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Guideline Summary
Guideline Title
Standards of medical care in diabetes. VI. Prevention and management of diabetes complications.
Bibliographic Source(s)
Standards of medical care in diabetes. VI. Prevention and management of diabetes complications. Diabetes Care 2012 Jan;35(Suppl 1):S28-38.
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: American Diabetes Association (ADA). Standards of medical care in diabetes. VI. Prevention and management of diabetes complications. Diabetes Care 2011 Jan;34(Suppl 1):S27-38.

Jump ToGuideline ClassificationRelated Content
FDA Warning/Regulatory Alert

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • March 1, 2012 – Statins and HIV or Hepatitis C drugs External Web Site Policy: The U.S. Food and Drug Administration (FDA) notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.
  • February 28, 2012 – Statin drugs External Web Site Policy: The U.S. Food and Drug Administration (FDA) has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury.
  • November 9, 2011 – Trilipix (fenofibric acid) External Web Site Policy: The U.S. Food and Drug Administration (FDA) notified healthcare professionals the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke. FDA reviewed the data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The ACCORD Lipid trial found no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with fenofibrate plus simvastatin compared with simvastatin alone. Information from the trial has been added to the Important Limitations of Use and Warnings and Precautions sections of the Trilipix physician label and to the patient Medication Guide.

Scope

Disease/Condition(s)

Complications of diabetes mellitus, including:

  • Cardiovascular disease (CVD)
    • Hypertension
    • Dyslipidemia
    • Coronary heart disease/coronary artery disease (CHD/CAD)
  • Nephropathy
  • Retinopathy
  • Neuropathy
    • Distal symmetric polyneuropathy (DPN)
    • Autonomic neuropathy
  • Foot ulceration
Guideline Category
Counseling
Diagnosis
Evaluation
Management
Prevention
Risk Assessment
Screening
Treatment
Clinical Specialty
Cardiology
Endocrinology
Family Practice
Geriatrics
Internal Medicine
Nephrology
Neurology
Nursing
Obstetrics and Gynecology
Ophthalmology
Optometry
Pediatrics
Podiatry
Preventive Medicine
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Dietitians
Health Care Providers
Health Plans
Hospitals
Managed Care Organizations
Nurses
Optometrists
Pharmacists
Physician Assistants
Physicians
Podiatrists
Public Health Departments
Guideline Objective(s)
  • To provide recommendations for the prevention and management of diabetes complications
  • To provide clinicians, patients, researchers, payers, and other interested individuals with the components of diabetes care, treatment goals, and tools to evaluate the quality of care
Target Population

Patients with type 1 or type 2 diabetes mellitus, including pregnant women

Interventions and Practices Considered

Risk Assessment/Screening/Diagnosis

  1. Blood pressure measurement (systolic and diastolic)
  2. Serum low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglyceride concentration testing
  3. Coronary heart disease (CHD) screening, including risk factor assessment*
  4. Annual testing for microalbuminuria and measurement of serum creatinine to estimate glomerular filtration rate (GFR) and staging of the level of chronic kidney disease (CKD)
  5. Dilated and comprehensive eye exam including retinal photography
  6. Screening for distal symmetric polyneuropathy and cardiovascular autonomic neuropathy, with electrophysiological testing in atypical situations
  7. Foot examination
  8. Screening for peripheral arterial disease (PAD), including history of claudication, pedal pulses, and ankle-brachial index

*Note: Routine coronary artery disease (CAD) screening is not recommended if cardiovascular disease (CVD) risk factors are treated.

