DL, Davis CL. Disordered eating behavior in individuals with diabetes: importane of ontext, evaluation, and lassifiation. Diabetes Care 2010;33: Beverly EA, Hultgren BA, Brooks KM, Ritholz MD, Abrahamson MJ, Weinger K. Understanding physiians hallenges when treating type 2 diabeti patients soial and emotional diffiulties: a qualitative study. Diabetes Care 2011;34: Ciehanowski P. Diapression: an integrated model for understanding the experiene of individuals with o-ourring diabetes and depression. Clinial Diabetes 2011;29: Katon WJ, Lin EHB, Von Korff M, et al. Collaborative are for patients with depression and hroni illnesses. N Engl J Med 2010;363: Akinsanya-Beysolow I; Advisory Committee on Immunization Praties (ACIP); ACIP Child/Adolesent Immunization Work Group; Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Praties reommended immunization shedules for persons aged 0 through 18 years - United States, MMWR Morb Mortal Wkly Rep 2014;63: Bridges CB, Coyne-Beasley T; Advisory Committee on Immunization Praties (ACIP); ACIP Adult Immunization Work Group; Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Praties reommended immunization shedule for adults aged 19 years or older - United States, MMWR Morb Mortal Wkly Rep 2014;63: Smith SA, Poland GA. Use of influenza and pneumooal vaines in people with diabetes. Diabetes Care 2000;23: Colquhoun AJ, Niholson KG, Botha JL, Raymond NT. Effetiveness of influenza vaine in reduing hospital admissions in people with diabetes. Epidemiol Infet 1997;119: Tomzyk S, Bennett NM, Stoeker C, et al. Use of 13-valent pneumooal onjugate vaine and 23-valent pneumooal polysaharide vaine among adults aged $65 years: reommendations of the Advisory Committee on Immunization Praties (ACIP). MMWR Morb Mortal Wkly Rep 2014;63:

32 Diabetes Care Volume 38, Supplement 1, January 2015 S31 5. Prevention or Delay of Type 2 Diabetes Diabetes Care 2015;38(Suppl. 1):S31 S32 DOI: /d15-S008 Amerian Diabetes Assoiation Reommendations Patients with impaired gluose tolerane (IGT) A, impaired fasting gluose (IFG) E, or an A1C % E should be referred to an intensive diet and physial ativity behavioral ounseling program targeting loss of 7% of body weight and inreasing moderate-intensity physial ativity (suh as brisk walking) to at least 150 min/week. Follow-up ounseling may 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, IFGE, or an A1C % E, espeially for those with BMI.35 kg/m 2, aged,60 years, and women with prior gestational diabetes mellitus (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 ardiovasular disease is suggested. B Diabetes self-management eduation (DSME) and support (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 POSITION STATEMENT LIFESTYLE MODIFICATIONS Randomized ontrolled trials have shown that individuals at high risk for developing type 2 diabetes (IFG, IGT, or both) an signifiantly derease the rate of diabetes onset with partiular interventions (1 5). These inlude intensive lifestyle modifiation programs that have been shown to be very effetive (;58% redution after 3 years). Follow-up of all three large studies of lifestyle intervention has shown sustained redution in the rate of onversion to type 2 diabetes: 43% redution at 20 years in the Da Qing study (6), 43% redution at 7 years in the Finnish Diabetes Prevention Study (DPS) (7), and 34% redution at 10 years in the U.S. Diabetes Prevention Program Outomes Study (DPPOS) (8). A ost-effetiveness model suggested that lifestyle interventions in the Diabetes Prevention Program (DPP) are ost-effetive (9). Atual ost data from the DPP and DPPOS onfirm that the lifestyle interventions are highly ost-effetive (10). Group delivery of the DPP intervention in ommunity settings has the potential to be signifiantly less expensive while still ahieving similar weight loss (11). The Centers for Disease Control and Prevention (CDC) helps oordinate the National Diabetes Prevention Program, a resoure designed to bring evidenebased lifestyle hange programs for preventing type 2 diabetes to ommunities ( Given the linial trial results and the known risks of progression of prediabetes to diabetes, people with an A1C %, IGT,orIFGshould be ounseled on lifestyle hanges with goals similar to those of the DPP (7% weight loss and moderateintensity physial ativity of at least 150 min/week). PHARMACOLOGICAL INTERVENTIONS Pharmaologial agents, suh as metformin, a-gluosidase inhibitors, orlistat, and thiazolidinediones, have eah been shown to derease inident diabetes to various Suggested itation: Amerian Diabetes Assoiation. Prevention or delay of type 2 diabetes. Se. 5. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S31 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.

33 S32 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 degrees. Metformin has the strongest evidene base and demonstrated longterm safety as pharmaologial therapy for diabetes prevention (12). For other drugs, ost, side effets, and lak of a persistent effet require onsideration. Metformin was less effetive than lifestyle modifiation in the DPP and DPPOS but may be ost-saving over a 10-year period (10). It was as effetive as lifestyle modifiation in partiipants with BMI $35 kg/m 2 but not signifiantly better than plaebo in those over 60 years of age (1). In the DPP, for women with a history of GDM, metformin and intensive lifestyle modifiation led to an equivalent 50% redution in diabetes risk (13). Metformin may be reommended for very high-risk individuals (e.g., with history of GDM, who are 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, and are at an inreased risk for ardiovasular disease events. While treatment goals are the same as for other patients without diabetes, inreased vigilane is warranted to identify and treat these and other risk fators (e.g., smoking). DIABETES SELF-MANAGEMENT EDUCATION AND SUPPORT The standards for DSME and DSMS (see Setion 4. Foundations of Care) an 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. Given their training and experiene, providers of DSME and DSMS are partiularly well equipped to assist people with prediabetes in developing and maintaining behaviors that an prevent or delay the onset of diabetes (14 16). Referenes 1. 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: Buhanan TA, Xiang AH, Peters RK, et al. Preservation of panreati b-ell funtion and prevention of type 2 diabetes by pharmaologial treatment of insulin resistane in high-risk hispani women. Diabetes 2002;51: Chiasson J-L, 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: Lin JS, O Connor E, Evans CV, Senger CA, Rowland MG, Groom HC. Behavioral ounseling to promote a healthy lifestyle in persons with ardiovasular risk fators: a systemati review for the U.S. Preventive Servies Task Fore. Ann Intern Med 2014;161: Paulweber B, Valensi P, Lindström J, et al. A European evidene-based guideline for the prevention of type 2 diabetes. Horm Metab Res 2010;42(Suppl. 1):S3 S36 6. Li G, Zhang P, Wang J, et al. The long-term effet of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: a 20-year follow-up study. Lanet 2008; 371: Lindström J, Ilanne-Parikka P, Peltonen M, et al.; Finnish Diabetes Prevention Study Group. Sustained redution in the inidene of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lanet 2006;368: Knowler WC, Fowler SE, Hamman RF, et al.; Diabetes Prevention Program Researh Group. 10-year follow-up of diabetes inidene and weight loss in the Diabetes Prevention Program Outomes Study. Lanet 2009;374: Herman WH, Hoerger TJ, Brandle M, et al.; Diabetes Prevention Program Researh Group. The ost-effetiveness of lifestyle modifiation or metformin in preventing type 2 diabetes in adults with impaired gluose tolerane. Ann Intern Med 2005;142: Diabetes Prevention Program Researh Group. The 10-year ost-effetiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care 2012;35: Akermann RT, Finh EA, Brizendine E, Zhou H, Marrero DG. Translating the Diabetes Prevention Program into the ommunity. The DEPLOY Pilot Study. Am J Prev Med 2008;35: Diabetes Prevention Program Researh Group. Long-term safety, tolerability, and weight loss assoiated with metformin in the Diabetes Prevention Program Outomes Study. Diabetes Care 2012;35: Ratner RE, Christophi CA, Metzger BE, et al.; Diabetes Prevention Program Researh Group. Prevention of diabetes in women with a history of gestational diabetes: effets of metformin and lifestyle interventions. J Clin Endorinol Metab 2008;93: Parekh D, Sarathi V, Shivane VK, Bandgar TR, Menon PS, Shah NS. Pilot study to evaluate the effet of short-term improvement in vitamin D status on gluose tolerane in patients with type 2 diabetes mellitus. Endor Prat 2010;16: Shah M, Kaselitz E, Heisler M. The role of ommunity health workers in diabetes: update on urrent literature. Curr Diab Rep 2013;13: Heisler M. Overview of peer support models to improve diabetes self-management and linial outomes. Diabetes Spetrum 2007;20:

34 Diabetes Care Volume 38, Supplement 1, January 2015 S33 6. Glyemi Targets Diabetes Care 2015;38(Suppl. 1):S33 S40 DOI: /d15-S009 Amerian Diabetes Assoiation ASSESSMENT OF GLYCEMIC CONTROL 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. Continuous gluose monitoring (CGM) may be a useful adjunt to SMBG in seleted patients. Reommendations When presribed as part of a broader eduational ontext, SMBG results may help guide treatment deisions and/or self-management for patients using less frequent insulin injetions B or noninsulin therapies. E When presribing SMBG, ensure that patients reeive ongoing instrution and regular evaluation of SMBG tehnique, SMBG results, and their ability to use SMBG data to adjust therapy. E Patients on multiple-dose insulin or insulin pump therapy should perform SMBG 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 used properly, CGM in onjuntion with intensive insulin regimens is 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. B CGM may be a supplemental tool to SMBG in those with hypoglyemia unawareness and/or frequent hypoglyemi episodes. C Given variable adherene to CGM, assess individual readiness for ontinuing use of CGM prior to presribing. E When presribing CGM, robust diabetes eduation, training, and support are required for optimal CGM implementation and ongoing use. E POSITION STATEMENT Self-monitoring of Blood Gluose Major linial trials of insulin-treated patients have inluded SMBG as part of the multifatorial interventions to demonstrate the benefit of intensive glyemi ontrol on diabetes ompliations. SMBG is thus an integral omponent of effetive therapy (1). SMBG allows patients to evaluate their individual response to therapy and assess whether glyemi targets are being ahieved. Integrating SMBG results into diabetes management an be a useful tool for guiding medial nutrition therapy and physial ativity, preventing hypoglyemia, and adjusting mediations (partiularly prandial insulin doses). Evidene supports a orrelation between greater SMBG frequeny and lower A1C (2). The patient s speifi needs and goals should ditate SMBG frequeny and timing. Optimization SMBG auray is dependent on the instrument and user (3), so 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 hek their blood gluose at least one daily, many report taking no ation when results are high or low (4). In a yearlong study of insulin-naïve patients with suboptimal initial glyemi ontrol, a group trained in strutured SMBG (a paper tool was used at least quarterly to ollet and interpret 7-point SMBG profiles taken on 3 onseutive days) redued their A1C by 0.3 perentage points more than the ontrol group (5). Patients should Suggested itation: Amerian Diabetes Assoiation. Glyemi targets. Se. 6. In Standards of Medial Care in Diabetesd2015. DiabetesCare 2015;38(Suppl. 1):S33 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.

35 S34 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 be taught how to use SMBG data to adjust food intake, exerise, or pharmaologial therapy to ahieve speifi goals. The ongoing need for and frequeny of SMBG should be reevaluated at eah routine visit. SMBG is espeially important for insulin-treated patients to monitor for and prevent asymptomati hypoglyemia and hyperglyemia. For Patients on Intensive Insulin Regimens Most patients on intensive insulin regimens (multiple-dose insulin or insulin pump therapy, inluding patients with type 1 diabetes) should onsider SMBG 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 10 (or more) times daily, although individual needs may vary. 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) and with fewer aute ompliations (6). For Patients Using Basal Insulin or Oral Agents The evidene is insuffiient regarding when to presribe SMBG and how often testing is needed for patients who do not use an intensive insulin regimen, suh as those with type 2 diabetes using basal insulin or oral agents. Several randomized trials have alled into question the linial utility and osteffetiveness of routine SMBG in noninsulintreated patients (7 9). A meta-analysis suggested that SMBG redued A1C by 0.25% at 6 months (10), but the redution subsides after 12 months (11). A key onsideration is that performing SMBG alone does not lower blood gluose levels. To be useful, the information must be integrated into linial and self-management plans. Continuous Gluose Monitoring Real-time CGM measures interstitial gluose (whih orrelates well with plasma gluose) and inludes sophistiated alarms for hypo- and hyperglyemi exursions, but the devies are still not approved by the U.S. Food and Drug Administration as a sole agent to monitor gluose. CGMs require alibration with SMBG, with the latter still required for making aute treatment deisions. 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 those using intensive insulin therapy with SMBG (12). Sensor use in those aged,25 years (hildren, teens, and adults) did not result in signifiant A1C lowering, and there was no signifiant differene in hypoglyemia in any group. The greatest preditor of A1C lowering for all age-groups was frequeny of sensor use, whih was highest in those aged $25yearsandlowerin younger age-groups. A reent registry study of 17,317 partiipants onfirmed that more frequent CGM use is assoiated with lower A1C (13), while another study showed that hildren with.70% sensor use missed fewer shool days (14). Small randomized ontrolled trials in adults and hildren with baseline A1C % have onfirmed favorable outomes (A1C and hypoglyemia ourrene) in groups using CGM, suggesting that CGM may provide further benefit for individuals with type 1 diabetes who already have tight ontrol (15,16). A meta-analysis suggests that, ompared with SMBG, CGM is assoiated with short-term A1C lowering of ;0.26% (17). The long-term effetiveness of CGM needs to be determined. This tehnology may be partiularly useful in those with hypoglyemia unawareness and/or frequent hypoglyemi episodes, although studies have not shown signifiant redutions in severe hypoglyemia (17,18). A CGM devie equipped with an automati low gluose suspend feature has been approved by the U.S. Food and Drug Administration. The AutomationtoSimulate Panreati Insulin Response (ASPIRE) trial of 247 patients showed that sensoraugmented insulin pump therapy with a low gluose suspend signifiantly redued noturnal hypoglyemia, without inreasing A1C levels for those over 16 years of age (19). These devies may offer the opportunity to redue severe hypoglyemia for those with a history of noturnal hypoglyemia. Due to variable adherene, optimal CGM use requires an assessment of individual readiness for the tehnology as well as initial and ongoing eduation and support (13,20,21). A1C Testing 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 point-of-are testing for A1C provides the opportunity for more timely treatment hanges. E A1C reflets average glyemia over several months (3) and has strong preditive value for diabetes ompliations (22,23). Thus, A1C testing should be performed routinely in all patients with diabetesdat initial assessment and as part of ontinuing are. Measurement approximately every 3 months determines whether patients glyemi targets have been reahed and maintained. The frequeny of A1C testing should depend on the linial situation, the treatment regimen, and the liniian s judgment. Some patients with stable glyemia well within target may do well with testing only twie per year. Unstable or highly intensively managed patients (e.g., pregnant women with type 1 diabetes) may require testing more frequently than every 3 months (24). A1C Limitations The A1C test is subjet to ertain limitations. Conditions that affet red blood ell turnover (hemolysis, blood loss) and hemoglobin variants must be onsidered, partiularly when the A1C result does not orrelate with the patient s blood gluose levels (3). For patients in whom A1C/ estimated average gluose (eag) and measured blood gluose appear disrepant, liniians should onsider the possibilities of hemoglobinopathy or altered red blood ell turnover and the options of more frequent and/or different timing of SMBG or CGM use. 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 for A1C. The 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 evaluated by the ombination of results

36 are.diabetesjournals.org Position Statement S35 from self-monitoring and the A1C. The A1C may also onfirm the auray of the patient s meter (or the patient s reported SMBG results) and the adequay of the SMBG testing shedule. A1C and Mean Gluose Table 6.1 shows the orrelation between A1C levels and mean gluose levels based on two studies: the international A1C- Derived Average Gluose (ADAG) trial, whih based the orrelation with A1C on frequent SMBG and CGM in 507 adults (83% non-hispani whites) with type 1, type 2, and no diabetes (25), and an empirial study of the average blood gluose levels at premeal, postmeal, and bedtime assoiated with speified A1C levels using data from the ADAG trial (21). The Amerian Diabetes Assoiation (ADA) and the Amerian Assoiation for Clinial Chemistry have determined that the orrelation (r ) in the ADAG trial is strong enough to justify reporting both the A1C result and the eag result when a liniian orders the A1C test. Cliniians should note that the mean plasma gluose numbers in the table are based on ;2,800 readings per A1C in the ADAG trial. A1C Differenes in Ethni Populations and Children In the ADAG study, 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 the Afrian/Afrian Amerian and non- Hispani white ohorts. A small study omparing A1C to CGM data in hildren with type 1 diabetes 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 (26). Whether there are signifiant differenes in how A1C relates to average gluose in hildren or in different ethniities is an area for further study (27,28). 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. A1C GOALS For glyemi goals in hildren, please refer to Setion 11. Children and Adolesents. For glyemi goals in pregnant women, please refer to Setion 12. Management of Diabetes in Pregnany. Reommendations Lowering A1C to approximately 7% or less has been shown to redue mirovasular ompliations of diabetes, and, if implemented soon after the diagnosis of diabetes, it 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, type 2 diabetes treated with lifestyle or metformin only, long life expetany, or no signifiant ardiovasular disease (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, or long-standing diabetes in whom the general goal is diffiult to attain despite diabetes self-management eduation, appropriate gluose monitoring, and effetive doses of multiple gluose-lowering agents inluding insulin. B A1C and Mirovasular Compliations Hyperglyemia defines diabetes, and glyemi ontrol is fundamental to diabetes management. The Diabetes Control and Compliations Trial (DCCT) (1), a prospetive randomized ontrolled trial 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 mirovasular (retinopathy and diabeti kidney disease) and neuropathi ompliations. Follow-up of the DCCT ohorts in the Table 6.1 Mean gluose levels for speified A1C levels (21,25) Mean plasma gluose* Mean fasting gluose Mean premeal gluose Mean postmeal gluose Mean bedtime gluose A1C (%) mg/dl mmol/l mg/dl mg/dl mg/dl mg/dl , A alulator for onverting A1C results into eag, in either mg/dl or mmol/l, is available at *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 (25).

37 S36 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Epidemiology of Diabetes Interventions and Compliations (EDIC) study (29,30) 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 (31) and UK Prospetive Diabetes Study (UKPDS) (32,33) onfirmed that intensive glyemi ontrol was assoiated with signifiantly dereased rates of mirovasular and neuropathi ompliations in type 2 diabeti patients. Long-term follow-up of the UKPDS ohorts showed enduring effets of early glyemi ontrol on most mirovasular ompliations (34). Three landmark trials (Ation to Control Cardiovasular Risk in Diabetes [ACCORD], Ation in Diabetes and Vasular Disease: Preterax and Diamiron MR Controlled Evaluation [ADVANCE], and Veterans Affairs Diabetes Trial [VADT]) showed that lower A1C levels were assoiated with redued onset or progression of mirovasular ompliations (35 37). Epidemiologial analyses of the DCCT (1) and UKPDS (38) 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/ 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, though the absolute risk redutions beome muh smaller. Given the substantially inreased risk of hypoglyemia in type 1 diabetes trials and in reent type 2 diabetes trials, the risks of lower glyemi targets may, on a population level, outweigh the potential benefits on mirovasular ompliations. The onerning mortality findings in the ACCORD trial, disussed below (39), and the relatively intense efforts required to ahieve near-euglyemia should also be onsidered when setting glyemi targets. However, based on physiian judgment and patient preferenes, selet patients, espeially those with little omorbidity and long life expetany, may benefit from adopting more intensive glyemi targets (e.g., A1C target,6.5%) as long as signifiant hypoglyemia does not beome a barrier. A1C and Cardiovasular Disease Outomes CVD is a more ommon ause of death than mirovasular ompliations in populations with diabetes. There is evidene for a ardiovasular benefitofintensive glyemi ontrol after long-term follow-up of study ohorts treated early intheourseoftype1andtype2diabetes. In the DCCT, there was a trend toward lower risk of CVD events with intensive ontrol. In the 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 (40). The benefitof intensive glyemi ontrol in this type 1 diabeti ohort has reently been shown to persist for several deades (41). In type 2 diabetes, there is evidene that more intensive treatment of glyemia in newly diagnosed patients mayreduelong-termcvdrates.during the UKPDS trial, there was a 16% redution in CVD 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 (e.g., stroke). However, after 10 years of follow-up, 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) (34). The ACCORD, ADVANCE, and VADT suggested no signifiant redution in CVD outomes with intensive glyemi ontrol in partiipants followed for years who had more advaned type 2 diabetes than UKPDS partiipants. All three trials were onduted in partiipants with more long-standing diabetes (mean duration 8 11 years) and either known CVD or multiple ardiovasular risk fators. The target A1C among intensive ontrol subjets was,6% in ACCORD,,6.5% in ADVANCE, and a 1.5% redution in A1C ompared with ontrol subjets in VADT. Details of these studies are reviewed extensively in the ADA position statement 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 (42). The glyemi ontrol omparison in ACCORDwashaltedearlyduetoan inreased mortality rate in the intensive ompared with the standard arm (1.41% vs. 1.14% per year; hazard ratio 1.22 [95% CI ]), with a similar inrease in ardiovasular deaths. Key Points 1. Analysis of the ACCORD data did not identify a lear explanation for the exess mortality in the intensive arm (39). 2. A group-level meta-analysis of ACCORD, ADVANCE, and VADT suggested that gluose lowering had a modest (9%) but statistially signifiant redution in major CVD outomes, primarily nonfatal MI, with no signifiant effet on mortality. 3. Heterogeneity of the mortality effets aross studies was noted. 4. A prespeified subgroup analysis suggested that major CVD outome redution ourred in patients without known CVD at baseline (hazard ratio 0.84 [95% CI ]) (43). 5. Mortality findings in ACCORD (39) and subgroup analyses of the VADT (44) suggested that the potential risks of intensive glyemi ontrol may outweigh its benefits in some patients. 6. Those with long duration of diabetes, known history of severe hypoglyemia, advaned atheroslerosis, or advaned age/frailty may benefit from less aggressive targets. 7. Severe hypoglyemia was signifiantly more likely in partiipants in all three trials randomized to the intensive glyemi ontrol arm.

38 are.diabetesjournals.org Position Statement S37 Table 6.2 Summary of glyemi reommendations for 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) *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. 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. 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 targets annot be safely and reasonably 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 (Table 6.2). negatively affeted by postprandial hyperglyemia (47). It is lear that postprandial hyperglyemia, like preprandial hyperglyemia, ontributes to elevated A1C levels, with its relative ontribution being greater 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, a randomized ontrolled trial in patients with known CVD found no CVD benefit of insulin regimens targeting postprandial gluose ompared with those targeting preprandial gluose (48). Therefore, it is reasonable for postprandial testing to be reommended for individuals who have premeal gluose values within target but have A1C values above target. Taking postprandial plasma gluose measurements 1 2 h after the start of a meal and using treatments aimed at reduing postprandial plasma gluose values to,180 mg/dl (10 mmol/l) may help lower A1C. An analysis of data from 470 partiipants of the ADAG study (237 with type 1 diabetes and 147 with type 2 diabetes) found that atual average gluose levels assoiated with onventional A1C targets were higher than older DCCT and ADA targets (Table 6.1) (21,25). These findings support that premeal gluose targets may be relaxed without undermining overall glyemi ontrol as measured by A1C. These data have prompted a revision in the ADAreommended premeal target to mg/dl ( mmol/l). A1C and Glyemi Targets Numerous aspets must be onsidered when setting glyemi targets. The ADA proposes optimal targets, but eah target must be individualized to the needs of eah patient and their disease fators. When possible, suh deisions should be made with the patient, refleting his or her preferenes, needs, and values. Figure 6.1 is not designed to be applied rigidly but used as a broad onstrut to guide linial deision making (45), both in type 1 and type 2 diabetes. Reommended glyemi targets for many nonpregnant adults are shown in Table 6.2. The reommendations inlude blood gluose levels that appear to orrelate with ahievement of an A1C of,7%. The issue of preprandial versus postprandial SMBG targets is omplex (46). Elevated posthallenge (2-h oral gluose tolerane test) gluose values have been assoiated with inreased ardiovasular risk independent of fasting plasma gluose in some epidemiologial studies. In subjets with diabetes, surrogate measures of vasular pathology, suh as endothelial dysfuntion, are Figure 6.1 Depited are patient and disease fators used to determine optimal A1C targets. Charateristis and prediaments toward the left justify more stringent efforts to lower A1C; those toward the right suggest less stringent efforts. Adapted with permission from Inzuhi et al. (45).

39 S38 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 HYPOGLYCEMIA 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. Fifteen minutes after treatment, if SMBG shows ontinued hypoglyemia, the treatment should be repeated. One SMBG 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 an inreased 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 reevaluation 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 in order to partially reverse hypoglyemia unawareness and 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 (49). Mild hypoglyemia may be inonvenient or frightening to patients with diabetes. Severe hypoglyemia an ause aute harm to the person with diabetes or others, espeially if it auses falls, motor vehile 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 (50). 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 (51). Evidene from the DCCT/EDIC, whih involved younger adults and adolesents with type 1 diabetes, found no assoiation between frequeny of severe hypoglyemia and ognitive deline (52), as disussed in Setion 11. Children and Adolesents. Severe hypoglyemia was assoiated withmortalityinpartiipantsinboththe standard and intensive glyemia arms oftheaccordtrial,buttherelationships between hypoglyemia, ahieved A1C, and treatment intensity were not straightforward. An assoiation of severe hypoglyemia with mortality was also found in the ADVANCE trial (53). An assoiation between self-reported severe hypoglyemia and 5-year mortality has also been reported in linial pratie (54). In 2013, the ADA and the Endorine Soiety published the onsensus report Hypoglyemia and Diabetes: A Report of a Workgroup of the Amerian Diabetes Assoiation and the Endorine Soiety (55) on the effet and treatment of hypoglyemia in patients with diabetes. Severe hypoglyemia was defined as an event requiring the assistane of another person. Young hildren with type 1 diabetes and the elderly were noted as partiularly vulnerable due to their limited ability to reognize hypoglyemi symptoms and effetively ommuniate their needs. Individualized patient eduation, dietary intervention (e.g., bedtime snak to prevent overnight hypoglyemia), exerise management, mediation adjustment, gluose monitoring, and routine linial surveillane may improve patient outomes. Hypoglyemia Treatment Hypoglyemia treatment requires ingestion of gluose- or arbohydrateontaining foods. The aute glyemi response orrelates better with the gluose ontent of food than with the arbohydrate ontent of food. Pure gluose is the preferred treatment, but any form of arbohydrate that ontains gluose will raise blood gluose. Added fat may retard and then prolong the aute glyemi response. Ongoing insulin ativity or insulin seretagogues may lead to reurrent hypoglyemia unless further food is ingested after reovery. Gluagon Those in lose ontat with, or having ustodial are of, people with hypoglyemiaprone diabetes (family members, roommates, shool personnel, hild are providers, orretional institution staff, or oworkers) should be instruted on the use of gluagon kits. An individual does not need to be a health are professional to safely administer gluagon. A gluagon kit requires a presription. Care should be taken to ensure that gluagon kits are not expired. Hypoglyemia Prevention Hypoglyemia prevention is a ritial omponent of diabetes management. SMBG and, for some patients, CGM are essential tools to assess therapy and detet inipient hypoglyemia. Patients should understand situations that inrease their risk of hypoglyemia, suh as fasting for tests or proedures, during or after intense exerise, and during sleep. Hypoglyemia may inrease the risk of harm to self or others, suh as with driving. Teahing people with diabetes to balane insulin use and arbohydrate intake and exerise are neessary, but these strategies are not always suffiient for prevention. In type 1 diabetes and severely insulin-defiient type 2 diabetes, hypoglyemia unawareness (or hypoglyemiaassoiated autonomi failure) an severely ompromise stringent diabetes ontrol and quality of life. This syndrome is haraterized by defiient ounterregulatory hormone release, espeially in older adults, and a diminished autonomi response, whih both are 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 ounterregulation and awareness to some extent in many patients (56). Hene, patients with one or more episodes of severe hypoglyemia may benefitfromatleast short-term relaxation of glyemi targets. INTERCURRENT ILLNESS For further information on management of patients with hyperglyemia in the hospital, please refer to Setion 13. Diabetes Care in the Hospital, Nursing

