Pediatric Diabetes. Why focus on pediatric diabetes? Type 1 and Type 2. What s inside? Goals for this CPM MODEL

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1 April 2008 Management of CARE PROCESS MODEL Pediatric Diabetes Type 1 and Type 2 This care process model (CPM) was developed by Intermountain Healthcare s Pediatric Clinical Program, the Diabetes Clinic at Primary Children s Medical Center, and the University of Utah Department of Pediatrics. The CPM is a first step in the development of a comprehensive care management system to help providers deliver the best clinical care in a consistent and integrated way to children and adolescents with diabetes. Why focus on pediatric diabetes? The burden of diabetes is enormous. Diabetes is one of the most common chronic diseases in school-aged children, and it can cause significant stress for children and their families. In addition to serious health concerns, it brings constant and often-overwhelming responsibility for daily care as well as potential financial difficulties. It also often causes emotional and behavioral challenges for the patient, which can complicate care and interfere with normal development. Published standards of care for children with diabetes have been limited. Children with diabetes require standards of care that are different from those of adults. Yet published national guidelines and recommendations regarding children and adolescents with diabetes have been few and quite general. The American Diabetes Association s (ADA s) 2005 statement Care of Children and Adolescents with Type 1 Diabetes provides more guidance than previously given, and forms the basis of the guidelines presented in this CPM. 1 Access to pediatric diabetes specialists is limited. The ADA reports that there are only about 700 board-certified pediatric endocrinologists available to care for the over 200,000 U.S. children and adolescents with diabetes. Further, many of these specialists do not practice full time because they focus on research.2 This national shortage is particularly acute within the Intermountain Healthcare system, as the problem is compounded by our large geographic referral area. Care for children with diabetes is a significant cost to the healthcare system. According to national estimates for the general population, per capita medical expenditures are more than 5 times higher for a person with diabetes than for a person without diabetes with 1 in every 10 healthcare dollars going toward diabetes care.3 Recent SelectHealth claims data show that overall medical expenditures for children and adolescents with diabetes are nearly 9 times higher than those for the general pediatric SelectHealth population. What s inside? Screening, Evaluation, Diagnosis and Initial Management ALGORITHM: Screening, evaluation, and diagnosis... 4 Diabetic Ketoacidosis (DKA) Management ALGORITHM: DKA management... 6 Type 1 Management SUMMARY TABLE: Insulin profiles... 9 ALGORITHM: Type 1 initial management ALGORITHM: Early adjustments to insulin therapy Type 2 Management SUMMARY TABLE: Oral medications for pediatric type 2 diabetes ALGORITHM: Type 2 management...13 Patient and Family Education Special Settings and Circumstances (school/daycare, intercurrent illness) Routine Care and Follow-up SUMMARY TABLE: Follow-up schedule at a glance SUMMARY: Ongoing blood glucose monitoring and control References 27 References Provider Resources Goals for this CPM Improve screening, evaluation, and diagnosis of diabetes in the primary care setting. Provide information to help primary care providers determine how and where to best manage initial care for newly diagnosed patients. This includes: Immediate care and/or transfer of patients in diabetic ketoacidosis (DKA). Initial insulin and/or medication therapy. Immediate and adequate survival education: critical self-management skills that must be learned immediately after diagnosis. Differentiation between type 1 and type 2 based on results of further testing. Provide guidelines for routine follow-up care and management. Provide information and resources to improve the knowledge and skills of primary care providers and their staff. Improve collaboration between primary care providers and pediatric diabetes specialists in the overall care of children and adolescents with diabetes. 1

2 Type 1 vs Type 2 While the majority of pediatric diabetes cases are type 1, some pediatric diabetes clinics are reporting that as many as 1/3 of their new-onset diabetes patients have type 2 diabetes with greatest incidence among ethnic minorities. 4 Much of this increased incidence can be attributed to obesity. Differentiation between type 1 and type 2 diabetes is important because of differences in care and potential complications. While this CPM does not focus on type 2 diabetes, it does provide basic guidance for screening, diagnosis, and management of this significant and growing health problem. DKA at diagnosis? About 30% of children newly diagnosed with diabetes present in diabetic ketoacidosis (DKA), which can be lifethreatening. Newly diagnosed patients with any level of DKA are best managed on an inpatient basis by a skilled pediatric team. Severe DKA may require care in a pediatric intensive care unit. (See the DKA algorithm on page 6.) Screening, Evaluation, and Diagnosis The algorithm on pages 4 and 5 outlines a care process for screening, evaluation, and diagnosis of both type 1 and type 2 diabetes for children and adolescents. Below are key issues to consider in this process. Issues to consider Screening asymptomatic patients. Recommendations vary by type: Type 1: The ADA does not recommend screening for type 1 diabetes in asymptomatic patients. 5 Reasons for this include the following: Cutoff values for some of the immune marker assays have not been completely established in clinical settings. There is no consensus as to what action should be taken when a positive autoantibody test result is obtained. The incidence of type 1 diabetes is low, and testing of healthy children will identify only a very small number (less than 5%) who at that moment may be pre-diabetic. Type 2: Screening for type 2 diabetes is recommended every 1 to 2 years for children and adolescents who meet the risk-based criteria presented in the algorithm. Screening is justified by the fact that type 2 diabetes is sufficiently common (it has followed the rise in childhood obesity) and sufficiently serious in terms of morbidity and mortality. Also, type 2 diabetes has a long latency period that may bring minimal symptoms yet during this time it can be reliably detected and should be treated. 