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Diabetes: Where Are We Now?

Diabetes: Where Are We Now?. Elaine M. Szewc, RN, BS, AALU, ALMI Assistant Chief Medical Director. Overview. According to the 2011 National Diabetes Fact Sheet (released 1/26/2011): 25.8 million individuals (8.3% of the population) in the U.S. have diabetes

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Diabetes: Where Are We Now?

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  1. Diabetes: Where Are We Now? Elaine M. Szewc, RN, BS, AALU, ALMI Assistant Chief Medical Director

  2. Overview • According to the 2011 National Diabetes Fact Sheet (released 1/26/2011): • 25.8 million individuals (8.3% of the population) in the U.S. have diabetes • 18.8 million have a diagnosis of diabetes • 7.0 million are undiagnosed • 1.9 million NEW cases of diabetes are diagnosed each year in individuals over age 20 • 79 million have “pre-diabetes” • Prevalence • 2 million adolescents, age 12-19 have “pre-diabetes” • 25.6 million (11.3 %) over age 20 • 10.9 million (26.9%) over age 65 Source: http://www.diabetes.org

  3. Adults with Diagnosed Diabetes, US, 1980--2009 www.cdc.gov/diabetes/statistics/prev/national/figadults.htm

  4. Overview (cont’d) • Morbidity and Mortality: • 7th leading cause of death listed on U.S. death certificates in 2007 as “underlying cause of death” • In 2004, heart disease was noted on 68% of diabetes-related death certificates among individuals 65 and up, while stroke was noted on 16% • Diabetics with heart disease have 2 to 4 times higher death rates than adults without diabetes • Risk for stroke is 2 to 4 times higher among diabetics • Diabetes is the leading cause of new cases of blindness each year, with 12,000 to 24,000 new cases of diabetic retinopathy Source: http://www.diabetes.org

  5. Overview (cont’d) • Morbidity and Mortality (cont’d): • Diabetes is the leading cause of kidney failure, accounting for 44% of new cases in 2008 • 60 to 70% of individuals with diabetes will have mild to severe peripheral neuropathy as a result of their diabetes • 60% of non-traumatic lower-limb amputations occur in individuals with diabetes Source: http://www.diabetes.org

  6. IGT/IFG/Pre-Diabetes – Defined • Impaired glucose tolerance (IGT)/impaired fasting glucose (IFG) is now known as pre-diabetes • Pre-diabetes is the state that occurs when blood glucose levels are higher than normal but not high enough for a diagnosis of diabetes • Just a name change • Clearer explanation of what it means to have higher than normal blood glucose levels • Individuals with pre-diabetes have 1.5 fold risk of CAD • Individuals with diabetes have 2 to 4 fold risk of CAD • Individuals with pre-diabetes can delay or prevent onset of diabetes through lifestyle changes • 25% of individuals will progress to diabetes over 3 to 5 years • Those with family history, obesity are more likely to progress more rapidly

  7. IGT/IFG/Pre-Diabetes – Defined (cont’d) • Undiagnosed diabetes can cause progressive microvascular disease • Approximately 20% of newly diagnosed patients with Type 2 DM have diabetic retinopathy and 10% have nephropathy (microvascular complications) • IGT/IFG/pre-diabetes are NOT clinical entities, but rather risk factors for diabetes as well as cardiovascular disease Source: http://www.diabetes.org

  8. Diabetes - Defined • 1997 – the ADA refined terms to describe diabetes • Encouraged use of Type 1 or Type 2 and discouraged use of terms such as juvenile onset, insulin-dependent, non-insulin dependent, mature onset or adult onset • 2003 – criteria for fasting plasma glucose level to define impaired fasting glucose (IFG) was lowered • Lowering level impacts many older age individuals • Allows early diagnosis and potential risk factor modifications to prevent micro and macrovascular risk • 2010 – added A1c to diagnostic criteria Source: Up-to-date, Diagnosis of diabetes mellitus, McCulloch David, updated August 2009