40 are.diabetesjournals.org Position Statement S39 Home, and Skilled Nursing Faility. Stressful events (e.g., illness, trauma, surgery, et.) frequently aggravate glyemi ontrol and may preipitate diabeti ketoaidosis or nonketoti hyperosmolar state, life-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; ketosis-prone patients also require urine or blood ketone monitoring. If aompanied by ketosis, vomiting, or alteration in level of onsiousness, marked hyperglyemia requires temporary adjustment of the treatment regimen and immediate interation with the diabetes are team. The patient treated with noninsulin therapies or medial nutrition therapy 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. A physiian with expertise in diabetes management should treat the hospitalized patient. For further information on diabeti ketoaidosis management or hyperglyemi nonketoti hyperosmolar state, please refer to the ADA statement Hyperglyemi Crises in Adult Patients With Diabetes (57). Referenes 1. The Diabetes Control and Compliations Trial Researh Group. The effet of intensive treatment of diabetes on the development and progression of long-term ompliations in insulin-dependent diabetes mellitus. N Engl J Med 1993;329: Miller KM, Bek RW, Bergenstal RM, et al.; T1D Exhange Clini Network. Evidene of a strong assoiation between frequeny of selfmonitoring of blood gluose and hemoglobin A1 levels in T1D Exhange lini registry partiipants. Diabetes Care 2013;36: Saks DB, Arnold M, Bakris GL, et al.; National Aademy of Clinial Biohemistry. Position statement exeutive summary: guidelines and reommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Diabetes Care 2011;34: Wang J, Zgibor J, Matthews JT, Charron- Prohownik D, Sereika SM, Siminerio L. Selfmonitoring of blood gluose is assoiated with problem-solving skills in hyperglyemia and hypoglyemia. Diabetes Edu 2012;38: Polonsky WH, Fisher L, Shikman CH, et al. Strutured self-monitoring of blood gluose signifiantly redues A1C levels in poorly ontrolled, noninsulin-treated type 2 diabetes: results from the Strutured Testing Program study. Diabetes Care 2011;34: Ziegler R, Heidtmann B, Hilgard D, Hofer S, Rosenbauer J, Holl R; DPV-Wiss-Initiative. Frequeny of SMBG orrelates with HbA1 and aute ompliations in hildren and adolesents with type 1 diabetes. Pediatr Diabetes 2011;12: Farmer A, Wade A, Goyder E, et al. Impat of self monitoring of blood gluose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. BMJ 2007;335: O Kane MJ, Bunting B, Copeland M, Coates VE; ESMON Study Group. Effiay of self monitoring of blood gluose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised ontrolled trial. BMJ 2008;336: Simon J, Gray A, Clarke P, Wade A, Neil A, Farmer A; Diabetes Glyaemi Eduation and Monitoring Trial Group. Cost effetiveness of self monitoring of blood gluose in patients with non-insulin treated type 2 diabetes: eonomi evaluation of data from the DiGEM trial. BMJ 2008;336: Willett LR. ACP Journal Club. Meta-analysis: self-monitoring in non-insulin-treated type 2 diabetes improved HbA1 by 0.25%. Ann Intern Med 2012;156:JC6 JC Malanda UL, Welshen LM, Riphagen II, Dekker JM, Nijpels G, Bot SD. Self-monitoring of blood gluose in patients with type 2 diabetes mellitus who are not using insulin. Cohrane Database Syst Rev 2012;1:CD Tamborlane WV, Bek RW, Bode BW, et al.; Juvenile Diabetes Researh Foundation Continuous Gluose Monitoring Study Group. Continuous gluose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008;359: Wong JC, Foster NC, Maahs DM, et al.; T1D Exhange Clini Network. Real-time ontinuous gluose monitoring among partiipants in the T1D Exhange lini registry. Diabetes Care 2014;37: Hommel E, Olsen B, Battelino T, et al.; SWITCH Study Group. Impat of ontinuous gluose monitoring on quality of life, treatment satisfation, and use of medial are resoures: analyses from the SWITCH study. Ata Diabetol 2014;51: Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effet of ontinuous gluose monitoring on hypoglyemia in type 1 diabetes. Diabetes Care 2011;34: Bek RW, Hirsh IB, Laffel L, et al.; Juvenile Diabetes Researh Foundation Continuous Gluose Monitoring Study Group. The effet of ontinuous gluose monitoring in well-ontrolled type 1 diabetes. Diabetes Care 2009;32: Yeh H-C, Brown TT, Maruthur N, et al. Comparative effetiveness and safety of methods of insulin delivery and gluose monitoring for diabetes mellitus: a systemati review and metaanalysis. Ann Intern Med 2012;157: Choudhary P, Ramasamy S, Green L, et al. Real-time ontinuous gluose monitoring signifiantly redues severe hypoglyemia in hypoglyemia-unaware patients with type 1 diabetes. Diabetes Care 2013;36: Bergenstal RM, Klonoff DC, Garg SK, et al.; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for redution of hypoglyemia. N Engl J Med 2013;369: MQueen RB, Ellis SL, Maahs DM, Anderson HD, Nair KV, Campbell JD. Frequeny of ontinuous gluose monitoring use and hange in hemoglobin A1 for adults with type 1 diabetes in a linial pratie setting. Endor Prat 2014;20: Wei N, Zheng H, Nathan DM. Empirially establishing blood gluose targets to ahieve HbA1 goals. Diabetes Care 2014;37: Albers JW, Herman WH, Pop-Busui R, et al.; Diabetes Control and Compliations Trial/ Epidemiology of Diabetes Interventions and Compliations Researh Group. Effet of prior intensive insulin treatment during the Diabetes Control and Compliations Trial (DCCT) on peripheral neuropathy in type 1 diabetes during the Epidemiology of Diabetes Interventions and Compliations (EDIC) study. Diabetes Care 2010;33: Stratton IM, Adler AI, Neil HAW, et al. Assoiation of glyaemia with marovasular and mirovasular ompliations of type 2 diabetes (UKPDS 35): prospetive observational study. BMJ 2000;321: Jovanovič L, Savas H, Mehta M, Trujillo A, Pettitt DJ. Frequent monitoring of A1C during pregnany as a treatment tool to guide therapy. Diabetes Care 2011;34: Nathan DM, Kuenen J, Borg R, Zheng H, Shoenfeld D, Heine RJ; A1-Derived Average Gluose Study Group. Translating the A1C assay into estimated average gluose values. Diabetes Care 2008;31: Wilson DM, Kollman; Diabetes Researh in Children Network (DireNet) Study Group. Relationship of A1C to gluose onentrations in hildren with type 1 diabetes: assessments by high-frequeny gluose determinations by sensors. Diabetes Care 2008;31: Buse JB, Kaufman FR, Linder B, Hirst K, El Ghormli L, Willi S; HEALTHY Study Group. Diabetes sreening with hemoglobin A(1) versus fasting plasma gluose in a multiethni middleshool ohort. Diabetes Care 2013;36: Kamps JL, Hempe JM, Chalew SA. Raial disparity in A1C independent of mean blood gluose in hildren with type 1 diabetes. Diabetes Care 2010;33: The Diabetes Control and Compliations Trial/Epidemiology of Diabetes Interventions and Compliations Researh Group. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med 2000;342: Martin CL, Albers J, Herman WH, et al.; DCCT/EDIC Researh Group. Neuropathy among the Diabetes Control and Compliations Trial ohort 8 years after trial ompletion. Diabetes Care 2006;29: Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabeti mirovasular ompliations in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospetive 6-year study. Diabetes Res Clin Prat 1995;28: UK Prospetive Diabetes Study (UKPDS) Group. Effet of intensive blood-gluose ontrol with metformin on ompliations in overweight patients with type 2 diabetes (UKPDS 34). Lanet 1998;352:

41 S40 Position Statement Diabetes Care Volume 38, Supplement 1, January UK Prospetive Diabetes Study (UKPDS) Group. Intensive blood-gluose ontrol with sulphonylureas or insulin ompared with onventional treatment and risk of ompliations in patients with type 2 diabetes (UKPDS 33). Lanet 1998;352: Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HAW. 10-year follow-up of intensive gluose ontrol in type 2 diabetes. N Engl J Med 2008;359: Dukworth W, Abraira C, Moritz T, et al.; VADT Investigators. Gluose ontrol and vasular ompliations in veterans with type 2 diabetes. N Engl J Med 2009;360: Patel A, MaMahon S, Chalmers J, et al.; ADVANCE Collaborative Group. Intensive blood gluose ontrol and vasular outomes in patients with type 2 diabetes. N Engl J Med 2008;358: Ismail-Beigi F, Craven T, Banerji MA, et al.; ACCORD trial group. Effet of intensive treatment of hyperglyaemia on mirovasular outomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lanet 2010;376: Adler AI, Stratton IM, Neil HAW, et al. Assoiation of systoli blood pressure with marovasular and mirovasular ompliations of type 2 diabetes (UKPDS 36): prospetive observational study. BMJ 2000;321: Gerstein HC, Miller ME, Byington RP, et al.; Ation to Control Cardiovasular Risk in Diabetes Study Group. Effets of intensive gluose lowering in type 2 diabetes. N Engl J Med 2008;358: Nathan DM, Cleary PA, Baklund J-YC, et al.; Diabetes Control and Compliations Trial/Epidemiology of Diabetes Interventions and Compliations (DCCT/EDIC) Study Researh Group. Intensive diabetes treatment and ardiovasular disease in patients with type 1 diabetes. N Engl J Med 2005;353: Nathan DM, Zinman B, Cleary PA, et al.; Diabetes Control and Compliations Trial/ Epidemiology of Diabetes Interventions and Compliations (DCCT/EDIC) Researh Group. Modern-day linial ourse of type 1 diabetes mellitus after 30 years duration: the Diabetes Control and Compliations Trial/Epidemiology of Diabetes Interventions and Compliations and Pittsburgh Epidemiology of Diabetes Compliations Experiene ( ). Arh Intern Med 2009;169: Skyler JS, Bergenstal R, Bonow RO, et al. Intensive glyemi ontrol and the prevention of ardiovasular 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. Diabetes Care 2009;32: Turnbull FM, Abraira C, Anderson RJ, et al. Intensive gluose ontrol and marovasular outomes in type 2 diabetes. Diabetologia 2009;52: Dukworth WC, Abraira C, Moritz TE, et al.; Investigators of the VADT. The duration of diabetes affets the response to intensive gluose ontrol in type 2 subjets: the VA Diabetes Trial. J Diabetes Compliations 2011;25: Inzuhi SE, Bergenstal RM, Buse JB, et al. Management of hyperglyemia in type 2 diabetes, 2015: a patient-entered approah. Update to a position statement of the Amerian Diabetes Assoiation and the European Assoiation for the Study of Diabetes. Diabetes Care 2015; 38: Amerian Diabetes Assoiation. Postprandial blood gluose. Diabetes Care 2001;24: Ceriello A, Taboga C, Tonutti L, et al. Evidene for an independent and umulative effet of postprandial hypertriglyeridemia and hyperglyemia on endothelial dysfuntion and oxidative stress generation: effets of short- and long-term simvastatin treatment. Cirulation 2002;106: Raz I, Wilson PWF, Strojek K, et al. Effets of prandial versus fasting glyemia on ardiovasular outomes in type 2 diabetes: the HEART2D trial. Diabetes Care 2009;32: Cryer PE. Hypoglyaemia: the limiting fator in the glyaemi management of type I and type II diabetes. Diabetologia 2002;45: Whitmer RA, Karter AJ, Yaffe K, Quesenberry CP Jr, Selby JV. Hypoglyemi episodes and risk of dementia in older patients with type 2 diabetes mellitus. JAMA 2009;301: Punthakee Z, Miller ME, Launer LJ, et al.; ACCORD Group of Investigators; ACCORD- MIND Investigators. Poor ognitive funtion and risk of severe hypoglyemia in type 2 diabetes: post ho epidemiologi analysis of the ACCORD trial. Diabetes Care 2012;35: Jaobson AM, Musen G, Ryan CM, et al.; Diabetes Control and Compliations Trial/ Epidemiology of Diabetes Interventions and Compliations Study Researh Group. Long-term effet of diabetes and its treatment on ognitive funtion. N Engl J Med 2007;356: Zoungas S, Patel A, Chalmers J, et al.; ADVANCE Collaborative Group. Severe hypoglyemia and risks of vasular events and death. N Engl J Med 2010;363: MCoy RG, Van Houten HK, Ziegenfuss JY, ShahND,WermersRA,SmithSA.Inreased mortality of patients with diabetes reporting severe hypoglyemia. Diabetes Care 2012;35: Seaquist ER, Anderson J, Childs B, et al. Hypoglyemia and diabetes: a report of a workgroup of the Amerian Diabetes Assoiation and the Endorine Soiety. Diabetes Care 2013;36: Cryer PE. Diverse auses of hypoglyemiaassoiated autonomi failure in diabetes. N Engl J Med 2004;350: Kitabhi AE, Umpierrez GE, Miles JM, Fisher JN. Hyperglyemi rises in adult patients with diabetes. Diabetes Care 2009;32:

42 Diabetes Care Volume 38, Supplement 1, January 2015 S41 7. Approahes to Glyemi Treatment Diabetes Care 2015;38(Suppl. 1):S41 S48 DOI: /d15-S010 Amerian Diabetes Assoiation PHARMACOLOGICAL THERAPY FOR TYPE 1 DIABETES Reommendations Most people with type 1 diabetes should be treated with multiple-dose insulin (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 Insulin Therapy There are exellent reviews to guide the initiation and management of insulin therapy to ahieve desired glyemi goals (1,2,3). 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 severe hypoglyemia rates in hildren and adults between the two forms of intensive insulin therapy (4). A large randomized trial in type 1 diabeti patients with noturnal hypoglyemia reported that sensor-augmented insulin pump therapy with the threshold suspend feature redued noturnal hypoglyemia, without inreasing glyated hemoglobin values (5). Overall, intensive management through pump therapy/ontinuous gluose monitoring and ative patient/family partiipation should be strongly enouraged (6 8). For seleted individuals who have mastered arbohydrate ounting, eduation on the impat of protein and fat on glyemi exursions an be inorporated into diabetes management (9). The Diabetes Control and Compliations Trial (DCCT) learly showed that intensive insulin therapy (three or more injetions per day of insulin) or CSII (insulin pump therapy) was a key part of improved glyemia and better outomes (10,11). The study was arried out with short- and intermediate-ating human insulins. Despite better mirovasular outomes, intensive insulin therapy was assoiated with a high rate of severe hypoglyemia (62 episodes per 100 patient-years of therapy). Sine the DCCT, a number of rapidating and long-ating insulin analogs have been developed. These analogs are assoiated with less hypoglyemia in type 1 diabetes, while mathing the A1C lowering of human insulins (1,12). POSITION STATEMENT Reommended therapy for type 1 diabetes onsists of the following: 1. Use MDI injetions (three to four injetions per day of basal and prandial insulin) or CSII therapy. 2. Math prandial insulin to arbohydrate intake, premeal blood gluose, and antiipated physial ativity. 3. For most patients (espeially those at an elevated risk of hypoglyemia), use insulin analogs. 4. For patients with frequent noturnal hypoglyemia and/or hypoglyemia unawareness, a sensor-augmented low gluose threshold suspend pump may be onsidered. Pramlintide Pramlintide, an amylin analog, is an agent that delays gastri emptying, blunts panreati seretion of gluagon, and enhanes satiety. It is a U.S. Food and Drug Suggested itation: Amerian Diabetes Assoiation. Approahes to glyemi treatment. Se. 7. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S41 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.

43 S42 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Administration (FDA)-approved therapy for use in type 1 diabetes. It has been shown to indue weight loss and lower insulin dose; however, it is only indiated in adults. Conurrent redution of prandial insulin dosing is required to redue the risk of severe hypoglyemia. Investigational Agents Metformin Adding metformin to insulin therapy may redue insulin requirements and improve metaboli ontrol in overweight/obese patients with poorly ontrolled type 1 diabetes. In a meta-analysis, metformin in type 1 diabetes was found to redue insulin requirements (6.6 U/day, P, 0.001) and led to small redutions in weight and total and LDL holesterol but not to improved glyemi ontrol (absolute A1C redution 0.11%, P ) (13). Inretin-Based Therapies Therapies approved for the treatment of type 2 diabetes are urrently being evaluated in type 1 diabetes. Gluagon-like peptide 1 (GLP-1) agonists and dipeptidyl peptidase 4 (DPP-4) inhibitors are not urrently FDA approved for those with type 1 diabetes, but are being studied in this population. Sodium Gluose Cotransporter 2 Inhibitors Sodium gluose otransporter 2 (SGLT2) inhibitors provide insulin-independent gluose lowering by bloking gluose reabsorption in the proximal renal tubule by inhibiting SGLT2. These agents provide modest weight loss and blood pressure redution. Although there are two FDAapproved agents for use in patients with type 2 diabetes, there are insuffiient data to reommend linial use in type 1 diabetes at this time (14). PHARMACOLOGICAL THERAPY FOR TYPE 2 DIABETES Reommendations Metformin, if not ontraindiated and if tolerated, is the preferred initial pharmaologial agent for type 2 diabetes. A In patients with newly diagnosed type 2 diabetes and markedly symptomati and/or elevated blood gluose levels or A1C, onsider initiating insulin therapy (with or without additional agents). E If noninsulin monotherapy at maximum tolerated dose does not ahieve or maintain the A1C target over 3 months, add a seond oral agent, a GLP-1 reeptor agonist, or basal insulin. A A patient-entered approah should be used to guide hoie of pharmaologial agents. Considerations inlude effiay, ost, potential side effets, weight, omorbidities, hypoglyemia risk, and patient preferenes. E Duetotheprogressivenatureof type 2 diabetes, insulin therapy is eventually indiated for many patients with type 2 diabetes. B An updated Amerian Diabetes Assoiation/European Assoiation for the Study of Diabetes position statement (15) evaluated the data and developed reommendations, inluding advantages and disadvantages, for antihyperglyemi agents for type 2 diabeti patients. A patient-entered approah is stressed, inluding patient preferenes, ost and potential side effets of eah lass, effets on body weight, and hypoglyemia risk. Lifestyle modifiations that improve health (see Setion 4. Foundations of Care) should be emphasized along with any pharmaologial therapy. Initial Therapy Most patients should begin with lifestyle hanges (lifestyle ounseling, weight-loss eduation, exerise, et.). When lifestyle efforts alone have not ahieved or maintained glyemi goals, metformin monotherapy should be added at, or soon after, diagnosis, unless there are ontraindiations or intolerane. Metformin has a long-standing evidene base for effiay and safety, is inexpensive, and may redue risk of ardiovasular events (16). In patients with metformin intolerane or ontraindiations, onsider an initial drug from other lasses depited in Fig. 7.1 under Dual therapy and proeed aordingly. Combination Therapy Although there are numerous trials omparing dual therapy with metformin alone, few diretly ompare drugs as add-on therapy. A omparative effetiveness meta-analysis (17) suggests that overall eah new lass of noninsulin agents added to initial therapy lowers A1Caround %. A omprehensive listing, inluding the ost, is available in Table 7.1. If the A1C target is not ahieved after approximately 3 months, onsider a ombination of metformin and one of these six treatment options: sulfonylurea, thiazolidinedione, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 reeptor agonists, or basal insulin (Fig. 7.1). Drug hoie is based on patient preferenes as well as various patient, disease, and drug harateristis, with the goal of reduing blood gluose levels while minimizing side effets, espeially hypoglyemia. Figure 7.1 emphasizes drugs ommonly used in the U.S. and/or Europe. Rapid-ating seretagogues (meglitinides) may be used instead of sulfonylureas in patients with irregular meal shedules or who develop late postprandial hypoglyemia on a sulfonylurea. Other drugs not shown in the figure (e.g., a-gluosidase inhibitors, olesevelam, bromoriptine, pramlintide) may be tried in speifi situations, but are generally not favored due to modest effiay, the frequeny of administration, and/or side effets. For all patients, onsider initiating therapy with a dual ombination when A1C is $9% to more expeditiously ahieve the target A1C level. Insulin has the advantage of being effetive where other agents may not be and should be onsidered as part of any ombination regimen when hyperglyemia is severe, espeially if symptoms are present or any ataboli features (weight loss, ketosis) are in evidene. Consider initiating ombination insulin injetable therapy when blood gluose is $ mg/dl ( mmol/l) and/or A1C is $10 12%. As the patient s gluose toxiity resolves, the regimen an, potentially, be subsequently simplified. Insulin Therapy Many patients with type 2 diabetes eventually require and benefit from insulin therapy. Providers may wish to onsider regimen flexibility when devising a plan for the initiation and adjustment of insulin therapy in people with type 2 diabetes (Fig. 7.2). The progressive nature of type 2 diabetes and its therapies should be regularly and objetively explained to patients. Providers should avoid using insulin as a threat or desribing it as a failure

44 are.diabetesjournals.org Position Statement S43 Figure 7.1 Antihyperglyemi therapy in type 2 diabetes: general reommendations (15). The order in the hart was determined by historial availability and the route of administration, with injetables to the right; it is not meant to denote any speifi preferene. Potential sequenes of antihyperglyemi therapy for patients with type 2 diabetes are displayed, with the usual transition moving vertially from top to bottom (although horizontal movement within therapy stages is also possible, depending on the irumstanes). DPP-4-i, DPP-4 inhibitor; fxs, fratures; GI, gastrointestinal; GLP-1-RA, GLP-1 reeptor agonist; GU, genitourinary; HF, heart failure; Hypo, hypoglyemia; SGLT2-i, SGLT2 inhibitor; SU, sulfonylurea; TZD, thiazolidinedione. *See ref. 15 for desription of effiay ategorization. Consider starting at this stage when A1C is $9%. Consider starting at this stage when blood gluose is $ mg/dl ( mmol/l) and/or A1C is $10 12%, espeially if symptomati or ataboli features are present, in whih ase basal insulin 1 mealtime insulin is the preferred initial regimen. Usually a basal insulin (NPH, glargine, detemir, deglude). Adapted with permission from Inzuhi et al. (15). or punishment. Equipping patients with an algorithm for self-titration of insulin doses based on self-monitoring of blood gluose (SMBG) improves glyemi ontrol in type 2 diabeti patients initiating insulin (18). Basal insulin alone is the most onvenient initial insulin regimen, beginning at 10 U or U/kg, depending on the degree of hyperglyemia. Basal insulin is usually presribed in onjuntion with metformin and possibly one additional noninsulin agent. If basal insulin has been titrated to an aeptable fasting blood gluose level, but A1C remains above target, onsider advaning to ombination injetable therapy (Fig. 7.2) to over postprandial gluose exursions. Options inlude adding a GLP-1 reeptor agonist or mealtime insulin, onsisting of one to three injetions of rapid-ating insulin analog (lispro, aspart, or glulisine) administered just before eating. A less studied alternative, transitioning from basal insulin to twie-daily premixed (or biphasi) insulin analog (70/30 aspart mix, 75/25 or 50/50 lispro mix), ould also be onsidered. Regular human insulin and human NPH-Regular premixed formulations (70/30) are less ostly alternatives to rapid-ating insulin analogs and premixed insulin analogs, respetively, but their pharmaodynami profiles make them suboptimal for the overage of postprandial gluose exursions. A less ommonly used and more ostly alternative to basal bolus therapy with multiple daily injetions is CSII (insulin pump). In addition to the suggestions provided for determining the starting dose of mealtime insulin under a basal bolus regimen, another method onsists of adding up the total urrent insulin dose and then providing one-half of this amount as basal and one-half as mealtime insulin, the latter split evenly between three meals.

45 S44 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Table 7.1 Properties of available gluose-lowering agents in the U.S. and Europe that may guide individualized treatment hoies in patients with type 2 diabetes (15) Class Compound(s) Cellular mehanism(s) Primary physiologial ation(s) Advantages Disadvantages Cost* Biguanides Metformin Ativates AMP-kinase (? other) Hepati gluose prodution Extensive experiene Gastrointestinal side effets (diarrhea, No hypoglyemia abdominal ramping) CVD events (UKPDS) Lati aidosis risk (rare) Vitamin B 12 defiieny Multiple ontraindiations: CKD, aidosis, hypoxia, dehydration, et. Sulfonylureas 2nd Generation Closes KATP hannels on Insulin seretion Extensive experiene Hypoglyemia Low Glyburide/glibenlamide b-ell plasma membranes Mirovasular risk Weight Glipizide (UKPDS)? Blunts myoardial ishemi Meglitinides (glinides) Glilazide Glimepiride Repaglinide Closes KATP hannels on Nateglinide b-ell plasma membranes Insulin seretion Postprandial gluose exursions Dosing flexibility Low preonditioning Low durability Hypoglyemia Moderate Weight? Blunts myoardial ishemi preonditioning Frequent dosing shedule TZDs Pioglitazone Ativates the nulear Insulin sensitivity No hypoglyemia Weight Low Rosiglitazone transription fator PPAR-g Durability Edema/heart failure HDL-C Bone fratures Triglyerides (pioglitazone) LDL-C (rosiglitazone)? MI (meta-analyses, rosiglitazone) a-gluosidase inhibitors Aarbose Inhibits intestinal a-gluosidase Slows intestinal arbohydrate digestion/absorption? CVD events (PROative, pioglitazone) Miglitol Postprandial gluose exursions DPP-4 inhibitors Sitagliptin Inhibits DPP-4 ativity, Vildagliptin inreasing postprandial Bile aid sequestrants Saxagliptin Linagliptin Alogliptin ative inretin (GLP-1, GIP) onentrations Colesevelam Binds bile aids in intestinal trat, inreasing hepati bile aid prodution Insulin seretion (gluose-dependent) Gluagon seretion (gluose-dependent)? Hepati gluose prodution? Inretin levels No hypoglyemia Generally modest A1C effiay Moderate? CVD events (STOP-NIDDM) Gastrointestinal side effets (flatulene, diarrhea) Frequent dosing shedule Nonsystemi No hypoglyemia Angioedema/urtiaria and other High Well tolerated immune-mediated dermatologial effets? Aute panreatitis? Heart failure hospitalizations No hypoglyemia Generally modest A1C effiay High LDL-C Constipation Triglyerides May absorption of other mediations Continued on p. S45

46 are.diabetesjournals.org Position Statement S45 Table 7.1 Continued Class Compound(s) Cellular mehanism(s) Primary physiologial ation(s) Advantages Disadvantages Cost* Dopamine-2 agonists Bromoriptine (quik release) Ativates dopaminergi reeptors SGLT2 inhibitors Canagliflozin Inhibits SGLT2 in the proximal nephron Modulates hypothalami regulation of metabolism Insulin sensitivity Bloks gluose reabsorption by the kidney, inreasing gluosuria No hypoglyemia Generally modest A1C effiay High? CVD events Dizziness/synope (Cyloset Safety Trial) Nausea Fatigue Rhinitis No hypoglyemia Genitourinary infetions High Dapagliflozin Weight Polyuria Empagliflozin Blood pressure Effetive at all stages of T2DM Volume depletion/hypotension/ dizziness LDL-C Creatinine (transient) GLP-1 reeptor Exenatide Ativates GLP-1 reeptors Insulin seretion (gluosedependent) No hypoglyemia Gastrointestinal side effets (nausea/ High agonists Exenatide extended release Liraglutide Gluagon seretion Weight Postprandial gluose vomiting/diarrhea) Heart rate Albiglutide (gluose-dependent) exursions? Aute panreatitis Lixisenatide Dulaglutide Slows gastri emptying Satiety Some ardiovasular risk fators C-ell hyperplasia/medullary thyroid tumors in animals Injetable Training requirements Amylin mimetis Pramlintide Ativates amylin reeptors Gluagon seretion Postprandial gluose Generally modest A1C effiay High Slows gastri emptying Satiety exursions Weight Gastrointestinal side effets (nausea/ vomiting) Hypoglyemia unless insulin dose is simultaneously redued Insulins Rapid-ating analogs Ativates insulin reeptors Gluose disposal Nearly universal Hepati gluose prodution response - Lispro - Aspart - Glulisine Short-ating - Human Regular Intermediate-ating - Human NPH Basal insulin analogs - Glargine - Detemir - Deglude Premixed (several types) Other Theoretially unlimited effiay Mirovasular risk (UKPDS) Injetable Frequent dosing shedule Training requirements Hypoglyemia Variable# Weight gain? Mitogeni effets Injetable Patient relutane Training requirements CKD, hroni kidney disease; CVD, ardiovasular disease; GIP, gluose-dependent insulinotropi peptide; HDL-C, HDL holesterol; LDL-C, LDL holesterol; MI, myoardial infartion; PPAR-g, peroxisome proliferator ativated reeptor g; PROative, Prospetive Pioglitazone Clinial Trial in Marovasular Events (30); STOP-NIDDM, Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (31); TZD, thiazolidinedione; T2DM, type 2 diabetes mellitus; UKPDS, UK Prospetive Diabetes Study (32,33). Cyloset trial of quik-release bromoriptine (34). *Cost is based on lowest-pried member of the lass (see ref. 15). Not liensed in the U.S. Initial onerns regarding bladder aner risk are dereasing after subsequent study. Not liensed in Europe for type 2 diabetes. #Cost is highly dependent on type/brand (analogs. human insulins) and dosage. Adapted with permission from Inzuhi et al. (15).