6 Making the diagnosis. As the algorithm on page 4 shows, diagnosis should be based on the following: Type 1: The diagnosis of type 1 diabetes in children is usually straightforward and requires little or no specialized testing. If the child has typical symptoms of diabetes and a random plasma glucose (RPG) of 200 mg/dl, repeat testing on another day is not required. Type 2: In the asymptomatic child screened for high risk of type 2 diabetes, a fasting plasma glucose (FPG) value of 126 mg/dl should be confirmed on a second day. 1 Differentiating between type 1 and type 2: With the increasing incidence of type 2 diabetes in children, it s important to differentiate newly diagnosed type 1 and type 2 patients. In a slender, prepubertal child, type 1 diagnosis can be confidently assumed. However, in the overweight adolescent, differentiation between type 1 and type 2 is not clear cut. 1 Patients with a BMI >85% for their age may need further testing and should be treated based on blood glucose and ketone levels while awaiting results. Directing initial care: The algorithm on pages 4 and 5 triages patients into the appropriate initial care algorithm (DKA management, type 1 management, or type 2 management) based on their condition and test results. Issues to consider for deciding where to provide this care are presented on the next page. 2

3 Determining where to provide initial care. In primary care, new cases of pediatric diabetes appear infrequently. When they do, it s daunting for any single practice to attempt to meet the array of urgent medical, educational, and emotional needs presented by newly diagnosed pediatric patients and their families. For this reason, many primary care providers choose to refer patients for inpatient care during this vulnerable period. In all cases, safe management requires carefully weighing the following factors in deciding where to treat these newly diagnosed pediatric patients: Can I provide the appropriate level of medical care and monitoring? The appropriate location to provide medical care at diagnosis depends on many factors, including: Level of monitoring dictated by the patient s condition The patient s age, maturity, and family support The physician s knowledge and skill in providing the necessary level of care including initial insulin therapy and early adjustments Can I provide the level of education needed at diagnosis? Newly diagnosed pediatric diabetes patients and their families need immediate education to understand their diagnosis and learn critical self-management skills. Families normal daily lives must be put on hold to receive this critical survival education. To be effective, survival education requires 12 to 20 hours of time, and should be delivered by staff skilled in delivering pediatric education (ideally, by a comprehensive pediatric diabetes management team). For this reason, many physicians choose to admit newly diagnosed patients to a pediatric unit of a hospital that can provide this level of education. It s not safe management to send a newly diagnosed patient home without this education. Provider resources Page 28 lists resources to support initial and ongoing management of children and adolescents with diabetes, including phone numbers for consultation in urgent and non-urgent cases. We have type 1 in our family what can we do? When a child is diagnosed with type 1 diabetes, the parents often express an urgent desire to take action on behalf of other (undiagnosed) children in the family. In this case, it may help to do the following: Explain that a family history of the disease increases the chance that a person will have islet cell antibodies, but does not predict that a person will develop type 1 diabetes. Only about 10% to 15% of those with type 1 have a family history. Here are the risks associated with having a first-degree relative with type 1: 7 Father 6% risk Sibling 5% risk Mother 2% risk Identical twin 30 to 50% risk Parent + 1 or more siblings 30% risk Provide the rationale for not screening asymptomatic children (see previous page under Issues to Consider ). Connect the family to the Utah Diabetes Center for information about clinical studies. (Call the Clinical Research Coordinator at ) Screening for type 1 is sometimes done in research contexts. Understand that, for reassurance, parents may test the unaffected child s blood glucose at home from time to time. Remind them to wash the child s hands before testing (sticky fingers can sometimes cause high blood glucose), and to keep in mind that only a lab test can diagnose diabetes. 3

4 (a) SYMPTOMS of diabetes Early: polyuria polydypsia weight loss fatigue Late: fruity breath vomiting abdominal pain Kussmaul respirations lethargy and confusion ALGORTIHM: screening, evaluation, and diagnosis SYMPTOMS suggestive of diabetes (a) Obtain LABS (c) Asymptomatic but high risk for type 2 (b) Stabilize and re-evaluate (b) ASYMPTOMATIC Criteria for screening for childhood type 2 diabetes: 6 1. Age 10 (or at onset of puberty if puberty occurs at a younger age) AND 2. Overweight: BMI >85% for age and sex AND 3. Any 2 of these risk factors: Family history of type 2 diabetes in 1st or 2nd degree relative High-risk race/ethnicity (American Indian, African American, Hispanic, or Asian/ Pacific Islander) Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, or polycystic ovary syndrome [PCOS]) (c) LABS All: Random plasma glucose (RPG) Normal or pre-diabetes: If symptomatic, look for other causes of symptoms If high-risk for type 2, schedule Fasting Plasma Glucose test (FPG) If FPG is 100 to 125, refer for education on lifestyle modifications RPG <140 FPG <126 Random Plasma Glucose (RPG)? RPG possible diabetes Within 1 to 2 days, schedule Fasting Plasma Glucose (FPG) Fasting Plasma Glucose (FPG )? FPG 126 (d) RPG >200 no yes Intercurrent illness/condition? (e.g., dehydration) no Diabetes symptoms? (a) yes Only if symptomatic: Electrolytes, BUN, and creatinine to assess degrees of acidosis and dehydration Urine dip for glucose and ketone; confirm with serum values ASAP REPEAT FPG for asymptomatic patients screened for high risk (d) (d) REPEAT FPG for asymptomatic patients Note that if the patient is being screened because of high-risk for type 2 diabetes and has no symptoms of diabetes, the FPG value of >126 mg/dl must be confirmed on a second day before a diagnosis can be made. Abbreviations: PG = plasma glucose FPG = fasting plasma glucose RPG = random plasma glucose DKA = diabetic ketoacidosis BMI = body mass index Diabetes Continue with algorithm on next page 4