  9. Diabetes – Defined (cont’d) • Criteria for the diagnosis of diabetes mellitus, 2010 • A1c > 6.5% OR • FPG 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 hours OR • 2-h plasma glucose 200mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as described by the World Health Organization, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water OR • Symptoms of diabetes and a random plasma glucose 200 mg/dl (11.1 mmol/l). Casual is defined as any time of day without regard to time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss Source: Up-to-date, Diagnosis of diabetes mellitus, McCulloch David, updated June 2011

  10. Diabetes – Defined (cont’d) • Categories of increased risk for diabetes: • Impaired fasting glucose (IFG) FPG > 100-125 mg/dL • Impaired glucose tolerance (IGT) 2 hour PG (75g OGTT) > 140 – 199 mg/dL • A1c 5.7 – 6.4% Normal fasting glucose < 100 mg/dL Source: Up-to-date, Diagnosis of diabetes mellitus, McCulloch David, updated June 2011

  11. ADA Guidelines – IGT/IFG • Goal of intervention in individuals with IGT or IFG includes prevention of diabetes and associated risk of cardiovascular disease • Lifestyle modifications are the primary intervention • Specific goals include: • Moderate weight loss (5 – 10% of body weight) • Moderate intensity exercise (30 minutes daily) • Smoking cessation • Pharmacologic agents (metformin) have demonstrated some ability to prevent or delay diabetes Source: Up-To-Date, Prediction and prevention of type 2 diabetes mellitus, McCulloch David K MD, Robertson R Paul MD; updated June 2009

  12. ADA Treatment -- Diabetes • Primary goal in treatment of diabetes is glycemic control (~ 7% for A1C) to reduce microvascular (retinopathy and nephropathy), and neuropathic complications, as well as macrovascular (cardiovascular, cerebrovascular) risk reduction • Less stringent control in subset of individuals with history of severe hypoglycemia, limited life expectancy (< 5 years), advanced microvascular or macrovascular complications and extensive co-morbid conditions • Risk factor modification to further reduce cardiovascular morbidity and risk of future cardiac events

  13. Diabetes and CAD • Compared to individuals without diabetes, those with diabetes have a higher prevalence of CAD, a greater extent of coronary ischemia and are more likely to have a MI, and silent ischemia Source: Up-To-Date, Prevalence of and risk factors for coronary heart disease in diabetes mellitus, Nesto, Richard W. MD; updated September 2009

  14. Diabetes and CAD (cont’d) • Based on results from Framingham Heart Study and MRFIT, diabetes remains a major independent cardiovascular risk factor even when adjusting for advancing age, hypertension, smoking, hypercholesterolemia and LVH • Presence of diabetes doubled the age-adjusted risk for cardiovascular disease in men and tripled it in women • Framingham study revealed in Type I diabetics that after age 30, CHD mortality increased rapidly • Cumulative CHD mortality was 35 % by age 55, compared to 8% for non-diabetic men

  15. Diabetes and CAD (cont’d) • TAMI trial provided cath data which revealed the diabetic patients had a significantly higher incidence of multivessel disease (66% versus 46%) and a greater number of diseased vessels then the non-diabetics • Multivessel disease is also common in asymptomatic individuals with Type 2 diabetes, particularly those with two or more coronary risk factors other then diabetes • Association between extent of coronary disease and the degree of glycemic control

  16. Diabetes and CAD (cont’d) • ARIC study in US, large population based study revealed Type 2 diabetics without a prior infarction were at the same risk for MI (20% versus 19%) and coronary mortality (15% versus 16%) as non-diabetics with a prior MI • Diabetics are more likely to experience a complication associated with an MI, including post infarction angina and heart failure

  17. Diabetes and CAD (cont’d) • Individuals with diabetes comprise as much as 25-30% of those individuals who undergo revascularization • PCI versus CABG • Diabetics having PCI have increased rates of both restenosis and progression of disease compared to non-diabetics • Drug-eluting stents (DES) are now used in preference to bare metal stents (BMS) due to marked reductions in incidence of restenosis • Long-term prognosis after CABG in patients with diabetes is worse then in non-diabetics • Future of PCI with DES versus CABG? Source: Up-To-Date, Coronary artery revascularization inpatients with diabetes mellitus, Nesto, Richard w. MD, updated June 2009