47 S46 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Figure 7.2 Approah to starting and adjusting insulin in type 2 diabetes (15). FBG, fasting blood gluose; GLP-1-RA, GLP-1 reeptor agonist; hypo, hypoglyemia; mod., moderate; PPG, postprandial gluose; #, number. Adapted with permission from Inzuhi et al. (15). Figure 7.2 fouses solely on sequential insulin strategies, desribing the number of injetions and the relative omplexity and flexibility of eah stage. One an insulin regimen is initiated, dose titration is important, with adjustments made in both mealtime and basal insulins based on the prevailing blood gluose levels and an understanding of the pharmaodynami profile of eah formulation (pattern ontrol). Noninsulin agents may be ontinued, although sulfonylureas, DPP-4 inhibitors, and GLP-1 reeptor agonists are typially stopped one more omplex insulin regimens beyond basal are used. In patients with suboptimal blood gluose ontrol, espeially those requiring inreasing insulin doses, adjuntive use of thiazolidinediones (usually pioglitazone) or SGLT2 inhibitors may be helpful in improving ontrol and reduing the amount of insulin needed. Comprehensive eduation regarding SMBG, diet, exerise, and the avoidane of and response to hypoglyemia are ritially important in any patient using insulin. BARIATRIC SURGERY Reommendations Bariatri surgery may be onsidered for adults with BMI.35 kg/m 2 and type 2 diabetes, espeially if 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. E Bariatriandmetabolisurgeries, either gastri banding or proedures that involve reseting, bypassing, or transposing setions of the stomah and small intestine, an be effetive weight-loss treatments for severe obesity when performed as part of a omprehensive weight-management program with lifelong lifestyle support

48 are.diabetesjournals.org Position Statement S47 and medial monitoring. National guidelines support onsideration for bariatri surgery for people with type 2 diabetes with BMI.35 kg/m 2. Advantages Treatment with bariatri surgery has been shown to ahieve near- or omplete normalization of glyemia 2 years following surgery in 72% of patients (ompared with 16% in a mathed ontrol group treated with lifestyle and pharmaologial interventions) (19). A study evaluated the long-term (3-year) outomes of surgial intervention (Roux-en-Y gastri bypass or sleeve gastretomy) and intensive medial therapy (quarterly visits, pharmaologial therapy, SMBG, diabetes eduation, lifestyle ounseling, and enouragement to partiipate in Weight Wathers) ompared with just intensive medial therapy on ahieving a target A1C #6% among obese patients with unontrolled type 2 diabetes (mean A1C 9.3%). This A1C target was ahieved by 38% (P, 0.001) in the gastri bypass group, 24% (P ) in the sleeve gastretomy group, and 5% in those reeiving medial therapy (20). Diabetes remission rates tend to be higher with proedures that bypass portions of the small intestine and lower with proedures that only restrit the stomah. Younger age, shorter duration of type 2 diabetes, lower A1C, higher serum insulin levels, and nonuse of insulin have all been assoiated with higher remission rates after bariatri surgery (21). Although bariatri surgery has been shown to improve the metaboli profiles of morbidly obese patients with type 1 diabetes, the role of bariatri surgery in suh patients will require larger and longer studies (22). Disadvantages Bariatri surgery is ostly and has assoiated risks. Morbidity and mortality rates diretly related to the surgery have dereased onsiderably in reent years, with 30-day mortality rates now 0.28%, similar to those for laparosopi holeystetomy (23). Outomes vary depending on the proedure and the experiene of the surgeon and enter. Longer-term onerns inlude vitamin and mineral defiienies, osteoporosis, and rare but often severe hypoglyemia from insulin hyperseretion. Cohort studies attempting to math surgial and nonsurgial subjets suggest that the proedure may redue longer-term mortality rates (19). In ontrast, a propensity sore-adjusted analysis of older, severely obese patients in Veterans Affairs Medial Centers found that bariatri surgery was not assoiated with dereased mortality ompared with usual are (mean follow-up 6.7 years) (24). Retrospetive analyses and modeling studies suggest that bariatri surgery may be ost-effetive for patients with type 2 diabetes, but the results are largely dependent on assumptions about the long-term effetiveness and safety of the proedures (25 27). Understanding the 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 therapy as the omparator (28). Unfortunately, suh studies may not be feasible (29). Referenes 1. DeWitt DE, Hirsh IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: sientifi review. JAMA 2003;289: Amerian Diabetes Assoiation. Intensive Diabetes Management. 4thed.WolfsdorfJI,Ed. Alexandria, VA, Amerian Diabetes Assoiation, Mooradian AD, Bernbaum M, Albert SG. Narrative review: a rational approah to starting insulin therapy. Ann Intern Med 2006;145: Yeh H-C, Brown TT, Maruthur N, et al. Comparative effetiveness and safety of methods of insulin delivery and gluose monitoring for diabetes mellitus: a systemati review and metaanalysis. Ann Intern Med 2012;157: Bergenstal RM, Klonoff DC, Garg SK, et al.; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for redution of hypoglyemia. N Engl J Med 2013;369: Wood JR, Miller KM, Maahs DM, et al.; T1D Exhange Clini Network. Most youth with type 1 diabetes in the T1D Exhange lini registry do not meet Amerian Diabetes Assoiation or International Soiety for Pediatri and Adolesent Diabetes linial guidelines. Diabetes Care 2013; 36: Kmietowiz Z. Insulin pumps improve ontrol and redue ompliations in hildren with type 1 diabetes. BMJ 2013;347:f Phillip M, Battelino T, Atlas E, et al. Noturnal gluose ontrol with an artifiial panreas at a diabetes amp. N Engl J Med 2013;368: Wolpert HA, Atakov-Castillo A, Smith SA, Steil GM. Dietary fat autely inreases gluose onentrations and insulin requirements in patients with type 1 diabetes: impliations for arbohydrate-based bolus dose alulation and intensive diabetes management. Diabetes Care 2013;36: The Diabetes Control and Compliations Trial Researh Group. The effet of intensive treatment of diabetes on the development and progression of long-term ompliations in insulin-dependent diabetes mellitus. N Engl J Med 1993;329: Nathan DM, Cleary PA, Baklund J-YC, et al.; Diabetes Control and Compliations Trial/Epidemiology of Diabetes Interventions and Compliations (DCCT/EDIC) Study Researh Group. Intensive diabetes treatment and ardiovasular disease in patients with type 1 diabetes. N Engl J Med 2005;353: Rosenstok J, Dailey G, Massi-Benedetti M, Fritshe A, Lin Z, Salzman A. Redued hypoglyemia risk with insulin glargine: a meta-analysis omparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care 2005; 28: Vella S, Buetow L, Royle P, Livingstone S, Colhoun HM, Petrie JR. The use of metformin in type 1 diabetes: a systemati review of effiay. Diabetologia 2010;53: Chiang JL, Kirkman MS, Laffel LM, Peters AL; Type 1 Diabetes Sourebook Authors. Type 1 diabetes through the life span: a position statement of the Amerian Diabetes Assoiation. Diabetes Care 2014;37: Inzuhi SE, Bergenstal RM, Buse JB, et al. Management of hyperglyemia in type 2 diabetes, 2015: a patient-entered approah. Update to a position statement of the Amerian Diabetes Assoiation and the European Assoiation for the Study of Diabetes. Diabetes Care 2015; 38: Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive gluose ontrol in type 2 diabetes. N Engl J Med 2008;359: Bennett WL, Maruthur NM, Singh S, et al. Comparative effetiveness and safety of mediations for type 2 diabetes: an update inluding new drugs and 2-drug ombinations. Ann Intern Med 2011;154: Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-direted titration for ahieving glyaemi goals using a one-daily basal insulin analogue: an assessment of two different fasting plasma gluose targets - the TITRATE study. Diabetes Obes Metab 2009;11: Sjöström L, Peltonen M, Jaobson P, et al. Assoiation of bariatri surgery with long-term remission of type 2 diabetes and with mirovasular and marovasular ompliations. JAMA 2014;311: Shauer PR, Bhatt DL, Kirwan JP, et al.; STAMPEDE Investigators. Bariatri surgery versus intensive medial therapy for diabetesd 3-year outomes. N Engl J Med 2014;370: Still CD, Wood GC, Benotti P, et al. Preoperative predition of type 2 diabetes remission after Roux-en-Y gastri bypass surgery: a retrospetive ohort study. Lanet Diabetes Endorinol 2014;2: Brethauer SA, Aminian A, Rosenthal RJ, Kirwan JP, Kashyap SR, Shauer PR. Bariatri surgery improves the metaboli profile of morbidly obese patients with type 1 diabetes. Diabetes Care 2014;37:e51 e Buhwald H, Estok R, Fahrbah K, Banel D, Sledge I. Trends in mortality in bariatri surgery:

49 S48 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 a systemati review and meta-analysis. Surgery 2007;142: Maiejewski ML, Livingston EH, Smith VA, et al. Survival among high-risk patients after bariatri surgery. JAMA 2011;305: Hoerger TJ, Zhang P, Segel JE, Kahn HS, Barker LE, Couper S. Cost-effetiveness of bariatri surgery for severely obese adults with diabetes. Diabetes Care 2010;33: Makary MA, Clark JM, Shore AD, et al. Mediation utilization and annual health are osts in patients with type 2 diabetes mellitus before and after bariatri surgery. Arh Surg 2010;145: Keating CL, Dixon JB, Moodie ML, Peeters A, Playfair J, O Brien PE. Cost-effiay of surgially indued weight loss for the management of type 2 diabetes: a randomized ontrolled trial. Diabetes Care 2009;32: Wolfe BM, Belle SH. Long-term risks and benefits of bariatri surgery: a researh hallenge. JAMA 2014;312: Couroulas AP, Goodpaster BH, Eagleton JK, et al. Surgial vs medial treatments for type 2 diabetes mellitus: a randomized linial trial. JAMA Surg 2014;149: Dormandy JA, Charbonnel B, Ekland DJ, et al.; PROative Investigators. Seondary prevention of marovasular events in patients with type 2 diabetes in the PROative Study (PROspetive pioglitazone Clinial Trial In marovasular Events): a randomised ontrolled trial. Lanet 2005;366: Chiasson JL, Gomis R, Hanefeld M, Josse RG, Karasik A, Laakso M; STOP-NIDDM Trial Researh Group. The STOP-NIDDM Trial: an international study on the effiay of an alphagluosidase inhibitor to prevent type 2 diabetes in a population with impaired gluose tolerane: rationale, design, and preliminary sreening data. Diabetes Care 1998;21: UK Prospetive Diabetes Study (UKPDS) Group. Intensive blood-gluose ontrol with sulphonylureas or insulin ompared with onventional treatment and risk of ompliations in patients with type 2 diabetes (UKPDS 33). Lanet 1998;352: UK Prospetive Diabetes Study (UKPDS) Group. Effet of intensive blood-gluose ontrol with metformin on ompliations in overweight patients with type 2 diabetes (UKPDS 34). Lanet 1998;352: Gaziano JM, Cinotta AH, O Connor CM, et al. Randomized linial trial of quik-release bromoriptine among patients with type 2 diabetes on overall safety and ardiovasular outomes. Diabetes Care 2010;33:

50 Diabetes Care Volume 38, Supplement 1, January 2015 S49 8. Cardiovasular Disease and Risk Management Diabetes Care 2015;38(Suppl. 1):S49 S57 DOI: /d15-S011 Amerian Diabetes Assoiation For prevention and management of diabetes ompliations in hildren and adolesents, please refer to Setion 11. Children and Adolesents. Cardiovasular disease (CVD) is the major ause of morbidity and mortality for individuals with diabetes and is 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 people with diabetes. Large benefits are seen when multiple risk fators are addressed globally (1,2). 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 (3). HYPERTENSION/BLOOD PRESSURE CONTROL 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 POSITION STATEMENT Goals People with diabetes and hypertension should be treated to a systoli blood pressure (SBP) goal of,140 mmhg. A Lower systoli targets, suh as,130 mmhg, may be appropriate for ertain individuals, suh as younger patients, if they an be ahieved without undue treatment burden. C Individuals with diabetes should be treated to a diastoli blood pressure (DBP),90 mmhg. A Lower diastoli targets, suh as,80 mmhg, may be appropriate for ertain individuals, suh as younger patients, if they an be ahieved without undue treatment burden. B Treatment Patients with blood pressure.120/80 mmhg should be advised on lifestyle hanges to redue blood pressure. B Patients with onfirmed offie-based blood pressure higher than 140/90 mmhg should, in addition to lifestyle therapy, have prompt initiation and timely subsequent titration of pharmaologial therapy to ahieve blood pressure goals. A Lifestyle therapy for elevated blood pressure onsists of weight loss, if overweight or obese; a 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 omprise a regimen that inludes either an ACE inhibitor or an angiotensin reeptor bloker (ARB). B If one lass is not tolerated, the other should be substituted. C Multiple-drug therapy (inluding a thiazide diureti and ACE inhibitor/arb, at maximal doses) is generally required to ahieve blood pressure targets. B Suggested itation: Amerian Diabetes Assoiation. Cardiovasular disease and risk management. Se. 8. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1): S49 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.

51 S50 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 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 targets of /65 79 mmhg are suggested in the interest of optimizing long-term maternal health and minimizing impaired fetal growth. ACE inhibitors and ARBs are ontraindiated during pregnany. E Hypertension is a ommon diabetes omorbidity that affets the majority of patients, with the 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 Blood pressure measurement should be done by a trained individual and follow the guidelines established for the general population: 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 evidene of white oat hypertension, masked hypertension, or other disrepanies between offie and true blood pressure. Studies in individuals without diabetes found that home measurements may better orrelate with CVD risk than offie measurements (4,5). However, most of the evidene of benefits of hypertension treatment in people with diabetes is based on offie 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 SBP.120 mmhg predits long-term end-stage renal disease. Randomized linial trials have demonstrated the benefit (redution of CHD events, stroke, and diabeti kidney disease) of lowering blood pressure to,140 mmhg systoli and,90 mmhg diastoli in individuals with diabetes (6). There is limited prespeified linial trial evidene for the benefits of lower SBP or DBP targets (7). A meta-analysis of randomized trials of adults with type 2 diabetes omparing intensive blood pressure targets (upper limit of 130 mmhg systoli and 80 mmhg diastoli) to standard targets (upper limit of mmhg systoli and mmhg diastoli)foundnosignifiant redution in mortality or nonfatal myoardial infartion (MI). There was a statistially signifiant 35% relative risk (RR) redution in stroke with intensive targets, but the absolute risk redution was only 1%, and intensive targets were assoiated with an inreased risk for adverse events suh as hypotension and synope (8). Given the epidemiologial relationship between lower blood pressure and better long-term linial outomes, two landmark trials, Ation to Control Cardiovasular Risk in Diabetes (ACCORD) andationindiabetesandvasular Disease: Preterax and Diamiron MR Controlled Evaluation Blood Pressure (ADVANCE-BP), were onduted in the past deade to examine the benefit of tighter blood pressure ontrol in patients with type 2 diabetes. The ACCORD trial examined whether a lower SBP of,120 mmhg, in type 2 diabeti patients at high risk for CVD, provided greater ardiovasular protetion than an SBP level of mmhg (9). The study did not find a benefitinprimary end point (nonfatal MI, nonfatal stroke, and ardiovasular death) omparing intensive blood pressure treatment (goal,120 mmhg, average blood pressure ahieved 5 119/64 mmhg on 3.4 mediations) with standard treatment (average blood pressure ahieved 5 143/70 mmhg on 2.1 mediations). In ACCORD, there was no benefit of aggressive blood pressure lowering, despite the extra ost and efforts. InADVANCE,theativebloodpressure intervention arm (a single-pill, fixed-dose ombination of perindopril and indapamide) showed a signifiant redution in the risk of the primary omposite end point (major marovasular or mirovasular event), as well as signifiant redutions in the risk of death from any ause and of death from ardiovasular auses (10). The baseline blood pressure among the study subjets was 145/81 mmhg. Compared with the plaebo group, the patients treated with a single-pill, fixed-dose ombination of perindopril and indapamide experiened an average redution of 5.6 mmhg in SBP and 2.2 mmhg in DBP. The final blood pressure in the treated group was 136/73 mmhg, not quite the intensive or tight ontrol ahieved in ACCORD. Reently published 6-year follow-up of the ADVANCE-BP study reported that the redutions in the risk of death from any ause and of death from ardiovasular auses in the intervention group were attenuated, but remained signifiant (11). These results undersore the important linial differene between patients who are able to easily ahieve lower blood pressure levels (e.g., as seen in observational epidemiology studies) and patients who require intensive medial management to ahieve these goals (e.g., the linial trials). Systoli Blood Pressure The lear body of evidene that SBP.140 mmhg is harmful suggests that liniians should promptly initiate and titrate therapyinanongoingfashiontoahieveand maintain SBP,140 mmhg in virtually all patients. Patients with long life expetany may have renal benefits from long-term intensive blood pressure ontrol. Additionally, individuals in whom stroke risk is a onern may, as part of shared deision making, have appropriately lower systoli targets suh as,130 mmhg. This is espeially true if lower blood pressure an be ahieved with few drugs and without side effets of therapy. Diastoli Blood Pressure Similarly, the learest evidene from randomized linial trials supports DBP targets of,90 mmhg. Prior reommendations for lower DBP targets (,80 mmhg) were based primarily on a post ho analysis of the Hypertension Optimal Treatment (HOT) trial (12). This level may still be appropriate for patients with long life expetany and those with hroni kidney disease and elevated urine albumin exretion (12). The 2015 Amerian Diabetes Assoiation (ADA) Standards of Care have been revised to reflet the higher-quality evidene that exists to support a goal of DBP,90 mmhg, although lower targets may be appropriate

52 are.diabetesjournals.org Position Statement S51 for ertain individuals. This is in harmonization with a reent publiation by the Eighth Joint National Committee that reommended, for individuals over 18 years of age with diabetes, a DBP threshold of,90 mmhg and SBP,140 mmhg (7). Treatment Strategies Lifestyle Modifiations 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 evaluated the impat of healthy dietary patterns in individuals without diabetes and has shown antihypertensive effets similar to those of pharmaologial monotherapy. Lifestyle therapy onsists of restriting sodium intake (,2,300 mg/day); reduing 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 2 servings per day in men and no more than 1 serving per day in women) (13); and inreasing ativity levels (14). For individuals with diabetes and hypertension, setting a sodium intake goal of,1,500 mg/day should be onsidered on an individual basis. These lifestyle (nonpharmaologial) strategies may also positively affet glyemia and lipid ontrol and should be enouraged in those with even mildly elevated blood pressure. The effets of lifestyle therapy on ardiovasular events have not been established. Nonpharmaologial therapy is reasonable in individuals with diabetes and mildly elevated blood pressure (SBP.120 mmhg or DBP.80 mmhg). If the blood pressure is onfirmed to be $140 mmhg systoli and/or $90 mmhg diastoli, pharmaologial therapy should be initiated along with nonpharmaologial therapy (14). To enable long-term adherene, lifestyle therapy should be adapted to suit the needs of the patient and disussed as part of diabetes management. Pharmaologial Interventions Lowering of blood pressure with regimens based on a variety of antihypertensive agents, inluding ACE inhibitors, ARBs, b-blokers, diuretis, and alium hannel blokers, has been shown to be effetive in reduing ardiovasular events. Several studies have suggested that ACE inhibitors may be superior to dihydropyridine alium hannel blokers in reduing ardiovasular events (15 17). However, several studies have also shown no speifi advantage to ACE inhibitors as initial treatment of hypertension in the general hypertensive population, while showing an advantage of initial therapy with low-dose thiazide diuretis on ardiovasular outomes (14,18,19). In people with diabetes, inhibitors of the renin-angiotensin system (RAS) may have unique advantages for initial or early treatment of hypertension. In a trial of individuals at high risk for CVD, inluding a large subset with diabetes, an ACE inhibitor redued CVD outomes (20). In patients with ongestive heart failure (CHF), inluding subgroups with diabetes, ARBs have been shown to redue major CVD outomes (21 24). In type 2 diabeti patients with signifiant diabeti kidney disease, ARBs were superior to alium hannel blokers for reduing heart failure (25). Although evidene for distint advantages of RAS inhibitors on CVD outomes in diabetes remains onfliting (10,19), the high CVD risks assoiated with diabetes, and thehighprevaleneofundiagnosed CVD, may still favor reommendations for their use as first-line hypertension therapy in people with diabetes (14). 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 death from ardiovasular auses and total mortality. The improved outomes ould also have been due to lower ahieved blood pressure in the perindoprilindapamide arm (10). Another trial showed a derease in morbidity and mortality in those reeiving benazepril and amlodipine versus benazepril and hydrohlorothiazide (HCTZ). The ompelling benefits of RAS inhibitors in diabeti patients with albuminuria or renal insuffiieny provide additional rationale for these agents (see Setion 9. Mirovasular Compliations and Foot Care). 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. Growing evidene suggests that there is an assoiation between inrease in sleeptime blood pressure and inidene of CVD events. A randomized ontrolled trial 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 (26). Consider administering one or more antihypertensive mediations at bedtime (27). An important aveat is that most patients with hypertension require multipledrug therapy to reah treatment goals (13). Identifying and addressing barriers to mediation adherene (suh as ost and side effets) should routinely be done. If blood pressure remains unontrolled 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. Pregnany and Antihypertensive Mediations In a pregnany ompliated by diabetes and hroni hypertension, target blood pressure goals of SBP mmhg and DBP mmhg are reasonable, as they ontribute to improved 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, sine they may 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 may redue uteroplaental perfusion (28). DYSLIPIDEMIA/LIPID MANAGEMENT Reommendations Sreening In adults, a sreening lipid profile is reasonable at the time of first diagnosis, at the initial medial evaluation, and/or at age 40 years and periodially (e.g., every 1 2 years) thereafter. E

53 S52 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Treatment Reommendations and Goals Lifestyle modifiation fousing on the redution of saturated fat, trans fat, and holesterol intake; inrease of omega-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 Intensify lifestyle therapy and optimize glyemi ontrol for patients with elevated triglyeride levels ($150 mg/dl [1.7 mmol/l]) and/or low HDL holesterol (,40 mg/dl [1.0 mmol/l] for men,,50 mg/dl [1.3 mmol/l] for women). C For patients with fasting triglyeride levels $500 mg/dl (5.7 mmol/l), evaluate for seondary auses and onsider medial therapy to redue risk of panreatitis. C For patients of all ages with diabetes and overt CVD, high-intensity statin therapy should be added to lifestyle therapy. A For patients with diabetes aged,40 years with additional CVD risk fators, onsider using moderateor high-intensity statin and lifestyle therapy. C For patients with diabetes aged years without additional CVD risk fators, onsider using moderate-intensity statin and lifestyle therapy. A For patients with diabetes aged years with additional CVD risk fators, onsider using high-intensity statin and lifestyle therapy. B For patients with diabetes aged.75 years without additional CVD risk fators, onsider using moderate-intensity statin therapy and lifestyle therapy. B For patients with diabetes aged.75 years with additional CVD risk fators, onsider using moderate- or high-intensity statin therapy and lifestyle therapy. B In linial pratie, providers may need to adjust intensity of statin therapy based on individual patient response to mediation (e.g., side effets, tolerability, LDL holesterol levels). E Cholesterol laboratory testing may be helpful in monitoring adherene to therapy, but may not be needed one the patient is stable on therapy. E Combination therapy (statin/ fibrate and statin/niain) has not been shown to provide additional ardiovasular benefit abovestatin therapy alone and is not generally reommended. A Statin therapy is ontraindiated in pregnany. B Lifestyle Intervention Lifestyle intervention, inluding MNT, inreased physial ativity, weight loss, and smoking essation, may allow some patients to redue CVD risk fators, suh as by lowering LDL holesterol. Nutrition intervention should be tailored aording to eah patient s age, diabetes type, pharmaologial treatment, lipid levels, and medial onditions. Reommendations should fous on reduing saturated fat, holesterol, and trans unsaturated fat intake and inreasing omega-3 fatty aids and visous fiber (suh as in oats, legumes, and itrus). Glyemi ontrol an also benefiially modify plasma lipid levels, partiularly in patients with very high triglyerides and poor glyemi ontrol. Statin Treatment Initiating Statin Therapy Based on Risk Patients with type 2 diabetes have an inreased prevalene of lipid abnormalities, ontributing to their high risk of CVD. Multiple linial trials have demonstrated signifiant effets of pharmaologial (primarily statin) therapy on CVD outomes in individual subjets with CHD and for primary CVD prevention (29,30). Subgroup analyses of diabeti patients in larger trials (31 35) and trials in patients with diabetes (36,37) showed signifiant primary and seondary prevention of CVD events 1/2 CHD deaths in patients with diabetes. Metaanalyses, inluding data from over 18,000 patients with diabetes from 14 randomized trials of statin therapy (mean follow-up 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 (38). As in those without diabetes, absolute redutions in objetive CVD outomes (CHD death and nonfatal MI) are greatest in people with high baseline CVD risk (known CVD and/or very high LDL holesterol levels), but the overall benefits of statin therapy in people with diabetes at moderate or high risk for CVD are onvining (39,40). Statins are the drugs of hoie for LDL holesterol lowering and ardioprotetion. Most trials of statins and CVD outomes tested speifi doses of statins against plaebo or other statins, rather than aiming for speifi LDL holesterol goals (41). In light of this fat, the 2015 ADA Standards of Care have been revised to reommend when to initiate and intensify statin therapy (high versus moderate) basedonriskprofile (Table 8.1). The Amerian College of Cardiology/ Amerian Heart Assoiation new Pooled Cohort Equation, the Risk Calulator, may be a useful tool to estimate 10- year atherosleroti CVD ( Sine diabetes itself onfers inreased risk for CVD, the Risk Calulator has limited use for assessing risk in individuals with diabetes. The following reommendations are Table 8.1 Reommendations for statin treatment in people with diabetes Reommended Age Risk fators statin dose* Monitoring with lipid panel,40 years None None Annually or as needed to monitor CVD risk fator(s)** Moderate or high for adherene Overt CVD*** High years None Moderate As needed to monitor adherene CVD risk fators High Overt CVD High.75 years None Moderate As needed to monitor adherene CVD risk fators Moderate or high Overt CVD High *In addition to lifestyle therapy. **CVD risk fators inlude LDL holesterol $100 mg/dl (2.6 mmol/l), high blood pressure, smoking, and overweight and obesity. ***Overt CVD inludes those with previous ardiovasular events or aute oronary syndromes.

54 are.diabetesjournals.org Position Statement S53 supported by evidene from trials fousing speifially on patients with diabetes. Age 40 Years In all patients with diabetes aged $40 years, and if linially indiated, moderateintensity statin treatment should be onsidered, in addition to lifestyle therapy. Clinial trials in high-risk patients, suh as those with aute oronary syndromes or previous ardiovasular events (42 44), have demonstrated that more aggressive therapy with high doses of statins led to a signifiant redution in further events. Therefore, in patients with inreased ardiovasular risk (e.g., LDL holesterol $100 mg/dl [2.6 mmol/l], high blood pressure, smoking, and overweight/obesity) or with overt CVD, high-dose statins are reommended. For adults with diabetes over 75 years of age, there are limited data regarding statin therapy. Statin therapy should be individualized based on risk profile. High-dose statins, if well tolerated, may still be appropriate and are reommended for older adults with overt CVD. However, the riskbenefit profile should be routinely evaluated in this population, with downward titration (e.g., high to moderate intensity) performed as needed. See Setion 10. Older Adults for more details on linial onsiderations for this unique population. Age <40 Years and/or Type 1 Diabetes Very little linial trial evidene exists for type 2 diabeti patients under the age of 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 proportionately similar, although not statistially signifiant, redution in risk to patients with type 2 diabetes (32). Even though the data are not definitive, similar statin treatment approahes should be onsidered for both type 1 and type 2 diabeti patients, partiularly in the presene of ardiovasular risk fators. Please refer to Type 1 Diabetes Mellitus and Cardiovasular Disease: A Sientifi Statement From the Amerian Heart Assoiation andameriandiabetesassoiation (45) for additional disussion. Treatment with a moderate dose of statin should be onsidered if the patient has inreased ardiovasular risk (e.g., ardiovasular risk fators suh as LDL holesterol $100 mg/dl) and with a high dose of statin if the patient has overt CVD. Ongoing Therapy and Monitoring With Lipid Panel In adults with diabetes, a sreening lipid profile (total holesterol, LDL holesterol, HDL holesterol, and triglyerides) is reasonable at the time of first diagnosis, at the initial medial evaluation, and/or at age 40 and periodially (e.g., every 1 2 years) thereafter. One a patient is on a statin, testing for LDL holesterol may be onsidered on an individual basis to, for example, monitor adherene and effiay. In ases where patients are adherent, but LDL holesterol level is not responding, linial judgment is reommended to determine the need for and timing of lipid panels. In individual patients, the highly variable LDL holesterol lowering response seen with statins is poorly understood (46). Redution of CVD events with statins orrelates very losely with LDL holesterol lowering (29). Cliniians should attempt to find a dose or alternative statin that is tolerable, if side effets our. There is evidene for signifiant LDL holesterol lowering from even extremely low, less than daily, statin doses (47). 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. Although niain, fenofibrate, ezetimibe, and bile aid sequestrants all offer additional LDL holesterol lowering to statins alone, there is insuffiient evidene that suh ombination therapy 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 derivatives or fish oil) to redue the risk of aute panreatitis. If severe hypertriglyeridemia is absent, then therapy targeting HDL holesterol or triglyerides laks the strong evidene base of statin therapy. If HDL holesterol is,40 mg/dl and LDL holesterol is between 100 and 129 mg/dl, a fibrate or niain might be used, espeially if a patient is intolerant to statins. 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 (48). In a large trial speifitodiabeti patients, fenofibrate failed to redue overall ardiovasular outomes (49). Combination Therapy Statin and Fibrate Combination therapy (statin and fibrate) maybeeffiaious for treatment for LDL holesterol, HDL holesterol, and triglyerides, but this ombination is assoiated with an inreased risk for abnormal transaminase levels, myositis, or rhabdomyolysis. The risk of rhabdomyolysis is more ommon with higher doses of statins and with renal insuffiieny and seems to be lower when statins are ombined with fenofibrate than gemfibrozil (50). In the ACCORD study, in patients with type 2 diabetes who were at high risk for CVD, the ombination of fenofibrate and simvastatin did not redue the rate of fatal ardiovasular events, nonfatal MI, or nonfatal stroke, as ompared with simvastatin alone. Prespeified subgroup analyses suggested heterogeneity in treatment effets aordingtosex,withabenefit of ombination therapy for men and possible harm for women, and a possible benefitforpatients with both triglyeride level $204 mg/dl (2.3 mmol/l) and HDL holesterol level #34 mg/dl (0.9 mmol/l) (51). Statin and Niain The Atherothrombosis Intervention in Metaboli Syndrome With Low HDL/High Triglyerides: Impat on Global Health Outomes (AIM-HIGH) trial randomized over 3,000 patients (about one-third with diabetes) with established CVD, low LDL holesterol levels (,180 mg/dl [4.7 mmol/l]), low HDL holesterol levels (men,40 mg/dl [1.0 mmol/l] and women,50 mg/dl [1.3 mmol/l]), and triglyeride levels of mg/dl ( mmol/l) 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 (first event of the omposite of death from CHD, nonfatal MI, ishemi stroke, hospitalization for an aute oronary syndrome, or symptom-driven oronary or erebral revasularization) and a possible inrease in ishemi stroke in those on ombination therapy (52). Hene, ombination therapy with niain is not reommended given the lak of effiay on major CVD outomes, possible inrease in risk of ishemi stroke, and side effets.

