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GO! Diabetes Train the Trainer Program

GO! Diabetes Train the Trainer Program. Glycemic Control - Injected Therapies.

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GO! Diabetes Train the Trainer Program

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  1. GO! DiabetesTrain the Trainer Program

  2. Glycemic Control - Injected Therapies

  3. A 66-year-old female patient has a 7-year history of type 2 diabetes that has been well-controlled with glipizide (Glucotrol), 10 mg/day, and rosiglitazone (Avandia), 8 mg/day. Over the past year her glycemic control has deteriorated, with her most recent laboratory tests revealing a fasting glucose level of 185 mg/dL and a glycosylated hemoglobin level of 8.9%. Her serum creatinine level is 1.7 mg/dL.Which one of the following would be the most appropriate intervention at this point?A) Increase the glipizideB) Add metformin (Glucophage)C) Add acarbose (Precose)D) Add repaglinide (Prandin)E) Begin basal insulin therapy by adding a bedtime dose of NPH or insulin glargine

  4. Beta Cell Function DeclinesUKPDS Data • Beta cell function declines with time • 5-10% failure per year • Eventually Insulin Needed

  5. 12.4% 37.2% >8% 7.8% 63% 7% 17.0% 25.8% 37.0% 63% Of Patients with DiabetesAre Not at ADA A1CGoal <7% Adults aged 20-74 years with previously diagnosed diabetes who participated in the interview and examination components of the National Health And Nutrition Examination Survey (NHANES), 1999-2000 A1C % of Subjects n=404 Saydah SH et al. JAMA 2004;291:335

  6. Difficulties In AchievingTarget A1C Values • Challenges • Late diagnosis and initiation of therapy • Therapeutic inertia • Lack of effective lifestyle intervention • Secondary failure • Adverse events associated with antihyperglycemic therapies • Complexity of care • Role of postprandial glucose in failure

  7. Common Concerns When Transitioning To Insulin • Fear of needles or pain from injections • Fear of hypoglycemia • Weight gain Funnel M. Self-management Support for Insulin Therapy in Type 2 Diabetes. The Diabetes Educator 2004;30:274

  8. Common Concerns When Transitioning To Insulin • Adverse impact on lifestyle; inconvenient; loss of personal freedom and independence • Belief that insulin means diabetes is worse or more serious disease • Insulin as a personal failure • Insulin causes complications • Treated differently by family members Funnel M. Self-management support for insulin therapy in type 2 diabetes. The Diabetes Educator 2004;30:274

  9. Potential Insulin Regimens • Insulin pump Physiologic/COMPLEX/Flexible • Multiple daily injections • Free mixing - twice daily • Pre-mixed - twice daily • Basal only SIMPLE/Inflexible How do we balance simplicity and flexibility to achieve glycemic control?

  10. Insulin InitiationProvider Concerns • Which Insulin? • How Much? • How do I adjust? • How do I teach? • How often do I change dosages?

  11. Indications for Insulin • Not contraindicated at anytime • Consider as initial therapy • HgbA1C > 10% • Fasting glucose > 250mg/dl • Random glucose > 300 • Recommended as initial therapy • Polyuria, polydipsia, weight loss, ketones

  12. Insulin InitiationAnswers to Provider Concerns • Normalize the fasting glucose • Fasting FSBS 70-130 • Once Daily Options • Start 10 units or 0.2 u/kg • Basal Insulin (glargine or detemir) • NPH (bedtime) • Premixed before dinner • Increase 2-3 units every 3 days prn to reach target of 70-130 fasting • Decrease 3 units for fasting < 70

  13. Once Daily Insulin OptionsBasals vs. NPH vs. Premixed

  14. Treatment to Target StudyMean A1C Concentrations During Study Failing 1-2 OAH Insulin glargine NPH insulin Mean A1C (%) Target A1C (%) Weeks Riddle M et al. Diabetes Care 2003;26(11)3080

  15. Treatment to Target Study Symptomatic Hypoglycemia by Time of Day Basal insulin Insulin glargine 35 * * NPH insulin 30 * * * 25 * 20 Patients (%) With 1 Hypoglycemia Episode 15 10 5 B L D 0 20 22 24 2 4 6 8 10 12 14 16 18 20 Time Of Day (Hours) *P<0.05 vs insulin glargine Hypoglycemia defined as PG 72 mg/dL Adapted with permission from Riddle M et al. Diabetes Care 2003;26(11)3080