  18. Diabetes and CAD (cont’d) • BUT………….. • Improving trends over the last 50 years with incidence of cardiovascular disease declining • Framingham Heart Study • 49% decline in cardiovascular events (MI, CAD death, stroke) in diabetics • 35% decline in cardiovascular events in non-diabetics • BUT…………… • Diabetes was still associated with a two-fold increase in risk

  19. Diabetes and Hypertension • UKPDS (United Kingdom Prospective Diabetes Study) noted at nine-year follow-up: • Each 10 mmHg reduction in mean systolic pressure was associated with a 12% reduction in any complication related to diabetes (including cardiovascular disease) • Lowest risk occurred at systolic pressure < 120 mmHg • Similar relationship noted with fatal or non-fatal MI as incidence fell from 33.1% per 1,000 patient years at systolic pressure >160 mmHg to 18.4% per 1,000 patient years at systolic pressure <120 mmHg • Aggressive antihypertensive therapy with recommended goal blood pressure <130/80 mmHg

  20. Diabetes and Dyslipidemia • With diabetes being considered a CHD equivalent • Goal LDL is <100 mg/dL in individuals without overt CAD – in those with CAD goal LDL is < 70 mg/dL • Triglyercide levels <150 mg/dL • HDL levels >40 mg/dL for men and >50 mg/dL for women

  21. Diabetes and Microalbuminuria • Microalbuminuria is defined as persistent urinary albumin excretion between 30 and 300 mg/day • Microalbuminuria is the earliest clinical manifestation of diabetic nephropathy • Associated with an increase risk of cardiovascular disease in both diabetic and non-diabetic patients • Relative risk for all cause mortality was 1.9 compared to individuals with no evidence for microalbuminuria • Relative risk for cardiovascular and coronary heart disease mortality was 2.0 and 2.3 compared to individuals with no evidence for microalbuminuria • Macroalbuminuria is defined as albumin excretion above 300 mg/day Source: Up-To-Date, Microabluminuria in type 2 diabetes mellitus, McCulloch, David K. MD, Barkris, George L. MD; updated August 2009

  22. Diabetes and Microalbuminuria (cont’d) • In individuals with Type 1 diabetes, the reported prevalence of microalbuminuria at 10 years is between 25-40% • Prevalence of microalbuminuria in Type 2 diabetes, varies with ethnicity, being higher in Asians and Hispanics than in whites (43% versus 33% in whites) • Prevalence of microalbuminuria in elderly individuals with Type 2 diabetes is higher (? Due to hypertension, coronary disease etc) Source: Up-To-Date, Microalbuminuria in type 2 diabetes mellitus, McCulloch, David K.MD, Bakris, George L. MD; updated August 2009

  23. Diabetes and Microalbuminuria (cont’d) • HOPE (Heart Outcomes Prevention Evaluation) trial • 9,000 participants • Presence of microalbuminuria was associated with an increased relative risk of primary aggregate end point (myocardial infarction, stroke, or cardiovascular death) in those with and without diabetes (1.97 and 1.61 respectively) • Risk of an adverse cardiovascular event increased progressively with increased absolute levels of microalbuminuria

  24. Diabetes and Microalbuminuria (cont’d) • Rate of progression to macroalbuminuria is approximately 2.5% in Type 1 and 2.8% per year in Type 2 • Higher baseline levels of albuminuria • Poor glycemic control • Inadequate blood pressure control • Smoking

  25. Diabetes and Microalbuminuria (cont’d) • Regression to normoalbuminuria • Short duration of microalbuminuria • Better glycemic control (Hgb A1C < 7%) • Systolic blood pressure <129 mmHg • Use of ACE inhibitors or angiotensin II receptor blockers • Regression or at least 50% reduction in albumin excretion compared to no reduction was associated with significant reductions in death from and hospitalization for renal and cardiovascular events (adjusted risk 0.41) Source: Up-To-Date, Microalbuminuria in type 2 diabetes mellitus, McCulloch, David K.MD, Bakris, George L. MD; updated August 2009

  26. Diabetes and Microalbuminuria (cont’d) • Focus of treatment: • Glycemic control • Blood pressure control • Angiotension converting enzyme (ACE) inhibitors • Angiotensin II receptor blockers (ARBs) • Calcium channel blockers – primarily diltiazem and verapamil for the antiproteinuric effect • Goal is to reduce both microalbuminuria and prevent progression to macroalbuminuria