55 S54 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Diabetes With Statin Use There is an inreased risk of inident diabetes with statin use (53,54), whih may be limited to those with diabetes risk fators. These patients may benefit from diabetes sreening when on statin therapy. An analysis of one of the initial studies suggested that statins were linked to diabetes risk, the ardiovasular event rate redution with statins far outweighed the risk of inident diabetes even for patients at highest risk for diabetes (55). 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) (56). A meta-analysis of 13 randomized statin trials with 91,140 partiipants showed an odds ratio of 1.09 for a new diagnosis of diabetes, so that (on average) treatment of 255 patients with statins for 4 years resulted in one additional ase of diabetes, while simultaneously preventing 5.4 vasular events among those 255 patients (54). The RR-benefit ratio favoring statins is further supported by metaanalysis 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 (30). ANTIPLATELET AGENTS Reommendations 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%, suh as in men aged,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 and a history of CVD. A For patients with CVD and doumented aspirin allergy, lopidogrel (75 mg/day) should be used. B Dual antiplatelet therapy is reasonable for up to a year after an aute oronary syndrome. B Risk Redution 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 (57,58). Two randomized ontrolled trials of aspirin speifially in patients with diabetes failed to show a signifiant redution in CVD end points, raising questions about the effiay of aspirin for primary prevention in people with diabetes (59,60). The Antithromboti Trialists (ATT) ollaborators published an individual patientlevel 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 CVD events in men, but not in women. Conversely, aspirin had no effet on stroke in men but signifiantly redued stroke in women. Sex differenes in aspirin s effets have not been observed in studies of seondary prevention (57). 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 RR 0.87 (95% CI ), respetively. The onfidene interval was wider for those with diabetes beause of smaller numbers. 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 5per 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 (61). Treatment Considerations In 2010, a position statement of the ADA, the Amerian Heart Assoiation, and the Amerian College of Cardiology Foundation reommended that low-dose ( mg/day) aspirin for primary prevention is reasonable for adults with diabetes and no previous history of vasular disease who are at inreased CVD risk (10-year risk of CVD events over 10%) 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: smoking, hypertension, dyslipidemia, family history of premature CVD, and albuminuria (62). 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. Aspirin use 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 dose may help redue side effets (63). In the U.S., the most ommon low dose tablet is 81 mg. Although platelets from patients with diabetes have altered funtion, it is

56 are.diabetesjournals.org Position Statement S55 unlear what, if any, impat that finding has on the required dose of aspirin for ardioprotetive 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 (64). Therefore, while aspirin resistane appears higher in patients with diabetes 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 that higher doses of aspirin be used in this group at this time. A P2Y12 reeptor antagonist in ombination with aspirin should be used for at least 1 year in patients following an aute oronary syndrome. Evidene supports use of either tiagrelor or lopidogrel if no perutaneous oronary intervention (PCI) was performed and the use of lopidogrel, tiagrelor, or prasugrel if PCI was performed (65). CORONARY HEART DISEASE Reommendations Sreening In asymptomati patients, routine sreening for oronary artery disease (CAD) is not reommended beause it does not improve outomes as long as CVD risk fators are treated. A Treatment In patients with known CVD, use aspirin and statin therapy (if not ontraindiated) A and onsider ACE inhibitor therapy C 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 In patients with symptomati heart failure, thiazolidinedione treatment should not be used. A In patients with stable CHF, metformin may be used if renal funtion is normal but should be avoided in unstable or hospitalized patients with CHF. B In all patients with diabetes, ardiovasular risk fators should be assessed at least annually. These risk fators inlude dyslipidemia, hypertension, smoking, a family history of premature oronary disease, and the presene of albuminuria. Abnormal risk fators should be treated as desribed elsewhere in these guidelines. Sreening Candidates for advaned or invasive ardia testing inlude those with 1)typial or atypial ardia symptoms and 2) an abnormal resting ECG. The sreening of asymptomati patients with high CVD risk is not reommended (39), in part beause these high-risk patients should alreadybereeivingintensivemedial therapy, an approah that provides similar benefit as invasive revasularization (66,67). There is also some evidene that silent MI may reverse over time, adding to the ontroversy onerning aggressive sreening strategies (68). A randomized observational trial demonstrated no linial benefit to routine sreening of asymptomati patients with type 2 diabetes and normal ECGs (69). Despite abnormal myoardial perfusion imaging in more than one in five patients, ardia outomes were essentially equal (and very low) in sreened versus unsreened patients. Aordingly, indisriminate sreening is not onsidered ost-effetive. Studies have found that a risk fator based approah to the initial diagnosti evaluation and subsequent follow-up for CAD fails to identify whih patients with type 2 diabetes will have silent ishemia on sreening tests (70,71). Any benefit of newer noninvasive CAD sreening methods, suh as omputed tomography and omputed tomography angiography, to identify patient subgroups for different treatment strategies, remain unproven. Although asymptomati diabeti patients with higher oronary disease burden have more future ardia events (72 74), 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. Lifestyle and Pharmaologial Interventions Intensive lifestyle intervention fousing on weight loss through dereased alori intake and inreased physial ativity as performed in the Ation for Health in Diabetes (Look AHEAD) trial may be onsidered for improving gluose ontrol, fitness, and some CVD risk fators. Patients at inreased CVD risk should reeive aspirin and a statin, and ACE inhibitor or ARB therapy if hypertensive, unless there are ontraindiations to a partiular drug lass. While 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 (75,76). In patients with a prior MI, b-blokers should be ontinued for at least 2 years after the event (77). A systemati review of 34,000 patients showed that metformin is as safe as other gluose-lowering treatments in patients with diabetes and CHF, even in those with redued left ventriular ejetion fration or onomitant hroni kidney disease; however, metformin should be avoided in hospitalized patients (78). Referenes 1. Buse JB, Ginsberg HN, Bakris GL, et al.; Amerian Heart Assoiation; Amerian Diabetes Assoiation. Primary prevention of ardiovasular diseases in people with diabetes mellitus: a sientifi statement from the Amerian Heart Assoiation and the Amerian Diabetes Assoiation. Diabetes Care 2007;30: Gaede P, Lund-Andersen H, Parving H-H, Pedersen O. Effet of a multifatorial intervention on mortality in type 2 diabetes. N Engl J Med 2008;358: Ali MK, Bullard KM, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Ahievement of goals in U.S. diabetes are, N Engl J Med 2013;368: Bobrie G, Genès N, Vaur L, et al. Is isolated home hypertension as opposed to isolated offie hypertension a sign of greater ardiovasular risk? Arh Intern Med 2001;161: Sega R, Fahetti R, Bombelli M, et al. Prognosti value of ambulatory and home blood pressures ompared with offie blood pressure in the general population: follow-up results from the Pressioni Arteriose Monitorate e Loro Assoiazioni (PAMELA) study. Cirulation 2005;111: Arguedas JA, Leiva V, Wright JM. Blood pressure targets for hypertension in people with diabetes mellitus. Cohrane Database Syst Rev 2013;10:CD James PA, Oparil S, Carter BL, et al evidene-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 2014;311:

57 S56 Position Statement Diabetes Care Volume 38, Supplement 1, January MBrien K, Rabi DM, Campbell N, et al. Intensive and standard blood pressure targets in patients with type 2 diabetes mellitus: systemati review and meta-analysis. Arh Intern Med 2012;172: ACCORD Study Group; Cushman WC, Evans GW, et al. Effets of intensive blood-pressure ontrol in type 2 diabetes mellitus. N Engl J Med 2010;362: Patel A; ADVANCE Collaborative Group; MaMahon S, et al. Effets of a fixed ombination of perindopril and indapamide on marovasular and mirovasular outomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised ontrolled trial. Lanet 2007;370: Zoungas S, Chalmers J, Neal B, et al.; ADVANCE-ON Collaborative Group. Follow-up of blood-pressure lowering and gluose ontrol in type 2 diabetes. N Engl J Med 2014;371: Cruikshank JM. Hypertension Optimal Treatment (HOT) trial. Lanet 1998;352: Saks FM, Svetkey LP, Vollmer WM, et al.; DASH-Sodium Collaborative Researh Group. Effets on blood pressure of redued dietary sodium and the Dietary Approahes to Stop Hypertension (DASH) diet. N Engl J Med 2001;344: Chobanian AV, Bakris GL, Blak HR, et al.; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detetion, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Eduation Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detetion, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003;289: Tatti P, Pahor M, Byington RP, et al. Outome results of the Fosinopril Versus Amlodipine Cardiovasular Events Randomized Trial (FACET)inpatientswithhypertensionand NIDDM. Diabetes Care 1998;21: Estaio RO, Jeffers BW, Hiatt WR, Biggerstaff SL, Gifford N, Shrier RW. The effet of nisoldipine as ompared with enalapril on ardiovasular outomes in patients with noninsulin-dependent diabetes and hypertension. N Engl J Med 1998;338: Shrier RW, Estaio RO, Mehler PS, Hiatt WR. Appropriate blood pressure ontrol in hypertensive and normotensive type 2 diabetes mellitus: a summary of the ABCD trial. Nat Clin Prat Nephrol 2007;3: ALLHAT Offiers and Coordinators for the ALLHAT Collaborative Researh Group. Major outomes in high-risk hypertensive patients randomized to angiotensin-onverting enzyme inhibitor or alium hannel bloker vs diureti: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attak Trial (ALLHAT). JAMA 2002;288: PsatyBM,SmithNL,SisovikDS,etal. Health outomes assoiated with antihypertensive therapies used as first-line agents. A systemati review and meta-analysis. JAMA 1997; 277: Heart Outomes Prevention Evaluation Study Investigators. Effets of ramipril on ardiovasular and mirovasular outomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy. Lanet 2000; 355: MMurray JJV, Ostergren J, Swedberg K, et al.; CHARM Investigators and Committees. Effets of andesartan in patients with hroni heart failure and redued left-ventriular systoli funtion taking angiotensin-onvertingenzyme inhibitors: the CHARM-Added trial. Lanet 2003;362: Pfeffer MA, Swedberg K, Granger CB, et al.; CHARM Investigators and Committees. Effets of andesartan on mortality and morbidity in patients with hroni heart failure: the CHARM-Overall programme. Lanet 2003;362: Granger CB, MMurray JJV, Yusuf S, et al.; CHARM Investigators and Committees. Effets of andesartan in patients with hroni heart failure and redued left-ventriular systoli funtion intolerant to angiotensin-onvertingenzyme inhibitors: the CHARM-Alternative trial. Lanet 2003;362: Lindholm LH, Ibsen H, Dahlöf B, et al.; LIFE Study Group. Cardiovasular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint redution in hypertension study (LIFE): a randomised trial against atenolol. Lanet 2002;359: Berl T, Hunsiker LG, Lewis JB, et al.; Irbesartan Diabeti Nephropathy Trial. Collaborative Study Group. Cardiovasular outomes in the Irbesartan Diabeti Nephropathy Trial of patients with type 2 diabetes and overt nephropathy. Ann Intern Med 2003;138: Hermida RC, Ayala DE, Mojón A, Fernández JR. Influene of time of day of blood pressurelowering treatment on ardiovasular risk in hypertensive patients with type 2 diabetes. Diabetes Care 2011;34: Zhao P, Xu P, Wan C, Wang Z. Evening versus morning dosing regimen drug therapy for hypertension. Cohrane Database Syst Rev 2011;10:CD Sibai BM. Treatment of hypertension in pregnant women. N Engl J Med 1996;335: Baigent C, Keeh A, Kearney PM, et al.; Cholesterol Treatment Trialists (CTT) Collaborators. Effiay and safety of holesterol-lowering treatment: prospetive meta-analysis of data from 90,056 partiipants in 14 randomised trials of statins. Lanet 2005;366: Mihaylova B, Emberson J, Blakwell L, et al.; Cholesterol Treatment Trialists (CTT) Collaborators. The effets of lowering LDL holesterol with statin therapy in people at low risk of vasular disease: meta-analysis of individual data from 27 randomised trials. Lanet 2012;380: Pyŏrälä K, Pedersen TR, Kjekshus J, Faergeman O, Olsson AG, Thorgeirsson G. Cholesterol lowering with simvastatin improves prognosis of diabeti patients with oronary heart disease. A subgroup analysis of the Sandinavian Simvastatin Survival Study (4S). Diabetes Care 1997;20: Collins R, Armitage J, Parish S, Sleigh P, Peto R; Heart Protetion Study Collaborative Group. MRC/BHF Heart Protetion Study of holesterollowering with simvastatin in 5963 people with diabetes: a randomised plaebo-ontrolled trial. Lanet 2003;361: Goldberg RB, Mellies MJ, Saks FM, et al.; Care Investigators. Cardiovasular events and their redution with pravastatin in diabeti and gluose-intolerant myoardial infartion survivors with average holesterol levels: subgroup analyses in the Cholesterol and Reurrent Events (CARE) trial. Cirulation 1998;98: Shepherd J, Barter P, Carmena R, et al. Effet of lowering LDL holesterol substantially below urrently reommended levels in patients with oronary heart disease and diabetes: the Treating to New Targets (TNT) study. Diabetes Care 2006;29: Sever PS, Poulter NR, Dahlöf B, et al. Redution in ardiovasular events with atorvastatin in 2,532 patients with type 2 diabetes: Anglo-Sandinavian Cardia Outomes Trialdlipidlowering arm (ASCOT-LLA). Diabetes Care 2005;28: Knopp RH, d Emden M, Smilde JG, Pook SJ. Effiay and safety of atorvastatin in the prevention of ardiovasular end points in subjets with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN). Diabetes Care 2006;29: Colhoun HM, Betteridge DJ, Durrington PN, et al.; CARDS investigators. Primary prevention of ardiovasular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multientre randomised plaebo-ontrolled trial. Lanet 2004; 364: Kearney PM, Blakwell L, Collins R, et al.; Cholesterol Treatment Trialists (CTT) Collaborators. Effiay of holesterol-lowering therapy in 18,686 people with diabetes in 14 randomised trials of statins: a meta-analysis. Lanet 2008;371: Taylor F, Huffman MD, Maedo AF, et al. Statins for the primary prevention of ardiovasular disease. Cohrane Database Syst Rev 2013;1:CD Carter AA, Gomes T, Camaho X, Juurlink DN, Shah BR, Mamdani MM. Risk of inident diabetes among patients treated with statins: population based study. BMJ 2013;346:f Hayward RA, Hofer TP, Vijan S. Narrative review: lak of evidene for reommended low-density lipoprotein treatment targets: a solvable problem. Ann Intern Med 2006;145: Cannon CP, Braunwald E, MCabe CH, et al.; Pravastatin or Atorvastatin Evaluation and Infetion Therapy-Thrombolysis in Myoardial Infartion 22 Investigators. Intensive versus moderate lipid lowering with statins after aute oronary syndromes. N Engl J Med 2004;350: de Lemos JA, Blazing MA, Wiviott SD, et al.; Investigators. Early intensive vs a delayed onservative simvastatin strategy in patients with aute oronary syndromes: phase Z of the A to Z trial. JAMA 2004;292: Nissen SE, Tuzu EM, Shoenhagen P, et al.; REVERSAL Investigators. Effet of intensive ompared with moderate lipid-lowering therapy on progression of oronary atheroslerosis: a randomized ontrolled trial. JAMA 2004;291:

58 are.diabetesjournals.org Position Statement S de Ferranti SD, de Boer IH, Fonsea V, et al. Type 1 diabetes mellitus and ardiovasular disease: a sientifi statement from the Amerian Heart Assoiation and Amerian Diabetes Assoiation. Cirulation 2014;130: Chasman DI, Posada D, Subrahmanyan L, Cook NR, Stanton VP Jr, Ridker PM. Pharmaogeneti study of statin therapy and holesterol redution. JAMA 2004;291: Meek C, Wierzbiki AS, Jewkes C, et al. Daily and intermittent rosuvastatin 5 mg therapy in statin intolerant patients: an observational study. Curr Med Res Opin 2012;28: Singh IM, Shishehbor MH, Ansell BJ. Highdensity lipoprotein as a therapeuti target: a systemati review. JAMA 2007;298: KeehA,SimesRJ,BarterP,etal.;FIELD study investigators. Effets of long-term fenofibrate therapy on ardiovasular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised ontrolled trial. Lanet 2005;366: Jones PH, Davidson MH. Reporting rate of rhabdomyolysis with fenofibrate 1 statin versus gemfibrozil 1 any statin. Am J Cardiol 2005; 95: Ginsberg HN, Elam MB, Lovato LC, et al.; ACCORD Study Group. Effets of ombination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362: Boden WE, Probstfield JL, Anderson T, et al.; AIM-HIGH Investigators. Niain in patients with low HDL holesterol levels reeiving intensive statin therapy. N Engl J Med 2011;365: Rajpathak SN, Kumbhani DJ, Crandall J, Barzilai N, Alderman M, Ridker PM. Statin therapy and risk of developing type 2 diabetes: a metaanalysis. Diabetes Care 2009;32: Sattar N, Preiss D, Murray HM, et al. Statins and risk of inident diabetes: a ollaborative meta-analysis of randomised statin trials. Lanet 2010;375: Ridker PM, Danielson E, Fonsea FAH, et al.; JUPITER Study Group. Rosuvastatin to prevent vasular events in men and women with elevated C-reative protein. N Engl J Med 2008; 359: Ridker PM, Pradhan A, MaFadyen JG, Libby P, Glynn RJ. Cardiovasular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lanet 2012; 380: Baigent C, Blakwell L, Collins R, et al.; Antithromboti Trialists (ATT) Collaboration. Aspirin in the primary and seondary prevention of vasular disease: ollaborative meta-analysis of individual partiipant data from randomised trials. Lanet 2009;373: Perk J, De Baker G, Gohlke H, et al.; European Assoiation for Cardiovasular Prevention & Rehabilitation (EACPR); ESC Committee for Pratie Guidelines (CPG). European Guidelines on ardiovasular disease prevention in linial pratie (version 2012). The Fifth Joint Task Fore of the European Soiety of Cardiology and Other Soieties on Cardiovasular Disease Prevention in Clinial Pratie (onstituted by representatives of nine soieties and by invited experts). Eur Heart J 2012;33: Ogawa H, Nakayama M, Morimoto T, et al.; Japanese Primary Prevention of Atheroslerosis With Aspirin for Diabetes (JPAD) Trial Investigators. Low-dose aspirin for primary prevention of atherosleroti events in patients with type 2 diabetes: a randomized ontrolled trial. JAMA 2008;300: Belh J, MaCuish A, Campbell I, et al. The prevention of progression of arterial disease and diabetes (POPADAD) trial: fatorial randomisedplaeboontrolledtrialofaspirinand antioxidants in patients with diabetes and asymptomati peripheral arterial disease. BMJ 2008;337:a Pignone M, Earnshaw S, Tie JA, Plether MJ. Aspirin, statins, or both drugs for the primary prevention of oronary heart disease events in men: a ost-utility analysis. Ann Intern Med 2006;144: Pignone M, Alberts MJ, Colwell JA, et al.; Amerian Diabetes Assoiation; Amerian Heart Assoiation; Amerian College of Cardiology Foundation. Aspirin for primary prevention of ardiovasular events in people with diabetes: a position statement of the Amerian Diabetes Assoiation, a sientifi statement of the Amerian Heart Assoiation, and an expert onsensus doument of the Amerian College of Cardiology Foundation. Diabetes Care 2010;33: Campbell CL, Smyth S, Montalesot G, Steinhubl SR. Aspirin dose for the prevention of ardiovasular disease: a systemati review. JAMA 2007;297: Davì G, Patrono C. Platelet ativation and atherothrombosis. N Engl J Med 2007;357: Vandvik PO, Linoff AM, Gore JM, et al.; Amerian College of Chest Physiians. Primary and seondary prevention of ardiovasular disease: antithromboti therapy and prevention of thrombosis, 9th ed: Amerian College of Chest Physiians Evidene-Based Clinial Pratie Guidelines. Chest 2012;141(Suppl.):e637S e668s 66. Boden WE, O Rourke RA, Teo KK, et al.; COURAGE Trial Researh Group. Optimal medial therapy with or without PCI for stable oronary disease. N Engl J Med 2007;356: BARI 2D Study Group; Frye RL, August P, et al. A randomized trial of therapies for type 2 diabetes and oronary artery disease. N Engl J Med 2009;360: Wakers FJT, Chyun DA, Young LH, et al.; Detetion of Ishemia in Asymptomati Diabetis (DIAD) Investigators. Resolution of asymptomati myoardial ishemia in patients with type 2 diabetes in the Detetion of Ishemia in Asymptomati Diabetis (DIAD) study. Diabetes Care 2007;30: Young LH, Wakers FJT, Chyun DA, et al.; DIAD Investigators. Cardia outomes after sreening for asymptomati oronary artery disease in patients with type 2 diabetes: the DIAD study: a randomized ontrolled trial. JAMA 2009;301: Wakers FJT, Young LH, Inzuhi SE, et al.; DetetionofIshemiainAsymptomatiDiabetis Investigators. Detetion of silent myoardial ishemia in asymptomati diabeti subjets: the DIAD study. Diabetes Care 2004;27: Sognamiglio R, Negut C, Ramondo A, Tiengo A, Avogaro A. Detetion of oronary artery disease in asymptomati patients with type 2 diabetes mellitus. J Am Coll Cardiol 2006;47: Hadamitzky M, Hein F, Meyer T, et al. Prognosti value of oronary omputed tomographi angiography in diabeti patients without known oronary artery disease. Diabetes Care 2010;33: Elkeles RS, Godsland IF, Feher MD, et al.; PREDICT Study Group. Coronary alium measurement improves predition of ardiovasular events in asymptomati patients with type 2 diabetes: the PREDICT study. Eur Heart J 2008; 29: Choi E-K, Chun EJ, Choi S-I, et al. Assessment of sublinial oronary atheroslerosis in asymptomati patients with type 2 diabetes mellitus with single photon emission omputed tomography and oronary omputed tomography angiography. Am J Cardiol 2009;104: Braunwald E, Domanski MJ, Fowler SE, et al.; PEACE Trial Investigators. Angiotensinonverting-enzyme inhibition in stable oronary artery disease. N Engl J Med 2004;351: Telmisartan Randomised AssessmeNt Study in ACE intolerant subjets with ardiovasular Disease (TRANSCEND) Investigators; Yusuf S, Teo K, et al. Effets of the angiotensin-reeptor bloker telmisartan on ardiovasular events in high-risk patients intolerant to angiotensinonverting enzyme inhibitors: a randomised ontrolled trial. Lanet 2008;372: Kezerashvili A, Marzo K, De Leon J. Beta bloker use after aute myoardial infartion in the patient with normal systoli funtion: when is it ok to disontinue? Curr Cardiol Rev 2012;8: Eurih DT, Weir DL, Majumdar SR, et al. Comparative safety and effetiveness of metformin in patients with diabetes mellitus and heart failure: systemati review of observational studies involving 34,000 patients. Cir Heart Fail 2013;6:

59 S58 Diabetes Care Volume 38, Supplement 1, January Mirovasular Compliations and Foot Care Diabetes Care 2015;38(Suppl. 1):S58 S66 DOI: /d15-S012 Amerian Diabetes Assoiation NEPHROPATHY Reommendations Optimize gluose ontrol to redue the risk or slow the progression of diabeti kidney disease. A Optimize blood pressure ontrol to redue the risk or slow the progression of diabeti kidney disease. A POSITION STATEMENT Sreening At least one a year, quantitatively assess urinary albumin (e.g., urine albuminto-reatinine ratio [UACR]) and estimated glomerular filtration rate (egfr) in patients with type 1 diabetes duration of $5 years and in all patients with type 2diabetes.B Treatment An ACE inhibitor or angiotensin reeptor bloker (ARB) is not reommended for the primary prevention of diabeti kidney disease in patients with diabetes who have normal blood pressure and normal UACR (,30 mg/g). B Either an ACE inhibitor or ARB is suggested for the treatment of the nonpregnant patient with modestly elevated urinary albumin exretion ( mg/day) C and is reommended for those with urinary albumin exretion.300 mg/day. A 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 UACR in patients with albuminuria is reasonable to assess progression of diabeti kidney disease. E When egfr is,60 ml/min/1.73 m 2, evaluate and manage potential ompliations of hroni kidney disease (CKD). E Consider referral to a physiian experiened in the are of kidney disease when there is unertainty about the etiology of kidney disease, diffiult management issues, or advaned kidney disease. B Nutrition For people with diabeti kidney disease, reduing the amount of dietary protein below the reommended daily allowane of 0.8 g/kg/day (based on ideal body weight) is not reommended beause it does not alter glyemi measures, ardiovasular risk measures, or the ourse of GFR deline. A The terms miroalbuminuria ( mg/24 h) and maroalbuminuria (.300 mg/24 h) will no longer be used, sine albuminuria ours on a ontinuum. Albuminuria is defined as UACR $30 mg/g. Diabeti kidney disease ours in 20 40% of patients with diabetes and is the leading ause of end-stage renal disease (ESRD). Persistent inreased albuminuria in the range of UACR mg/g is an early indiator of diabeti kidney disease in type 1 diabetes and a marker for development of diabeti kidney diseaseintype2diabetes.itisawell-established marker of inreased ardiovasular disease (CVD) risk (1 3). However, there is inreasing evidene of spontaneous remission of UACR levels mg/g in up to 40% of patients with type 1 diabetes. About 30 40% remain with UACR levels of mg/g and do not Suggested itation: Amerian Diabetes Assoiation. Mirovasular ompliations and foot are. Se. 9. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S58 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.

60 are.diabetesjournals.org Position Statement S59 progress to higher levels ($300 mg/g) over 5 10 years of follow-up (4 7). Patients with persistent albuminuria are likely to develop ESRD (8,9). Interventions Glyemia A number of interventions have been demonstrated to redue the risk and slow the progression of diabeti kidney 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 and redued egfr in patients with type 1 (9) and type 2 diabetes (10 14). Despite prior onerns and published ase reports, urrent data indiate that the overall risk of metformin-assoiated lati aidosis is low (14). GFR may be a more appropriate measure to assess ontinued metformin use than serum reatinine onsidering that the serum reatinine level an translate into widely varying egfr levels depending on age, ethniity, and musle mass (15). A reent review (16) proposes that metformin use should be reevaluated at an egfr,45 ml/min/1.73 m 2 with a redution in maximum dose to 1,000 mg/day and disontinued when egfr,30 ml/min/1.73 m 2 or in linial situations in whih there is an inreased risk of lati aidosis, suh as sepsis, hypotension, and hypoxia, or in whih there is a high risk of aute kidney injury resulting in a worsening of GFR, suh as administration of radioontrast dye in those with egfr,60 ml/min/1.73 m 2. Blood Pressure The UK Prospetive Diabetes Study (UKPDS) provided strong evidene that blood pressure ontrol an redue the development of diabeti kidney disease (17). In addition, large prospetive randomized studies in patients with type 1 diabetes have shown that ACE inhibitors have ahieved lower systoli blood pressure levels (,140 mmhg) and have provided 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 (18,19). In patients with type 2 diabetes, hypertension, and normoalbuminuria, renin-angiotensin system inhibition has been demonstrated to delay onset of elevated albuminuria (20,21). Of note, in the latter study, there was an unexpeted higher rate of fatal ardiovasular events with olmesartan ompared with plaebo among patients with preexisting CVD. ACE inhibitors have been shown to redue major CVD outomes (i.e., myoardial infartion, stroke, death) in patients with diabetes (22), thus further supporting the use of these agents in patients with elevated albuminuria, a CVD risk fator. ARBs do not have the same benefiial effet on ardiovasular outomes or prevent the onset of elevated albuminuria in normotensive patients with type 1 or type 2 diabetes (23). However, ARBs have been shown to redue the progression of albuminuria, as well as ESRD,inpatientswithtype2diabetes (24 26). In those with diabeti kidney disease, some evidene suggests that ARBs are assoiated with a smaller inrease in serum potassium levels ompared with ACE inhibitors (27). Combination Therapy Drug ombinations that blok the reninangiotensin system (e.g., an ACE inhibitorplusanarb,amineraloortioid antagonist, or a diret renin inhibitor) provide additional lowering of albuminuria (28). However, ompared with single-agent use, suh ombinations have been found to provide no additional benefit on CVD or diabeti kidney disease and have higher adverse event rates (hyperkalemia or aute kidney injury) (29). Therefore, the ombined use of different inhibitors of the renin-angiotensin system should be avoided. Diuretis, alium hannel blokers, and b-blokers an be used as additional therapy to further lower blood pressure in patients already treated with maximum doses of ACE inhibitors or ARBs (30) or as alternate therapy in the rare individual unable to tolerate ACE inhibitors and ARBs. Studies in patients with varying stages of diabeti kidney disease have shown that the limitation of dietary protein to avoid exess intake slows the progression of albuminuria, GFR deline, and ourrene of ESRD (31 34), although more reent studies have provided onfliting results (35). Dietary protein limitation, if protein intake is high, is a onsideration partiularly in patients whose diabeti kidney disease is progressing despite optimal gluose and blood pressure ontrol and use of an ACE inhibitor or ARB (34). Assessment of Albuminuria Status and Renal Funtion Sreening for inreased urinary albumin exretion an be performed by UACR in a random spot urine olletion; 24-h or timed olletions are more burdensome and add little to predition or auray (36,37). Measurement of a spot urine sample for albumin alone (whether by immunoassay or by using a sensitive dipstik test speifi for albuminuria) without simultaneously measuring urine reatinine is less expensive but suseptible to false-negative 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 UACR and 24-h albumin exretion are defined in Table 9.1. 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 albuminuria. Exerise within 24 h, infetion, fever, ongestive heart failure, marked hyperglyemia, and marked hypertension may elevate urinary albumin exretion over baseline values. Abnormal urine albumin exretion and GFR level may be used to stage CKD. The National Kidney Foundation lassifiation (Table 9.2) is primarily based on GFR levels and may be superseded by other systems in whih staging Table 9.1 Definitions of abnormalities in albumin exretion Spot olletion Category (mg/g reatinine) Normal,30 Inreased urinary albumin exretion* $30 *Historially, ratios between 30 and 299 mg/g have been alled miroalbuminuria and those.300 mg/g have been alled maroalbuminuria (or linial albuminuria).