5 Newly diagnosed with DIABETES (e) BODY MASS INDEX (BMI) Reference tables and calculators for determing BMI for children and teens are available at intermountainhealthcare. org/preventivecare (f) ADDITIONAL LABS to help identify type 2 diabetes: Possible DKA? (serum ph <7.35 OR serum bicarb <18) yes no Lab Fasting c-peptide (C PEP) Glutamic acid decarboxylase antibody (GAD AB) Islet cell antibody 512 (IA-2) Values consistent with type 2* >3.5 ng/ml <1.45 units/ml <0.8 units/ml *Reference ranges from ARUP labs Type 1 or Type 2? (Calculate body mass index [BMI]) (e) BMI <85% for age BMI >85% for age Obtain ADDITIONAL LABS to help identify type 2 (f) Look for other TYPE 2 MARKERS/RISKS (g) (g) Other TYPE 2 MARKERS/RISKS Hypertension High triglycerides Acanthosis nigricans Strong family history Ethnicity RPG >300, regardless of ketones OR RPG <300, with positive ketones While awaiting results, treat per blood glucose and ketone values (h) RPG <300 with negative ketones (h) INITIAL CARE decisions The appropriate location to provide medical care at diagnosis depends on many factors, including: Level of monitoring dictated by the patient s condition The patient s age, maturity, and family support The physician s knowledge and skill in providing the necessary level of care - including initial insulin therapy and early adjusments Ability to provide critical patient/family survival education See the discussion on page 3 for other issues to consider when making initial care decisions. DKA Management (page 6) Type 1 Management (page 8) Type 2 Management (page 12) 5

6 Diabetic Ketoacidosis (DKA) Management Diabetic ketoacidosis (DKA) is the leading cause of morbidity and mortality in children with type 1 diabetes. 8 DKA is defined as a state of absolute or relative insulin deficiency resulting in hyperglycemia (glucose level greater than 200 mg/dl) and metabolic acidosis from accumulation of ketoacids in the blood. 9 A child or adolescent in DKA (or ketosis) requires immediate medical attention. Use the algorithm below to guide clinical decisions including the decision about the best site to deliver care. ALGORitHM: DKA Management DKA or ketosis (ph <7.35, HCO3 <18) identified from patient evaluation (a) ORDER SETS for pediatric DKA (mild, moderate, severe) are in the forms database: intermountain.net/ portal/site/forms/ Ketosis / Mild DKA ph: HCO3: Urine ketones: small-large Moderate DKA ph: HCO3: Urine ketones: moderate-large ph:<7.2 HCO3: <10 Severe DKA Urine ketones: large Dehydration >10% Ketosis can usually be managed with PO hydration and subcutaneous (subcut) insulin. Outpatient treatment is possible, but newly diagnosed patients should be admitted for monitoring and education (see page 14 for more on initial survival education). 1. No IV necessary. 2. Bedside PG checks as outlined on page 11, and urine ketones checked with every void until negative. 3. No other labs, unless initial labs were abnormal or child is unable to eat. 4. Start newly diagnosed patients on subcut insulin per page 10 guidelines; established patients should follow sick day guidelines (see page 17). 5. Encourage intake of clear fluids that do not contain sugar. Once stabilized, manage as follows: Newly diagnosed type 1: refer to Type I Management (page 8) Newly diagnosed type 2: refer to Type 2 Management (page 12) For established type 1 or 2: refer to Subsequent DKA episodes (page 7) May require intravenous fluids, but may often be managed with subcutaneous (subcut) insulin. Transfer as necessary to a facility that can provide the level of care and monitoring outlined below. If child looks well and is able to eat, monitor PG and give -acting insulin correction doses as outlined on pages 10 and 11. If the child s appearance is concerning or she/he is not able to eat: Give a ml/kg bolus of NS. After bolus, recheck PG and give a boost of -acting insulin (0.1 units/kg) subcut to cover the 4-6 hours until the next dose. Order medical nutrition therapy and PG checks as outlined on pages 10 and 11. Monitor electrolytes every hours until normal. (a) Because primary care providers may have limited access to experienced pediatric specialists, the values recommended here for treatment stratification are more conservative than those in the ADA s 2005 statement on type 1 management. (b) For guidance in treating severe DKA with CNS involvement, call (Primary Children s Medical Center); ask for the diabetes physician on call. DKA is a life-threatening condition, and never more so than in this circumstance. yes Discontinue IV fluids, if given Child looks well (still), is able to eat? no Treat as severe DKA Requires IV volume expansion and IV insulin. Transfer as necessary to a facility with a pediatric ICU, based on patient s needs: Consult, stabilize, and transfer immediately to a facility with a pediatric ICU if DKA with any of the following (b): Clouded consciousness suggesting cerebral edema Shock Other organ involvement Need for mechanical ventilation Need for ICP monitoring Inotrope infusion Note: Cerebral edema accounts for 57%-87% of all DKA deaths of which there were 2,000 nationwide in Initiate treatment below as able while awaiting transfer: IV volume expansion: Often this volume expansion results in a substantial reduction in glucose level. 1. IV bolus of normal saline: ml/kg over 20 minutes. 2. Repeat as needed if there is evidence of cardiovascular instability (shock). 