of patients with diabetes mellitus and its complications. diagnosis and treatment of diabetes in pregnancy, refer to your OB department or …
CONTRA COSTA REGIONAL MEDICAL CENTER CONTRA COSTA HEALTH PLAN Guidelines for the Diagnosis and Management of Diabetes Mellitus in Adults
This is meant as a guide and not meant to replace clinical judgment
Based on a review of recent literature, guidelines, and discussions among family practitioners, specialists, nutritionists, nurses and health educators, these guidelines are deemed as valuable interventions in preventing morbidity and mortality in patients with diabetes mellitus As further information from studies are published, these guidelines are subject to change and modification to meet our patients needs in the context of our health care delivery/managed care system Purpose To present evidence-based interventions shown to decrease morbidity and/or mortality in the care of patients with diabetes mellitus and its complications The following guidelines support clinical care in a primary care setting; they are not a substitute for clinical judgment The guidelines are specifically not standards to measure performance for audit purposes However, the guidelines may overlap with standards, which state and national organizations use for audits Target Population The following are
recommended for most adult patients with diabetes: For recommendations regarding the care of children, please refer to your pediatric specialists or guidance as summarized by the American Diabetes Association For recommendations for the diagnosis and treatment of diabetes in pregnancy, refer to your OB department or consultant or guidance as summarized by the American Diabetes Association Target Audience Our target audience includes primary care providers, specialists, health educators, nurses, dieticians and other staff who care for adults with diabetes
American Diabetes Association, 2004 Clinical Practice Recommendations, Diabetes Care, January 2004 Supplement
Clinical Practice Guidelines for the Diagnosis and Management of Diabetes Mellitus in Adults October 2004
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Strength of Evidence Rating As with other Contra Costa Regional Medical Center CCRMC/Contra Costa Health Plan CCHP guidelines, each recommendation is followed by a letter designating the strength of its evidence basis: A There is good scientific evidence to recommend an intervention or standard eg well designed, randomized clinical trials relevant to the recommendation and yielding consistent findings There
is fair evidence to recommend an intervention or standard, but scientific support was not optimal eg some support from a few randomized controlled trials, large retrospective or case-control studies or some but not all populations studied There is insufficient scientific support to strongly recommend for or against, but there may be a benefit based on expert opinion or less than adequate scientific studies
B
C
Evidence referenced is from a review of the literature, which includes review articles, metaanalyses, randomized controlled studies when available, and American Diabetes Association technical reviews, consensus statements, and position statements Footnotes refer to references which are listed by recommendations in the appendix For CCRMC staff, references are available in the medical library 925 370-5530
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DIAGNOSIS OF DIABETES MELLITUS B1 Fasting plasma glucose 126 mg/dl no caloric intake - for at least 8h and on two different days - or Symptoms of diabetes plus casual plasma glucose concentration 200 mg/dl on two different days 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 -orA 75-gram oral glucose tolerance test OGTT with a 2-hour Plasma Glucose 200 mg/dl The test should be performed as described by WHO,2 using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water This is not commonly used or recommended for diagnosis, and is listed for completeness SUMMARY OF CHANGES: FOCUS ON THE ABCS 1 A1C goal is 70 2 Blood Pressure control goal is now 130/80 ACE inhibitors are now considered acceptable first line therapy for diabetics even without proteinuria 3 Cholesterol goals now focus on LDL 100 and HDL 40 4 Daily ASA changes to a dosage of 81mg at age 40 and over for those without other risk factors 5 Prevention of Renal Disease Annual screening of urine for microalbumin is now recommended unless the patient is known to have existing proteinuria 6 Hormone Replacement Therapy Eliminate recommendation for Hormone Replacement Therapy 7 Pneumovax can be repeated if the first dose was given before 65 years of age
KEEP YOUR EYE ON THE ABCS
1 Kidney Annual screen for urine microalbumin in