61 S60 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 inludes other variables suh as urinary albumin exretion (38). Studies have found dereased GFR without inreased urine albumin exretion in a substantial perentage of adults with type 2 diabetes (39). Substantial evidene shows that in patients with type 1 diabetes and persistent UACR mg/g, sreening with albumin exretion rate alone would miss.20% of progressive disease (7). Serum reatinine with egfr should therefore be assessed at least annually in all adults with 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 (40) or the Chroni Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. The latter is the urrent preferred GFR estimating equation. GFR alulators are available at The need for annual quantitative assessment of albumin exretion after diagnosis of albuminuria and institution of ACE inhibitor or ARB therapy and blood pressure ontrol is a subjet of debate. Continued surveillane an assess both response to therapy and disease progression and may aid in assessing adherene to ACE inhibitor or ARB therapy. Some suggest that reduing UACR to normal (,30 mg/g) or near normal may improve CKD and CVD prognosis, but this approah has not been formally evaluated in prospetive trials, and evidene demonstrates spontaneous remission of albuminuria in up to 40% of type 1 diabeti patients. Conversely, patients with inreasing albumin levels, delining GFR, inreasing blood pressure, retinopathy, marovasular disease, elevated lipids and/or uri aid onentrations, or a family history of CKD are more likely to experiene a progression of diabeti kidney disease (7). 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 9.3). Early vaination against hepatitis B virus is Table 9.2 Stages of CKD Stage Desription GFR (ml/min/1.73 m 2 ) 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 is defined as abnormalities on pathologial, urine, blood, or imaging tests. Adapted from Levey et al. (37). indiatedinpatientslikelytoprogress to ESRD. Referral to Nephrologist 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). Other triggers for referral may inlude diffiult management issues (anemia, seondary hyperparathyroidism, metaboli bone disease, resistant hypertension, 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 disease. Consultation with a nephrologist when stage 4 CKD develops has been found to redue ost, improve quality of are, and delay dialysis (41). However, other speialists and providers should not delay eduating their patients about the progressive nature of diabeti kidney disease, the kidney preservation benefits of proative treatment of blood pressure and blood gluose, and the potential need for renal transplant. RETINOPATHY Reommendations Optimize glyemi ontrol to redue the risk or slow the progression of retinopathy. A Optimize blood pressure ontrol to redue the risk or slow the progression of retinopathy. A Sreening Adults 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 Table 9.3 Management of CKD in diabetes (7) GFR (ml/min/1.73 m 2 ) Reommended management All patients Yearly measurement of reatinine, urinary albumin exretion, potassium Referral to a nephrologist if possibility for nondiabeti kidney disease exists (duration of type 1 diabetes,10 years, persistent albuminuria, abnormal findings on renal ultrasound, resistant hypertension, rapid fall in GFR, or ative urinary sediment on ultrasound) Consider the 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 6 months Consider the need for dose adjustment of mediations,30 Referral to a nephrologist

62 are.diabetesjournals.org Position Statement S61 If there is no evidene of retinopathy for one or more eye exams, then exams every 2 years may be onsidered. If diabeti retinopathy is present, subsequent examinations for patients with type 1 and type 2 diabetes should be repeated annually by an ophthalmologist or optometrist. If retinopathy is progressing or sight-threatening, then examinations will be required more frequently. 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 preexisting 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, severe NPDR. A Antivasular 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 aspirin 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 diabetes duration, fators that inrease the risk of, or are assoiated with, retinopathy inlude hroni hyperglyemia (42), nephropathy (43), and hypertension (44). 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 (11,45). Lowering bloodpressurehasbeenshowntoderease retinopathy progression, although tight targets (systoli,120 mmhg) do not impart additional benefit (45). Several ase series and a ontrolled prospetive study suggest that pregnany in type 1 diabeti patients may aggravate retinopathy (46,47). Laser photooagulation surgery an minimize this risk (47). Sreening 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. Beause 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 diabetes diagnosis (48). Patients with type 2 diabetes who may have had years of undiagnosed diabetes and have a signifiant risk of prevalent diabeti retinopathy at the time of diagnosis should have an initial dilated and omprehensive eye examination shortly after diagnosis. Examinations should be performed by an ophthalmologist or optometrist who is knowledgeable and experiened in diagnosing diabeti retinopathy. Subsequent examinations for type 1 and type 2 diabeti patients are generally repeated annually. Exams every 2 years may be ost-effetive after oneormorenormaleyeexams,and in a population with well-ontrolled type 2 diabetes, there was essentially no risk of development of signifiant retinopathy with a 3-year interval after a normal examination (49). Examinations will be required more frequently if retinopathy is progressing. Retinal photography, with remote reading by experts, has great potential in areas where qualified eye are professionals are not readily available (50). It also may enhane effiieny and redue osts when the expertise of ophthalmologistsanbeusedformoreomplex examinations and for therapy (51). Inperson exams are still neessary when the photos are unaeptable and for follow-up if abnormalities are 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. Treatment One of the main motivations for sreening for diabeti retinopathy is the longestablished 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 (52) 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 the greatest risk-benefit ratio in those with baseline disease (dis neovasularization or vitreous hemorrhage). The ETDRS (53) 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 older-onset patients with severe NPDR or less-than-high-risk PDR. Laser photooagulation surgery in both trials was benefiial in reduing

63 S62 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 the risk of further visual loss, but generally not benefiial in reversing already diminished auity. Reombinant monolonal neutralizing antibody to VEGF improves vision and redues the need for laser photooagulation in patients with maular edema (54). Other emerging therapies for retinopathy inlude sustained intravitreal delivery of fluoinolone (55) and the possibility of prevention with fenofibrate (56,57). NEUROPATHY Reommendations All patients should be sreened for diabeti peripheral neuropathy (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, suh as a 10-g monofilament. B Sreening for signs and symptoms (e.g., orthostasis, resting tahyardia) of ardiovasular autonomi neuropathy (CAN) should be onsidered with more advaned disease. E Tight glyemi ontrol is the only strategy onviningly shown to prevent or delay the development of DPN and CAN in patients with type 1 diabetes A and to slow the progression of neuropathy in some patients with type 2 diabetes. B Assess and treat patients to redue pain related to DPN B and symptoms of autonomi neuropathy and to improve quality of life. E The diabeti neuropathies are heterogeneous with diverse linial manifestations. They may be foal or diffuse. The most prevalent neuropathies are DPN and autonomi neuropathy. Although DPN is a diagnosis of exlusion, omplex investigations or referral for neurology onsultation to exlude other onditions is rarely needed. The early reognition and appropriate management of neuropathy in the patient with diabetes is important for a number of reasons: 1. Nondiabeti 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. 4. Autonomi neuropathy, partiularly CAN, is an independent risk fator for ardiovasular mortality (58,59). Speifi treatment for the underlying nerve damage, other than improved glyemi ontrol, is urrently not available. Glyemi ontrol was shown to effetively prevent DPN and CAN in type 1 diabetes (60,61) and may modestly slow progression in type 2 diabetes (13) but does not reverse neuronal loss. Therapeuti strategies (pharmaologial and nonpharmaologial) for the relief of speifi symptoms related to painful DPN or autonomi neuropathy are reommended beause they an potentially redue pain (62) and improve quality of life. Diagnosis Diabeti Peripheral Neuropathy Patients with diabetes should be sreened annually for DPN symptoms using simple linial tests. Symptoms vary aording to the lass of sensory fibers involved. The most ommon symptoms are indued by the involvement of small fibers and inlude pain, dysesthesias (unpleasant abnormal sensations of burning and tingling), and numbness. Clinial tests inlude assessment of pinprik sensation, vibration threshold using a 128-Hz tuning fork, light touh pereption using a 10-g monofilament, and ankle reflexes. Assessment should follow the typial DPN pattern, starting distally (the dorsal aspet of the hallux) on both sides and move proximally until threshold is deteted. Several linial instruments that ombine more than one test have.87% sensitivity in deteting DPN (63 65). Eletrophysiologial testing or referral to a neurologist is rarely needed, exept in situations where the linial features are atypial or the diagnosis is unlear. In patients with severe or atypial neuropathy, auses other than diabetes should always be onsidered, suh as neurotoxi mediations, heavy metal poisoning, alohol abuse, vitamin B 12 defiieny (66), renal disease, hroni inflammatory demyelinating neuropathy, inherited neuropathies, and vasulitis (67). 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, gastroparesis, onstipation, eretile dysfuntion, sudomotor dysfuntion, impaired neurovasular funtion, and, potentially, autonomi failure in response to hypoglyemia. Cardiovasular Autonomi Neuropathy CAN is the most studied and linially important form of diabeti autonomi neuropathy beause of its assoiation with mortality independent of other ardiovasular risk fators (58,68). In early stages, CAN may be ompletely asymptomati and deteted by hanges in heart rate variability with deep breathing and abnormal ardiovasular reflex tests (R-R interval response to deep breathing, standing, and Valsalva maneuver tests). Advaned disease may be indiated by resting tahyardia (.100 bpm) and orthostasis (a fall in systoli blood pressure.20 mmhg or diastoli blood pressure of at least 10 mmhg upon standing without an appropriate heart rate response). The standard ardiovasular reflex tests (deep breathing, standing, and Valsalva maneuver) are noninvasive, easy to perform, reliable, and reproduible, espeially the deep breathing test, and have prognosti value (69). Although some soieties have developed guidelines for sreening for CAN, the benefits of sophistiated testing beyond risk stratifiation are not lear (69). Gastrointestinal Neuropathies Gastrointestinal neuropathies (e.g., esophageal enteropathy, gastroparesis, onstipation, diarrhea, feal inontinene) may involve any setion of the gastrointestinal trat. Gastroparesis should be suspeted in individuals with errati gluose ontrol or with upper gastrointestinal symptoms without another identified ause. Evaluation of solidphase gastri emptying using doubleisotope 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. Genitourinary Trat Disturbanes Diabeti autonomi neuropathy is also assoiated with genitourinary trat disturbanes. In men, diabeti autonomi

64 are.diabetesjournals.org Position Statement S63 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. Treatment Glyemi Control Tight glyemi ontrol, implemented early in the ourse of diabetes, has been shown to effetively prevent or delay the development of DPN and CAN in patients with type 1 diabetes (70 73). While the evidene is not as strong for type 2 diabetes, some studies have demonstrated a modest slowing of progression (74,75) without reversal of neuronal loss. Several observational studies further suggest that neuropathi symptoms improve not only with optimization of glyemi ontrol but also with the avoidane of extreme blood gluose flutuations. Diabeti Peripheral Neuropathy DPN symptoms, and espeially neuropathi pain, an be severe, have sudden onset, and are assoiated with lower quality of life, limited mobility, depression, and soial dysfuntion (76). There is limited linial evidene regarding the most effetive treatments for individual patients given the wide range of available mediations (77,78). Several drugs have been approved speifially for relief of DPN pain in the U.S. (pregabalin, duloxetine, and tapentadol), but none affords omplete relief, even when used in ombination. Venlafaxine, amitriptyline, gabapentin, valproate, and other opioids (morphine sulfate, tramadol, oxyodone ontrolled release) may be effetive and may be onsidered for treatment of painful DPN. Head-tohead treatment omparisons and studies that inlude quality-of-life outomes are rare, so treatment deisions must onsider eah patient s presentation and omorbidities and often follow a trial-and-error approah. Given the range of partially effetive treatment options, a tailored and stepwise pharmaologial strategy with areful attention to relative symptom improvement, mediation adherene, and mediation side effets is reommended to ahieve pain redution and improve quality of life (62). Autonomi Neuropathy An intensive multifatorial ardiovasular risk intervention targeting gluose, blood pressure, lipids, smoking, and other lifestyle fators has been shown to redue the progression and development of CAN among patients with type 2 diabetes (79). For those with signifiant CAN, referral to a ardiologist may be indiated. Orthostati Hypotension Treatment of orthostati hypotension is hallenging. The therapeuti goal is to minimize postural symptoms rather than to restore normotension. Most patients require the use of both pharmaologial and nonpharmaologial measures (e.g., avoiding mediations that aggravate hypotension, using ompressive garments over the legs and abdomen). Midodrine is the only drug approved by the U.S. Food and Drug Administration for the treatment of orthostati hypotension. Gastroparesis Symptoms Gastroparesis symptoms may improve with dietary hanges and prokineti agents suh as erythromyin. Reently, the European Mediines Ageny ( Press_release/2013/07/WC pdf) deided that risks of extrapyramidal symptoms with metolopramide outweigh benefits. In Europe, metolopramide use is now restrited to a maximum of 5 days andisnolongerindiatedforthelongterm treatment of gastroparesis. Although the U.S. Food and Drug Administration s deision is pending, it is suggested that metolopramide be reserved for only the most severe ases that are unresponsive to other therapies. Side effets should be losely monitored. Eretile Dysfuntion 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 Amerian Diabetes Assoiation (ADA) statement on neuropathy (78). 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. FOOT CARE 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 and assessment of foot pulses. B Patients with insensate feet, foot deformities, and ulers should have their feet examined at every visit. E 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 (e.g., dialysis patients and those with Charot foot, prior ulers, or amputation). B Refer patients who smoke or who have a loss of protetive sensation (LOPS), strutural abnormalities, or a history of prior lowerextremity 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. C Refer patients with signifiant laudiation or a positive anklebrahial index (ABI) for further vasular assessment and onsider exerise, mediations, and surgial options. C Amputation and foot uleration, whih are onsequenes of diabeti neuropathy and/or PAD, are ommon and represent major auses of morbidity and disability in people with diabetes. Loss of 10-g monofilament pereption and redued vibration pereption predit foot ulers (78). Early reognition and management of risk fators an prevent or delay adverse outomes. The risk of ulers or amputations is inreasedinpeoplewhohavethefollowing risk fators: Previous amputation Past foot uler history Peripheral neuropathy Foot deformities

65 S64 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Peripheral vasular disease Visual impairment Diabeti nephropathy (espeially patients on dialysis) Poor glyemi ontrol Cigarette smoking Cliniians are enouraged to review ADA sreening reommendations for further details and pratial desriptions of how to perform omponents of the omprehensive foot examination (80). Examination All adults with diabetes should undergo a omprehensive foot examination at least annually 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 general inspetion of skin integrity and musuloskeletal deformities should be done in a well-lit room. Vasular assessment would inlude inspetion and assessment of pedal pulses. The neurologial 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. Any of the five tests listed above ould be used by liniians to identify LOPS, although ideally two of these should be regularly performed during the sreening examd normally 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. Sreening Initial sreening for PAD should inlude a history for laudiation and an assessment of the pedal pulses. A diagnosti ABI should be onsidered in patients with 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 report on PAD (81) 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 (81). Patient Eduation Patients with diabetes and high-risk foot onditions should be eduated about their risk fators and appropriate management. Patients at risk should understand the impliations of LOPS; 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. 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. Treatment 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. Calluses 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 deep shoes. People with extreme bony deformities (e.g., Charot foot) who annot be aommodated with ommerial therapeuti footwear may need ustom-molded shoes. Most diabeti foot infetions are polymirobial, with aerobi gram-positive oi (GPC). Staphylooi are the most ommon ausative organisms. Wounds without evidene of soft-tissue or bone infetion do not require antibioti therapy. Empiri antibioti therapy an be narrowly targeted at GPC in many autely infeted patients, but those at risk for infetion with antibioti-resistant organisms or with hroni, previously treated, or severe infetions require broader-spetrum regimens and should be referred to speialized are enters (82). 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 (82). Referenes 1. Krolewski AS, Niewzas MA, Skupien J, et al. Early progressive renal deline preedes the onset of miroalbuminuria and its progression to maroalbuminuria. Diabetes Care 2014;37: Garg JP, Bakris GL. Miroalbuminuria: marker of vasular dysfuntion, risk fator for ardiovasular disease. Vas Med 2002;7: Klausen K, Borh-Johnsen K, Feldt-Rasmussen B, et al. 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Am J Kidney Dis 2003;42: Levey AS, Coresh J, Balk E, et al.; National Kidney Foundation. National Kidney Foundation pratie guidelines for hroni kidney disease: evaluation, lassifiation, and stratifiation. Ann Intern Med 2003;139: Kramer H, Molith ME. Sreening for kidney disease in adults with diabetes. Diabetes Care 2005;28: Kramer HJ, Nguyen QD, Curhan G, Hsu C-Y. Renal insuffiieny in the absene of albuminuria and retinopathy among adults with type 2 diabetes mellitus. JAMA 2003;289: Levey AS, Bosh JP, Lewis JB, Greene T, Rogers N, Roth D; Modifiation of Diet in Renal Disease Study Group. A more aurate method to estimate glomerular filtration rate from serum reatinine: a new predition equation. Ann Intern Med 1999;130: Smart NA, Dieberg G, Ladhani M, Titus T. Early referral to speialist nephrology servies for preventing the progression to end-stage kidney disease. Cohrane Database Syst Rev 2014; 6:CD Klein R. Hyperglyemia and mirovasular and marovasular disease in diabetes. Diabetes Care 1995;18: Estaio RO, MFarling E, Biggerstaff S, Jeffers BW, Johnson D, Shrier RW. Overt albuminuria predits diabeti retinopathy in Hispanis with NIDDM. Am J Kidney Dis 1998;31: Leske MC, Wu S-Y, Hennis A, et al.; Barbados Eye Study Group. Hyperglyemia, blood pressure, and the 9-year inidene of diabeti retinopathy: the Barbados Eye Studies. Ophthalmology 2005;112: Chew EY, Ambrosius WT, Davis MD, et al.; ACCORD Study Group; ACCORD Eye Study Group. Effets of medial therapies on retinopathy progression in type 2 diabetes. N Engl J Med 2010;363: Fong DS, Aiello LP, Ferris FL 3rd, Klein R. Diabeti retinopathy. Diabetes Care 2004;27: Diabetes Control and Compliations Trial Researh Group. Effet of pregnany on mirovasular ompliations in the diabetes ontrol and ompliations trial. Diabetes Care 2000;23: Hooper P, Bouher MC, Cruess A, et al. Canadian Ophthalmologial Soiety evidenebased linial pratie guidelines for the management of diabeti retinopathy. Can J Ophthalmol 2012;47(Suppl. 2):S12S Agardh E, Tababat-Khani P. Adopting 3-year sreening intervals for sight-threatening retinal vasular lesions in type 2 diabeti subjets without retinopathy. Diabetes Care 2011;34: Bragge P, Gruen RL, Chau M, Forbes A, Taylor HR. Sreening for presene or absene of diabeti retinopathy: a meta-analysis. Arh Ophthalmol 2011;129: Ahmed J, Ward TP, Bursell S-E, Aiello LM, Cavallerano JD, Vigersky RA. The sensitivity and

67 S66 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 speifiity of nonmydriati digital stereosopi retinal imaging in deteting diabeti retinopathy. Diabetes Care 2006;29: The Diabeti Retinopathy Study Researh Group. Preliminary report on effets of photooagulation therapy. Am J Ophthalmol 1976;81: Early Treatment Diabeti Retinopathy Study Researh Group. Photooagulation for diabeti maular edema. Early Treatment Diabeti Retinopathy Study report number 1. Arh Ophthalmol 1985;103: Nguyen QD, Brown DM, Marus DM, et al.; RISE and RIDE Researh Group. Ranibizumab for diabeti maular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology 2012;119: Pearson PA, Comstok TL, Ip M, et al. Fluoinolone aetonide intravitreal implant for diabeti maular edema: a 3-year multienter, randomized, ontrolled linial trial. Ophthalmology 2011;118: Chew EY, Ambrosius WT. Update of the ACCORD Eye Study. N Engl J Med 2011;364: Keeh AC, Mithell P, Summanen PA, et al.; FIELD study investigators. Effet of fenofibrate on the need for laser treatment for diabeti retinopathy (FIELD study): a randomised ontrolled trial. Lanet 2007;370: Pop-Busui R, Evans GW, Gerstein HC, et al.; Ation to Control Cardiovasular Risk in Diabetes Study Group. Effets of ardia autonomi dysfuntion on mortality risk in the Ation to Control Cardiovasular Risk in Diabetes (ACCORD) trial. Diabetes Care 2010;33: Spallone V, Ziegler D, Freeman R, et al.; Toronto Consensus Panel on Diabeti Neuropathy. Cardiovasular autonomi neuropathy in diabetes: linial impat, assessment, diagnosis, and management. Diabetes Metab Res Rev 2011;27: Ang L, Jaiswal M, Martin C, Pop-Busui R. Gluose ontrol and diabeti neuropathy: lessons from reent large linial trials. Curr Diab Rep 2014;14: Martin CL, Albers JW, Pop-Busui R; DCCT/ EDIC Researh Group. Neuropathy and related findings in the Diabetes Control and Compliations Trial/Epidemiology of Diabetes Interventions and Compliations study. Diabetes Care 2014;37: 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 [published orretion appears in Neurology 2011;77:603]. Neurology 2011;76: Pop-Busui R, Lu J, Brooks MM, et al.; BARI 2D Study Group. Impat of glyemi ontrol strategies on the progression of diabeti peripheral neuropathy in the Bypass Angioplasty Revasularization Investigation 2 Diabetes (BARI 2D) ohort. Diabetes Care 2013;36: Martin CL, Albers J, Herman WH, et al.; DCCT/EDIC Researh Group. Neuropathy among the diabetes ontrol and ompliations trial ohort 8 years after trial ompletion. Diabetes Care 2006;29: Herman WH, Pop-Busui R, Braffett BH, et al.; DCCT/EDIC Researh Group. Use of the Mihigan Neuropathy Sreening Instrument as a measure of distal symmetrial peripheral neuropathy in type 1 diabetes: results from the Diabetes Control and Compliations Trial/ Epidemiology of Diabetes Interventions and Compliations. Diabet Med 2012;29: Wile DJ, Toth C. Assoiation of metformin, elevated homoysteine, and methylmaloni aid levels and linially worsened diabeti peripheral neuropathy. Diabetes Care 2010;33: Freeman R. Not all neuropathy in diabetes is of diabeti etiology: differential diagnosis of diabeti neuropathy. Curr Diab Rep 2009;9: Young LH, Wakers FJT, Chyun DA, et al.; DIAD Investigators. Cardia outomes after sreening for asymptomati oronary artery disease in patients with type 2 diabetes: the DIAD study: a randomized ontrolled trial. JAMA 2009;301: Spallone V, Bellavere F, Sionti L, et al.; Diabeti Neuropathy Study Group of the Italian Soiety of Diabetology. Reommendations for the use of ardiovasular tests in diagnosing diabeti autonomi neuropathy. Nutr Metab Cardiovas Dis 2011;21: Diabetes Control and Compliations Trial (DCCT) Researh Group. Effet of intensive diabetes treatment on nerve ondution in the Diabetes Control and Compliations Trial. Ann Neurol 1995;38: CDC Study Group. The effet of intensive diabetes therapy on measures of autonomi nervous system funtion in the Diabetes Control and Compliations Trial (DCCT). Diabetologia 1998;41: Albers JW, Herman WH, Pop-Busui R, et al.; Diabetes Control and Compliations Trial/ Epidemiology of Diabetes Interventions and Compliations Researh Group. Effet of prior intensive insulin treatment during the Diabetes Control and Compliations Trial (DCCT) on peripheral neuropathy in type 1 diabetes during the Epidemiology of Diabetes Interventions and Compliations (EDIC) study. Diabetes Care 2010;33: Pop-Busui R, Low PA, Waberski BH, et al.; DCCT/EDIC Researh Group. Effets of prior intensive insulin therapy on ardia autonomi nervous system funtion in type 1 diabetes mellitus: the Diabetes Control and Compliations Trial/Epidemiology of Diabetes Interventions and Compliations study (DCCT/EDIC). Cirulation 2009;119: Callaghan BC, Little AA, Feldman EL, Hughes RAC. Enhaned gluose ontrol for preventing and treating diabeti neuropathy. Cohrane Database Syst Rev 2012;6:CD Riddle MC, Ambrosius WT, Brillon DJ, et al.; Ation to Control Cardiovasular Risk in Diabetes Investigators. Epidemiologi relationships between A1C and all-ause mortality during a median 3.4-year follow-up of glyemi treatment in the ACCORD trial. Diabetes Care 2010; 33: Sadosky A, Shaefer C, Mann R, et al. Burden of illness assoiated with painful diabeti peripheral neuropathy among adults seeking treatment in the US: results from a retrospetive hart review and ross-setional survey. Diabetes Metab Syndr Obes 2013;6: Snedeor SJ, Sudharshan L, Cappelleri JC, Sadosky A, Mehta S, Botteman M. Systemati review and meta-analysis of pharmaologial therapies for painful diabeti peripheral neuropathy. Pain Prat 2014;14: Boulton AJM, Vinik AI, Arezzo JC, et al.; Amerian Diabetes Assoiation. Diabeti neuropathies: a statement by the Amerian Diabetes Assoiation. Diabetes Care 2005;28: Gaede P, Vedel P, Larsen N, Jensen GVH, Parving H-H, Pedersen O. Multifatorial intervention and ardiovasular disease in patients with type 2 diabetes. N Engl J Med 2003;348: Boulton AJM, Armstrong DG, Albert SF, et al.; Amerian Diabetes Assoiation; Amerian Assoiation of Clinial Endorinologists. Comprehensive foot examination and risk assessment: a report of the task fore of the foot are interest group of the Amerian Diabetes Assoiation, with endorsement by the Amerian Assoiation of Clinial Endorinologists. Diabetes Care 2008;31: Amerian Diabetes Assoiation. 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 e173

68 Diabetes Care Volume 38, Supplement 1, January 2015 S Older Adults Diabetes Care 2015;38(Suppl. 1):S67 S69 DOI: /d15-S013 Amerian Diabetes Assoiation Reommendations Older adults who are funtional and 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-lowering 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 Older adults ($65 years of age) with diabetes should be onsidered a highpriority population for depression sreening and treatment. B POSITION STATEMENT 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 is 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, oronary heart disease, and stroke, than those without diabetes. Older adults with diabetes are also at a greater risk than other older adults for several ommon geriatri syndromes, suh as polypharmay, ognitive impairment, urinary inontinene, injurious falls, and persistent pain. Sreening for diabetes ompliations in older adults also should be individualized. Older adults are at an inreased risk for depression and should therefore be sreened and treated aordingly (1). 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. Please refer to the Amerian Diabetes Assoiation onsensus report Diabetes in Older Adults for details (2). 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 are newly diagnosed and may have had years of undiagnosed diabetes with resultant ompliations; and still other older adults may have truly reent-onset disease with few or no ompliations. Some older adults with diabetes are frail and have other underlying hroni onditions, substantial diabetes-related 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 are often longer than liniians realize. Providers aring for older adults with diabetes must take this heterogeneity into onsideration when setting and prioritizing treatment goals (Table 10.1). 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 physial funtion, and who hoose to do so via shared deision making may be treated using therapeuti interventions and goals similar to Suggested itation: Amerian Diabetes Assoiation. Older adults. Se. 10. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S67 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.

69 S68 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Table 10.1 Framework for onsidering treatment goals for glyemia, blood pressure, and dyslipidemia in older adults with diabetes Patient harateristis/ health status Healthy (few oexisting hroni illnesses, intat ognitive and funtional status) Complex/intermediate (multiple oexisting hroni illnesses* or 21 instrumental ADL impairments or mild-tomoderate ognitive impairment) Very omplex/poor health (long-term are or endstage hroni illnesses** or moderate-to-severe ognitive impairment or 21 ADL dependenies) Rationale Longer remaining life expetany Intermediate remaining life expetany, high treatment burden, hypoglyemia vulnerability, fall risk Limited remaining life expetany makes benefit unertain Reasonable A1C goal Fasting or preprandial gluose (mg/dl) Bedtime gluose (mg/dl) Blood pressure (mmhg) Lipids,7.5% ,140/90 Statin unless ontraindiated or not tolerated,8.0% ,140/90 Statin unless ontraindiated or not tolerated,8.5% ,150/90 Consider likelihood of benefit with statin (seondary prevention more so than primary) This represents a onsensus framework for onsidering treatment goals for glyemia, blood pressure, and dyslipidemia in older adults with diabetes. The patient harateristi ategories are general onepts. Not every patient will learly fall into a partiular ategory. Consideration of patient and aregiver preferenes is an important aspet of treatment individualization. Additionally, a patient s health status and preferenes may hange over time. ADL, ativities of daily living. A lower A1C goal may be set for an individual if ahievable without reurrent or severe hypoglyemia or undue treatment burden. *Coexisting hroni illnesses are onditions serious enough to require mediations or lifestyle management and may inlude arthritis, aner, ongestive heart failure, depression, emphysema, falls, hypertension, inontinene, stage 3 or worse hroni kidney disease, myoardial infartion, and stroke. By multiple, we mean at least three, but many patients may have five or more (6). **The presene of a single end-stage hroni illness, suh as stage 3 4 ongestive heart failure or oxygen-dependent lung disease, hroni kidney disease requiring dialysis, or unontrolled metastati aner, may ause signifiant symptoms or impairment of funtional status and signifiantly redue life expetany. A1C of 8.5% equates to an estimated average gluose of ;200 mg/dl. Looser glyemi targets than this may expose patients to aute risks from glyosuria, dehydration, hyperglyemi hyperosmolar syndrome, and poor wound healing. those for younger adults with diabetes. As with all diabeti patients, diabetes self-management eduation and ongoing diabetes self-management support 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 hyperglyemia ontrol may be important in older individuals with diabetes, greater redutions in morbidity and mortality are likely to 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 treatinghypertensionintheelderly(3,4). 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. HYPOGLYCEMIA Older adults are at a higher risk of hypoglyemia for many reasons, inluding insulin defiieny and progressive renal insuffiieny. In addition, older adults tend to have higher rates of unidentified ognitive defiits, ausing diffiulty in omplex self-are ativities (e.g., gluose monitoring, adjusting insulin doses, et.). These defiits have been assoiated with inreased risk of hypoglyemia and with severe hypoglyemia linked to inreased dementia. Therefore, it is important to routinely sreen older adults for ognitive dysfuntion and disuss findings with the aregivers. Hypoglyemi events should be diligently monitored, and glyemi targets may need to be adjusted to aommodate for the hanging needs of the older adult (2). PHARMACOLOGICAL THERAPY Speial are is required in presribing and monitoring pharmaologial therapy in older adults. Cost may be a signifiant fator, espeially as 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, ongestive heart failure and have 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. GLP-1 agonists and dipeptidyl peptidase-4 inhibitors have few side effets, but their osts may be a barrier to some older patients. A linial trial, Saxagliptin Assessment of Vasular

70 are.diabetesjournals.org Position Statement S69 Outomes Reorded in Patients with Diabetes Mellitus Thrombolysis in Myoardial Infartion 53 (SAVOR-TIMI 53), evaluated saxagliptin (a dipeptidyl peptidase-4 inhibitor) and its impat on ardiovasular outomes (5). Patients treated with saxagliptin were more likely to be hospitalized for heart failure than were those given a plaebo (3.5% vs. 2.8%, respetively, aording to 2-year Kaplan-Meier estimates; hazard ratio 1.27 [95% CI ]; P ). Referenes 1. Kimbro LB, Mangione CM, Steers WN, et al. Depression and all-ause mortality in persons with diabetes mellitus: are older adults at higher risk? Results from the Translating Researh Into Ation for Diabetes Study. J Am Geriatr So 2014; 62: Kirkman MS, Brisoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care 2012;35: Bekett NS, Peters R, Flether AE, et al.; HYVET Study Group. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008;358: James PA, Oparil S, Carter BL, et al evidene-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 2014;311: Siria BM, Bhatt DL, Braunwald E, et al.; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and ardiovasular outomes in patients with type 2 diabetes mellitus. N Engl J Med 2013;369: Laiteerapong N, Iveniuk J, John PM, Laumann EO, Huang ES. Classifiation of older adults who have diabetes by omorbid onditions, United States, Prev Chroni Dis 2012;9:E100

71 S70 Diabetes Care Volume 38, Supplement 1, January Children and Adolesents Amerian Diabetes Assoiation Diabetes Care 2015;38(Suppl. 1):S70 S76 DOI: /d15-S014 POSITION STATEMENT TYPE 1 DIABETES Three-quarters of all ases of type 1 diabetes are diagnosed in individuals,18 years of age. The provider must onsider the unique aspets of are and management of hildren and adolesents with type 1 diabetes, suh as hanges in insulin sensitivity related to sexual maturity and physial growth, ability to provide self-are, supervision in hild are and shool, and unique neurologial vulnerability to hypoglyemia and possibly hyperglyemia as well as diabeti ketoaidosis. Attention to family dynamis, developmental stages, and physiologial differenes related to sexual maturity are all essential in developing and implementing an optimal diabetes regimen. Due to the pauity of linial researh in hildren, the reommendations for hildren and adolesents are less likely to be based on linial trial evidene. However, expert opinion and a review of available and relevant experimental data are summarized in the Amerian Diabetes Assoiation (ADA) position statement Care of Children and Adolesents With Type 1 Diabetes (1) and have been updated in the reently published ADA position statement Type 1 Diabetes Through the Life Span (2). A multidisiplinary team of speialists trained in pediatri diabetes management and sensitive to the hallenges of hildren and adolesents with type 1 diabetes should provide are for this population. It is essential that diabetes self-management eduation (DSME) and support (DSMS), medial nutrition therapy (MNT), and psyhosoial support be provided at diagnosis and regularly thereafter by individuals experiened with the eduational, nutritional, behavioral, and emotional needs of the growing hild and family. The balane between adult supervision and self-are should be defined at the first interation and reevaluated at eah lini visit. This relationship will evolve as the hild reahes physial, psyhologial, and emotional maturity. Glyemi Control Reommendation An A1C goal of,7.5% is reommended aross all pediatri age-groups. E Current standards for diabetes management reflet the need to lower gluose as safely as possible. This should be done with stepwise goals. Speial onsideration should be given to the unique risks of hypoglyemia in young hildren (aged,6 years), as they are often unable to reognize, artiulate, and/or manage their hypoglyemi symptoms. This hypoglyemia unawareness should be onsidered when establishing individualized glyemi targets. Although it was previously thought that young hildren were at risk for ognitive impairment after episodes of severe hypoglyemia, urrent data have not onfirmed this (3 5). Furthermore, new therapeuti modalities, suh as rapid- and long-ating insulin analogs, tehnologial advanes (e.g., ontinuous gluose monitors, low gluose suspend insulin pumps), and eduation, may mitigate the inidene of severe hypoglyemia (6). The Diabetes Control and Compliations Trial (DCCT) demonstrated that near-normalization of blood gluose levels was more diffiult to ahieve in adolesents than in adults. Nevertheless, the inreased use of basal bolus regimens and insulin pumps in youth from infany through adolesene has been assoiated with more hildren reahing the blood gluose targets set by the ADA (7 9) in those families in whih both parents and the hild with diabetes partiipate jointly to perform the required diabetes-related tasks. Furthermore, studies doumenting neuroognitive imaging differenes related to hyperglyemia in hildren provide another ompelling motivation for lowering glyemi targets (10). In seleting glyemi goals, the long-term health benefits of ahieving a lower A1C should be balaned against the risks of hypoglyemia and the developmental burdens Suggested itation: Amerian Diabetes Assoiation. Children and adolesents. Se. 11. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S70 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.