3. IV fluids, usually 1.5 x maintenance IV fluid rate of ½ NS + 20 meqk + acetate and 20 meqk + phospate. IV insulin: Start after initial fluid bolus. 1. Repeat PG before starting insulin therapy. 2. Give insulin drip 0.1 units/kg/hr (25 units regular insulin in 250 ml NS). Aim is to reduce PG gradually (about mg/dl/hr) to a level of mg/dl to prevent hypoglycemia or acute changes in osmolarity. 3. When the PG approaches 200 mg/dl, add dextrose to the IV fluids (D10w at 1.5 x maintenance IV fluid rate ½ NS + 20 meqk + acetate and 20 meqk + phospate). 4. Except for cases of true hypoglycemia, do NOT decrease insulin below 0.08 units/kg/hr until the acidosis is resolved (bicarb >15, ph >7.3), since insulin is required to prevent ketogenesis and correct the acidosis. Note: Patient s ph and bicarbonate may continue to decline for the first 2 to 4 hours after treatment is initiated. If patient is not improved by 6 to 8 hours after beginning treatment, transfer immediately to facility with a PICU. 6

7 Subsequent DKA episodes In addition to being present in approximately 30% of children and adolescents newly diagnosed with diabetes, DKA can also occur in patients with established type 1 diabetes. Precipitating factors Investigating the cause or precipitating factors for subsequent episodes of DKA is important. First, consider whether the episode is an isolated event, or part of a recurring pattern: Isolated DKA episode(s): In a child with known diabetes, the most common cause of a subsequent DKA episode is omitted insulin injections. Another common cause is the failure to adjust insulin dosing to compensate for illness, trauma, or surgery. Recurrent DKA: This is almost always caused by insulin omission. A child or adolescent with recurring DKA should be referred for psychological counseling and/or additional education (along with their families, in many instances) due to the fact that these children: Have a higher incidence of psychiatric illness, especially depression Are more likely to have or develop eating disorders in adolescence Risk far greater morbidity and mortality than those without recurring DKA Management during intercurrent illness When ill, children and adolescents with diabetes may need different amounts of insulin and food than usual. They often require more insulin even when they are vomiting or eating very little. Sick Day Guidelines for patients are outlined on page 17 of this CPM and are also included as part of Intermountain s initial survival education. Assessment parameters If a child or adolescent with known diabetes presents looking ill with symptoms suggesting DKA, assessment should include the elements shown in the table below. History and Physical Precipitating event or factors Vital signs Hydration status, peripheral perfusion Signs of infection Acetone/ fruity breath (note that 15% of people cannot smell acetone) Kussmaul respirations ( and deep) Neurologic status If recurrent DKA, screen for mental health conditions per guidelines on page 26 Labs Venous or capillary blood gas for ph (arterial gas is not necessary) Serum electrolytes, glucose, Ca++, BUN, Cr, phosphorus, Mg++ As indicated by symptoms: CBC with diff, blood cultures, UA with micro and culture DKA management and regular care The DKA management algorithm guides care for both newly diagnosed and established diabetes patients. A patient with established diabetes may return to regular home routine (subcut insulin) as soon as the DKA has resolved. In general, patients with established diabetes can often manage non-serious episodes of hyperglycemia and ketosis at home by following Sick Day Guidelines summarized on page 17. 7

8 Overview of insulin regimens: why basalbolus is preferred There are three insulin regimens for pediatric type 1 patients: Long-acting + -acting insulin (basal-bolus) regimen. A regimen that combines long-acting and -acting insulin (basal-bolus) is preferred for most pediatric patients with type 1 diabetes. This regimen offers the following advantages: Most closely mimics natural physiologic insulin production. See the graphs below right. Lowers risk of hypoglycemia. The sustained, peakless activity of long-acting insulin helps prevent preprandial lows. Simplifies meal planning. A patient on a basal-bolus regimen can eat normally, dosing their -acting insulin based on carbohydrate intake. Intermediate-acting + -acting regimen. Before long-acting insulin was approved for use in pediatric populations, this was the more commonly prescribed regimen. Now, however, most physicians prefer a basal-bolus regimen for most pediatric patients, for reasons listed above. The box at the bottom of the next page gives comments on the use of intermediateacting insulin. Regimen combining all three types of insulin (-, intermediate-, and long-acting insulin). This regimen generally does not provide the same degree of control or flexibility as does a basalbolus insulin regimen. With this regimen, intermediate-acting NPH insulin in the morning covers the lunchtime meal (useful in a circumstance where the child has no support for the lunchtime shot) and the use of long-acting insulin at night significantly decreases the risk of overnight hypoglycemia. Type 1 Management Issues to consider Managing type 1 diabetes can be intense and complex for providers, patients, and families especially initially, and particularly in children and adolescents. Providers must always keep in mind the major differences between treating children and adolescents with type 1 diabetes versus treating adults with this disease. Following are key issues: Starting doses of insulin for children and adolescents are based on age and body weight, and must be adjusted based on individual response and glucose levels over the first several weeks. Recognizing hypoglycemia in children can be difficult, and depends on the child s age, cognitive abilities, and communication skills. Physicians and families must be alert to behavior patterns that suggest hypoglycemia. Shakiness, irritability or tearfulness, hunger, headache, drowsiness, and dizziness are common signals. Tight control must be carefully balanced with the risk of hypoglycemia. The