  16. Glargine: Mechanism Of Action Injection of an acidic solution (pH 4.0)  Clear Solution pH4 pH 7.4 Precipitation of glargine in subcutaneous tissue (pH 7.4)  Precipitation Dissolution Dimers Monomers Hexamers Slow dissolution of free glargine hexamers from precipitated glargine (stabilized aggregates) 10-3 M 10-5M 10-8 M Capillary Membrane  Protracted action Insulin In Blood Adapted from: Kramer W. Exp Clin Endocrinol Diabetes 1999;107:Suppl 2

  17. Rapid (Glulisine,Lispro, Aspart,) Long (Glargine) Insulin ActionEffect Of Various Formulations 140 120 100 Short (Regular) Insulin Level (U/ml) 80 Intermediate (NPH) 60 40 Detimir 20 0 0 2 4 8 10 12 14 16 6 Hours

  18. Fasting Glucose at TargetHgbA1C Not at Goal • Normalize Post Prandial Glucose • Options • Change HS NPH to BID NPH • Change Pre-mixed Insulin from QD to BID • Add Mealtime Insulin to Basal Insulins

  19. Monomeric Insulin Analogs • How to switch or start • Insulin immediately before the meal (or after) • Review signs, symptoms and management of hypoglycemia • Safety • Arguably, glulisine, aspart, lispro and are safer than regular human insulin • Patient preference • Significant patient preference for monomeric analog versus regular human insulin • Duration of action • Covers postprandial glucose surge well • In type 1 diabetes, will need an additional injection of basal or NPH

  20. Carbohydrate Counting • Technique based on the concept that most meal-related glucose increase is due to the carbohydrate content • Patients count either • Carbohydrate choices (milk, fruit, breads, sweets, starchy vegetables) • Grams of “total carbohydrates” on food label • Providers prescribe insulin-to-carbohydrate ratio • Start with 1 unit per choice or 1 unit per 15 grams • Typical dose is 2-4 units per choice in type 2 diabetes • Titrate based on postprandial glucose monitoring • Generally, start with glulisine/lispro/aspart administered just after meals

  21. Mixed-Analog Insulin BID • Starting dose in most • Pre-breakfast 10 units • Pre-supper 10 units • Titration, once or twice a week (self-adjusted or with supervision) • Increase/decrease AM insulin dose based on pre-supper values • Increase/decrease PM insulin dose based on pre-breakfast values • Do not increase (consider decrease) if any glucose <70 in the prior 3 days • Alternatively, could just increase at both breakfast and supper in parallel Buse JB et al. Clinical Diabetes 2005;23:78

  22. Pre-Mixed Insulin BID Compared to Basal Alone - INITIATE Study glargine SC Q HS + metformin (± TZD) n=210 Type 2 DM A1C ≥8.0 on metformin Treat­to­target: plasma glucose 80-110 mg/dL Insulin aspart premix 70/30 SC, before breakfast and dinner + metformin (± TZD) 4­week run­in: 28 week treatment period d/c secretagogues & a­glucosidase inhibitors Optimize metformin Switch rosiglitazone to pioglitazone; stratify by ± TZDs Titration by algorithm Raskin P et al. Diabetes Care 2005;28:260

  23. Pre-Mixed Insulin BID Compared to Basal Alone - INITIATE Study p=0.0002* p=0.0356* Patients Reaching Target At End Of Study (%) A1C ≤6.5% (ACE and IDF goal) A1C <7.0% (ADA goal) A1C Target *p value from Fisher’s exact test Raskin P et al. Diabetes Care 2005;28:260

  24. Pre-Mixed Insulin BID Compared to Basal Alone – INITIATE Study Aspart 70/30 bid Glargine qhs • Minor hypoglycemia 43% 16% • Median rate per pt per mo 0.30.2 • Severe hypoglycemia None 1 episode • Weight gain (Kg) 5.4 4.8 3.5 4.5 • Total daily insulin (u/Kg) 0.82 0.40 0.55 0.27 Raskin P et al. Diabetes Care 2005;28:260

  25. Oral Meds – What to Do When Insulin Started (General Rules) • Metformin • Continue unless contraindicated • Sulfonylureas • Continue with basals generally • Stop if using large doses of insulin • Stop if using premixed insulin • TZDs • Proceed with caution • Exacerbates weight gain and edema