72 are.diabetesjournals.org Position Statement S71 of intensive regimens in hildren and youth. In addition, ahieving lower A1C levels is more likely to be related to setting lower A1C targets (11). A1C goals are presented in Table Autoimmune Conditions Reommendation Assess for the presene of additional autoimmune onditions at diagnosis and if symptoms develop. E Beause of the inreased frequeny of other autoimmune diseases in type 1 diabetes, sreening for thyroid dysfuntion, vitamin B 12 defiieny (due to autoimmune gastritis), and elia disease should be onsidered based on signs and symptoms. Periodi sreening in asymptomati individuals has been reommended, but the effetiveness and optimal frequeny are unlear. Although less ommon than elia disease and thyroid dysfuntion, there are other autoimmune onditions that our more ommonly in type 1 diabetes, suh as Addison s disease (primary adrenal insuffiieny), autoimmune hepatitis, dermatomyositis, myasthenia gravis, et., whih should be assessed and monitored as linially indiated. Celia Disease Reommendations Consider sreening hildren with type 1 diabetes for elia disease by measuring tissue transglutaminase or deamidated gliadin antibodies, with doumentation of normal total serum IgA levels, soon after the diagnosis of diabetes. E Consider sreening in hildren with a positive family history of elia disease, 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 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 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) (12,13). Testing for elia disease inludes measuring serum levels of IgA antitissue transglutaminase antibodies or, with IgA defiieny, sreening an inlude measuring IgG tissue transglutaminase antibodies or IgG deamidated gliadin peptide antibodies. A small-bowel biopsy in antibodypositive hildren is reommended to onfirm the diagnosis(14). European guidelines on sreening for elia disease in hildren (not speifi to hildren with type 1 diabetes) suggested that biopsy may not be neessary in symptomati hildren with high-positive antibody titers as long as further testing suh as geneti or HLA testing was supportive, but that asymptomati atrisk hildren should have biopsies (15). In symptomati hildren with type 1 diabetes and onfirmed elia disease, gluten-free diets redue symptoms and rates of hypoglyemia (16). The hallenging dietary restritions assoiated with having both type 1 diabetes and elia disease plae a signifiant burden on individuals. Therefore, we reommend a biopsy onfirming the diagnosis of elia disease before endorsing signifiant dietary hanges, espeially in asymptomati hildren. Thyroid Disease Reommendations Consider testing hildren with type 1 diabetes for antithyroid peroxidase and antithyroglobulin antibodies soon after diagnosis. E Measuring thyroid-stimulating hormone onentrations soon after diagnosis of type 1 diabetes is reasonable. If normal, onsider reheking every 1 2 yearsorsooner if the patient develops symptoms of thyroid dysfuntion, thyromegaly, an abnormal growth rate, or unusual glyemi variation. E Autoimmune thyroid disease is the most ommon autoimmune disorder assoiated with diabetes, ourring in 17 30% of patients with type 1 diabetes (17). About one-quarter of hildren with type 1 diabetes have thyroid autoantibodies at the time of diagnosis (18), and the presene of thyroid autoantibodies is preditive of thyroid dysfuntiond most ommonly hypothyroidism, although hyperthyroidism may our (19). Sublinial hypothyroidism may be assoiated with inreased risk of symptomati hypoglyemia (20) and redued linear growth. Hyperthyroidism alters gluose metabolism, potentially resulting in deterioration of metaboli ontrol. Management of Cardiovasular Risk Fators Hypertension Reommendations Sreening Blood pressure should be measured at eah routine visit. Children found to have high-normal blood pressure (systoli blood pressure [SBP] or diastoli blood pressure [DBP] $90th perentile for age, sex, and height) or hypertension (SBP or DBP $95th perentileforage,sex,andheight) should have blood pressure onfirmed on three separate days. B Table 11.1 Plasma blood gluose and A1C goals for type 1 diabetes aross all pediatri age-groups Plasma blood gluose goal range Before meals Bedtime/overnight A1C Rationale mg/dl mg/dl,7.5% A lower goal (,7.0%) is reasonable if it an be ( mmol/l) ( mmol/l) 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.

73 S72 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 Treatment Initial treatment of high-normal blood pressure (SBP or DBP onsistently $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 (SBP or DBP onsistently $95th perentile for age, sex, and height) should be onsidered as soon as hypertension is onfirmed. E ACE inhibitors or angiotensin reeptor blokers (ARBs) should be onsidered for the initial pharmaologial treatment of hypertension, following appropriate reprodutive ounseling due to its potential teratogeni effets. E The goal of treatment is blood pressure onsistently,90th perentile for age, sex, and height. E Blood pressure measurements should be determined orretly, using the appropriate size uff, and with the hild seated and relaxed. Hypertension should be onfirmed on at least three separate days. Evaluation should proeed as linially indiated. Treatment is generally initiated with an ACE inhibitor, but an ARB an be used if the ACE inhibitor is not tolerated (e.g., due to ough). Normal blood pressure levels for age, sex, and height and appropriate methods for measurement are available online at prof/heart/hbp/hbp_ped.pdf. Dyslipidemia Reommendations Testing Obtain a fasting lipid profile on hildren $2 years of age soon after the diagnosis (after gluose ontrol has been established). E 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. B 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 ardiovasular disease (CVD) risk fators is reasonable. E The goal of therapy is an LDL holesterol value,100 mg/dl (2.6 mmol/l). E Children diagnosed with type 1 diabetes have a high risk of early sublinial (21,22) and linial(23) 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(24,25). 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 does not interfere with normal growth and development (26). For hildren with signifiant family history of CVD, the National Heart, Lung, and Blood Institute reommends a fasting lipid panel beginning at 2 years of age (27). Abnormal results from a random lipid panel should be onfirmed with a fasting lipid panel. Evidene has shown that improved gluose ontrol orrelates with a more favorable lipid profile. However, improved glyemi ontrol alone will not reverse signifiant dyslipidemia (28). Neither long-term safety nor ardiovasular outome effiay of statin therapy has been established for hildren. However, 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 (29,30). Statins are not approved for use in patients 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, as statins are ategory X in pregnany (see Setion 12. Management of Diabetes in Pregnany for more information). Smoking Reommendation Eliit smoking history at initial and follow-up diabetes visits and disourage smoking in nonsmoking youth and enourage smoking essation in those who smoke. B The adverse health effets of smoking are well reognized with respet to future aner and CVD risk. In youth with diabetes, it remains important to avoid additional CVD risk fators; thus, disouraging igarette smoking, inluding e-igarettes, is important as part of routine diabetes are. In younger hildren, it is important to assess exposure to igarette smoke in the home due to the adverse effets of seondhand smoke and to disourage youth from adopting smoking behaviors if exposed to them in hildhood. In addition, smoking has been assoiated with onset of albuminuria; therefore, avoiding smoking is important to prevent both mirovasular and marovasular ompliations (31,32). Mirovasular Compliations Nephropathy Reommendations Sreening At least an annual sreening for albuminuria, with a random spot urine sample for albumin-toreatinine ratio (UACR), should be onsidered one the hild has had diabetes for 5 years. B Measure reatinine learane/estimated glomerular filtration rate at initial evaluation and then based on age, diabetes duration, and treatment. E Treatment Treatment with an ACE inhibitor, titrated to normalization of albumin exretion, should be onsidered when elevated UACR (.30 mg/g) is doumented with at least two of three urine samples. This should be obtained over a 6-month interval following efforts to improve glyemi ontrol and normalize blood pressure for age. B

74 are.diabetesjournals.org Position Statement S73 Reent researh demonstrates the importane of tight glyemi and blood pressure ontrol, espeially as diabetes duration inreases (33). A reatinine learane using an estimated glomerular filtration rate an be obtained with the serum reatinine, height, age, and sex of the patient (34) and should be obtained at baseline and repeated as indiated based on linial status, age, diabetes duration, and therapies. There are ongoing linial trials assessing the effiay of early treatment with ACE inhibitors for persistent albuminuria (35). Retinopathy Reommendations An initial dilated and omprehensive eye examination should be onsidered for the hild at the start of puberty or at age $10 years, whihever is earlier, one the youth has had diabetes for 3 5 years. B After the initial examination, annual routine follow-up is generally reommended. Less frequent examinations, every 2 years, 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 (36), 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 retinopathy risk in the pediatri population, and experiene in ounseling the pediatri patient and family on the importane of early prevention/ intervention. Neuropathy Reommendation Consider an annual omprehensive foot exam for the hild at the start of puberty or at age $10 years, whihever is earlier, one the youth has had type 1 diabetes for 5 years. E Neuropathy rarely ours in prepubertal hildren or in youth with 1 2 years of duration of diabetes (36). A omprehensive foot exam, inluding inspetion, palpation of dorsalis pedis and posterior tibial pulses, assessment of the presene or absene of patellar and Ahilles reflexes, and determination of proprioeption, vibration, and monofilament sensation, should be performed annually along with assessment of symptoms of neuropathi pain. Foot inspetion an be performed at eah visit as eduation for youth regarding the importane of foot are. Diabetes Self-management Eduation and Support Reommendation Youth with type 1 diabetes and parents/aregivers (for patients aged,18 years) should reeive ulturally sensitive and developmentally appropriate individualized DSME and DSMS aording to national standards when their diabetes is diagnosed and routinely thereafter. B 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 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. DSME and DSMS are ativities that require ongoing reassessment, espeially as the youth grows, develops, and aquires need for greater self-are skills. In addition, it may be neessary to assess the eduational needs and skills of day are providers, shool nurses, or shool personnel who may partiipate in the are of the young hild with diabetes (37). Shool and Child Care As a large portion of a hild s day is 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. Please refer to the ADA position statements Diabetes Care in the Shool and Day Care Setting (38) and Care of Young Children With Diabetes in the Child Care Setting (39) for additional details. Transition From Pediatri to Adult Care 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 are inreasingly shifted from parents and other adults to the youth with diabetes 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 (40), whih is 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 fully responsible for their diabetes are. Their new responsibilities inlude the many aspets of managing self-are, making medial appointments, and finaning health are, one they are no longer overed under their parents health insurane (although ongoing overage until age 26 years is possible with reent U.S. health are reform). In addition to lapses in health are, this is also a period of deterioration in glyemi ontrol; inreased ourrene of aute ompliations and psyhosoial, emotional, and behavioral issues; and emergene of hroni ompliations (41 44). Although sientifi evidene ontinues to be limited, it is lear that omprehensive and oordinated planning, beginning early and with ongoing attention, failitates a seamless transition from pediatri to adult health are (41,42). Transition planning should begin in early adolesene. Even after the transition to adult are is made, support and reinforement are reommended.

75 S74 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 A omprehensive disussion regarding the hallenges faed during this period, inluding speifi reommendations, is found in the ADA position statement Diabetes Care for Emerging Adults: Reommendations for Transition From Pediatri to Adult Diabetes Care Systems (42). The National Diabetes Eduation Program (NDEP) has materials available to failitate the transition proess ( and the Endorine Soiety in ollaboration with ADA and other organizations has developed transition tools for liniians and youth and families ( transition_of_are.fm). TYPE 2 DIABETES For information on testing for type 2 diabetes and prediabetes in hildren and adolesents, please refer to Setion 2. Classifiation and Diagnosis of Diabetes. The Centers for Disease Control and Prevention reently published projetions for type 2 diabetes prevalene using the SEARCH database. Assuming a 2.3% annual inrease, the prevalene of type 2 diabetes in those under 20 years of age will quadruple in 40 years (45,46). Given the urrent obesity epidemi, distinguishing between type 1 and type 2 diabetes in hildren an be diffiult. For example, autoantibodies and ketosis may be present in patients with features of type 2 diabetes (inluding obesity and aanthosis nigrians). Nevertheless, aurate diagnosis is ritial as treatment regimens, eduational approahes, dietary ounsel, and outomes will differ markedly between the two diagnoses. Signifiant omorbidities may already be present at the time of a type 2 diabetes diagnosis (47). It is reommended that blood pressure measurement, a fasting lipid panel, assessment for albumin exretion, and dilated eye examination be performed at diagnosis. Thereafter, sreening guidelines and treatment reommendations for hypertension, dyslipidemia, albumin exretion, 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 ovary disease and the various omorbidities assoiated with pediatri obesity, suh as sleep apnea, hepati steatosis, orthopedi ompliations, and psyhosoial onerns. The ADA onsensus report Type 2 Diabetes in Children and Adolesents (48) provides guidane on the prevention, sreening, and treatment of type 2 diabetes and its omorbidities in young people. PSYCHOSOCIAL ISSUES Reommendations At diagnosis and during routine follow-up are, assess psyhosoial issues and family stresses thatouldimpatadherenewith diabetes management and provide appropriate referrals to trained mental health professionals, preferably experiened in hildhood diabetes. E Enourage developmentally appropriate family involvement in diabetes management tasks for hildren and adolesents, reognizing that premature transfer of diabetes are to the hild an result in nonadherene and deterioration in glyemi ontrol. B Diabetes management throughout hildhood and adolesene plaes substantial burdens on the youth and family, neessitating ongoing assessment of psyhosoial issues and distress during routine diabetes visits (49 51). Further, the omplexities of diabetes management require ongoing parental involvement in are throughout hildhood with developmentally appropriate family teamwork between the growing hild/ teen and parent in order to maintain adherene and prevent deterioration in glyemi ontrol (52,53). In addition, as diabetes-speifi family onflit is related to poorer adherene and glyemi ontrol, it is appropriate to inquire about suh onflit during visits and to either help negotiate a plan for resolution or refer to an appropriate mental health speialist (54). Sreening for psyhosoial distress and mental health problems is an important omponent of ongoing are. It is important to onsider the impat of diabetes on quality of life as well as the development of mental health problems related to diabetes distress, fear of hypoglyemia (and hyperglyemia), symptoms of anxiety, disordered eating behaviors as well as eating disorders, and symptoms of depression (55). Consider sreening for depression and disordered eating behaviors using available sreening tools, and, with respet to disordered eating, it is important to reognize the unique and dangerous disordered eating behavior of insulin omission for weight ontrol in type 1 diabetes (49,56). The presene of a mental health professional on pediatri multidisiplinary teams highlights the importane of attending to the psyhosoial issues of diabetes. These psyhosoial fators are signifiantly related to nonadherene, suboptimal glyemi ontrol, redued quality of life, and higher rates of aute and hroni diabetes ompliations. Referenes 1. Silverstein J, Klingensmith G, Copeland K, et al. Care of hildren and adolesents with type 1 diabetes: a statement of the Amerian Diabetes Assoiation. Diabetes Care 2005;28: Chiang JL, Kirkman MS, Laffel LMB, Peters AL; Type 1 Diabetes Sourebook Authors. Type 1 diabetes through the life span: a position statement of the Amerian Diabetes Assoiation. Diabetes Care 2014;37: Seaquist ER, Anderson J, Childs B, et al. Hypoglyemia and diabetes: a report of a workgroup of the Amerian Diabetes Assoiation and the Endorine Soiety. Diabetes Care 2013;36: Wysoki T, Harris MA, Mauras N, et al. Absene of adverse effets of severe hypoglyemia on ognitive funtion in shool-aged hildren with diabetes over 18 months. Diabetes Care 2003;26: Blasetti A, Chiuri RM, Too AM, et al. The effet of reurrent severe hypoglyemia on ognitive performane in hildren with type 1 diabetes: a meta-analysis. J Child Neurol 2011;26: Cooper MN, O Connell SM, Davis EA, Jones TW. A population-based study of risk fators for severe hypoglyaemia in a ontemporary ohort of hildhood-onset type 1 diabetes. Diabetologia 2013;56: Zuijdwijk CS, Cuerden M, Mahmud FH. Soial determinants of health on glyemi ontrol in pediatri type 1 diabetes. J Pediatr 2013;162: 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 JAH, Vinent M, Tamborlane WVA. A randomized, prospetive trial omparing the effiay of ontinuous subutaneous insulin infusion with multiple daily injetions using insulin glargine. Diabetes Care 2004;27: Barnea-Goraly N, Raman M, Mazaika P, et al.; Diabetes Researh in Children Network (DireNet). Alterations in white matter struture in young hildren with type 1 diabetes. Diabetes Care 2014;37:

76 are.diabetesjournals.org Position Statement S Maahs DM, Hermann JM, DuBose SN, et al.; DPV Initiative; T1D Exhange Clini Network. Contrasting the linial are and outomes of 2,622 hildren with type 1 diabetes less than 6 years of age in the United States T1D Exhange and German/Austrian DPV registries. Diabetologia 2014;57: Holmes GKT. Sreening for oelia disease in type 1 diabetes. Arh Dis Child 2002;87: Rewers M, Liu E, Simmons J, Redondo MJ, Hoffenberg EJ. Celia disease assoiated with type 1 diabetes mellitus. Endorinol Metab Clin North Am 2004;33: Rubio-Tapia A, Hill ID, Kelly CP, Calderwood AH, Murray JA; Amerian College of Gastroenterology. ACG linial guidelines: diagnosis and management of elia disease. Am J Gastroenterol 2013;108: Husby S, Koletzko S, Korponay-Szabó IR, et al.; ESPGHAN Working Group on Coelia Disease Diagnosis; ESPGHAN Gastroenterology Committee; European Soiety for Pediatri Gastroenterology, Hepatology, and Nutrition. European Soiety for Pediatri Gastroenterology, Hepatology, and Nutrition guidelines for the diagnosis of oelia disease. J Pediatr Gastroenterol Nutr 2012;54: Abid N, MGlone O, Cardwell C, MCallion W, Carson D. Clinial and metaboli effets of gluten free diet in hildren with type 1 diabetes and oelia disease. Pediatr Diabetes 2011;12: Roldán MB, Alonso M, Barrio R. Thyroid autoimmunity in hildren and adolesents with type 1 diabetes mellitus. Diabetes Nutr Metab 1999;12: Triolo TM, Armstrong TK, MFann K, et al. Additional autoimmune disease found in 33% of patients at type 1 diabetes onset. Diabetes Care 2011;34: Kordonouri O, Deiss D, Danne T, Dorow A, Bassir C, Grüters-Kieslih A. Preditivity of thyroid autoantibodies for the development of thyroid disorders in hildren and adolesents with type 1 diabetes. Diabet Med 2002;19: Mohn A, Di Mihele S, Di Luzio R, Tumini S, Chiarelli F. The effet of sublinial hypothyroidism on metaboli ontrol in hildren and adolesents with type 1 diabetes mellitus. Diabet Med 2002;19: Hörtenhuber T, Rami-Mehar B, Satler M, et al. Endothelial progenitor ells are related to glyemi ontrol in hildren with type 1 diabetes over time. Diabetes Care 2013;36: Haller MJ, Samyn M, Nihols WW, et al. Radial artery tonometry demonstrates arterial stiffness in hildren with type 1 diabetes. Diabetes Care 2004;27: Orhard TJ, Forrest KY-Z, Kuller LH, Beker DJ; Pittsburgh Epidemiology of Diabetes Compliations Study. Lipid and blood pressure treatment goals for type 1 diabetes: 10-year inidene data from the Pittsburgh Epidemiology of Diabetes Compliations Study. Diabetes Care 2001;24: Kavey R-EW, Allada V, Daniels SR, et al. Cardiovasular risk redution in high-risk pediatri patients: a sientifi statement from the Amerian Heart Assoiation Expert Panel on Population and Prevention Siene; the Counils on Cardiovasular Disease in the Young, Epidemiology and Prevention, Nutrition, Physial Ativity and Metabolism, High Blood Pressure Researh, Cardiovasular Nursing, and the Kidney in Heart Disease; and the Interdisiplinary Working Group on Quality of Care and Outomes Researh: endorsed by the Amerian Aademy of Pediatris. Cirulation 2006;114: MCrindle BW, Urbina EM, Dennison BA, et al. Drug therapy of high-risk lipid abnormalities in hildren and adolesents: a sientifi statement from the Amerian Heart Assoiation Atheroslerosis, Hypertension, and Obesity in Youth Committee, Counil of Cardiovasular Disease in the Young, with the Counil on Cardiovasular Nursing. Cirulation 2007;115: Salo P, Viikari J, Hämäläinen M, et al. Serum holesterol ester fatty aids in 7- and 13-monthold hildren in a prospetive randomized trial of a low-saturated fat, low-holesterol diet: the STRIP baby projet. Speial Turku oronary Risk fator Intervention Projet for hildren. Ata Paediatr 1999;88: National Heart, Lung, and Blood Institute. Lipids and lipoproteins. In Expert Panel on Intergrated Guidelines for Cardiovasular Health and Risk Redution in Children and Adolesents: Summary Report [Internet]. Available from urrent/ardiovasular-health-pediatriguidelines/summary.htm#hap9. Aessed 17 Otober Maahs DM, Dabelea D, D Agostino RB, et al.; SEARCH for Diabetes in Youth Study. Gluose ontrol predits 2-year hange in lipid profile in youth with type 1 diabetes. J Pediatr 2013; 162: e1 29. MCrindle BW, Ose L, Marais AD. Effiay and safety of atorvastatin in hildren and adolesents with familial hyperholesterolemia or severe hyperlipidemia: a multienter, randomized, plaebo-ontrolled trial. J Pediatr 2003; 143: Wiegman A, Hutten BA, de Groot E, et al. Effiay and safety of statin therapy in hildren with familial hyperholesterolemia: a randomized ontrolled trial. JAMA 2004;292: Sott LJ, Warram JH, Hanna LS, Laffel LM, Ryan L, Krolewski AS. A nonlinear effet of hyperglyemia and urrent igarette smoking are major determinants of the onset of miroalbuminuria in type 1 diabetes. Diabetes 2001;50: Expert Panel on Integrated Guidelines for Cardiovasular Health and Risk Redution in Children and Adolesents; National Heart, Lung, and Blood Institute. Expert panel on integrated guidelines for ardiovasular health and risk redution in hildren and adolesents: summary report. Pediatris 2011;128(Suppl. 5): S213 S Daniels M, DuBose SN, Maahs DM, et al.; T1D Exhange Clini Network. Fators assoiated with miroalbuminuria in 7,549 hildren and adolesents with type 1 diabetes in the T1D Exhange lini registry. Diabetes Care 2013;36: Shwartz GJ, Work DF. Measurement and estimation of GFR in hildren and adolesents. Clin J Am So Nephrol 2009;4: Marovehio ML, Woodside J, Jones T, et al.; AdDIT Investigators. Adolesent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT): urinary sreening and baseline biohemial and ardiovasular assessments. Diabetes Care 2014;37: Cho YH, Craig ME, Hing S, et al. Mirovasular ompliations assessment in adolesents with 2- to 5-yr duration of type 1 diabetes from 1990 to Pediatr Diabetes 2011;12: Drisoll KA, Volkening LK, Haro H, et al. Are hildren with type 1 diabetes safe at shool? Examining parent pereptions. Pediatr Diabetes. 30 September 2014 [Epub ahead of print] 38. Amerian Diabetes Assoiation. Diabetes are in the shool and day are setting. Diabetes Care 2014;37(Suppl. 1):S91 S Siminerio LM, Albanese-O Neill A, Chiang JL, et al. Care of young hildren with diabetes in the hild are setting: a position statement of the Amerian Diabetes Assoiation. Diabetes Care 2014;37: Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psyhol 2000;55: Weissberg-Benhell J, Wolpert H, Anderson BJ. Transitioning from pediatri to adult are: a new approah to the post-adolesent young person with type 1 diabetes. Diabetes Care 2007;30: Peters A, Laffel L; Amerian Diabetes Assoiation Transitions Working Group. Diabetes are for emerging adults: reommendations for transition from pediatri to adult diabetes are 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, Children with Diabetes, 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). 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: Imperatore G, Boyle JP, Thompson TJ, et al.; SEARCH for Diabetes in Youth Study Group. Projetions of type 1 and type 2 diabetes burden in the U.S. population aged,20 years through 2050: dynami modeling of inidene, mortality, and population growth. Diabetes Care 2012; 35: Pettitt DJ, Talton J, Dabelea D, et al.; SEARCH for Diabetes in Youth Study Group. Prevalene of diabetes in U.S. youth in 2009: the SEARCH for Diabetes In Youth study. Diabetes Care 2014;37: 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:

77 S76 Position Statement Diabetes Care Volume 38, Supplement 1, January Amerian Diabetes Assoiation. Type 2 diabetes in hildren and adolesents. Diabetes Care 2000;23: Corathers SD, Kihler J, Jones N-HY, et al. Improving depression sreening for adolesents with type 1 diabetes. Pediatris 2013;132:e13952e Hood KK, Beavers DP, Yi-Frazier J, et al. Psyhosoial burden and glyemi ontrol during the first 6 years of diabetes: results from the SEARCH for Diabetes in Youth Study. J Adoles Health 2014;55: Duat L, Philipson LH, Anderson BJ. The mental health omorbidities of diabetes. JAMA 2014;312: Katz ML, Volkening LK, Butler DA, Anderson BJ, Laffel LM. Family-based psyhoeduation and are ambassador intervention to improve glyemi ontrol in youth with type 1 diabetes: a randomized trial. Pediatr Diabetes 2014;15: Laffel LMB, Vangsness L, Connell A, Goebel- Fabbri A, Butler D, Anderson BJ. Impat of ambulatory, family-foused teamwork intervention on glyemi ontrol in youth with type 1 diabetes. J Pediatr 2003;142: Anderson BJ, Vangsness L, Connell A, Butler D, Goebel-Fabbri A, Laffel LMB. Family onflit, adherene, and glyaemi ontrol in youth with short duration type 1 diabetes. Diabet Med 2002;19: Lawrene JM, Yi-Frazier JP, Blak MH, et al. Demographi and linial orrelates of diabetes-related quality of life among youth with type 1 diabetes. J Pediatr 2012;161: e2 56. Markowitz JT, Butler DA, Volkening LK, Antisdel JE, Anderson BJ, Laffel LMB. Brief sreening tool for disordered eating in diabetes: internal onsisteny and external validity in a ontemporary sample of pediatri patients with type 1 diabetes. Diabetes Care 2010;33:

78 Diabetes Care Volume 38, Supplement 1, January 2015 S Management of Diabetes in Pregnany Diabetes Care 2015;38(Suppl. 1):S77 S79 DOI: /d15-S015 Amerian Diabetes Assoiation For guidelines related to the diagnosis of gestational diabetes mellitus (GDM), please refer to Setion 2. Classifiation and Diagnosis of Diabetes. Reommendations Provide preoneption ounseling that addresses the importane of tight ontrol in reduing the risk of ongenital anomalies with an emphasis on ahieving A1C,7%, if this an be ahieved without hypoglyemia. B Potentially teratogeni mediations (ACE inhibitors, statins, et.) should be avoided in sexually ative women of hildbearing age who are not using reliable ontraeption. B GDM should be managed first with diet and exerise, and mediations should be added if needed. A Women with pregestational diabetes should have a baseline ophthalmology exam in the first trimester and then be monitored every trimester as indiated by degree of retinopathy. B Due to alterations in red blood ell turnover that lower the normal A1C level in pregnany, the A1C target in pregnany is,6% if this anbe ahievedwithout signifiant hypoglyemia. B Mediations widely used in pregnany inlude insulin, metformin, and glyburide; most oral agents ross the plaenta or lak long-term safety data. B POSITION STATEMENT DIABETES IN PREGNANCY The prevalene of diabetes in pregnany has been inreasing in the U.S. The majority is GDM with the remainder divided between pregestational type 1 diabetes and type 2 diabetes. Both pregestational type 1 diabetes and type 2 diabetes onfer signifiantly greater risk than GDM, with differenes aording to type as outlined below. PRECONCEPTION COUNSELING All women of hildbearing age with diabetes should be ounseled about the importane of strit glyemi ontrol prior to oneption. Observational studies show an inreased risk of diabeti embryopathy, espeially anenephaly, miroephaly, and ongenital heart disease, that inreases diretly with elevations in A1C. Spontaneous abortion is also inreased in the setting of unontrolled diabetes. While observational studies are onfounded by the relationship between elevated perioneptional A1C and other poor self-are behaviors, the quantity and onsisteny of data are onvining, and the reommendation remains to aim for an A1C,7% prior to oneption to minimize risk (1,2). There are opportunities to eduate adolesents of reprodutive age with diabetes about the risks of unplanned pregnanies and the opportunities for healthy maternal and fetal outomes with pregnany planning (3). Targeted preoneption ounseling visits should inlude routine rubella, rapid plasma reagin, hepatitis B virus, and HIV testing as well as Pap smear, ervial ultures, blood typing, and presription of prenatal vitamins (with at least 400 mg of foli aid). Diabetesspeifi management should inlude A1C, thyroid-stimulating hormone, reatinine, and urine albumin-to-reatinine ratio testing; review of the mediation list for potentially teratogeni drugs (i.e., ACE inhibitors, statins); and referral for an ophthalmologi exam. Speifi risks of unontrolled diabetes inlude fetal anomalies, preelampsia, marosomia, intrauterine fetal demise, neonatal hypoglyemia, and neonatal hyperbilirubinemia, among others. In addition, diabetes in pregnany inreases the risk of obesity and type 2 diabetes in offspring later in life (4,5). Suggested itation: Amerian Diabetes Assoiation. Management of diabetes in pregnany. Se. 12. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38 (Suppl. 1):S77 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.