Type 1 and Type 2 Diabetics C1 I Renal Progression: The preponderance of evidence suggests that the presence of microalbuminuria at baseline is associated with progression of chronic kidney disease The relation of urine albumin excretion at baseline to progression of chronic kidney disease appears graded; higher levels of urine albumin excretion at baseline are associated with greater magnitude of decrease in renal function as well as a faster rate of decline in renal function over time A3,5 II Cardiovascular Risk: The preponderance of evidence demonstrates an association between microalbuminuria at baseline and increased risk of cardiovascular morbidity, cardiovascular mortality, and all-cause mortality The relation of urine albumin excretion at baseline to cardiovascular morbidity, cardiovascular mortality, and all-cause mortality appears graded; greater levels of urine albumin excretion at baseline are independently associated with a greater magnitude of risk of cardiovascular morbidity, cardiovascular mortality, and all-cause mortality over time A3
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III
IV
Effective Intervention: Large prospective randomized studies show that intensive diabetes management A and treatment of hypertension A delay the onset of microalbuminuria and progression of micro to macroalbuminuria in Type I and Type II diabetics Evidence supports the benefit of Angiotensin Converting Enzyme ACE Inhibitors and Angiotensin Receptor Blockers ARB over other classes of antihypertensives in reducing progression to nephropathy A4,5,6,7,8 Screening Interval: The American Diabetic Association ADA supports annual screening for microalbumin unless previously positive for proteinuria The measurement of a spot sample for the albumin-to-creatinine ratio in a random collection is the preferred method 2 of 3 random urines positive for microalbumin preferably within 6 months There is no clear role for continued surveillance of microalbumin after the diagnosis of microalbuminuria is established C9 Most diabetics need annual eye exams Initiate eye exams 5 years after diagnosis for Type 1 diabetics C1 Initiate immediate eye exams in Type 2 diabetics, given the frequent lag time in diagnosis C1 There is controversy over the follow-up screening interval in low risk ie,
well controlled diabetes, no evidence of retinopathy, not requiring insulin diabetics B2,10,11,12 The primary care provider and the eye specialist should make the clinical decision
2
Eye
3
A1C: The United Kingdom Prospective Diabetes Study UKPDS showed decreased microvascular complication in diabetic patients whose average A1C was less than 73 A The American Diabetic Association1, government agencies, and quality review entities use the rounded figure of 70 as a benchmark C We have chosen to round the goal to 70 to coordinate our quality improvement goals with this benchmark A randomized control trial of regular monitoring with A1C showed improved metabolic control of diabetes B13 Experts recommend monitoring A1C at least one to two times a year C1 In patients with advanced diabetes complications, life-limiting comorbid illness, or cognitive or functional impairment, it is reasonable to set less intensive glycemic target goals These patients are less likely to benefit from reducing the risk of microvascular complications and more likely to suffer serious adverse effects from hypoglycemia C2
4
Blood Pressure Blood Pressure control goal was lowered to 130/80 based on
recommendations of the Joint National Committee JNC7 on Blood Pressure Control and the American Diabetes Association C1,14 The goal is based on large prospective randomized controlled trials demonstrating that stringent blood pressure control significantly reduces microvascular and macrovascular mortality and morbidity A15,16,17,18 Because Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ALLHAT15 showed an improved cardiovascular outcome in diabetics treated with diuretics over ACE inhibitors, a low dose thiazide should be first choice for initial
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therapy A However, for patients with Stage 2 or greater hypertension SBP 160 and/or DBP 100, JNC 7 advises initial treatment with a low dose thiazide plus a second blood pressure agent C14 The HOPE and EUROPA trials indicate that ACE inhibitors confer a better cardiovascular outcome in diabetics with risk factors for Coronary Artery Disease CAD Therefore, an ACE inhibitor is a reasonable choice for this second blood pressure agent A19,20 5 Cholesterol/Cardiovascular Diabetes is now considered a
cardiovascular disease equivalent due to the high incidence of cardiovascular complication in diabetes This is supported by subgroup analyses of major lipid lowering trials, including the 4S trial, the CARE trial, and the Heart Protection Study A21,22,23,24 As a result, both the National Cholesterol Education Program Expert Panel NCEP Third Report25 and the ADA1 recommend a goal LDL 100 C Because a low HDL confers an increased cardiovascular risk, once the LDL target has been achieved, efforts should be made to raise HDL 40 C26 Smoking Cessation Smoking cessation significantly reduces diabetics risk of macrovascular and microvascular disease Providers can assist patients with counseling, referrals and pharmacotherapy A27
6