Management/Treatment/Prevention

  1. Patient education
    • Lifestyle modification (e.g., diet, weight loss, physical activity, smoking cessation)
    • Foot care
  2. Drug therapy
    • Angiotensin-converting enzyme (ACE) inhibitors
    • Angiotensin II receptor blockers (ARBs)
    • β-blockers
    • Diuretics
    • Calcium channel blockers (CCBs)
    • Statins
    • Fibrates
    • Niacin
    • Combination drug therapy
    • Antiplatelet agents, including aspirin and clopidogrel
    • Medications for relieving symptoms of polyneuropathy
  3. Smoking cessation therapy
  4. Laser photocoagulation to reduce the risk of vision loss
  5. Referral to specialists

Monitoring

  1. Renal function tests
  2. Serum potassium levels
  3. Glomerular filtration rate
Major Outcomes Considered
  • Changes in lipid levels
  • Incidence of cardiovascular events
  • Morbidity and mortality associated with cardiovascular disease
  • Progression of microalbuminuria to macroalbuminuria
  • Changes in glomerular filtration rate (GFR)
  • Incidence of retinopathy and vision loss
  • Incidence of neuropathy
  • Incidence of foot ulcers or amputation
  • Efficacy and cost-effectiveness of interventions

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

For the current revision of this position statement, committee members systematically searched Medline for human studies related to each subsection and published since 1 January 2010.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

American Diabetes Association's Evidence Grading System for Clinical Practice Recommendations

A

Clear evidence from well-conducted, generalizable randomized controlled trials (RCTs) that are adequately powered, including:

  • Evidence from a well-conducted multicenter trial
  • Evidence from a meta-analysis that incorporated quality ratings in the analysis

Compelling nonexperimental evidence (i.e., "all or none" rule developed by the Centre for Evidence-Based Medicine at Oxford)

Supportive evidence from well-conducted RCTs that are adequately powered, including:

  • Evidence from a well-conducted trial at one or more institutions
  • Evidence from a meta-analysis that incorporated quality ratings in the analysis

B

Supportive evidence from well-conducted cohort studies, including:

  • Evidence from a well-conducted prospective cohort study or registry
  • Evidence from a well-conducted meta-analysis of cohort studies

Supportive evidence from a well-conducted case-control study

C

Supportive evidence from poorly controlled or uncontrolled studies, including:

  • Evidence from RCTs with one or more major or three or more minor methodological flaws that could invalidate the results
  • Evidence from observational studies with high potential for bias (such as case series with comparison to historical controls)
  • Evidence from case series or case reports

Conflicting evidence with the weight of evidence supporting the recommendation

E

Expert consensus or clinical experience

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

A grading system (see the "Rating Scheme for the Strength of the Evidence" field), developed by the American Diabetes Association (ADA) and modeled after existing methods, was utilized to clarify and codify the evidence that forms the basis for the recommendations.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Recommendations (bulleted at the beginning of each subsection and also listed in the "Executive Summary: Standards of Medical Care in Diabetes 2012" [see the "Availability of Companion Documents" field]) were revised based on new evidence or, in some cases, to clarify the prior recommendation or match the strength of the wording to the strength of the evidence. A table linking the changes in recommendations to new evidence can be reviewed at http://professional.diabetes.org/CPR_Search.aspx External Web Site Policy.

Feedback from the larger clinical community was valuable for the 2012 revision of the standards.

Rating Scheme for the Strength of the Recommendations

Recommendations have been assigned ratings of A, B, or C, depending on the quality of evidence (see the "Rating Scheme for the Strength of the Evidence" field). Expert opinion (E) is a separate category for recommendations in which there is as yet no evidence from clinical trials, in which clinical trials may be impractical, or in which there is conflicting evidence. Recommendations with an "A" rating are based on large, well-designed clinical trials or well-done meta-analyses. Generally, these recommendations have the best chance of improving outcomes when applied to the population to which they are appropriate. Recommendations with lower levels of evidence may be equally important but are not as well supported.

Cost Analysis
  • A number of large randomized clinical trials have demonstrated the efficacy and cost-effectiveness of brief counseling in smoking cessation, including the use of quit lines, and in the reduction of tobacco use.
  • The overall effectiveness, especially the cost-effectiveness, of an indiscriminate aggressive screening strategy for coronary heart disease (CHD) is now questioned.
  • The ultimate balance of benefit, cost, and risks of newer noninvasive cardiovascular artery disease (CAD) screening methods, such as computed tomography (CT) and CT angiography, in asymptomatic patients remains controversial, particularly in the modern setting of aggressive cardiovascular disease (CVD) risk factor control.
  • Consultation with a nephrologist when stage 4 chronic kidney disease (CKD) develops has been found to reduce cost, improve quality of care, and keep people off dialysis longer.
  • The use of retinal photography with remote reading by experts has great potential in areas where qualified eye care professionals are not available, and may also enhance efficiency and reduce costs when the expertise of ophthalmologists can be utilized for more complex examinations and for therapy.
Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

The standards of care were reviewed and approved by the Executive Committee of the American Diabetes Association's (ADA's) Board of Directors, which includes health care professionals, scientists, and lay people.

