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Diabetes Management in the Outpatient Setting

Diabetes Management in the Outpatient Setting. Diagnostic Criteria (before 2010). FPG≥126 mg/dl. Prediabetes (IFG)≥100 mg/dl. 75 gram OGTT 2 hour-value≥200 mg/dl. Prediabetes (IGT)≥140 mg/dl. Random blood glucose≥200 mg/dl + symptoms (polyuria, polydipsia, unexplained weight loss).

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Diabetes Management in the Outpatient Setting

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  1. Diabetes Management in the Outpatient Setting

  2. Diagnostic Criteria (before 2010) • FPG≥126 mg/dl. • Prediabetes (IFG)≥100 mg/dl. • 75 gram OGTT 2 hour-value≥200 mg/dl. • Prediabetes (IGT)≥140 mg/dl. • Random blood glucose≥200 mg/dl + symptoms (polyuria, polydipsia, unexplained weight loss).

  3. International Expert Committee Report on the Role of A1C in the Diagnosis of Diabetes 6.5% THE INTERNATIONAL EXPERT COMMITTEE. Diabetes Care 2009;32:1327

  4. 2010 Diagnosis of Diabetes and Categories of Increased Risk for Diabetes ADA, Diabetes Care 33: Suppl. 1, S11-S61, 2010

  5. Main factors in support of using HbA1C as a screening and diagnostic test • A1c does not require patients to be fasting. • HbA1c reflects longer-term glycemia than does plasma glucose. • Relatively unaffected by acute (e.g., stress or illness related) perturbations in glucose levels. • Currently used to guide management and adjust therapy. • HbA1c laboratory methods are now well standardized and reliable. J Clin Endocrinol Metab 93: 2447–2453, 2008 Diabetes Care 32 (7):1327-1334, 2009

  6. Limitations of the Use of A1C for the Diagnosis of Diabetes • Greater cost • Limited availability of A1C testing in certain regions of the developing world • Incomplete correlation between A1C and average glucose • Misleading in patients with anemia and hemoglobinopathies.

  7. Factors influencing A1c

  8. Recommendation of the International Expert Committee for the diagnosis of diabetes • Diabetes should be diagnosed when A1C is ≥6.5% • Diagnosis should be confirmed with a repeat A1C test • Confirmation is not required in symptomatic subjects with plasma glucose levels >200 mg/dl • If A1C testing is not possible, previously recommended diagnostic methods (e.g., FPG or2HPG, with confirmation) are acceptable. DIABETES CARE, VOLUME 32, NUMBER 7, JULY 2009

  9. Who To Screen • No major risk factors, FPG every 3 years beginning at 45 y.o. • Any risk factors, screen earlier and more often: • Overweight (BMI>25 kg/m2). • First degree relative with T2DM. • High risk ethnic group. • Hypertension (≥140/90 mmHg). • HDL≤35 mg/dl and/or triglycerides≥250 mg/dl. • History of gestational diabetes or delivered baby ≥9lb. • Polycystic ovary syndrome. • History of vascular disease. • Habitual physical inactivity.

  10. Treatment Goals for Type 2 Diabetes

  11. Guidelines for Glycemic, BP, & Lipid Control HDL = high-density lipoprotein; LDL = low-density lipoprotein; PG = plasma glucose; TG = triglycerides. ADA. Diabetes Care. 2012;35:S11-63

  12. Standard of Care-Multifactorial Therapy • DCCT (1993) and UKPDS (1998) established role for better glycemic control on prevention of microvascular complications. • Studies that improved BP or lipids generally showed lower CAD in type 2 diabetes. • Steno 2 trial (2003) showed a marked lowering of both micro and macrovascular events when all 3 utilized.

  13. Standard of Care-Multifactorial Therapy • DCCT (1993) and UKPDS (1998) established role for better glycemic control on prevention of microvascular complications. • Studies that improved BP or lipids generally showed lower CAD in type 2 diabetes. • Steno 2 trial (2003) showed a marked lowering of both micro and macrovascular events when all 3 utilized. • Memory effect-longterm micro and macrovascular • protection years after stopping the trial-in DCCT, UKPDS, and Steno 2 trials.