  27. Diabetes and Elderly Adults • Prevalence of Type 2 diabetes continues to increase with increasing age • 1.4% in ages 25-44 • 3.6% in ages 45-54 • 7.8% in ages 55-64 • Over 10% in ages >65 • Prevalence of Type 2 diabetes is likely to further increase with the new diagnostic criteria and current recommendations to screen individuals over age 45 once every three years Source: Up-To-Date, Treatment of diabetes mellitus in elderly adults, McCulloch, David K. MD, Munshi, Medha, MD, updated June 2009

  28. Diabetes and Elderly Adults (cont’d) • According to ADA, goals for glycemic control as well as risk factor management in the elderly adult should be based upon the overall health • Target A1C in a fit elderly individual with life expectancy >5 years, should be 7.0 to 8.0% • Somewhat higher if life expectancy is less or if multiple medical and functional co-morbidities

  29. Diabetes and Elderly Adults (cont’d) • Managing elderly adults with diabetes and co-existing medical conditions is a challenge • Hypoglycemia & Hyperglycemia • Cognition difficulties • Increased risk for falls and injuries • Hypoglycemic episodes increase the risk of adverse cardiovascular events • Drug interactions from poly pharmacy • Start slow and go slow with medication changes or additions • Natural history of diabetic retinopathy may differ in elderly adults • Macular degeneration

  30. Diabetes and Elderly Adults (cont’d) • Diabetic nephropathy • Renal artery stenosis • Diabetic neuropathy • Vascular conditions • Neurologic conditions • Cardiovascular risk reduction • Maintain risk factor modifications

  31. What has Changed in Underwriting Diabetes? • Type I diabetic • Life insurance coverage available! • Insulin Pumps • Pancreatic & islet transplantation • Type II diabetic • Increased prevalence • Use of insulin to control blood glucose • Changing focus of control, more emphasis on cardiovascular risk factor modifications

  32. What’s New, What’s Pending • Insulin inhalers in clinical trials • Afrezza – ultra rapid acting inhaled insulin, absorbed through lungs, peaks 12 to 14 minutes after inhaled – short acting (3 hours) used at meal time to buffer the “glucose spikes” • Oral-lyn – rapid acting inhaled insulin, sprayed in mouth absorbed through buccal mucosa, used at meal time • PH20 – new ultrafast insulin analog – Phase 2 trials • Juvisnyc FDA approval 10/7/11 – combines Sitagliptin (Januvia) & simvastatin to treat high cholesterol and Type 2 diabetes • Insulin degludec – awaiting FDA approval -- long acting insulin, clinical trials have favorable results in lowering frequency of hypoglycemia especially during night

  33. What’s New, What’s Pending (cont’d) • Awaiting FDA approval for clinical trials – wireless insulin delivery system that functions like a human pancreas – continuous glucose monitor, programmable insulin pump, computer algorithm that calculates how much insulin is need and when needed • Pending FDA approval – Iglucose, wirelessly collects, stores and transmits glucose readings from select glucose monitors to a secure HIPPA compliant database that can be sent to your healthcare provider • FDA approved iPro2 is a 3 day evaluation system for continuous glucose monitoring – glucose sensor inserted into patients skin, after 3 days sensor removed – helps identify nocturnal hypoglycemia or postprandial hyperglycemia • The list goes on…………………………

  34. Controlling Diabetes • Disability and premature death are not inevitable consequence of diabetes • Physical activity, diet, medications can control effects of diabetes • Reducing A1c by 1% can reduce risk of eye, kidney, retinopathy by 40% • Controlling blood pressure can reduce risk of heart disease and stroke by 33 – 50% • Improving LDL cholesterol can reduce cardiovascular complications by 20 – 50% • Laser therapy for diabetic retinopathy can reduce risk of blindness by 50 – 60% • Foot care programs can reduce amputation rates by 45-85% www.cdc.gov/chronicdisease/resources/publications/AAG/ddt.htm

  35. The Many Faces of Diabetes Can you identify who has diabetes? Who has Type I, Type II? Who has multiple complications?