  26. Non Insulin Injectables

  27. Incretins Play an Important Role in Glucose Homeostasis Food ingestion  Insulin from beta cells (GLP-1 and GIP) Glucose Dependent ↑Glucose uptake by peripheral tissue2,4 Release of gut hormones— Incretins1,2 Pancreas2,3 ↓ Blood glucose Beta cellsAlpha cells GI tract Active GLP-1 & GIP ↓Glucose production by liver  Glucagon fromalpha cells (GLP-1) Glucose Dependent DPP-4 enzyme 1. Kieffer TJ, Habener JF. Endocr Rev. 1999;20:876–913. 2. Ahrén B. Curr Diab Rep. 2003;2:365–372. 3. Drucker DJ. Diabetes Care. 2003;26:2929–2940. 4. Holst JJ. Diabetes Metab Res Rev. 2002;18:430–441. InactiveGLP-1 InactiveGIP

  28. Multiple Sites of Action of Exenatide CNS Promotes satiety and reduction of appetite LiverReduces hepatic glucose output by inhibiting glucagon release Beta Cell Stimulates glucose-dependent insulin secretion Alpha CellInhibits glucagon secretion StomachSlows gastricemptying Flint A et al. J Clin Invest 1998;101:515 Larsson H et al. Acta Physiol Scand 1997;160:413 Nauck MA et al. Diabetologia 1996;1546 Drucker DJ. Diabetes 1998;47:159

  29. 1.2±0.1% 5.5±0.5 kg Exenatide: A1C And Body Weight Reductions- Preliminary Analysis For Subjects Treated For 2 Years 2 year data for 82 week cohort (n=146) Mean ± SE Δ A1C (%) Δ Body Weight (kg) Placebo Controlled Placebo Controlled Open-Label Extensions Open-Label Extensions 0 0.0 -2 -0.5 -4 -1.0 -1.5 -6 0.0 0.0 0.5 1.0 1.5 2.0 0.5 1.0 1.5 2.0 Duration Of Treatment (Years) Duration Of Treatment (Years) Baseline A1C=8.2% Baseline Weight=100 kg Diabetes Metab Res Rev. 2006 Nov-Dec;22(6):483-91.

  30. General Prescribing ConsiderationsDosing Stable Dose 10 mcg BID Stable Dose 5 mcg BID 1 Mo Initiation Indicated for use in patients failing metformin or sulfonylurea Generally reduce SFU dose to smallest tablet to minimize risk of hypoglycemia No dosage adjustments based on meal size or physical activity No additional glucose monitoring required Exenatide Prescribing Information. 2005

  31. A1C (%) Body Weight (lbs) * * * * * * Glargine Vs Exenatidein Patients Failing Oral Therapies ITT patient sample Mean ± SE shown * p<0.0001, exenatide vs insulin glargine at same time point Heine RJ et al. Ann Intern Med 2005;143(8):559

  32. Quarterly to semi-annual follow-up Monthly to quarterly follow-up Lifestyle intervention MNT, physical activity, education Yes No Are A1C/FPG targets achieved? FPG >200 mg/dL FPG <130 mg/dL * Target Insulin Deficiency Target Insulin Resistance Target PPG * Keep adding agents until target reached. Self-titration at home when possible Metformin, glitazone Exenatide, nateglinide, α-glucosidase inhibitors, rapid-acting insulin, pramlintide SFUs/glinide, insulin, exenatide Treatment Algorithm - Glucose Diagnosis by screening or with symptoms

  33. Causes of Hypoglycemia • Incorrect amount of insulin/oral agents • Skipped or delayed meal/snack • Carbohydrate intake less than normal • Alcohol intake without food • Exercise without insulin/food adjustment • Not re-testing 1 to 2 hours after hypoglycemia treatment if meal or snack is not eaten

  34. Treatment of Hypoglycemia • Definition of hypoglycemia: Plasma glucose <70 mg/dL • Symptoms may or may not be present • Sweaty, cold, unable to concentrate, dizzy • Treatment • Treat with 15 g carbohydrate; wait 15 minutes; test BG, if BG not >70 mg/dL, treat again • All carbohydrates raise blood glucose • On average, 15 g of glucose can increase BG from 60 to ~110 mg/dL (50mg/dL) over ~40 minutes • BG starts to fall at 60 minutes and reaches previous treatment level at 2 hours Cryer et al. Diabetes Care 2003;26:1902

