Diabetes Mellitus: Evaluation and Care Management Michael King, MD Assistant Professor Residency Program Director University of Kentucky Dept. of Family & Community Medicine
Learning Objectives 1. Review the development and progression of Diabetes Mellitus. 2. Review screening recommendations for Diabetes in adults, children and with pregnancy. 3. Review the ADA s diagnostic criteria for Diabetes. 4. Review the care goals and management of Diabetes based on evidence.
Type 2 Diabetes: Epidemiology and Impact Affects 23.6 million US children and adults (5.7 million are undiagnosed) 1.6 million new cases a year in adults Seventh leading cause of death in US Total cost (direct and indirect) is $174 billion in 2007. Source: American Diabetes Association. Diabetes Statistics. http://www.diabetes.org/diabetes-statistics.jsp.
Types of Diabetes Type 1: traditionally age <20 but may be 15 or 50, no endogenous insulin thus Rx = insulin only. Can be late onset and slow progressing. Type 2: traditionally >40, multiple problems with insulin secretion and action, may be 15 or 50, Rx may include oral agents and/or insulin. Can present with ketoacidosis.
Development and Progression of Type 2 Diabetes Mellitus Insulin Resistance Pre-DM FGI or IGT Dx DM Diabetes Mellitus 10 to 5 yrs 5 to 0 yrs 0 yrs 0 to 30 yrs Insulin Resistance Develops Persists Persists Insulin Levels (eventual below normal) Beta Cells Postprandial Glucose Normal Dx Levels Fasting Glucose Normal Dx Levels
ADA Evidence Grading A: Clear evidence from well-conducted, generalizable, randomized controlled trials B: Supportive evidence from wellconducted cohort studies C: Supportive evidence from poorly controlled or uncontrolled studies E: Expert consensus or clinical experience
USPSTF Screning for T2DM Providers should screen adults with hypertension or hyperlipidemia for type 2 diabetes (B). USPSTF, AHRQ: Screening for diabetes mellitus, adult type 2 (February 2003). http://www.ahrq.gov/clinic/uspstf/uspsdiab.htm
Screening for T2DM in Adults (B) All individuals aged > 45 years Individuals < 45 years who are overweight (BMI > 25 kg/m 2 ) with >1 risk factor: Family history of diabetes Cardiovascular disease Overweight/obese (BMI > 25 kg/m 2 ) Sedentary lifestyle High-risk race/ethnicity (Latino, African-American, Asian-American, Native American, Pacific Islander)
Screening for T2DM in Adults (B) Individuals < 45 years who are overweight (BMI > 25 kg/m 2 ) with >1 risk factor: Hypertension (blood pressure > 140/90 mm Hg) Elevated triglycerides ( > 250 mg/dl) Low HDL cholesterol (< 35 mg/dl) Gestational diabetes/delivery of 9+ pound baby Polycystic ovarian syndrome Impaired fasting glucose/impaired glucose tolerance Clinical conditions associated with insulin resistance (e.g., acanthosis nigricans)
Screening for Type 2 Diabetes in Children/Adolescents Overweight individuals > 10 years with 2 of the following: Family history of type 2 diabetes in 1 st - or 2 nd -degree relative High-risk race/ethnicity Insulin resistance or associated conditions (acanthosis nigricans, hypertension, dyslipidemia, or PCOS) Maternal history of diabetes or gestational diabetes mellitus Diabetes Care, Vol. 32; 2009, 193-203
Screening for GDM Very high risk women should be screened for diabetes (standard diagnostic tests) after the confirmation of pregnancy: Severe obesity Hx GDM or delivery of LGA infant Glycosuria PCOS FH T2DM Low Risk women, does not require GDM screening, but must meet ALL the following criteria: Age <25 years Normal weight before pregnancy Ethnic group with a low prevalence of diabetes No diabetes in first-degree relatives No hx of abnormal GTT No hx of poor obstetrical outcome
Screening for GDM All non-low risk of GDM should get testing at 24 28 weeks of gestation by either: 1) Two-step approach: Initial 50g OGTT with plasma/serum glucose at 1 hr >140 mg/dl identifies 80% >130 mg/dl, sensitivity increased to 90% Diagnostic 100-g OGTT, separate day if exceeds the threshold on 50-g screening. 2) OR, One-step approach: Diagnostic 100-g OGTT in all women after 8 hour fast. Diagnosis of GDM, > 2 plasma glucoses as follows: 1-h 180 mg/dl 2-h 155 mg/dl 3-h 140 mg/dl
Diagnosing Type 2 Diabetes (Should be confirmed, repeated) A1C >6.5% Lab certified by NGSP, standarized to DCCT assay. Not Point of Care. Fasting Plasma Glucose >126 mg/dl (7.0 mmol/l) No caloric intake for at least 8 hrs 2-hr plasma glucose >200 mg/dl (11.1 mmol/l) after 75g oral glucose tolerance test (OGTT) Classic symptoms (polyuria, polydipsia, unexplained weight loss) and a random plasma glucose 200 mg/dl (11.1 mmol/l).