OTHER RECOMMENDATIONS TO IMPROVE OUTCOMES 1 Formal diabetes education Patient education has been shown to be effective in improving patient outcomes improved glycemic control and behavior change daily foot inspection and getting annual eye exams Individualized medical nutrition therapy is effective in helping to normalize blood glucose levels A28 It is recommended that patients newly diagnosed with diabetes and those with poor control or inadequate knowledge of
understanding be referred for additional Diabetes Education Daily Aspirin Daily prophylactic aspirin reduces nonfatal myocardial infarction and stroke by one-third, and vascular death by one-sixth in all high-risk patients A29,30 There is no evidence for a specific age to start aspirin, but aspirin prophylaxis has not been studied below age 30 Specifying age 40 and over for those without risk factors and a dosage of 81mg is based on ADA recommendations C1 Hormone Replacement Therapy HRT HRT is no longer recommended as a measure to prevent cardiovascular events The Womens Health Initiative and HERS Randomized controlled trials A31,32,33 showed that HRT increases the risk of stroke without cardiovascular benefit Direct inquiry about regular physical exercise34 In Type 1 diabetes, a large retrospective study showed that regular exercise significantly reduced nephropathy, but not retinopathy B35 In the Nurses Health Study, Type 2
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Clinical Practice Guidelines for the Diagnosis and Management of Diabetes Mellitus in Adults October 2004
diabetic women who spent at least four hours per week performing moderate eg walking or vigorous exercise had a 40 percent lower risk of
developing cardiovascular disease including coronary heart disease and stroke than those who did not36 Exercise also improved cardiovascular outcomes in a prospective cohort study of 2896 Type 2 diabetic adults who walked at least two hours per week versus inactive individuals 14 versus 21 percent per year, respectively The protective effect was independent of sex, age, race, body mass index, duration of diabetes, comorbid conditions, and physical limitations One death per year would be prevented for every 61 adults with diabetes who could be persuaded to walk at least two hours per week37 5 Prevention of complications of peripheral vascular disease and lower extremity amputation Risk factors for this complication an estimated 55,000 amputations/yr, 44-85 which are preventable include peripheral neuropathy, especially with unperceived, excessive and repetitive pressure on plantar bony prominences, infection, and arterial insufficiency Associated factors include smoking, advancing age, male sex, and low socioeconomic status38,39 All patients with diabetes should have a screening foot exam B40,41,42 on a yearly basis C This includes visual inspection of the feet and testing for loss
of protective sensation with a Semmes-Weinstein 10 gram monofilament B43,44,45 or threshold tests for vibration using electronic or graduated tuning forks Ten-gram monofilaments are available to patients single filament and clinicians packs of 50 filaments at no charge from LEAP Lower Extremity Amputation Prevention Program at http://bphchrsagov/leap/ All patients with a loss of protective sensation should have foot examinations at all regular visits B46 and efforts be made to normalize blood sugar when not contraindicated due to other patient risk factors to decrease neuropathy A47,48 Prevention is more successful when providers and patients have education and guidelines for proper foot care and assessment Teaching patients effectively how to care for their feet and adhere to a program of daily self-inspection and having a health system to facilitate these behaviors reduces risk factors and high-risk conditions A49 6 Depression screening and treatment Clinically significant depression and other mental health and psychosocial issues may adversely impact diabetes treatment effectiveness Screening for depression in all adults with diabetes and offering effective treatment may improve
glycemic control B50,51 Screening is recommended on initial evaluation and subsequently as deemed appropriate by the primary care provider eg for poor glycemic control C52 Pre-conception counseling Unplanned pregnancies occur in two-thirds of women with diabetes, leading to an excess of malformations in their infants Several studies have established an association between elevated maternal glucose or glycohemoglobin levels during embryogenesis, high rates of spontaneous abortions and major malformations in newborns Clinical trials of stringent blood glucose control in the preconception period and during the first trimester of pregnancy have demonstrated striking reductions in rates of malformations53 To minimize
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Clinical Practice Guidelines for the Diagnosis and Management of Diabetes Mellitus in Adults October 2004