  36. Diabetes Case Studies So, is diabetes with a little of this and a little of that really all that bad?

  37. Case Study #1 • 82 year-old female, Non-Smoker, informal $120,000 • Exam: • 5’3”, 192 lbs, 164/87 (exam average) • Type 2 DM, diet controlled • HBP on meds • ^ lipids on meds • Neuropathy on neurontin • DWR 10/10 • GUG 8 seconds • Drives, socially active with senior center, mows her own lawn

  38. Case Study #1 (cont’d) • Labs: • Glucose 81 mg/dL • Fructosamine 2mmol/L • BUN 19 • Creatinine 0.7 • Cholesterol 184 – ratio 4.6 • proBNP 110 pg/mL • Urine: • Protein 7 mg • p/c ratio 0.12 mg/mg cr • Hemogloblin screen (+) • WBC 3 • RBC 5

  39. Case Study #1 (cont’d) • APS: • Diabetes for last 5+ years, diet controlled • A1C in aps ranges from 6.0 to 7.1 (2/10 labs) • Hx of UTI in 3/09 and again in 2/10 • Random urine MA in 3/09 35 ug/mL (normal to 17) • Serum creatinine range from 0.6 to 0.75 mg/dL • eGFR >59 • Blood pressure average in APS was 120/80 over the last three years

  40. Additional urine #1 Protein 2mg Creatinine 8.2 mg/dL p/c ratio 0.24 mg/mg cr Hemogloblin screen (-) MA 0.7 mg/dL (normal <3) Malb/creat ratio 85.3 mg/Gcre (normal <30) Opinion? Additional urine #2 Protein 2mg Creatinine 5.7 mg/dL p/c ratio 0.35 mg/mg cr Hemogloblin screen (-) MA 0.6 mg/dL Malb/creat ratio 105.2 mg/Gcre Case Study #1 (cont’d)

  41. Opinion? (+) urine MA with good KFT’s, good blood pressure control Mild substandard to standard Case Study #1 (cont’d)

  42. Case Study #2 • 49 year-old male, Non-Smoker, formal $750,000 • Exam: • 6’2”, 200 lbs • DM since age 24 • HBP • Meds – novolog, lantus, caduet, avalide

  43. Case Study #2 (cont’d) • Labs: • Glucose 117 mg/dL • Fructosamine 2.94 mmol/L • A1C 9.2% • BUN 16 mg/dL • Creatinine 1.17 mg/dL • Urine: • Glucose 0.053 g/dL • Protein 7 mg/dL • Creatinine 62 mg/dL • MA 4.3 mg/dL • MA/creatinine ratio 69.354 mg/Gcre

  44. Case Study #2 (cont’d) • APS: • LOV 9/09, c/o pain tingling numbness bilateral feet • A1C difficult to control, occasional hypoglycemia • Hx syncopal episode secondary to hypoglycemia • 5/09 episode hypoglycemia • A1c trends • 09/09 8.5 • 05/09 8.5 • 12/08 9.0 • 07/08 8.9 • Opinion?

  45. Case Study #2 (cont’d) • Opinion? • Type I diabetic • Fair to poor control • Syncopal episode due to hypoglycemia • Neuropathy • Microalbuminuria • Decline

  46. Case Study #3 • 75 year-old male, Non-Smoker, informal $5,000,000 • Exam: • 5’10’’, 185 lbs, 124/72 • HBP on meds • ^ lipids on meds • Type 2 DM, diagnosed 2 years ago, metformin • CABG 10 years ago to two vessels

  47. Case Study #3 (cont’d) • Labs: • Glucose 116 • A1C 6.1 • Cholesterol 184, ratio 3.3 • Urine: • MA 2.1

  48. Case Study #3 (cont’d) • APS: • 2/00 cath due to abnormal perfusion study to evaluate chest pain • LM 40% distally • RCA 80% • Circumflex 50% with good collateral fill • 3/00 CABG with LIMA to proximal LAD, sapphenous vein graft to mid RCA • Serial stress echo’s, last in 1/10 – exercised 9 min, achieved 10 METS, normal blood pressure response to exercise, normal wall motion, no evidence for ischemia, EF 60%

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