Categories of Increased Risk for Diabetes Previously referred to as Pre-diabetes: A1C range of 5.7 6.4% Impaired Fasting Glucose (IFG) of 100-125 mg/dl 2 hr Impaired Glucose Tolerance(IGT) of 140-199 mg/dl after 75g OGTT
Prevention of T2DM in those with increased risk Patients with IGT (A), IFG (E), or an A1C of 5.7 6.4% (E) should be referred for: effective ongoing support program weight loss of 5 10% increased physical activity >150 min/week, moderate activity such as walking Metformin may be considered if very high risk for developing diabetes (E) Yearly screening for Diabetes is recommended (E)
2010 ADA DSME Curriculum (B) Disease process and treatment options Nutritional management into lifestyle Physical activity into lifestyle Medication safety and maximum therapeutic effectiveness Monitoring blood glucose and other parameters for self management decision making Preventing, detecting, and treating acute complications Personal strategies for psychosocial issues and concerns Personal strategies for health and behavior change
Goals of Diabetes Care Focused on evidenced based outcomes: DCCT, Kumamoto study, UKPDS Clinical Surrogate of Disease (A1C) vs. Patient-oriented Outcomes (Mortality, MI, CVA) American Diabetes Association: A1C <7.0 Preprandial FSBS 90 130 mg/dl Peak postprandial FSBS <180 mg/dl
Glycemic Control Reduces Incidence of Complications DCCT (9 to 7%) Study, A1C Change Kumamoto (9 to 7%) UKPDS (8 to 7%) Retinopathy 63% 69% 17-21% Nephropathy 54% 70% 24-33% Neurophathy 60% - - Macrovascular Disease *Not statistically significant 41%* - 16%* References: Diabetes Control and Complications Trial (DCCT) Research Group. N Engl J Med. 1993;329:997-986. DCCT Research Group. Diabetes. 1995;44:968-983. Ohkubo Y, et al. Diabetes Res Clin Pract. 1995;28:103-117 UK Prospective Diabetes Study Group (UKPDS) 33: Lancet. 1998;352:837-853.
Glycemic Control and the Evidence A1C Goal of 7% for microvascular risk reduction (A) A1C Goal of 7% for macrovascular risk reduction (B) Long-term follow-up DCCT and UKPDS cohorts suggests targets < 7% is associated with long-term reduction in risk of macrovascular disease. Randomized controlled trials of intensive versus standard glycemic control have not shown a significant reduction in cardiovascular disease (CVD) outcomes.
Glycemic Control and the Evidence For selected patients (recent diagnosis, long life expectancy, and no CVD) lower A1C goals close to normal (6.0), are reasonable if this can be achieved without significant hypoglycemia or other adverse effects of treatment (B). Subgroup analyses DCCT, UKPDS and the ADVANCE trial suggest a small but incremental benefit in microvascular outcomes with A1C values closer to normal (6.0).
Glycemic Control and the Evidence Less stringent A1C goals, between 7-8% may be appropriate for some patients (C): with a history of severe hypoglycemia, limited life expectancy, advanced micro- or macrovascular complications, and extensive comorbid conditions.
Medical Nutrition Therapy (A) Individualized MNT for DM or Pre-DM Modest weight loss for overweight/obese at risk for DM Low-Carb, Low-Fat diets effective in short term Physical Activity and behavior modification importance for maintenance of weight loss Saturated fat <7% of total calories Reducing trans fat lowers LDL, increases HDL (Recommendation to minimize intake, E level) Monitoring carbohydrate (counting, exchanges or estimation) for glycemic control Glycemic index and load considerations Sugar alcohols, nonnutritive sweeteners are safe Vitamins E, C and carotene, are not advised A A A B A A B B A A A: RCT s C: Poorly Contr/Uncontr B: Good Cohort E: Consensus
Lifestyle Modifications Modest weight loss (5-10% of body weight) lowers risk for CVD and type 2 diabetes (A). Achieved and maintained safely by dietary adjustments, regular physical activity and behavior change. Exercise significantly improves glycemic control and reduces visceral adipose tissue and plasma triglycerides (even without weight loss) (A).
Physical Activity To improve glycemic control, assist with weight maintenance, and reduce risk of CVD: (A) 150 min/week of moderate-intensity aerobic physical activity (50 70% of maximum HR) and/or 90 min/week of vigorous aerobic exercise (>70% of maximum HR) At least 3 days/week and with no more than two 2 consecutive days without physical activity. Resistance exercise 3X a week, targeting all major muscle groups, progressing to three sets of 8 10 repetitions at a weight that cannot be lifted more than 8 10 times. (A)
Smoking Because of diabetic smokers heightened risk of morbidity and premature death from macrovascular complications: All should be advised not to smoke (A), and Tobacco Cessation counseling should be offered as routine care (B).
Immunizations Infuenza vaccine annually to all diabetic patients >6 months of age (C). Pneumococcal polysaccharide vaccine to all diabetic patients 2 years of age (C). One-time revaccination at >64 yo (but at least 5 years since last vaccination).