the occurrence of malformations, all women with diabetes who have child-bearing potential should receive counseling about: 1 the risk of malformations associated with unplanned pregnancies and poor metabolic control and 2 The use of effective contraception at all times unless the patient is in good metabolic control and actively trying to conceive GENERAL
PREVENTION MEASURES54 1 2 Influenza vaccine every year B Give Pneumovax Pneumovax is indicated for all diabetics Expert opinion supports giving a second dose after five years if first dose was given before 65 years of age C
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REFERENCES DIAGNOSIS OF DIABETES: 1 American Diabetes Association, 2004 Clinical Practice Recommendations, Diagnosis and Classification of Diabetes Mellitus, Diabetes Care 2004;27: S5-10, Table 1 World Health Organization: Diabetes Mellitus: Report of a WHO Study Group Geneva, World Health Org, 1985 Tech Rep Ser, No 727 KIDNEY: 3 Agency for Healthcare Research and Quality AHRQ Use of Glycelated Hemoglobin and Microalbuminuria in the Monitoring of Diabetes Mellitus Summary, Evidence Report/Technology Assessment: Number 84 AHRQ Publication No 03-E048, July 2003 The Diabetes Control and Complications Trial Research Group The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus N Engl J Med 1993 Sep 30;32914:977-86 Sustained effect of intensive treatment of Type 1
diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications EDIC study JAMA 2003 Oct 22;29016:2159-67
6 7 5 4 2
Hostetter, TH Prevention of end-stage renal disease due to Type 2 diabetes N Engl J Med 2001; 345:910
Lewis EJ; Hunsicker LG; Clarke WR; Berl T; Pohl MA; Lewis JB; Ritz E; Atkins RC; Rohde R; Raz I Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to Type 2 diabetes N Engl J Med 2001 Sep 20;34512:851-60
8
Brenner BM, Cooper ME, de Zeeuw D, et al Effects of losartan on renal and cardiovascular outcomes in patients with Type 2 diabetes and nephropathy N Engl J Med 2001 Sep 20;34512:861-9 Nephropathy in Diabetes, Diabetes Care 2004 27: S79-83, Table 1
9
EYE: 10 Retinopathy in Diabetes, Diabetes Care 2004 27: S84-87
11
Vijan S, Hofer TP, Hayward RA: Cost-utility analysis of screening intervals for diabetic retinopathy in patients with Type 2 diabetes mellitus JAMA 2000, 283:889-896
Younis N, Broadbent DM, Vora JP, Harding SP Incidence of sight-threatening retinopathy in patients with Type 2 diabetes in the Liverpool Diabetic Eye Study: a
cohort study Lancet 2003; 361:195-200 A1C: Larsen ML, Horder M, Mogensen EF Effect of long-term monitoring of glycosylated hemoglobin levels in insulindependent diabetes mellitus N Engl J Med 1990;323:1021-1025
13
12
BLOOD PRESSURE: 14 Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure Chobanian et al Hypertension2003; 42: 1206-1252
15
ALLHAT Collaborative Research Group Major Outcomes in High-Risk Hypertensive Patients Randomized to ACEPage 8
Clinical Practice Guidelines for the Diagnosis and Management of Diabetes Mellitus in Adults October 2004
I or CCV vs Diuretic ALLHAT JAMA 2002;28823 Hansson, L, Zanchetti, A, Carruthers, SG, et al for the HOT Study Group Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: Principal results of the Hypertension Optimal Treatment HOT randomized trial Lancet 1998; 351:1755 UKPDS 38 Tight blood pressure control and risk of macrovascular and microvascular complications in Type 2 diabetes UK Prospective Diabetes Study Group BMJ 1998; 317:703 Schrier, RW, Estacio, RO, Esler, A, Mehler, P Effects of aggressive blood pressure
control in normotensive Type 2 diabetic patients on albuminuria, retinopathy and strokes Kidney Int 2002; 61:1086
19 18 17 16
Effects of an angiotensin-converting-enzyme Inhibitor, ramipril, on cardiovascular events in high-risk patients N Engl J Med 2000; 342:145
Fox, KM Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomized, double-blind, placebo-controlled, multicentre trial the EUROPA study Lancet 2003; 362:782 CHOLESTEROL/CARDIOVASCULAR: Pyörälä, K, Pedersen, TR, Kjekshus, J, et al Cholesterol lowering with simvastatin improves prognosis of diabetic patients with coronary heart disease A subgroup analysis of the Scandinavian Simvastatin Survival Study Diabetes Care 1997; 20:614
21 22
20
Haffner, SM, Alexander, CM, Cook, TJ, et al Reduced coronary events in simvastatin-treated patients with coronary heart disease and diabetes or impaired fasting glucose levels Subgroup analyses in the Scandinavian Simvastatin Survival Study Arch Intern Med 1999; 159:2661
Goldberg, RB, Mellies, MJ, Sacks, FM, et al, for the CARE Investigators Cardiovascular events and their reduction with pravastatin in diabetic and
glucose-intolerant myocardial infarction survivors with average cholesterol levels: subgroup analyses in the Cholesterol and Recurrent Events CARE trial Circulation 1998; 98:2513
24 MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomized placebo-controlled trial Lancet 2003; 361:2005 25 NCEP Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults: Executive Summary of the Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III JAMA 285:2486-2497, 2001 26
23
Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J: Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of highdensity lipoprotein cholesterol: Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group N Engl J Med 341:410418, 1999
SMOKING CESSATION: The Tobacco Use and Dependence Clinical Practice Guideline Panel, Staff, and Consortium Representatives A clinical practice
guideline for treating tobacco use and dependence A US public health service report JAMA 2000;283:3244-54
27
FORMAL DIABETES EDUCATION 28 Franz, MJ, et al Effectiveness of medical nutrition therapy provided by dietitians in the management of non-insulindependent diabetes mellitus: A randomized, controlled clinical trial J Am Diet Assoc 1995;95:1009-1017
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DAILY ASPIRIN: 29 Early Treatment Diabetic Retinopathy Study Investigators Aspirin effects on mortality and morbidity in patients with diabetes mellitus Early Treatment Diabetic Retinopathy Study Report 14 JAMA 268:1291-1300, 1992 Antiplatelet Trialists Collaboration Collaborative overview of randomized trials of antiplatelet therapy–I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients BMJ 308:81-106, 1994 HORMONE REPLACEMENT THERAPY: 31 Writing Group for the Womens Health Initiative WHI Investigators Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Womens Health Initiative randomized
controlled trial JAMA 2002;288:321-333
32 Hulley S, Grady D, Bush T, et al Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women JAMA 1998;280:605-613 33 30
The Womens Health Initiative WHI Steering Committee Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: The Womens Health Initiative WHI Randomized Controlled Trial JAMA 2004;291:1701-1712
DIRECT INQUIRY ABOUT REGULAR PHYSICAL EXERCISE American Diabetes Association Physical Activity/Exercise and Diabetes Diabetes Care 2004;27:S58-62 The ADA recommendations are based on the evidence reviewed in the following publications: Exercise and NIDDM Technical Review Diabetes Care 13:785789, 1990; and Exercise in individuals with IDDM Technical Review Diabetes Care 17:924937, 1994
34 35
Kriska AM, LaPorte RE, Patrick SL, Kuller LH, Orchard TJ The association of physical activity and diabetic complications in individuals with insulin-dependent diabetes mellitus: the epidemiology of diabetes complications study VII J Clin Epidemiology 1991;44:1207-14
Hu FB; Stampfer MJ; Solomon C; et al Physical activity and risk for cardiovascular events in
diabetic women Ann Intern Med 2001 Jan 16;1342:96-105
37
36
Gregg EW; Gerzoff RB; Caspersen CJ; et al Relationship of walking to mortality among US adults with diabetes Arch Intern Med 2003 Jun 23;16312:1440-7
PREVENTION OF COMPLICATIONS OF PERIPHERAL VASCULAR DISEASE AND LOWER EXTREMITY AMPUTATION Reiber, GF, et al Risk factors for amputation in patients with diabetes mellitus a case-control study Ann Intern Med 1992;117:97-105
38 39
Bild, DE, et al Lower extremity amputation in people with diabetes, epidemiology and prevention Diabetes Care 1989;12:24-31 Ibid 58 Mayfield, JA, et al Preventive Foot Care in People With Diabetes Technical Review Diabetes Care 1998;21:2161-77 American Diabetes Association, Preventive Foot Care in People with Diabetes Diabetes Care 2000;23:S55-56 Birke, JA, Sim, DS Plantar sensory thresholds in the ulcerative foot Lept Rev 1986;57:261-67 Olmos PR, et al The Semmes-Weinstein Monofilament as a Potential Predictor of Foot Ulceration in Patients With
40 41 42 43 44
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Non-insulin-Dependent Diabetes The American Journal of Medical Science
1995;309:76-82
45 Mueller, MJ Identifying Patients With Diabetes Mellitus Who Are at Risk for Lower-Extremity Complications: Use of Semmes-Weinstein Monofilaments Physical Therapy, 1996;76:68-71 46 47 48 49
Ibid 60, 61 Ibid 45 Ibid 46
Litzelman, DK, et al Reduction of Lower Extremity Clinical Abnormalities in Patients with Non-Insulin-Dependent Diabetes Mellitus A randomized, controlled trial Ann Intern Med 1993;119:36-41 DEPRESSION SCREENING AND TREATMENT: 50 Lustman P J, et al: Cognitive behavior therapy for depression in Type 2 diabetes mellitus Ann Intern Med 1998;12999:613-620 Lustman P J, et al: Effects of nortriptyline on depression and glycemic control in diabetes: Results of a double blind, placebo-controlled trial Psychosom Med 1997;59:241-250
52 51
Diabetes Coalition of California Basic Guidelines for Diabetes Care 1999, California Department of Health Services wwwdhscagov/diabetes
53
GENERAL PREVENTION MEASURES: Kitzmiller JL, Buchanan TA, Kjos S, Combs CA, Ratner R: Preconception care of diabetes, congenital malformations, and spontaneous abortions Technical Review Diabetes Care 19:514541, 1996
Centers for Disease Control and Prevention Advisory Committee on
Immunization Practices ACIP Recommended Immunization Schedule by Age Group and Medical Conditions, United States, 2003-2004 http://wwwcdcgov/nip/recs/adult-schedule-2pagepdf
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Source:scmh.org