  14. But…then the role of intensive glucose control management came under active debate.

  15. Conclusions • Intensive treatment of glycemia in the ACCORD cohort did not reduce the risk of composite measures of advanced microvascular outcomes • renal failure: initiation of dialysis or ESRD, or renal transplant, or a rise of serum creatinine above 3.3 mg/dL • retinal photocoagulation or vitrectomy to treat diabetic retinopathy, • or development of neuropathy • Intensive therapy delayed the onset of albuminuria and some measures of eye complications and neuropathy • Microvascular benefits of intensive therapy should be weighed against increase in total and CVD-related mortality, increased weight gain, and high risk for severe hypoglycemia

  16. Figure 1 Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print] (Adapted with permission from: Ismail-Beigi F, et al. Ann Intern Med 2011;154:554)

  17. Main Pathophysiological Defects in T2DM pancreatic insulin secretion incretin effect pancreatic glucagon secretion ? - gut carbohydrate delivery & absorption HYPERGLYCEMIA - + peripheral glucose uptake hepatic glucose production Adapted from: Inzucchi SE, Sherwin RS in: Cecil Medicine 2011

  18. Antihyperglycemic Agents Major Sites of Action Plasma glucose Glucosidase Inhibitors (-) Glucose Uptake Glucose Production Carbohydrate Absorption Muscle/Fat GI tract (-) Injected Insulin Liver (+) Metformin Glitazones Insulin Secretion Sulfonylureas Meglitinides Insulin Secretion (+) Pancreas 1. Hines SE. Intensive management of type 2 diabetes. Patient Care.April 30, 2000:91-107. 2. Kelley DB, ed. Medical Management of Type 2 Diabetes. 4th ed. Alexandria, Va: American Diabetes Association; 1998:56-72.

  19. Natural History of Type 2 DM Plasma Glucose Postmeal glucose Fasting glucose 126mg/dL Insulin resistance Relative -Cell Function Insulin secretion -30 -20 -10 0 10 20 30 Years of Diabetes DeFronzo RA. Pathogenesis of type 2 diabetes: Implications for metformin. Drugs. 1999;58 (suppl 1):29-30.

  20. Management of Hyperglycemia in T2DM • ANTI-HYPERGLYCEMIC THERAPY • Therapeutic options: Lifestyle • Weight optimization • Healthy diet • Increased activity level Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  21. Management of Hyperglycemia in T2DM • ANTI-HYPERGLYCEMIC THERAPY • Therapeutic options: • Oral agents & non-insulin injectables • Metformin • Sulfonylureas • Thiazolidinediones • DPP-4 inhibitors • GLP-1 receptor agonists • Meglitinides • a-glucosidase inhibitors • Bile acid sequestrants • Dopamine-2 agonists • Amylin mimetics Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  22. Table 1. Properties of anti-hyperglycemic agents Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  23. Table 1. Properties of anti-hyperglycemic agents Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  24. Table 1. Properties of anti-hyperglycemic agents Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  25. Management of Hyperglycemia in T2DM • ANTI-HYPERGLYCEMIC THERAPY • Implementation strategies: • Initial therapy • Advancing to dual combination therapy • Advancing to triple combination therapy • Transitions to & titrations of insulin Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  26. Management of Hyperglycemia in T2DM • ANTI-HYPERGLYCEMIC THERAPY • Implementation strategies: • If A1c >9% start with 2 meds. • Consider insulin if BS>300 or A1c>10% • Adding a second agent drops A1c on average 1%. • A1c>8.5% and on 2 drugs=insulin.

  27. Management of Hyperglycemia in T2DM • CONSIDERATIONS • Age • Weight • Sex / racial / ethnic / genetic differences • Comorbidities • Coronary artery disease • Heart Failure • Chronic kidney disease • Liver dysfunction • Hypoglycemia Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  28. Management of Hyperglycemia in T2DM • CONSIDERATIONS • Age: Older adults • Reduced life expectancy • Higher CVD burden • Reduced GFR • At risk for adverse events from polypharmacy • More likely to be compromised from hypoglycemia • Less ambitious targets • HbA1c <7.5–8.0% if tighter targets not easily achieved • Focus on drug safety Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  29. Management of Hyperglycemia in T2DM • CONSIDERATIONS • Weight • Majority of T2DM patients overweight / obese • Intensive lifestyle program • Metformin • GLP-1 receptor agonists • ? Bariatric surgery • Consider LADA in lean patients Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  30. Management of Hyperglycemia in T2DM • CONSIDERATIONS • Sex/ethnic/racial/genetic differences • Little is known • MODY & other monogenic forms of diabetes • Latinos: more insulin resistance • East Asians: more beta cell dysfunction • Gender may drive concerns about adverse effects (e.g., bone loss from TZDs) Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  31. Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print] T2DM Anti-hyperglycemic Therapy: General Recommendations