Complications of Type 2 Diabetes Heart Coronary heart disease Cardiovascular disease Blood Vessels Peripheral artery disease Intermittent claudication Kidneys Microalbinuria Nephropathy Hyperglycemia Eyes Retinopathy Glaucoma Nerves Neuropathy Gastroparesis
DM and HTN If SBP>140, DBP>90, Drug therapy as well as lifestyle and behavioral therapy (A). If Prehypertension, SBP=130-139, DBP=80-89, Lifestyle and behavioral therapy for 3 months, pharmacological agent if not achieved (E). The goals of SBP<130 (C), DBP<80 (B).
DM and HTN Lifestyle and behavioral therapy (B) Reducing sodium intake Reducing body weight Increasing fruit and vegetable consumption Increasing low-fat dairy consumption Avoiding excessive alcohol consumption Increasing activity levels
DM and HTN Initiate HTN therapy with an agent that has been shown to reduce cardiovascular events in patients with diabetes ACE inhibitors, ARBs, Beta-blockers, diuretics, and calcium channel blockers (A). All patients with diabetes and hypertension should be on an ACEI or an ARB (C). If necessary, a thiazide diuretic should be added if GFR >30 (loop diuretic for GFR <30).
DM and Dyslipidemia without CVD The primary goal is an LDL <100 (A) Patients over 40 with one or more risk factors, benefit from a 30-40% reduction in LDL cholesterol by statin therapy (A)
DM and Dyslipidemia with CVD Treated with a Statin to achieve an LDL reduction of 30-40%, regardless of baseline level (A). LDL goal should be 70 (B). Combination therapy (statins and other lipidlowering agents) may be considered but have not been evaluated in outcome studies for either CVD outcomes or safety (E).
Antiplatelet Agent Use aspirin therapy (75 162 mg/day) as a primary prevention strategy (C): In Type 1 or Type 2 diabetes at increased cardiovascular risk (10- year risk >10%). Includes most men >50 years, women >60 years with one additional major risk factor (FH CVD, HTN, smoking, dyslipidemia, or albuminuria). Secondary prevention strategy in DM and history of CVD (A). CVD and documented ASA allergy, clopidogrel (75 mg/day) should be used (B). Combination therapy with aspirin (75 162 mg/day) and clopidogrel (75 mg/day) is reasonable for up to a year after an acute coronary syndrome (B).
Foot Care and Neuropathy Screening for signs and symptoms of cardiovascular autonomic neuropathy (E): T1DM: Annually, beginning 5 years after diagnosis T2DM: Annually, beginning at diagnosis Inspection of insensate feet at 3- to 6-month intervals. An abnormality should trigger referral for special footwear, preventive specialist, or podiatric care (B). Perform a comprehensive foot examination and provide foot selfcare education annually to identify risk factors predictive of ulcers and amputations. Examination should include: inspection, assessment of foot pulses, and testing for loss of protective sensation (10-g monofilament plus any one of the following: vibration using 128-Hz tuning fork, pinprick sensation, ankle reflexes, or vibration perception threshold) (B)
Microalbuminuria Screening Albuminuria screening (E): T1DM: Annually, beginning 5 years after diagnosis T2DM: Annually, beginning at diagnosis Regardless of microalbuminuria, Creatinine should be used to assess GFR, annually (E).
ACE/ARB therapy Treating microalbuminuria with ACEI/ARB therapy and glycemic control (A): Delays progression to nephropathy Microalbuminuria is a marker of increased CVD risk Delays progression to macroalbuminuria, which is associated with progression to ESRD over a period of years
Ophthalmological Exam Optimal glycemic and blood pressure control reduces risk and progression of retinopathy (A). Ophthalmologist or optometrist examination in the absence of retinopathy: T2DM, at diagnosis, then annually or as deemed necessary (B) T1DM within 3-5 years of diagnosis, then annually (B)
Diabetes and the Evidence Care area Goal or Intervention Evidence A1C Lipids Statin Therapy A1C lowering to reduce complications Goal <7 (Microvascular Complications) Goal <7 (Macrovascular Complications) Goal 6-7 (Microvascular Complications) Goal LDL < 100 30-40% LDL reduction Goal LDL <70 Blood Pressure < 140/90 < 130/80 ACEI/ARB Therapy Self Care DSME B Nutrition MNT A TLC 5-10% Wt loss ( fat/calories, activity) A A: RCT s C: Poorly Contr/Uncontr B: Good Cohort E: Consensus A A B B A A B A B C
Diabetes and the Evidence Care area Goal or Intervention Evidence Smoking cessation Immunizations Aspirin, 75-162 mg/day Advised not to smoke Counseled on Cessation Flu Vaccine Pneumococcal Vaccine Primary Prevention, CV Risk >10% Secondary Prevention with CVD A B C C C A Foot Exams Nephropathy Inspection every 3-6 months Comprehensive Foot Exam yearly (including monofilament) Urine Microalbumin Creatinine/GFR Treatment with ACEI/ARB Retinopathy Ophthamologic/Optometrist Eye Exams B A: RCT s C: Poorly Contr/Uncontr B: Good Cohort E: Consensus B A E E A