Recommendations

Major Recommendations

The evidence grading system for clinical practice recommendations (A–C, E) is defined at the end of the "Major Recommendations" field.

Cardiovascular Disease (CVD)

Hypertension/Blood Pressure Control

Screening and Diagnosis

Blood pressure should be measured at every routine diabetes visit. Patients found to have systolic blood pressure (SBP) ≥130 mm Hg or diastolic blood pressure (DBP) ≥80 mm Hg should have blood pressure confirmed on a separate day. Repeat SBP ≥130 mm Hg or DBP ≥80 mm Hg confirms a diagnosis of hypertension. (C)

Goals

  • A goal SBP <130 mm Hg is appropriate for most patients with diabetes. (C)
  • Based on patient characteristics and response to therapy, higher or lower SBP targets may be appropriate. (B)
  • Patients with diabetes should be treated to a DBP <80 mm Hg. (B)

Treatment

  • Patients with a SBP of 130 to 139 mm Hg or a DBP of 80 to 89 mm Hg may be given lifestyle therapy alone for a maximum of 3 months and then, if targets are not achieved, be treated with addition of pharmacologic agents. (E)
  • Patients with more severe hypertension (SBP ≥140 mm Hg or DBP ≥90 mm Hg) at diagnosis or follow-up should receive pharmacologic therapy in addition to lifestyle therapy. (A)
  • Lifestyle therapy for hypertension consists of weight loss if overweight, Dietary Approaches to Stop Hypertension (DASH)-style dietary pattern including reducing sodium and increasing potassium intake, moderation of alcohol intake, and increased physical activity. (B)
  • Pharmacologic therapy for patients with diabetes and hypertension should be with a regimen that includes either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). If one class is not tolerated, the other should be substituted. (C)
  • Multiple drug therapy (two or more agents at maximal doses) is generally required to achieve blood pressure targets. (B)
  • Administer one or more antihypertensive medications at bedtime. (A)
  • If ACE inhibitors, ARBs, or diuretics are used, kidney function and serum potassium levels should be monitored. (E)
  • In pregnant patients with diabetes and chronic hypertension, blood pressure target goals of 110 to 129/65 to 79 mm Hg are suggested in the interest of long-term maternal health and minimizing impaired fetal growth. ACE inhibitors and ARBs are contraindicated during pregnancy. (E)

Dyslipidemia/Lipid Management

Screening

In most adult patients, measure fasting lipid profile at least annually. In adults with low-risk lipid values (low-density lipoprotein [LDL] cholesterol <100 mg/dL, high-density lipoprotein [HDL] cholesterol >50 mg/dL, and triglycerides <150 mg/dL), lipid assessments may be repeated every 2 years. (E)