cognitive deficits that may occur with recurring hypoglycemia can impact normal learning and school performance. The onset of puberty can significantly alter insulin needs and participation in self-management. Management must therefore include developmentally appropriate education, an emphasis on transition to adult diabetes care, and screening for long-term complications. (See pages 18 to 25 for guidelines for ongoing management.) Education must be tailored to the developmental stage of the patient and include parents or other caregivers. Clinical outcomes are closely tied to family participation in day-to-day management. (See pages 14 and 15 for more on education.) For most type 1 patients, a basal-bolus regimen is preferred. This regimen most closely mimics natural physiologic insulin production, lowers risk of hypoglycemia, and simplifies breakfast meal planning. lunch lunch lunch See the sidebar at left dinner and dinner the graphs below for details. Physiologic insulin production shot: shot: shot: -acting insulin insulin shot: -acting insulin shot: shot: shot: -acting insulin insulin breakfast lunch dinner Basal-bolus insulin regimen shot: -acting insulin shot: shot: -acting -acting insulin insulin long-acting breakfast lunch dinner shot: -acting insulin shot: shot: shot: shot: shot: shot: -acting long-acting insulin insulin insulin insulin shot: long-acting insulin long-acting breakfast lunch lunch lunch dinner dinner breakfast lunch dinner shot: -acting insulin A basal-bolous insulin regimen closely mimics physiologic insulin production. shot: long-acting insulin breakfast lunch dinner long-acting 8

9 SUMMARY TABLE: insulin profiles This table lists the major types of insulin approved for use with pediatric populations. However, new insulins, insulin delivery systems, and home glucose meters frequently appear on the market. Check the pediatric diabetes topic page at intermountainhealthcare.org/clinicalprograms for periodic updates from the ADA, the Joslin Diabetes Center, and others. Insulin type and notes on use* generic (Brand) name Onset* Peak* Max duration* day average. wholesale $ Rapid-acting: use as bolus Since the onset of action for -acting insulin is 5 to 15 minutes, it should be given just before eating. To avoid cumulative action when using a correction for high glucose levels, this type of insulin should NOT be given more often than every 3 hours. Waiting for blood glucose levels to come down is safer than risking hypoglycemia. aspart (NovoLog) lispro (Humalog) 5 to 15 minutes 45 to 90 minutes 3 to 5 hours 10 ml: $81 Intermediate-acting The dose of intermediate-acting insulin does not vary with blood glucose level. It should be given subcut only; NOT administered IV. Use of this type of insulin requires that the child eat a consistent amount of carbohydrate at a consistent time (e.g., 60 grams at 12 noon for lunch). Late meals and unusual activity increase the risk of hypoglycemia. NPH (Novolin N) NPH (Humulin N) 1 to 3 hours 4 to 12 hours up to 24 hours 10 ml: $35 Long-acting or peakless : use as basal Long-acting insulin has a more sustained, stable activity curve and substantially less peak than - or intermediate-acting insulin; its duration of action is 12 to 24 hours (once to twice daily injections). It should be given subcut only; NOT administered IV. Additional injections of -acting insulin are required to cover food intake. Note that long-acting insulin shouldn t be diluted or mixed with any other insulin solution. glargine (Lantus) 2 to 4 hours none >24 hours 10 ml: $70 Insulin detemir (Levemir) has also been approved for use with pediatric populations; however, this CPM does not recommend its use. Numerous reports from providers and patients at Primary Childrens Medical Center attest that detemir is not truly peakless and is not as consistent as glargine insulin. Note that if detemir is used in a pediatric population, it must be dosed twice daily. *Notes on information included in this table: Information in the table above derives from manufacturer prescribing information and results from independent studies. The time course of action of any insulin may vary considerably in different individuals, and may also vary based on such factors as dose, site of injection, temperature, and physical activity. In children and adolescents, absorption may tend to be more, and peak action shorter-lived, than the manufacturers literature suggests. Notes on use of intermediate-acting insulin: Despite the advantages of long-acting + -acting (basal-bolus) insulin regimens, some physicians continue to prescribe a regimen that combines long-acting and intermediate-acting (NPH) insulin. Using NPH eliminates the need for a daily lunchtime shot, which may be an issue for some children in daycare or preschool, but may increase the risk of hypoglycemia. Below are comments and guidelines for initiating and adjusting a regimen that uses NPH insulin: The starting dose of NPH insulin is an estimate based on age and weight. It must be adjusted every day or two for the first several weeks. Meal planning is less flexible with this regimen; it requires the child to eat the same amount of carbohydrates at the same time every day. This is often a challenge that children between 6 and 12 meet better than toddlers or teens. Meal planning centers on: 3 meals, and 2 to 3 snacks, at scheduled times. (Note that toddlers often eat the same amount of carbohydrate at meals and snacks thus their plans should accommodate 6 small meals a day, rather than larger meals and smaller snacks.) kcal needs per age. Dietitians providing Medical Nutrition Therapy (MNT) will begin with calorie estimates based on age, sex, and activity level. Early adjustments of NPH insulin (at 2 weeks to 2 months post diagnosis) should conform to these guidelines: Use dinner PG to adjust morning NPH insulin; increase 1 to 2 units (10%) to target dinner PG. (Morning NPH dose also affects lunch PG, so watch for lows.) Use breakfast PG to adjust bedtime insulin; increase 1 to 2 units (10%) to target FPG. 9