  32. Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print] Adapted Recommendations: When Goal is to Avoid Weight Gain

  33. Management of Hyperglycemia in T2DM • CONSIDERATIONS • Comorbidities • Coronary Disease • Heart Failure • Renal disease • Liver dysfunction • Hypoglycemia • Metformin: CVD benefit (UKPDS) • Avoid hypoglycemia • ? SUs & ischemic preconditioning • ? Pioglitazone &  CVD events • ? Effects of incretin-based therapies Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  34. Management of Hyperglycemia in T2DM • CONSIDERATIONS • Comorbidities • Coronary Disease • Heart Failure • Renal disease • Liver dysfunction • Hypoglycemia • Metformin: May use unless condition is unstable or severe • Avoid TZDs • ? Effects of incretin-based therapies Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  35. Management of Hyperglycemia in T2DM • CONSIDERATIONS • Comorbidities • Coronary Disease • Heart Failure • Renal disease • Liver dysfunction • Hypoglycemia • Increased risk of hypoglycemia • Metformin & lactic acidosis • US: stop @SCr ≥ 1.5 (1.4 women) • UK:  dose @GFR <45 & stop @GFR <30 • Caution with SUs (esp. glyburide) • DPP-4-i’s – dose adjust for most • Avoid exenatide if GFR <30 Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  36. Management of Hyperglycemia in T2DM • CONSIDERATIONS • Comorbidities • Coronary Disease • Heart Failure • Renal disease • Liver dysfunction • Hypoglycemia • Most drugs not tested in advanced liver disease • Pioglitazone may help steatosis • Insulin best option if disease severe Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  37. Management of Hyperglycemia in T2DM • CONSIDERATIONS • Comorbidities • Coronary Disease • Heart Failure • Renal disease • Liver dysfunction • Hypoglycemia • Emerging concerns regarding association with increased mortality • Proper drug selection in the hypoglycemia prone Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print]

  38. Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print] T2DM Anti-hyperglycemic Therapy: General Recommendations

  39. Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print] Adapted Recommendations: When Goal is to Avoid Hypoglycemia

  40. Diabetes Care,Diabetologia. 19April 2012 [Epub ahead of print] Adapted Recommendations: When Goal is to Minimize Costs

  41. Physiologic Insulin Secretion :Basal/Bolus Concept Prandial Insulin 50 Insulin (µU/mL) 25 0 Basal Insulin Breakfast Lunch Supper 150 Prandial Glucose • Suppresses Glucose Production Between Meals & Overnight • Basal  50% of Daily Needs 100 Glucose (mg/dL) 50 Basal Glucose 0 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 A.M. P.M. Time of Day

  42. Management of Hyperglycemia in T2DM • ANTI-HYPERGLYCEMIC THERAPY • Therapeutic options: Insulin Rapid (Lispro, Aspart, Glulisine) Short (Regular) Insulin level Intermediate (NPH) Long (Detemir) Long (Glargine) Hours 0 2 4 6 8 10 12 14 16 18 20 22 24 Hours after injection

  43. Establishing Basal Requirement for Glargine • Initial calculation of basal dose • BW in kilograms x sensitivity index (0.15 – 0.2 ) • Or • Body Weight in pounds x 0.1 • From BID NPH • Take total NPH dose and decrease by 20% for starting dose

  44. Establishing Basal Requirement for Glargine • Sequential increase • Increase every 2-3 days by • 4 U if FBG>140 mg/dL • 2 U if FBG=120mg/dL to 140 mg/dL • OR • Mean of am BG after five days • Add to initial Glargine by formula • (Average BG-100)/10 • Example: 200 pounds on 20 units glargine q hs, mean am BG is200 on 6th and 7th day • Add (Av BG -100)10 to glargine, (200-100/10) • i.e. increase from 20 to 30 units q hs • 2nd week--average 130 ,increase glargine from 30 to 33

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