Treatment Recommendations and Goals

  • Lifestyle modification focusing on the reduction of saturated fat, trans fat, and cholesterol intake; increase of omega-3 fatty acids, viscous fiber, and plant stanols/sterols; weight loss (if indicated); and increased physical activity should be recommended to improve the lipid profile in patients with diabetes. (A)
  • Statin therapy should be added to lifestyle therapy, regardless of baseline lipid levels, for diabetic patients:
    • With overt cardiovascular disease (CVD) (A)
    • Without CVD who are over the age of 40 and have one or more other CVD risk factors (A)
  • For patients at lower risk than described above (e.g., without overt CVD and under the age of 40 years), statin therapy should be considered in addition to lifestyle therapy if LDL cholesterol remains >100 mg/dL or in those with multiple CVD risk factors. (E)
  • In individuals without overt CVD, the primary goal is an LDL cholesterol <100 mg/dL (2.6 mmol/L). (A)
  • In individuals with overt CVD, a lower LDL cholesterol goal of <70 mg/dL (1.8 mmol/L), using a high dose of a statin, is an option. (B)
  • If drug-treated patients do not reach the above targets on maximal tolerated statin therapy, a reduction in LDL cholesterol of ~30% to 40% from baseline is an alternative therapeutic goal. (A)
  • Triglyceride levels <150 mg/dL (1.7 mmol/L) and HDL cholesterol >40 mg/dL (1.0 mmol/L) in men and >50 mg/dL (1.3 mmol/L) in women are desirable. However, LDL cholesterol–targeted statin therapy remains the preferred strategy. (C)
  • If targets are not reached on maximally tolerated doses of statins, combination therapy using statins and other lipid-lowering agents may be considered to achieve lipid targets but has not been evaluated in outcome studies for either CVD outcomes or safety. (E)
  • Statin therapy is contraindicated in pregnancy. (E)

Summary of Recommendations for Glycemic, Blood Pressure, and Lipid Control for Most Adults with Diabetes

  • Glycosylated hemoglobin (A1C) <7.0%*
  • Blood pressure <130/80 mm Hg†
  • Lipids
    • LDL cholesterol <100 mg/dL (<2.6 mmol/L)‡

*More or less stringent glycemic goals may be appropriate for individual patients. Goals should be individualized based on: duration of diabetes, age/life expectancy, comorbid conditions, known CVD or advanced microvascular complications, hypoglycemia unawareness, and individual patient considerations.
†Based on patient characteristics and response to therapy, higher or lower SBP targets may be appropriate.
‡In individuals with overt CVD, a lower LDL cholesterol goal of <70 mg/dL (1.8 mmol/L), using a high dose of a statin, is an option.

Antiplatelet Agents

  • Consider aspirin therapy (75 to 162 mg/day) as a primary prevention strategy in those with type 1 and type 2 diabetes at increased cardiovascular risk (10-year risk >10%). This includes most men >50 years of age or women >60 years of age who have at least one additional major risk factor (family history of CVD, hypertension, smoking, dyslipidemia, or albuminuria). (C)
  • Aspirin should not be recommended for CVD prevention for adults with diabetes at low CVD risk (10-year CVD risk <5%, such as in men <50 and women <60 years of age with no major additional CVD risk factors), since the potential adverse effects from bleeding likely offset the potential benefits. (C)
  • In patients in these age groups with multiple other risk factors (e.g., 10-year risk 5% to 10%), clinical judgment is required. (E)
  • Use aspirin therapy (75 to 162 mg/day) as a secondary prevention strategy in those with diabetes with history of CVD. (A)
  • For patients with CVD and documented aspirin allergy, clopidogrel (75 mg/day) should be used. (B)
  • Combination therapy with aspirin (75 to 162 mg/day) and clopidogrel (75 mg/day) is reasonable for up to a year after an acute coronary syndrome. (B)

Smoking Cessation

  • Advise all patients not to smoke. (A)
  • Include smoking cessation counseling and other forms of treatment as a routine component of diabetes care. (B)

Coronary Heart Disease (CHD) Screening and Treatment

Screening

In asymptomatic patients, routine screening for coronary artery disease (CAD) is not recommended, as it does not improve outcomes as long as CVD risk factors are treated. (A)

Treatment

  • In patients with known CVD, consider ACE inhibitor therapy (C) and use aspirin and statin therapy (A) (if not contraindicated) to reduce the risk of cardiovascular events. In patients with a prior myocardial infarction, β-blockers should be continued for at least 2 years after the event. (B)
  • Longer-term use of β-blockers in the absence of hypertension is reasonable if well tolerated, but data are lacking. (E)
  • Avoid thiazolidinedione (TZD) treatment in patients with symptomatic heart failure. (C)
  • Metformin may be used in patients with stable congestive heart failure (CHF) if renal function is normal. It should be avoided in unstable or hospitalized patients with CHF. (C)