10 (a) Comments about the basal-bolus regimen for toddlers and preschoolers (<6 years old): Young children, especially toddlers, are notorious grazers who rarely eat regular meals. Long-acting insulin may need to cover some snacks. Long-acting insulin dose may be slightly higher as a % of the total daily dose to cover frequent intake of small amounts of carbohydrate (necessary because of erratic eating patterns). Rapid-acting insulin may be used more as a correction dose to bring glucose down if it s over 200 mg/dl, rather than as a carb dose to cover anticipated carb intake. (b) Comments about the basalbolus regimen for 6- to 19-year-olds School-age children may need some support for the lunchtime shot; most are able to master the skills needed for this regimen. Note that the long-acting insulin is a pure basal or background insulin. Rapid-acting insulin MUST be taken before ALL meals and snacks to have good control. (Unlike toddlers, older children especially adolescents eat too many carbs at a time to expect adequate coverage with longacting insulin alone.) (c) Estimating insulin dosing with the 500 Rule and 1700 Rule 1. Estimate total daily dose (TDD) based on patient s weight. 2. Use the 500 Rule to estimate insulin-to-carb ratio: 500 the TDD = number of carb grams covered by a unit of insulin. Example: =10; 1 unit of insulin will cover approximately 10 grams of carbohydrate. 3. Use the 1700 Rule to estimate a correction dose: 1700 the TDD = the expected drop in glucose (mg/dl) in response to 1 unit of insulin. Example: = 48; 1 unit of insulin will drop the serum glucose approximately 50 mg/dl. Note that these are estimates only. Initial doses must be adjusted based on patient response rather than the calculations. ALGORITHM: type 1 initial management Insulin therapy, survival education, and medical nutrition therapy (MNT) must begin immediately after diagnosis. Type 1 confirmed or suspected In some cases, may begin therapy while awaiting results of lab tests to confirm type (see page 5) Initiate Insulin Therapy based on age of child Toddlers and preschoolers (<6 years) Suggested basal-bolus regimen (a) Long-acting insulin: 0.3 to 0.4 units/kg/day at breakfast + Rapid-acting insulin: Before meals: 0.5 units per 15 to 20 grams carbs As correction dose: 0.5 units per every 50 mg/dl over 200 mg/dl (example: If pre-meal glucose is 300 mg/dl, take 1 additional unit NovoLog) Note: If you want to calculate your own insulin regimen, use the 500 and 1700 rules (c) AND Initiate Survival Education (page 14) See page 14 for complete guidelines. Focus on the following information and skills: SMBG (self-monitoring of blood glucose) and record keeping Insulin injections, storage, dosing School-age children (6 to12 years) OR adolescents and young adults (13 to 19 years) Suggested basal-bolus regimen (b) Long-acting insulin: 0.4 to 0.6 units/kg/day at bedtime + Rapid-acting insulin: Before meals and snacks: 1 unit per 10 to 20 grams carbs As correction dose: 1 unit per every 50 g/dl over 150 mg/dl (example: if pre-meal glucose is 250 mg/dl, take 2 additional units Novolog) Note: If you want to calculate your own insulin regimen, use the 500 and 1700 rules (c) Instructions for home management of hypoglycemia, hyperglycemia, sick days AND AND Refer for Medical Nutrition Therapy (MNT) Dietitian should provide a meal plan that approximates normal eating patterns AND is tailored to the basal-bolus regimen: Set up a meal plan, matching as closely as possible the patient s/family s normal eating habits and patterns. Teach basic carbohydrate-counting to patient and/or family members. Note that -acting insulin is dosed to cover carb intake EVERY TIME the patient eats except, in some cases, for toddlers. Follow up with the patient and family within the first 2 weeks to reinforce carb-counting teaching and make meal plan adjustments as needed. Due to their excessive hunger in the first few days after diagnosis, children often overestimate how much they regularly eat. This usually resolves after 2 weeks on insulin. 10

11 ALGORITHM: early adjustments to insulin therapy For the first several months of treatment, providers should expect to adjust initial therapy based on the patient s response and changing needs, especially with respect to the honeymoon phase (a). Therapy may also change based on the emerging picture of how the patient and family live with and manage diabetes. Note that insulin pump therapy is rarely appropriate during this initial period. Insulin pumps are best initiated after diabetes treatment is well established; this usually requires 6 to 12 months of treatment. For more information on pump therapy and insulin adjustments, see pages 22 and 23. Diagnosis to 2 weeks: Monitor often, watch for nighttime lows Monitor often and watch for nighttime lows (b) If PG before meals is <80 mg/dl: give 15 grams extra carbohydrate with the meal. If PG before bedtime snack is to 100 mg/dl: give 15 grams extra carbohydrate. <80 mg/dl: give extra 30 grams carbohydrate before bed, recheck in 2 hours, and treat again if still low. If PG at 2:00 AM is consistently... High (>200 mg/dl): adjust the NEXT DAY s long-acting (basal) insulin dose. Low (<100 mg/dl): give 30 grams of carbohydrate, recheck in 1 to 2 hours, and continue to treat/re-check until PG is >100 mg/dl. Decrease long-acting insulin. Review records from SMBG (self-monitoring of blood glucose) every 2 to 3 days. Follow up with patient and family within 5 to 14 days of diagnosis to reinforce and build on basic diabetes education (c) 2 weeks to 2 months after diagnosis Adjust insulin, up or down 5 to 10%, to target PG (d) When adjusting, anticipate the honeymoon phase (a) and consider the family s skills and the patient s ability to perceive blood glucose lows. Continue to review SMBG records every 1 to 2 weeks. This can be done by fax, phone, or . Long-acting insulin Use afternoon/evening PG to adjust morning long-acting insulin (for toddlers); increase 0.5 to 1 unit, once or twice in a week, to target PG. Use breakfast FPG to adjust evening long-acting insulin (for school-age children and adolescents); increase 1 to 2 units, once or twice in a week, to target PG. Rapid-acting insulin Use post-prandial (2 to 4 hrs) PG to adjust AM -acting insulin; increase 0.5 to 2 units (5% to 10%) to target PG. Use dinner PG to adjust