79 S78 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 GLYCEMIC TARGETS IN PREGNANCY The goals for glyemi ontrol for GDM are based on reommendations from the Fifth International Workshop-Conferene on Gestational Diabetes Mellitus (6) and have the following targets for maternal apillary gluose onentrations: Preprandial #95 mg/dl (5.3 mmol/l) and either One-hour postmeal #140 mg/dl (7.8 mmol/l) or Two-hour postmeal #120 mg/dl (6.7 mmol/l) For women with preexisting type 1 diabetes or type 2 diabetes who beome pregnant, the following are reommended as optimal glyemi goals if they an be ahieved without exessive hypoglyemia (7): Premeal, bedtime, and overnight gluose mg/dl ( mmol/l) Peak postprandial gluose mg/dl ( mmol/l) A1C,6.0% Metaboli physiology of pregnany is haraterized by fasting hypoglyemia due to insulin-independent gluose uptake by the plaenta, postprandial hyperglyemia, and arbohydrate intolerane as a result of diabetogeni plaental hormones. In addition, insulin resistane inreases exponentially during the seond trimester and levels off toward the end of the third trimester. Refleting this physiology, pre- and postprandial monitoring of blood gluose is reommended to ahieve metaboli ontrol. The Amerian College of Obstetriians and Gyneologists (ACOG) reommends the following targets: fasting,90 mg/dl, preprandial,105 mg/dl, 1-h postprandial, mg/dl, and 2-h postprandial,120 mg/dl. If women annot ahieve these targets without signifiant hypoglyemia, the Amerian Diabetes Assoiation (ADA) suggests onsideration of slightly higher targets: fasting,105 mg/dl, 1-h postprandial,155 mg/dl, and 2-h postprandial,130 mg/dl. Until harmonization of these guidelines is ahieved, the ADA reommends setting targets based on linial experiene, individualizing are, as needed. Due to inreases in red blood ell turnover assoiated with pregnany, A1C levels fall during pregnany. Additionally, as A1C represents an average, it may not fully apture physiologially relevant glyemi parameters in pregnany. A1C should be used as a seondary measure, next to self-monitoring of blood gluose. The reommended A1C target in pregnany is,6% if this an be ahieved without hypoglyemia. Given the alteration in red blood ell kinetis during pregnany, A1C levels may need to be monitored more frequently than usual (e.g., monthly). PREGNANCY AND ANTIHYPERTENSIVE DRUGS In a pregnany ompliated by diabetes and hroni hypertension, target blood pressure goals of systoli blood pressure mmhg and diastoli blood pressure mmhg are reasonable, as they ontribute to improved longterm maternal health. Lower blood pressure levels may be assoiated with impaired fetal growth. During pregnany, treatment with ACE inhibitors and angiotensin reeptor blokers is ontraindiated beause they may 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 may redue uteroplaental perfusion (8). MANAGEMENT OF GESTATIONAL DIABETES MELLITUS As highlighted in Setion 2. Classifiation and Diagnosis of Diabetes, GDM is haraterized by inreased risk of marosomia and birth ompliations, without a risk threshold (9). Treatment starts with medial nutrition therapy, exerise, and gluose monitoring aiming for the targets desribed previously. A total of 70 to 85% of women diagnosed with GDM under older riteria an ontrol GDM with lifestyle modifiation alone; it is antiipated that this number will inrease using the lower International Assoiation of the Diabetes and Pregnany Study Groups (IADPSG) thresholds. Treatment has been demonstrated to improve perinatal outomes in randomized studies and in a U.S. Preventive Servies Task Fore review (10). Historially, insulin has been the reommended treatment for GDM in the U.S. Randomized ontrolled trials support the effiay and short-term safety of glyburide (11) (pregnany ategory B) and metformin (12,13) (pregnany ategory B) for the treatment of GDM. However, both agents ross the plaenta, and long-term safety data are not available (14). Insulin also maybeusedandshouldfollowthe guidelines below. MANAGEMENT OF PREGESTATIONAL TYPE 1 DIABETES AND TYPE 2 DIABETES IN PREGNANCY Insulin Use in Pregnany Insulin is the preferred agent for management of diabetes in pregnany beause of the lak of long-term safety data for noninsulin agents. The physiology of pregnany requires frequent titration of insulin to math hanging requirements. In the first trimester, there is often a derease in total daily dose of insulin. In the seond trimester, rapidly inreasing insulin resistane requires weekly or biweekly inrease in insulin dose to ahieve glyemi targets. In general, a small proportion of the total daily dose should be given as basal insulin and a greater proportion as prandial insulin. Due to the omplexity of insulin management in pregnany, referral to a speialized enter is reommended if this resoure is available. All insulins are pregnany ategory B exept for glargine and glulisine, whih are labeled C. Conerns Related to Type 1 Diabetes in Pregnany Women with type 1 diabetes have an inreased risk of hypoglyemia in the first trimester. Frequent hypoglyemia an be assoiated with intrauterine growth restrition. In addition, rapid implementation of tight glyemi ontrol in the setting of retinopathy is assoiated with worsening of retinopathy (15). Insulin resistane drops rapidly with delivery of the plaenta, and women beome very insulin sensitive, requiring muh less insulin than in the prepartum period. Conerns Related to Type 2 Diabetes in Pregnany Pregestational type 2 diabetes is often assoiated with obesity. Reommended weight gain during pregnany for

80 are.diabetesjournals.org Position Statement S79 overweight women is lb and for obese women is lb. Glyemi ontrol is often easier to ahieve in type 2 diabetes than in type 1 diabetes, but hypertension and other omorbidities often render pregestational type 2 diabetes as high or higher risk than pregestational type 1 diabetes (16,17). POSTPARTUM CARE Latation All women should be supported in attempts to nurse their babies, given immediate nutritional and immunologial benefits of breastfeeding for the baby; there may also be a longer-term metaboli benefit to both mother (18) and offspring (19), though data are mixed. Gestational Diabetes Mellitus Beause GDM may represent preexisting undiagnosed type 2 diabetes, women with GDM should be sreened for persistent diabetes or prediabetes at 6 12 weeks postpartum using nonpregnany riteria and every 1 3 years thereafter depending on other risk fators. Women with a history of GDM have a greatly inreased risk of onversion to type 2 diabetes over time and not solely within the 6 12 weeks postpartum time frame (20). In the prospetive Nurses Health Study II (21), subsequent diabetes risk 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. Interpregnany or postpartum weight gain is assoiated with inreased risk of adverse pregnany outomes in subsequent pregnanies (22) and earlier progression to type 2 diabetes. Both metformin and intensive lifestyle intervention prevent or delay progression to diabetes in women with a history of GDM. Of women with a history of GDM and impaired gluose tolerane, only 5 6 individuals need to be treated with either intervention to prevent one ase of diabetes over 3 years (23). Type 1 Diabetes Insulin sensitivity inreases in the immediate postpartum period and then returns to normal over the following 1 2 weeks, and many women will require signifiantly less insulin at this time than during the prepartum period. Breastfeeding may ause hypoglyemia, whih maybeamelioratedbyonsumingasnak (suh as milk) prior to nursing. Diabetes self-management often suffers in the postpartum period. Type 2 Diabetes If the pregnany has motivated the adoption of a healthier diet, building on these gains to support weight loss is reommended in the postpartum period. Contraeption All women of hildbearing age, inluding those who are postpartum, should have ontraeption options reviewed at regular intervals. Referenes 1. Guerin A, Nisenbaum R, Ray JG. Use of maternal GHb onentration to estimate the risk of ongenital anomalies in the offspring of women with prepregnany diabetes. Diabetes Care 2007;30: Jensen DM, Korsholm L, Ovesen P, et al. Peri-oneptional A1C and risk of serious adverse pregnany outome in 933 women with type 1 diabetes. Diabetes Care 2009;32: Charron-Prohownik D, Sereika SM, Beker D, et al. Long-term effets of the boosterenhaned READY-Girls preoneption ounseling program on intentions and behaviors for family planning in teens with diabetes. Diabetes Care 2013;36: Holmes VA, Young IS, Patterson CC, et al.; Diabetes and Pre-elampsia Intervention Trial Study Group. Optimal glyemi ontrol, preelampsia, and gestational hypertension in women with type 1 diabetes in the diabetes and pre-elampsia intervention trial. Diabetes Care 2011;34: Dabelea D, Hanson RL, Lindsay RS, et al. Intrauterine exposure to diabetes onveys risks for type 2 diabetes and obesity: a study of disordant sibships. Diabetes 2000;49: Metzger BE, Buhanan TA, Coustan DR, et al. Summary and reommendations of the Fifth International Workshop-Conferene on Gestational Diabetes Mellitus. Diabetes Care 2007; 30(Suppl. 2):S251 S Kitzmiller JL, Blok JM, Brown FM, et al. Managing preexisting diabetes for pregnany: summary of evidene and onsensus reommendations for are. Diabetes Care 2008;31: Sibai BM. Treatment of hypertension in pregnant women. N Engl J Med 1996;335: Metzger BE, Lowe LP, Dyer AR, et al.; HAPO Study Cooperative Researh Group. Hyperglyemia and adverse pregnany outomes. N Engl J Med 2008;358: Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systemati review and meta-analysis for the U.S. Preventive Servies Task Fore and the National Institutes of Health Offie of Medial Appliations of Researh. Ann Intern Med 2013;159: Langer O, Conway DL, Berkus MD, Xenakis EM-J, Gonzales O. A omparison of glyburide and insulin in women with gestational diabetes mellitus. N Engl J Med 2000;343: Rowan JA, Hague WM, Gao W, Battin MR, Moore MP; MiG Trial Investigators. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med 2008;358: Gui J, Liu Q, Feng L. Metformin vs insulin in the management of gestational diabetes: a meta-analysis. PLoS One 2013;8:e Coustan DR. Pharmaologial management of gestational diabetes: an overview. Diabetes Care 2007;30(Suppl. 2):S206 S Chew EY, Mills JL, Metzger BE, et al.; National Institute of Child Health and Human Development Diabetes in Early Pregnany Study. Metaboli ontrol and progression of retinopathy: the Diabetes in Early Pregnany Study. Diabetes Care 1995;18: Clausen TD, Mathiesen E, Ekbom P, Hellmuth E, Mandrup-Poulsen T, Damm P. Poor pregnany outome in women with type 2 diabetes. Diabetes Care 2005;28: Cundy T, Gamble G, Neale L, et al. Differing auses of pregnany loss in type 1 and type 2 diabetes. Diabetes Care 2007;30: Stuebe AM, Rih-Edwards JW, Willett WC, Manson JE, Mihels KB. Duration of latation and inidene of type 2 diabetes. JAMA 2005; 294: Pereira PF, Alfenas R de CG, Araújo RMA. Does breastfeeding influene the risk of developing diabetes mellitus in hildren? A review of urrent evidene. J Pediatr (Rio J) 2014;90: Kim C, Newton KM, Knopp RH. Gestational diabetes and the inidene of type 2 diabetes: a systemati review. Diabetes Care 2002;25: Tobias DK, Hu FB, Chavarro J, Rosner B, Mozaffarian D, Zhang C. Healthful dietary patterns and type 2 diabetes mellitus risk among women with a history of gestational diabetes mellitus. Arh Intern Med 2012;172: Villamor E, Cnattingius S. Interpregnany weight hange and risk of adverse pregnany outomes: a population-based study. Lanet 2006;368: Ratner RE, Christophi CA, Metzger BE, et al.; Diabetes Prevention Program Researh Group. Prevention of diabetes in women with a history of gestational diabetes: effets of metformin and lifestyle interventions. J Clin Endorinol Metab 2008;93:

81 S80 Diabetes Care Volume 38, Supplement 1, January Diabetes Care in the Hospital, Nursing Home, and Skilled Nursing Faility Diabetes Care 2015;38(Suppl. 1):S80 S85 DOI: /d15-S016 Amerian Diabetes Assoiation POSITION STATEMENT Reommendations Diabetes disharge planning should start at hospital admission, and lear diabetes management instrutions should be provided at disharge. E The sole use of sliding sale insulin (SSI) in the inpatient hospital setting is strongly disouraged. A All patients with diabetes admitted to the hospital should have their diabetes type learly identified in the medial reord. E 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 Nonritially Ill Patients If treated with insulin, generally premeal blood gluose targets of,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. C A basal plus orretion insulin regimen is the preferred treatment for patients with poor oral intake or who are taking nothing by mouth (NPO). An insulin regimen with basal, nutritional, and orretion omponents is the preferred treatment for patients with good nutritional intake. A 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 in patients with diabetes admitted to the hospital if the result of testing in the previous 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 follow-up testing and are doumented at disharge. E Suggested itation: Amerian Diabetes Assoiation. Diabetes are in the hospital, nursing home, and skilled nursing faility. Se. 13. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S80 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.

82 are.diabetesjournals.org Position Statement S81 HYPERGLYCEMIA IN THE HOSPITAL Hyperglyemia in the hospital an reflet previously known or previously undiagnosed diabetes or may be hospital related. The diffiulty distinguishing between the seond and third ategories during the hospitalization may be overome by measuring A1C, as long as onditions interfering with A1C equilibrium (suh as hemolysis, blood transfusion, blood loss, or erythropoietin therapy) have not ourred. A1C values $6.5% in undiagnosed patients suggest that diabetes preeded hospitalization (1). Hyperglyemia management in the hospital has often been onsidered seondary in importane to the ondition that prompted admission. However, a body of literature now supports targeted gluose ontrol in the hospital setting for improved linial outomes (2). Hyperglyemia in the hospital may result from stress or deompensation of type 1, type 2, or other forms of diabetes and/or may be iatrogeni due to withholding of antihyperglyemi mediations or administration of hyperglyemiaprovoking agents, suh as gluoortioids, vasopressors, and enteral or parenteral nutrition. 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 randomized ontrolled trials (RCTs) suggested that intensive treatment of hyperglyemia improved hospital outomes (3,4). In general, these studies were heterogeneous in terms of patient population, blood gluose targets, insulin protools, provision of nutritional support, and the proportion of patients reeiving insulin, whih limits the ability to make meaningful omparisons among them. Trials in ritially ill patients have failed to show a signifiant improvement in mortality with intensive glyemi ontrol or have even shown inreased mortality risk (5). Moreover, RCTs have highlighted the risk of severe hypoglyemia resulting from suh efforts (6 9). The largest study to date, Normoglyemia in Intensive Care Evaluation- Survival Using Gluose Algorithm Regulation (NICE-SUGAR), a multienter, multinational RCT, ompared the effet of intensive glyemi ontrol (target mg/dl [ mmol/l]; mean blood gluose attained 115 mg/dl [6.4 mmol/l]) to standard glyemi ontrol (target mg/dl [ mmol/l]; mean blood gluose attained 144 mg/dl [8.0 mmol/l]) on outomes among 6,104 ritially ill partiipants, almost all of whom required mehanial ventilation (6). Ninety-day mortality was signifiantly higher in the intensive versus the onventional treatment group in both surgial and medial patients, 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 study results lie in stark ontrast to a 2001 single-enter 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 (3). The NICE- SUGAR 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 (7.8 mmol/l) and that a highly stringent target of,110 mg/dl (6.1 mmol/l) may atually be dangerous. In a meta-analysis of 26 trials (n 5 13,567), whih inluded the NICE- SUGAR data, the pooled relative risk [RR] of death with intensive insulin therapy was 0.93 as ompared with onventional therapy (95% CI ) (9). 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 ]), while those in other medial and mixed ritial are settings did not. It was onluded that, overall, intensive insulin therapy inreased the risk of hypoglyemia and provided no overall benefit on mortality in the ritially ill, although a possible mortality benefit to patients admitted to the surgial ICU was suggested. GLYCEMIC 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 patients, that diabetes preeded hospitalization (1). Hypoglyemia has been defined as any blood gluose,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 (10). Both hyperglyemia and hypoglyemia among inpatients are assoiated with adverse short- and longterm 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 (11). Critially Ill Patients Based on available evidene, for the majority of ritially ill patients in the ICU setting, intravenous 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 mg/dl ( mmol/l). Greater benefit may be realized at the lower end of this range. Although strong evidene is laking, lower gluose targets may be appropriate in selet patients. One small study suggested that ICU patients treated to targets of mg/dl ( mmol/l) had less negative nitrogen balane than those treated to higher targets (12). However, targets,110 mg/dl (6.1 mmol/l) are not reommended. Insulin infusion protools with demonstrated safety and effiay, resulting in low rates of hypoglyemia, are highly reommended (11). Nonritially Ill Patients With no prospetive RCT data to inform speifi glyemi targets in nonritially ill patients, reommendations are based on linial experiene and judgment (13). For the majority of nonritially ill patients treated with insulin, premeal gluose targets should generally be,140 mg/dl (7.8 mmol/l) with

83 S82 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 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). Modifying 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 (14). 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 aforementioned 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 onomitant mediations that might affet gluose levels (e.g., gluoortioids, otreotide), must be inorporated into the day-to-day deisions regarding insulin dosing (11). ANTIHYPERGLYCEMIC AGENTS IN HOSPITALIZED PATIENTS In most linial situations in the hospital, insulin therapy is the preferred method of glyemi ontrol (11). 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 (15,16). Outside of ritial are units, sheduled subutaneous insulin that delivers basal, nutritional, and orretion omponents (basal bolus regimen) is reommended for patients with good nutritional intake. A basal plus orretion insulin regimen is the preferred treatment for patients with poor oral intake or who are NPO. SSI is strongly disouraged in hospitalized patients as the sole method of insulin treatment. Forpatientswithtype1diabetes, dosing insulin solely based on premeal gluose levels does not aount for basal insulin requirements or alori intake, inreasing both hypoglyemia and hyperglyemia risks and potentially leading to diabeti ketoaidosis. It has been shown in an RCT that basal bolus treatment improved glyemi ontrol and redued hospital ompliations ompared with SSI in general surgery patients with type 2 diabetes (17). Typial dosing shemes are based on body weight, with some evidene that patients with renal insuffiieny should be treated with lower doses (18). The reader is referred to publiations and reviews that desribe available insulin preparations and protools and provide guidane in the use of insulin therapy in speifi linial settings, inluding parenteral nutrition (19), enteral tube feedings, and high-dose gluoortioid therapy (11). Reent studies have investigated the safety and effiay of oral agents and injetable noninsulin therapies, suh as GLP- 1 analogs, in the hospital. A small study in general mediine and surgial wards showed that treatment with sitagliptin resulted in similar glyemi ontrol as a basal bolusregimeninpatientswithtype 2 diabetes who had an A1C,7.5% and, in addition to a nutrition intervention, were treated with oral agents or low doses of insulin prior to hospitalization (20). Use of intravenous exenatide infusion resulted in improved glyemi ontrol in patients admitted to a ardia ICU (21). Further studies are needed to define the role of inretin mimetis in the inpatient management of hyperglyemia. PREVENTING HYPOGLYCEMIA Patients with or without diabetes may experiene hypoglyemia in the hospital setting 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, redued oral intake, emesis, new NPO status, inappropriate timing of short- or rapid-ating insulin in relation to meals, redued infusion rate 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 hypoglyemia treatment than for its prevention. Traking suh episodes and analyzing their auses are important quality-improvement ativities (22). DIABETES CARE PROVIDERS IN THE HOSPITAL Inpatient diabetes management may be effetively hampioned and/or provided by primary are physiians, endorinologists, intensive are speialists, or hospitalists. Involvement of appropriately trained speialists or speialty teams may redue length of stay, improve glyemi ontrol, and improve outomes (11). Standardized orders for sheduled and orretion-dose insulin should be implemented, while sole reliane on an SSI regimen is strongly disouraged. As hospitals move to omply with meaningful use regulations for eletroni health reords, as mandated by the Health Information Tehnology for Eonomi and Clinial Health At, efforts should be made to ensure that all omponents of strutured insulin order sets are inorporated into eletroni insulin order sets (23,24). To ahieve glyemi targets assoiated with improved hospital outomes, hospitals will need a multidisiplinary approah to develop insulin management protools that effetively and safely enable ahievement of glyemi targets (25). SELF-MANAGEMENT IN THE HOSPITAL Diabetes self-management in the hospital may be appropriate for ompetent youth and adult patients who have a stable level of onsiousness and reasonably stable daily insulin requirements, suessfully ondut self-management of diabetes at home, have physial skills needed to suessfully self-administer insulin and perform self-monitoring of blood gluose, have adequate oral intake, are profiient in arbohydrate ounting, use multiple daily insulin injetions or insulin pump therapy, and understand sik-day management. The patient and physiian, in onsultation with nursing staff, must agree that patient self-management is appropriate while hospitalized.

84 are.diabetesjournals.org Position Statement S83 Patients who use ontinuous subutaneous insulin infusion (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 (11). 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 daily basis. MEDICAL NUTRITION THERAPY IN THE HOSPITAL The goals of medial nutrition therapy are to optimize glyemi ontrol, provide adequate alories to meet metaboli demands, and reate a disharge plan for follow-up are (2,26). The Amerian Diabetes Assoiation (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 use. Consistent arbohydrate meal plans are preferred by many hospitals as they failitate mathing the prandial insulin dose to the amount of arbohydrate onsumed (27). Beause of the omplexity of nutrition issues in the hospital, a registered dietitian, knowledgeable and skilled in medial nutrition therapy, should serve as an inpatient team member. The dietitian is responsible for integrating information about the patient s linial ondition, meal planning, and lifestyle habits and for establishing treatment goals to determine a realisti plan for nutrition therapy (28). BEDSIDE BLOOD GLUCOSE MONITORING Bedside point-of-are (POC) blood gluose monitoring is used to guide insulin dosing. In the patient reeiving nutrition, the timing of gluose monitoring should math arbohydrate exposure. In the patient not reeiving nutrition, gluose monitoring is performed every 4 6 h (29,30). 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 that prohibit the 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 sharing syringes and needles (31). Auray of blood gluose measurements using POC meters has limitations that must be onsidered. Although the U.S. Food and Drug Administration urrently allows a 620% error for blood gluose meters, questions about the appropriateness of these riteria have been raised, espeially for lower blood gluose readings (32). 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 (33). Signifiant disrepanies between apillary, venous, and arterial plasma samples have been observed in patients with low or high hemoglobin onentrations, hypoperfusion, and interfering substanes suh as maltose (ontained in immunoglobulins) (34). Analytial variability has been desribed with several meters (35). 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 status should be onfirmed through onventional laboratory sampling of plasma gluose. The U.S. Food and Drug Administration has beome inreasingly onerned about POC blood gluose meter use in the hospital and is presently reviewing matters related to their use. DISCHARGE PLANNING 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 extensive literature onerning safe transition within and from the hospital, little of it is speifi to diabetes (36). Diabetes disharge planning is not a separate entity but is an important part of an overall disharge plan. As suh, disharge planning begins at admission to the hospital andisupdatedasprojetedpatient needs hange. Inpatients may be disharged to varied settings, inluding home (with or without visiting nurse servies), assisted living, rehabilitation, or skilled nursing failities. 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. 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 of hyperglyemia (or the plan for determining the ause), related ompliations and omorbidities, and reommended treatments an assist outpatient providers as they assume ongoing are. The Ageny for Healthare Researh and Quality reommends that, at a minimum, disharge plans inlude the following: Mediation Reoniliation The patient s mediations must be ross-heked to ensure that no hroni mediations were stopped and to ensure the safety of new presriptions. Presriptions for new or hanged mediation should be filled and reviewed with the patient and family at or before disharge. Strutured Disharge Communiation Information on mediation hanges, pending tests and studies, and followup 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 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 primary are provider, endorinologist, and diabetes eduator (37).

85 S84 Position Statement Diabetes Care Volume 38, Supplement 1, January 2015 DIABETES SELF-MANAGEMENT EDUCATION 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 require eduation to prevent subsequent episodes of hospitalization. Assessing the need for a home health referral or referral to an outpatient diabetes eduation program should be part of disharge planning for all patients. Expanded diabetes eduation an be arranged in the ommunity. Diabetes self-management eduation should start upon admission or as soon as feasible, 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 the health are provider who will provide diabetes are after disharge Level of understanding related to the diagnosis of diabetes, self-monitoring of blood gluose, and explanation of home blood gluose goals Definition, reognition, treatment, and prevention of hyperglyemia and hypoglyemia Informationononsistenteatingpatterns 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 devies Urine ketone strips (type 1 diabetes) Gluagon emergeny kit (insulintreated patients) Medial alert appliation/harms Referenes 1. Saudek CD, Herman WH, Saks DB, Bergenstal RM, Edelman D, Davidson MB. A new look at sreening and diagnosing diabetes mellitus. J Clin Endorinol Metab 2008;93: Clement S, Braithwaite SS, Magee MF, et al.; Amerian Diabetes Assoiation Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglyemia in hospitals [published orretion in Diabetes Care 2004;27: 856]. Diabetes Care 2004;27: van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in ritially ill patients. N Engl J Med 2001;345: Malmberg K, Norhammar A, Wedel H, Rydén L. Glyometaboli state at admission: important risk marker of mortality in onventionally treated patients with diabetes mellitus and aute myoardial infartion: long-term results from the Diabetes and Insulin-Gluose Infusion in Aute Myoardial Infartion (DIGAMI) study. Cirulation 1999;99: Finar S, Liu B, Chittok DR, et al.; NICE-SUGAR Study Investigators. Hypoglyemia and risk of deathinritiallyillpatients.nengljmed 2012;367: Finfer S, Chittok DR, Su SY, et al.; NICE-SUGAR Study Investigators. Intensive versus onventional gluose ontrol in ritially ill patients. N Engl J Med 2009;360: Krinsley JS, Grover A. Severe hypoglyemia in ritially ill patients: risk fators and outomes. Crit Care Med 2007;35: Van den Berghe G, Wilmer A, Hermans G, et al. Intensive insulin therapy in the medial ICU. N Engl J Med 2006;354: Griesdale DE, de Souza RJ, van Dam RM, et al. Intensive insulin therapy and mortality among ritially ill patients: a meta-analysis inluding NICE- SUGAR study data. CMAJ 2009;180: Cryer PE, Davis SN, Shamoon H. Hypoglyemia in diabetes. Diabetes Care 2003;26: Moghissi ES, Korytkowski MT, DiNardo M, et al.; Amerian Assoiation of Clinial Endorinologists; Amerian Diabetes Assoiation. Amerian Assoiation of Clinial Endorinologists and Amerian Diabetes Assoiation onsensus statement on inpatient glyemi ontrol. Diabetes Care 2009;32: Hsu C-W, Sun S-F, Lin S-L, Huang H-H, Wong K-F. Moderate gluose ontrol results in less negative nitrogen balanes in medial intensive are unit patients: a randomized, ontrolled study. Crit Care 2012;16:R Umpierrez GE, Hellman R, Korytkowski MT, et al.; Endorine Soiety. Management of hyperglyemia in hospitalized patients in non-ritial are setting: an endorine soiety linial pratie guideline. J Clin Endorinol Metab 2012;97: Bernard JB, Munoz C, Harper J, Muriello M, Rio E, Baldwin D. Treatment of inpatient hyperglyemia beginning in the emergeny department: a randomized trial using insulins aspart and detemir ompared with usual are. J Hosp Med 2011;6: Czosnowski QA, Swanson JM, Lobo BL, Broyles JE, Deaton PR, Finh CK. Evaluation of glyemi ontrol following disontinuation of an intensive insulin protool. J Hosp Med 2009;4: Shomali ME, Herr DL, Hill PC, Pehlivanova M, Sharretts JM, Magee MF. Conversion from intravenous insulin to subutaneous insulin after ardiovasular surgery: Transition to Target Study. Diabetes Tehnol Ther 2011;13: Umpierrez GE, Smiley D, Jaobs S, et al. Randomized Study of Basal-Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes undergoing general surgery (RABBIT 2 Surgery). Diabetes Care 2011;34: Baldwin D, Zander J, Munoz C, et al. A randomized trial of two weight-based doses of insulin glargine and glulisine in hospitalized subjets with type 2 diabetes and renal insuffiieny. Diabetes Care 2012;35: Pasquel FJ, Spiegelman R, MCauley M, et al. Hyperglyemia during total parenteral nutrition: an important marker of poor outome and mortality in hospitalized patients. Diabetes Care 2010;33: Umpierrez GE, Gianhandani R, Smiley D, et al. Safety and effiay of sitagliptin therapy for the inpatient management of general mediine and surgery patients with type 2 diabetes: a pilot, randomized, ontrolled study. Diabetes Care 2013;36: Abuannadi M, Kosiborod M, Riggs L, et al. Management of hyperglyemia with the administration of intravenous exenatide to patients in the ardia intensive are unit. Endor Prat 2013;19: Seaquist ER, Anderson J, Childs B, et al. Hypoglyemia and diabetes: a report of a workgroup of the Amerian Diabetes Assoiation and the Endorine Soiety. Diabetes Care 2013;36: Shnipper JL, Liang CL, Ndumele CD, Pendergrass ML. Effets of a omputerized order set on the inpatient management of hyperglyemia: a luster-randomized ontrolled trial. Endor Prat 2010;16: Wexler DJ, Shrader P, Burns SM, Cagliero E. Effetiveness of a omputerized insulin order template in general medial inpatients with type 2 diabetes: a luster randomized trial. Diabetes Care 2010;33: Furnary AP, Braithwaite SS. Effets of outome on in-hospital transition from intravenous insulin infusion to subutaneous therapy. Am J Cardiol 2006;98:

86 are.diabetesjournals.org Position Statement S Shafer RG, Bohannon B, Franz MJ, et al.; Amerian Diabetes Assoiation. Diabetes nutrition reommendations for 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: Evert AB, Bouher JL, Cypress M, et al. Nutrition therapy reommendations for the management of adults with diabetes. Diabetes Care 2014;37(Suppl. 1):S120 S 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. Diabetes Care 2009;32: Klonoff DC, Perz JF. Assisted monitoring of blood gluose: speial safety needs for a new paradigm in testing gluose. J Diabetes Si Teh 2010;4: Vandvik PO, Linoff AM, Gore JM, et al.; Amerian College of Chest Physiians. Primary and seondary prevention of ardiovasular disease: Antithromboti Therapy and Prevention of Thrombosis, 9th ed: Amerian College of Chest Physiians Evidene-Based Clinial Pratie Guidelines. Chest 2012;141(Suppl.):e637S e668s 33. D Orazio P, Burnett RW, Fogh-Andersen N, et al.; International Federation of Clinial Chemistry Sientifi Division Working Group on Seletive Eletrodes and Point of Care Testing. Approved IFCC reommendation on reporting results for blood gluose (abbreviated). Clin Chem 2005;51: Dungan K, Chapman J, Braithwaite SS, Buse J. Gluose measurement: onfounding issues in setting targets for inpatient management. Diabetes Care 2007;30: Boyd JC, Bruns DE. Quality speifiations for gluose meters: assessment by simulation modeling of errors in insulin dose. Clin Chem 2001; 47: Shepperd S, Lannin NA, Clemson LM, MCluskey A, Cameron ID, Barras SL. Disharge planning from hospital to home. Cohrane Database Syst Rev 2013;1:CD Ageny for Healthare Researh and Quality. AHRQ Patient Safety Networkdadverse events after hospital disharge [Internet], Available from primer.aspx?primerid511. Aessed 1 Otober 2014

87 S86 Diabetes Care Volume 38, Supplement 1, January Diabetes Advoay Amerian Diabetes Assoiation Diabetes Care 2015;38(Suppl. 1):S86 S87 DOI: /d15-S017 POSITION STATEMENT Managing the daily health demands of diabetes an be hallenging. People living with diabetes should not have to fae additional disrimination due to diabetes. By advoating for the rights of those with diabetes at all levels, the Amerian Diabetes Assoiation (ADA) an help ensure that they live a healthy and produtive life. A strategi goal of the ADA is that by the end of 2015, more hildren and adults with diabetes will be living free from the burden of disrimination. One tati for ahieving this goal is to implement the ADA s Standards of Medial Care through advoay-oriented position statements. The ADA publishes evidenebased, peer-reviewed statements on topis suh as diabetes and employment, diabetes and driving, and diabetes management in ertain settings suh as shools, hild are programs, and orretional institutions. In addition to ADA s linial position statements, these advoay position statements are important tools in eduating shools, employers, liensing agenies, poliy makers, and others about the intersetion of diabetes mediine and the law. ADVOCACY POSITION STATEMENTS Partial list, with most reent publiations appearing first Care of Young Children With Diabetes in the Child Care Setting (1) First publiation: 2014 Very young hildren (aged,6 years) with diabetes have legal protetions and an be safely ared for by hild are providers with appropriate training, aess to resoures, and a system of ommuniation with parents and the hild s diabetes provider. See the ADA position statement Care of Young Children With Diabetes in the Child Care Setting for further disussion: Diabetes and Driving (2) First publiation: 2012 People with diabetes who wish to operate motor vehiles 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 impaired onsiousness or ognition may lead to drivers being evaluated for fitness to drive. People with diabetes should be individually assessed by a health are professional knowledgeable in diabetes if liense restritions are being onsidered, and patients should be ounseled about deteting and avoiding hypoglyemia while driving. See the ADA position statement Diabetes and Driving for further disussion: Diabetes and Employment (3) First publiation: 1984 (revised 2009) Any person with diabetes, whether insulin-treated or noninsulin-treated, should be eligible for any employment for whih he or 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 Diabetes and Employment for further disussion: ontent/37/supplement_1/s112. Diabetes Care in the Shool and Day Care Setting (4)* First publiation: 1998 (revised 2008) As a sizeable portion of a hild s day is spent in shool, lose ommuniation with and ooperation of shool personnel are essential for optimal diabetes management, safety, and maximal aademi opportunities. See the ADA position statement Diabetes Suggested itation: Amerian Diabetes Assoiation. Diabetes advoay. Se. 14. In Standards of Medial Care in Diabetesd2015. Diabetes Care 2015;38(Suppl. 1):S86 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.

88 are.diabetesjournals.org Position Statement S87 Care in the Shool and Day Care Setting for further disussion: Supplement_1/S91. *In Otober 2014, a separate statement on the are of young hildren with diabetes in the hild are setting was published. Diabetes Management in Corretional Institutions (5) First publiation: 1989 (revised 2008) 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 Diabetes Management in Corretional Institutions for further disussion: Referenes 1. Siminerio LM, Albanese-O Neill A, Chiang JL, et al. Care of young hildren with diabetes in the hild are setting: a position statement of the Amerian Diabetes Assoiation. Diabetes Care 2014;37: Amerian Diabetes Assoiation. Diabetes and driving. Diabetes Care 2014;37(Suppl. 1): S972S Amerian Diabetes Assoiation. Diabetes and employment. Diabetes Care 2014;37(Suppl. 1):S112 S Amerian Diabetes Assoiation. Diabetes are in the shool and day are setting. Diabetes Care 2014;37(Suppl. 1):S91 S96 5. Amerian Diabetes Assoiation. Diabetes management in orretional institutions. Diabetes Care 2014;37(Suppl. 1):S104 S111

89 PROFESSIONAL PRACTICE COMMITTEE S88 Diabetes Care Volume 38, Supplement 1, January 2015 Professional Pratie Committee for the Standards of Medial Care in Diabetesd2015 Diabetes Care 2015;38(Suppl. 1):S88 S89 DOI: /d15-S018 Committee members dislosed the following finanial or other onflits of interest overing the period 12 months before 7 September 2014 Member Employment Researh grant Other researh support Rihard W. Grant, MD, MPH (Chair) Division of Researh, Kaiser NIDDK, NHLBI None Permanente, Oakland, CA Thomas W. Donner, MD Johns Hopkins University Shool of Novo Nordisk*# None Mediine, Baltimore, MD Judith E. Fradkin, MD National Institutes of Health, Bethesda, MD None None Charlotte Hayes, MMS, MS, RD, CDE, ACSM CES Private pratie: (NF) 2 Nutrition and Fitness Consulting, Atlanta, GA William H. Herman, MD, MPH University of Mihigan, Ann Arbor, MI None None William C. Hsu, MD Joslin Diabetes Center, Boston, MA None None Eileen Kim, MD Kaiser Permanente Northern None None California Region, Oakland, CA Lori Laffel, MD, MPH Joslin Diabetes Center and Harvard Dexom, Boehringer None Medial Shool, Boston, MA Ingelheim Rodia Pop-Busui, MD, PhD University of Mihigan, Ann Arbor, MI NHLBI, NIDDK, ADA, None Bristol-Myers Squibb Neda Rasouli, MD University of Colorado, Denver, CO Novo Nordisk,# Bristol- Myers Squibb,# Merk Sharp & Dohme,# NIDDK,# Pfizer# None Desmond Shatz, MD University of Florida, Gainesville, FL None NIDDK, NIAID, Jaeb Center for Health Researh, JDRF, Helmsley Charitable Trust Joseph A. Stankaitis, MD, MPH Monroe Plan for Medial Care, Rohester, NY Milbank Memorial Fund None Traey H. Taveira, PharmD, CDOE, CVDOE University of Rhode Island College of Pharmay, Kingston, RI; Providene VA Medial Center, Warren Alpert Medial Shool of Brown University, Providene, RI Deborah J. Wexler, MD Massahusetts General Hospital, NIDDK None Boston, MA Jane L. Chiang, MD (Staff) ADA, Alexandria, VA None None Erika Gebel Berg, PhD (Staff) ADA, Alexandria, VA None None ADA, Amerian Diabetes Assoiation; AHA, Amerian Heart Assoiation; MEDCAC, Mediare Evidene Development & Coverage Advisory Committee; NHLBI, National Heart, Lung, and Blood Institute; NIAID, National Institute of Allergy and Infetious Diseases; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases. *$$10,000 per year from ompany to individual. #Grant or ontrat is to university or other employer. None AHA None None

90 are.diabetesjournals.org Professional Pratie Committee S89 Member Speakers bureau/ honoraria Ownership interest Consultant/advisory board Other R.W.G. None None None None T.W.D. None None None None J.E.F. None None None None C.H. None Sherer Clinial Communiations Emory University, Emory Diabetes Course at Grady, Team Novo Nordisk W.H.H. None None AstraZenea, Novo Nordisk (self and spouse), Merk Sharp & Dohme,* GI Dynamis, Boehringer Ingelheim Reeives royalties from the ADA, Aademy of Nutrition and Dietetis (Chair, Legislative and Publi Poliy Committee) National Committee for Quality Assurane (Chair, Diabetes Panel), Centers for Mediare & Mediaid Servies (member, MEDCAC), Diabeti Mediine (Editor for the Amerias) W.C.H. None None Novo Nordisk None E.K. None None None None L.L. None None Johnson & Johnson, Eli Lilly, Sanofi, Bristol-Myers Squibb, Menarini, Novo Nordisk, AstraZenea, LifeSan/ Animas, Boehringer Ingelheim, Dexom None R.P.-B. None None Aorda Therapeutis, AstraZenea, None T1D Exhange N.R. None None None None D.S. None None Daiihi Sankyo, Andromeda Bioteh ADA Board of Diretors, ADA offier J.A.S. None None TPG National Payor Roundtable, Amgen, Celgene, Gilead, Salix Pharmaeutials, Janssen Pharmaeutials, Bayer, Medtroni National Committee for Quality Assurane (physiian surveyor and member of Reonsideration Committee), New York State Department of Health Mediaid Redesign Team s Evidene-Based Benefit Review Workgroup, Board member (Chair-Elet) for St. Ann s Community, Rohester, NY, a nonprofit senior living/long-term are organization T.H.T. None None None None D.J.W. None None None Diabetes Care (Editorial Board) J.L.C. None None None None E.G.B. None None None None

91 S90 Diabetes Care Volume 38, Supplement 1, January 2015 Index INDEX A1C. see also glyemi targets CGM, S34 hildren and adolesents, S35, S71 glyemi target determination, S37 goals, S35 limitations, S34 S35 marovasular ompliations, S36 mean gluose levels, S35 mirovasular ompliations, S35 S36 rae/ethniity differenes, S9, S35 reommendations, S34, S35, S37 SMBG, S33 S34 testing, S8 S10, S12, S34 S35 aarbose, S44 ACCORD trial, S19, S36, S38, S50, S53 A1C Derived Average Gluose (ADAG) trial, S35, S37 ACE inhibitors, S49 S51, S55, S58 S60, S72, S78 aute oronary syndrome, S54, S55 adolesents. see hildren and adolesents ADVANCE-BP trial, S50, S51 ADVANCE trial, S36, S38 advoay, S5, S86 S87 Afrian Amerians, S9, S11, S12, S24, S35 age. see older adults AIM-HIGH trial, S53 albiglutide, S45 albuminuria, S25, S58 S60, S73 alohol, S23, S51 alogliptin, S44 amlodipine, S51 amputations, S63 S64 amylin mimetis, S45 anemia, S9 angiotensin reeptor blokers (ARBs), S49 S51, S55, S58 S60, S72, S78 ankle-brahial index (ABI), S63, S64 antihypertensive mediations, S51, S59, S78 antiplatelet agents, S54 S55, S61 Antithromboti Trialists (ATT) Collaboration, S54 Asian Amerians, S9 S12 aspart, S43, S45 aspirin resistane, S55 aspirin therapy, S54 S55, S61 assisted living. see hospital are autoimmune disease, S10 S11 Automation to Simulate Panreati Insulin Response (ASPIRE) trial, S34 autonomi neuropathy, S25, S62 S63 bariatri surgery, S46 S47 benazepril, S51 biguanides, S31, S32, S42 S44 bile aid sequestrants, S42, S44, S53 b-blokers, S51, S55 blood pressure ontrol. see hypertension body mass index (BMI), S12 bromoriptine, S42, S45 alium hannel blokers, S51, S59 anagliflozin, S45 aner, S18 arbohydrates, S21 S23 ardiovasular disease A1C relationship to, S36 autonomi neuropathy, S25, S62 S63 hildren and adolesents, S72 dietary fat management, S23 S24 patient-enteredness, S5 pharmaologial therapy, S51 S55, S59 postprandial plasma gluose testing, S37 revisions summary, S4 risk alulator, S52 risk fators, S10, S12, S25, S32 risk management, S49 S55 sreening, S31, S55 testing frequeny, S9 Care of Young Children With Diabetes in the Child Care Setting, S86 elia disease, S71 Charot foot, S64 hildren and adolesents A1C goals, S35, S71 autoimmune onditions, S71 ardiovasular disease, S72 elia disease, S71 ognitive impairment, S70 DSME/DSMS, S73 dyslipidemia, S72 family stresses, S74 glyemi ontrol, S70 S71 hypertension, S71 S72 hypoglyemia, S70 nephropathy, S72 S73 neuropathy, S73 pediatri to adult are transition, S73 S74 plasma blood gluose goals, S71 psyhosoial issues, S74 resoures, S86 retinopathy, S73 revisions summary, S4 shool, hild are, S73 smoking, S72 statins, S72 thyroid disease, S71 type 1 diabetes, S10 S11, S70 S74 type 2 diabetes, S12 S13, S74 hlorthalidone, S51 holesterol. see also dyslipidemia hildren and adolesents, S72 ontrol, S51 monitoring, S53 sreening, S10, S52 treatment, S52, S55 Chroni Care Model (CCM), S5, S6 hroni kidney disease, S23, S25, S58 S60 lassifiation, diagnosis overview, S8 prediabetes, S9 S10, S12 S13 revisions summary, S4 testing, S8 S10 testing frequeny, S9 laudiation, S63 linial management advoay, S5, S86 S87 behavior hange support, S6 behavior optimization, S6 are delivery systems, S6 hanges, initiatives, S6 demographi hanges, S5 improvement strategies, S5 patient-enteredness, S5 regime reevaluation, S6 S7 resoures, S6 lonidine, S78 lopidogrel, S54, S55 ognitive impairment, S19, S38, S70 olesevelam, S42, S44 omorbidities, S17 S19, S26 ongestive heart failure, S51, S55 onsensus reports, S1 ontinuous gluose monitoring (CGM), S4, S33, S34 ontinuous subutaneous insulin infusion (CSII), S83 ontraeption, S79 oronary heart disease, S55 ysti fibrosis related diabetes, S15 dapagliflozin, S45 Da Qing study, S31 DAWN2 study, S26 day are, S73, S86 S87 deglude, S45 depression, S18, S26, S67, S74 detemir, S45 Diabetes and Driving, S86 Diabetes and Employment, S86 Diabetes Care in the Shool and Day Care Setting, S86 S87 Diabetes Control and Compliations Trial (DCCT), S35, S36, S38, S41, S70 Diabetes Management in Corretional Institutions, S87 Diabetes Prevention Program (DPP), S31, S32 Diabetes Prevention Program Outomes Study (DPPOS), S31, S32 diabetes-related distress, S26 diabetes self-management eduation (DSME) benefits, S6, S20 S21 arbohydrate management, S21 S23 hildren and adolesents, S73 dietary fat management, S23 S24 eating patterns, S21 S23 herbal supplements, S23 hospital are, S84 medial nutrition therapy, S21 S23, S52, S72, S83 mironutrients, S23 national standards, S21 overview, S17, S20 S21 prediabetes, S32 protein management, S22, S23, S59 reommendations, S20, S31 reimbursement, S21 sodium, S23, S24, S51 weight loss, S21, S55 diabetes self-management support (DSMS). see diabetes self-management eduation (DSME) Diabeti Retinopathy Study (DRS), S61 diastoli blood pressure goals, S4

92 are.diabetesjournals.org Index S91 diet, nutrition, S21 S23 diltiazem, S78 dipeptidyl peptidase 4 (DPP-4) inhibitors, S42 S44, S46, S68 disordered eating, S74 diuretis, S49 S51, S58, S59, S78 dopamine-2 agonists, S45 driving, S86 dulaglutide, S45 dyslipidemia. see also holesterol; triglyerides hildren and adolesents, S72 ontrol, S51 lifestyle modifiation, S52, S55 monitoring reommendations, S4, S53 reommendations, S51 S52 sreening, S51 treatment, S52 S55 Early Treatment Diabeti Retinopathy Study (ETDRS), S61 eating abnormalities, S74 eating patterns, S21 S23 e-igarettes, S4, S25 empagliflozin, S45 employment, S86 end-stage renal disease (ESRD), S59 Epidemiology of Diabetes Interventions and Compliations (EDIC) study, S35 S36, S38 eretile dysfuntion, S63 exenatide/exenatide ER, S45, S82 exerise albuminuria, S25 autonomi neuropathy, S25, S62 S63 benefits, S24 hildren, S24 frequeny, type, S24 glyemi ontrol, S24 hyperglyemia, S25 hypoglyemia, S25 kidney disease, S23, S25, S58 S60, S72 S73 peripheral neuropathy, S25, S62 S63 prediabetes, S24 pre-exerise evaluation, S24 S25 reommendations, S24 retinopathy, S25, S60 S62, S73 ezetimibe, S53 fasting plasma gluose testing, S9 fatty liver disease, S18 fenofibrate, S53 fibrates, S53 Finnish Diabetes Prevention Study (DPS), S31 foot are, S4, S63 S64 foot infetions, S64 foundations of are revisions summary, S4 fratures, S18 S19 FRAX sore, S18 fundus photographs, S61 gastrointestinal neuropathies, S62 gastroparesis, S63 genitourinary trat disturbanes, S62 S63 gestational diabetes mellitus (GDM). see also pregnany lassifiation, S8 diagnosis, S13 S14 glyemi targets, S77, S78 management, S78 one-step strategy, S13, S14 overview, S13, S77 postpartum are, S79 reommendations, S13 sreening, S10 two-step strategy, S13 S14 glargine, S45 glilazide, S44 glimepiride, S44 glipizide, S44 gluagon, S38 gluagon-like peptide 1 (GLP-1) agonists, S42, S43, S45, S46, S68, S82 a-gluosidase inhibitors, S42, S44 glulisine, S43, S45 glyburide/glibenlamide, S44 glyemi targets. see also A1C A1C/mirovasular ompliations relationships, S35 S36 determination, S37 glyemi ontrol assessment, S33 S35 hospital are, S80 S82 interurrent illness, S39 mean gluose levels, S35 mortality findings, S36 older adults, S68 pregnany, S77, S78 reommendations, S33, S36 S37 revisions summary, S4 glyemi treatment approahes bariatri surgery, S46 S47 pharmaologial therapy, S41 S46 revisions summary, S4 gram-positive oi, S64 hearing impairment, S19 hemoglobinopathies, S9 hepatitis B vaination, S26 herbal supplements, S23 hospital are bedside blood gluose monitoring, S83 ritially ill patients, S80, S81 disharge planning, S80, S83 DSME, S84 gluose abnormalities definitions, S81 glyemi targets, S80 S82 hyperglyemia, S80 S81 hypoglyemia, S80 S82 insulin therapy, S80 S82 management team, S82 medial nutrition therapy, S83 mediation reoniliation, S83 non ritially ill patients, S80 S82 reommendations, S80 self-management, S82 S83 sliding sale insulin (SSI), S80, S82 strutured disharge ommuniation, S83 type 1 diabetes, S82 hydrohlorothiazide, S51 hyperglyemia ognitive impairment, S19 exerise, S25 glyemi target determination, S37 hospital are, S80 S81 older adults, S67, S68 plasma gluose testing, S9 postprandial, S37 risk fators, S11 Hyperglyemia and Adverse Pregnany Outome (HAPO) study, S13 hyperglyemi risis, S9 hypertension hildren and adolesents, S71 S72 diagnosis, S49, S50 diastoli blood pressure, S50 S51 goals, S49, S50 lifestyle modifiation, S49, S51 older adults, S67 overview, S49 S50 pharmaologial therapy, S49 S51 reommendations, S49 sreening, S10, S49, S50 sodium guidelines, S24, S51 systoli blood pressure, S50, S59 treatment, S49, S50 Hypertension Optimal Treatment (HOT) trial, S50 hypertriglyeridemia, S53 hypoglyemia A1C goals, S35, S37 CGM, S34 hildren and adolesents, S70 exerise, S25 hospital are, S80 S82 noturnal, S34 older adults, S68 overview, S38 pregnany, S78 prevention, S38, S82 reommendations, S38 treatment, S38 hypoglyemia unawareness CGM, S33, S34 hildren and adolesents, S70 effets, haraterization, S38 reommendations, S38 immune-mediated diabetes, S10 S11 immunization reommendations, S4, S26 S27 impaired fasting gluose (IFG), S10, S31 impaired gluose tolerane (IGT), S10, S31 inretin-based therapies, S42 indapamide, S50, S51 infetions, S64 influenza vaine, S26 S27 insulin basal bolus, S43, S45, S46, S70, S71, S82 ombination therapy, S42 glyemi targets, S38 hospital are, S80 S82 hypoglyemia treatment, S38 intensive insulin regimens, S34 MDI, S41 older adults, S68 pregnany, S78 reommendations, S33 sliding sale insulin (SSI), S80, S82 type 1 diabetes, S41 type 2 diabetes, S42 S46 insulin dependent diabetes, S10 S11 insulin pump therapy, S33, S41, S43, S83 insulin resistane, S10, S78 insulin seretagogues, S38, S68 International Assoiation of the Diabetes and Pregnany Study Groups (IADPSG), S13 jail, S87 juvenile-onset diabetes, S10 S11 kidney disease, S23, S25, S58 S60, S72 S73 Kumamoto Study, S36 labetalol, S78 latation, S79

93 S92 Index Diabetes Care Volume 38, Supplement 1, January 2015 laser photooagulation therapy, S61 S62 lifestyle modifiations dyslipidemia, S52, S55 hypertension, S49, S51 type 2 diabetes, S31, S42 linagliptin, S44 liraglutide, S45 lispro, S43, S45 lixisenatide, S45 Look AHEAD trial, S18, S55 loss of protetive sensation (LOPS), S63, S64 marovasular ompliations, S35, S36, S51 maular edema, S61 management planning, S17 S19, S26 maturity-onset diabetes of the young (MODY), S14 medial evaluation, S17, S18, S24 S25 medial nutrition therapy, S21 S23, S52, S72, S83 Mediare/Mediaid, S21 mediations, S12. see also pharmaologial therapy; speifi mediations, onditions meglitinides, S42, S44 mental health speialist referrals, S26 metformin, S31, S32, S42 S44, S55, S59, S68 methyldopa, S78 mirovasular ompliations A1C goals, S35 A1C relationship to, S35 S36 eretile dysfuntion, S63 gastroparesis, S63 glyemi ontrol, S63 kidney disease, S23, S25, S58 S60, S72 S73 neuropathy, S25, S62 S63, S73 orthostati hypotension, S63 patient eduation, S64 pharmaologial therapy, S51 retinopathy, S25, S60 S62, S73 revisions summary, S4 risk fators, S11 miglitol, S44 monogeni diabetes syndromes, S14 S15 myoardial infartion (MI), S36, S50, S54, S55, S59 nateglinide, S44 National Diabetes Eduation Program (NDEP), S6, S74 National Diabetes Prevention Program, S31 National Institutes of Health (NIH), S13 S14 neonatal diabetes, S14 nephropathy, S23, S25, S58 S60, S72 S73 neuropathy, S25, S62 S63, S73 niain, S53 NICE-SUGAR trial, S81 nonproliferative diabeti retinopathy (NPDR), S61 nursing home. see hospital are obstrutive sleep apnea, S18 older adults A1C levels, S9 depression sreening, S67 diabetes ompliations sreening, S67 glyemi targets, S68 hyperglyemia, S67, S68 hypertension, S67 hypoglyemia, S68 pharmaologial therapy, S68 S69 reommendations, S67 sodium guidelines, S24 statin therapy, S52, S53 treatment goals, S67 S68 type 2 diabetes sreening, S12 orthostati hypotension, S63 overweight, obesity, S9, S10, S21, S55, S78 S79 Patient-Centered Medial Home, S6 perindopril, S50, S51 periodontal disease, S19 peripheral arterial disease, S63, S64 peripheral neuropathy, S25, S62 S63 pharmaologial therapy ardiovasular disease, S51 S55, S59 hypertension, S49 S51 mirovasular ompliations, S51 older adults, S68 S69 prediabetes, S32 type 2 diabetes, S31 S32, S42 S46 pioglitazone, S44, S46 pneumooal polysaharide vaine 23 (PPSV23), S26, S27 polyysti ovary syndrome, S10 position statements, S1 pramlintide, S41 S42, S45 prasugrel, S55 prazosin, S78 prediabetes lassifiation, diagnosis, S9 S10, S12 S13 DSME/DSMS, S32 exerise, S24 pharmaologial therapy, S32 pre-exerise medial evaluation, S24 S25 pregnany A1C testing, S9, S78 antihypertensive mediations, S51, S78 ontraeption, S79 GDM (see gestational diabetes mellitus [GDM]) glyemi targets, S77, S78 hypertension, S50 hypoglyemia, S78 insulin, S78 insulin resistane, S78 latation, S79 mediations ontraindiated, S77, S78 metaboli physiology, S78 overweight, obesity, S78 S79 postpartum are, S79 preoneption ounseling, S77 reommendations, S77 retinopathy, S25, S60 S62, S73 revisions summary, S4 sreening, S10 statins, S72 prison, S87 Professional Pratie Committee, S3, S88 S89 proliferative diabeti retinopathy, S61 protein, S22, S23, S59 psyhosoial sreening, are, S25 S26 P2Y12 reeptor antagonist, S55 rae/ethniity, S9, S12, S35. see also Afrian Amerians; Asian Amerians RAS inhibitors, S51, S59 repaglinide, S44 retinal photography, S61 retinopathy, S25, S60 S62, S73 revisions summary, S4 Reye syndrome, S54 risk management, S4, S6, S9, S11 rosiglitazone, S44 SAVOR-TIMI 53 trial, S68 S69 saxagliptin, S44, S68 S69 shool, S73, S86 S87 sientifi evidene grading, S1 S2 sientifi statements, S1 self-monitoring of blood gluose (SMBG) basal insulin/oral agents, S34 intensive insulin regimens, S34 optimization, S33 S34 overview, S33 reommendations, S33 sikle ell trait, S9 sitagliptin, S44, S82 skilled nursing failities. see hospital are sliding sale insulin (SSI), S80, S82 smoking, S4, S25, S63, S72 sodium, S23, S24, S51 sodium gluose otransporter 2 (SGLT2) inhibitors, S42, S43, S45, S46 Standards of Care reommendations, S1 Staphylooi, S64 statins, S4, S52 S55, S72 stroke, S36, S54, S59 sulfonylureas A1C/CVD relationships, S36 ombination therapy, S42, S43 older adults, S68 type 2 diabetes, S43, S44, S46 testosterone levels, S19 thiazolidinediones, S43, S44, S46 thyroid disease, S71 tiagrelor, S55 triglyerides, S10, S52, S53. see also dyslipidemia 2-hour plasma gluose testing, S9 type 1 diabetes A1C/mean gluose relationship, S35 autoimmune onditions, S71 arbohydrate management, S21 CGM, S33, S34 hildren and adolesents, S10 S11, S70 S74 lassifiation, S8 diagnosis, S10 S11 glyemi ontrol, S70 S71 hospital are, S82 hypoglyemia, S38 insulin, S41 pharmaologial therapy, S41 S42 pregnany, S78 S79 progression estimates, S11 retinopathy, S25, S60 S62, S73 SMBG, S34 statin therapy, S53 testing, S11 type 2 diabetes A1C goals, S35 A1C/marovasular ompliations relationships, S36

94 are.diabetesjournals.org Index S93 hildren and adolesents, S12 S13, S74 lassifiation, S8 ombination therapy, S42, S43 ommunity sreening, S12 omorbidities, S74 diagnosis, S11 S13 diagnosti tests, S12 hypoglyemia, S38 ketoaidosis, S11 lifestyle modifiations, S31, S42 overview, S11 pharmaologial therapy, S31 S32, S42 S46 pregnany, S78 S79 prevention, delay of, S31 S32 reommendations, S11, S31 retinopathy, S25, S60 S62, S73 risk fators, S11 S12 sreening, S12, S31 testing interval, S12 UK Prospetive Diabetes Study (UKPDS), S36, S59 ulers, S63 S64 vasular endothelial growth fator (VEGF), S61, S62 vasular pathology measures, S37 Veterans Affairs Diabetes Trial (VADT), S36 vildagliptin, S44 weight loss, S21, S55