  35. 15 Gram Carbohydrate Choices BG 1 fruit or 1 milk or 1 starch = Blood Glucose Increase ~50 mg/dL or “Fun-size” = 1 oz Instruct patients on insulin therapy (or on insulin secretagogue) to carry source of carbohydrate that is convenient, readily available, easily and quickly consumed and doesn’t spoil

  36. Treatment of Hypoglycemia Cont. • Hypoglycemia increases gastric emptying from ~50 minutes to ~25 minutes; emptying rates of solid foods and liquids are the same • Adding protein to carbohydrate does not help in the treatment and does not prevent subsequent hypoglycemia Schvarcz et al. Diabetic Med 1993;10:660 Gray et al. J Clin Endocrinol Metab 1996;81:1508

  37. Treatment of Severe Hypoglycemia • Definition: Requires assistance to treat • Inject glucagon with loss of consciousness or seizure • Administered by another person • May be given intramuscular or subcutaneous • Standard dose • 1.0 mg for adults; 0.5 mg for children under 5 yrs • Prescription is required • Precautions • May cause nausea/vomiting/headache • Call 911

  38. Hypoglycemia Prevention • Instruct patients to… • Follow food and insulin plan • Test blood glucose daily • Carry carbohydrate • Wear medical identification • Teach others how to inject glucagon

  39. Which one of the following types of insulin should never be mixed with any other form of insulin?A) LenteB) UltralenteC) Insulin glargineD) NPHE) Insulin lispro

  40. A 42-year-old female with a body mass index (BMI) of 31 kg/m2 has a 3-week history of polyuria and polydipsia, accompanied by a 10-lb weight loss. Her fasting plasma glucose level is 320 mg/dL, and her hemoglobin 1c A level is 11.1%. Initial treatment with which one of the following will reverse glucose toxicity and improve glycemic response?A) Metformin (Glucophage)B) Pioglitazone (Actos)C) Glipizide (Glucotrol)D) Acarbose (Precose)E) Insulin

  41. Patients must eat within 15 minutes of administration of which one of the following types of insulin?A) LenteB) Insulin glulisineC) Insulin glargineD) NPHE) Insulin lispro

  42. A 58-year-old male with type 2 diabetes is started on a twice-daily insulin regimen consisting of 20 units of NPH/10 units of regular insulin in the morning and 10 units of NPH/4 units of regular insulin in the evening before dinner. His fasting glucose levels have generally been in the 140-180 mg/dL range, as have his glucose levels just before lunch and dinner.He complains of frequent midmorning hypoglycemic episodes requiring midmorning snacks, as well as hypoglycemic episodes just before bedtime, also requiring snacks.Which one of the following adjustments is most likely to be effective?A) Reduce the regular insulin dosageB) Reduce the NPH dosageC) Have the patient eat later in the morning and eveningD) Have the patient increase meal sizes at breakfast and dinnerE) Change the patient's regimen to insulin glargine in the evening and insulin lispro for each meal

  43. Mechanisms of action of exenatide (Byetta) include which of the following? (Mark all that are true.)A) Enhanced insulin secretionB) Suppression of glucagon secretionC) Enhanced insulin sensitivity of muscleD) Slowing of gastric motilityE) Reduction of the rate of polysaccharide digestion in the small intestine

  44. Matt is a 19 year old type 1 diabetic who is in college. He is on insulin glargine 25 units daily. He uses insulin glulisine at meals in a 1 unit to 10 grams carbohydrate ratio. His most recent HbA1C was 7.1%. He is in college and you are his primary care physician. He expresses frustration to you because he is having frequent hypoglycemia. In fact, he recently had to be transported to an ER because his college found him unresponsive. His blood glucose was 22 mg/dl when paramedics arrived.His problem times include mornings when he sleeps in and often with exercise. Outside of those times his fasting glucoses are between 120 and 150 mg/dl. He wonders what his options are. Which of the following is the best recommendation to help him:a) lower the insulin glargine dosage b) lower the insulin to carbohydrate ratio c) consider an insulin pump d) set his alarm when he plans on sleeping

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