lunch -acting insulin. Use bedtime PG to adjust dinner -acting insulin; increase 0.5 to 2 units (5% to 10%) to target bedtime PG. Note that very young children may not eat in a predictable way. If necessary, dose -acting insulin 20 minutes after child has started to eat, based on carbohydrate intake to that point. (a) Honeymoon phase Within a few days to a few weeks of initiation of insulin therapy, there is a transient phase during which endogenous insulin secretion improves. Clinically, this results in excellent control of blood glucose on a relatively low dose of insulin, with little variability in day-to-day glucose values. This honeymoon phase can last from weeks to months; it ends gradually with increasing blood glucose and increasing insulin requirement. (b) Monitoring frequency (SMBG, or Self-Monitoring of Blood Glucose) Before meals Before bedtime snack As needed, with symptoms of hyper- or hypoglycemia (e.g., irritability, shakiness, sleepiness) For first 3 to 5 days after diagnosis, ALSO monitor at 2:00 a.m. (c) Education follow-up 6 Reinforce self-management skills taught in survival education: SMBG, insulin use, etc. Provide more in-depth MNT as needed, e.g., advanced carb-counting Help develop individualized plans for school or daycare (d) TARGET PG based on age (type 1) Target PG based on age (type 1) Age HbA1c PG before meals Under 6 yr 7.5% - 8.5% mg/dl 6-12 yr <8% mg/dl yr <7.5% mg/dl PG bedtime/ overnight mg/dl mg/dl mg/dl HbA1c should be as low as possible without significant risk of hypoglycemia. 11

12 A second epidemic The frequency of type 2 diabetes in youth is following the steep upward curve of childhood obesity. Type 2 Management Issues to consider Recent reports indicate that between 8% and 45% of children with newly diagnosed diabetes have type 2, with incidence dependent on ethnicity, family history, and other risk factors. (More than 90% of pediatric patients with type 2 have a family history of the disease. 6 ) Key management issues to consider include the following: Confirming type. As indicated in the evaluation and diagnosis algorithm on pages 4 and 5, type can usually be confirmed with further laboratory testing. If the testing indicates type 1, follow the guidelines for type 1 management while pursuing education for lowering risk factors (obesity, dyslipidemia, etc.) as appropriate. Lifestyle modification. As with adults, diet, exercise, and weight loss are central components of self-management for most children and adolescents with type 2. But the education and other support required for lifestyle changes must be tailored to younger patients, and must include their families. Oral medications. Only 15% of patients can control their blood glucose longer than a few months with lifestyle changes alone. 6 Medications must often be used as well. However, metformin is the only oral hypoglycemic agent that is FDA-approved for use with children and adolescents. Insulin therapy. For patients who cannot achieve glycemic control with lifestyle modification and oral medication, insulin may be appropriate. The algorithm on the following page explains the recommended approach for insulin therapy for children or adolescents with type 2. SUMMARY TABLE: oral medication for pediatric type 2 diabetes Generic Name Brand Name Usual Dosing 2005 AWP Cost for 30 day supply Pros Cons metformin Glucophage 500 mg once daily (start) to 1000 mg twice daily Glucophage XR 500 to 1000 mg once daily with food Generic: 500 mg once daily $ mg twice daily $55 Brand Name: 500 mg once daily $ mg twice daily $ mg once daily $ mg once daily $82 Prevents weight gain (preferred for obese patients most of the patients have type 2 diabetes) Favorable lipid effects No hypoglycemia Maximum PG effect at 3 to 4 weeks GI distress (nausea/diarrhea) Increased risk of acidosis (very rare but serious): Use with caution in patients with CHF, chronic liver disease, history of alcohol abuse, or renal failure Risk increases with age; monitor renal function regularly Increased pregnancy risk and should NOT be used during pregnancy Note: Metformin is the only oral hypoglycemic agent that has been reliably studied and used with children and adolescents, and therefore is the only oral agent FDAapproved for use in this population. There are anecdotal reports of successful use of other oral hypoglycemic agents in pediatric populations, but consultation with a pediatric endocrinologist is recommended before they are prescribed. 12

13 6, 14 ALGORITHM: type 2 management RPG <250 No symptoms No ketosis Suspected or confirmed type 2 diabetes in child or adolescent May be awaiting results of lab tests to confirm type 2 (see page 5) yes yes Initiate survival education (a) Refer for Medical Nutrition Therapy (b) Reassess within 2 to 4 weeks Able to maintain target PG (c) at least 75% of time? no Initiate or review survival education (a) Refer for or review Medical Nutrition Therapy (b) Initiate metformin therapy: Start with 500 mg by mouth once a day with meals for 4 to 7 days Increase dose to a maximum of 1,000 mg twice daily as tolerated Reassess within 2 to 4 weeks Able to maintain target PG (c) at least 75% of time? no Check compliance with oral medications and reinforce lifestyle self-management as necessary Consider adding insulin to metformin (d) Consult with a pediatric endocrinologist before trying other oral antiglycemic agents (e) Reassess within 2 to 4 weeks RPG No or mild symptoms No ketosis (a) Initiate survival education Survival education for type 2 has a particular focus on lifestyle and self-management. Education should include the following: Teaching SMBG (self-monitoring of blood glucose) and record keeping. Providing instructions for home and school for hyperglycemia and intercurrent illness Developing personal exercise plan See pages 14 to 16 for complete guidelines for patient and family education. (b) Refer for Medical Nutrition Therapy (MNT) Medical Nutrition Therapy for type 2 should be done by a registered dietitian who has experience with pediatric patients. Dietitian should provide a meal plan to support weight loss (if necesary) as well as control glucose, lipids, and blood pressure levels. Individual counseling and group classes are available throughout the Intermountain system via the LiVe Health Habits for Kids weight management program; call for information. (c) Target PG based on age (type 2) Target PG based on age (type 2) Age HbA1c PG before meals 6-12 yrs yrs <6.5% mg/dl <6.5% mg/dl PG bedtime/ overnight mg/dl mg/dl HbA1c should be as low as possible without significant risk of hypoglycemia. (d) Guidelines for adding insulin to metformin Initially, the addition of once daily longacting insulin to metformin may provide improved control. A starting dose of 5 to 10 units subcut at bedtime can be used (0.1 to 0.2 units/kg/day). The dose should be titrated up every 3 to 4 days based upon the fasting glucose value, with a target of <120 mg/ dl. If the fasting glucose is in target and the rest of the glucose values during the day are high, then -acting insulin (pre-meal) should be added next. Able to maintain target PG (c) at least 75% of time? no When PG is under control: Monitor HbA1c at least quarterly Follow other routine screening guidelines summarized on pages 20 and 21 Provide continuing education per guidelines on pages 14 and 15 Refer to pediatric endocrinologist (e) (e) Referral to a pediatric endocrinologist Only metformin and insulin have been reliably studied and used in children and adolescents. Although there are anecdotal reports of successful use of other antidiabetic agents in pediatric patients, they should be considered only if patients fail to respond to these outlined therapy guidelines and only after a pediatric endocrinologist has been consulted. 13

14 Survival education curriculum Survival education requires 12 to 20 hours of instruction. Patient and family must demonstrate proficiency at selfmanagement. In the first 3 days, teach: Pathophysiology of diabetes. Basics only, as context for self-management. SMBG (self-monitoring of blood glucose) and ketone testing. Hands-on training in using a glucose meter and checking for ketones. Insulin therapy and/or other medication. How-to information re: insulin injections, syringe disposal, glucagon use, and so on. MNT (medical nutrition therapy). Basic concepts, sufficient to allow self-management at home. Hypoglycemia, hyperglycemia, and intercurrent illness. How-to information on recognizing and treating high/low blood glucose and self-care on a sick day. Within 5 to 14 days: Re-assess and provide additional support for all basic self-management skills listed above: SMBG, insulin use, and so on. Provide more in-depth MNT as needed to promote lifestyle changes, add flexibility, and improve medication therapy. Help develop individualized plans for school and daycare management (see page 16), and counsel families about how to help other caregivers implement plans. Refer to local and national resources (see page 15). Patient and Family Education Patient and family education is a central element of pediatric diabetes management not just at diagnosis, but also in the months and years to come. Survival education Education must be provided immediately after the diagnosis of diabetes. The patient and family must quickly acquire new skills to begin assuming responsibility for day-to-day management of diabetes. The challenge of this survival education is that it must be delivered at a time when the family is still adjusting to the shock of the diagnosis. To help overcome this challenge and set the stage for a productive, ongoing relationship with the patient and family providers should do the following: Keep it simple. Offer mostly basic, actionable information and hands-on skill training. The main goal is to help the patient and family learn to fit diabetes into their lifestyle so that they can confidently provide care on their own. If available, use professionals experienced in pediatric diabetes education. Ideally, education should be provided by a skilled team consisting of a physician, a diabetes educator, a registered dietitian (RD), and a mental health professional. However, since these team members aren t always available, it s important that providers know how children s developmental stages affect diabetes management. Personalize, and be sensitive to family dynamics. To lay the foundation for effective, ongoing collaboration, make every effort to connect personally with the child and family. Tailor education to the patient s age, needs, capacities, and interests. Make sure education is culturally sensitive and appropriate for the family s lifestyle. And finally, in the rush to impart medical information, remember to pay attention to the patient s siblings, and to address any of the family s feelings of guilt and anxiety. Include take-home materials for reference and further study. Proper diabetes education is intense and complex, and can only happen over time beyond the difficult first days after diagnosis. Everyone involved in the patient s care should receive additional materials that support and extend the survival education. The Intermountain resources described on the following page are an excellent start. Continuing education This CPM recommends education sessions as part of an annual diabetes follow-up visit with a pediatric endocrinologist and diabetes team experienced in self-management assessment and education. Ongoing education should address the following: Assess self-management and update treatment goals as needed always with a view to gradually increasing patient independence and preparing for the transition to adult care. Provide anticipatory guidance for issues that may affect self-management and treatment, e.g., beginning school, starting a sports season or exercise program, entering puberty, avoiding smoking and substance abuse, typical teenage challenges and issues, etc. Address nutrition concerns such as weight management, eating disorders, lipid abnormalities, the typical teen diet, etc. Educate about new technologies affecting care, such as new pumps, meters, forms and types of insulin, etc. Offer updates on diabetes research and opportunities to participate in trials. Reinforce the importance of optimizing blood glucose, lipid, and blood pressure treatment to help prevent microvascular and macrovascular complications. 14