Nephropathy Screening and Treatment

General Recommendations

  • To reduce the risk or slow the progression of nephropathy, optimize glucose control. (A)
  • To reduce the risk or slow the progression of nephropathy, optimize blood pressure control. (A)

Screening

  • Perform an annual test to assess urine albumin excretion in type 1 diabetic patients with diabetes duration of ≥5 years and in all type 2 diabetic patients, starting at diagnosis. (B)
  • Measure serum creatinine at least annually in all adults with diabetes regardless of the degree of urine albumin excretion. The serum creatinine should be used to estimate glomerular filtration rate (GFR) and stage the level of chronic kidney disease (CKD), if present. (E)

Treatment

  • In the treatment of the nonpregnant patient with micro- and macroalbuminuria, either ACE inhibitors or ARBs should be used. (A)
  • If one class is not tolerated, the other should be substituted. (E)
  • Reduction of protein intake to 0.8 to 1.0 g·kg body wt-1·day-1 in individuals with diabetes and the earlier stages of CKD and to 0.8 g·kg body wt-1·day-1 in the later stages of CKD may improve measures of renal function (e.g., urine albumin excretion rate and GFR) and is recommended. (B)
  • When ACE inhibitors, ARBs, or diuretics are used, monitor serum creatinine and potassium levels for the development of increased creatinine and hyperkalemia. (E)
  • Continued monitoring of urine albumin excretion to assess both response to therapy and progression of disease is recommended. (E)
  • When estimated GFR is <60 ml/min/1.73 m2, evaluate and manage potential complications of CKD. (E)
  • Consider referral to a physician experienced in the care of kidney disease for uncertainty about the etiology of kidney disease, difficult management issues, or advanced kidney disease. (B)

Table. Management of CKD in Diabetes

GFR Recommended
All patients Yearly measurement of creatinine, UAE, potassium
45-60 Referral to nephrology if possibility for nondiabetic kidney disease exists (duration type 1 diabetes <10 years, heavy proteinuria, abnormal findings on renal ultrasound, resistant hypertension, rapid fall in GFR, or active urinary sediment on ultrasound)
Consider need for dose adjustment of medications
Monitor eGFR every 6 months
Monitor electrolytes, bicarbonate, hemoglobin, calcium, phosphorus, parathyroid hormone at least yearly
Assure vitamin D sufficiency
Consider bone density testing
Referral for dietary counseling 
30-44 Monitor eGFR every 3 months
Monitor electrolytes, bicarbonate, calcium, phosphorus, parathyroid hormone, hemoglobin, albumin, weight every 3 to 6 months
Consider need for dose adjustment of medications
<30 Referral to nephrologists

Abbreviations: CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; UAE, urinary albumin excretion
Adapted from National Kidney Foundation guidelines (available at http://www.kidney.org/professionals/KDOQI/guideline_diabetes/ External Web Site Policy)

Retinopathy Screening and Treatment

General Recommendations

  • To reduce the risk or slow the progression of retinopathy, optimize glycemic control. (A)
  • To reduce the risk or slow the progression of retinopathy, optimize blood pressure control. (A)

Screening

  • Adults and children aged 10 years or older with type 1 diabetes should have an initial dilated and comprehensive eye examination by an ophthalmologist or optometrist within 5 years after the onset of diabetes. (B)
  • Patients with type 2 diabetes should have an initial dilated and comprehensive eye examination by an ophthalmologist or optometrist shortly after the diagnosis of diabetes. (B)
  • Subsequent examinations for type 1 and type 2 diabetic patients should be repeated annually by an ophthalmologist or optometrist. Less frequent exams (every 2 to 3 years) may be considered following one or more normal eye exams. Examinations will be required more frequently if retinopathy is progressing. (B)
  • High-quality fundus photographs can detect most clinically significant diabetic retinopathy. Interpretation of the images should be performed by a trained eye care provider. While retinal photography may serve as a screening tool for retinopathy, it is not a substitute for a comprehensive eye exam, which should be performed at least initially and at intervals thereafter as recommended by an eye care professional. (E)
  • Women with pre-existing diabetes who are planning pregnancy or who have become pregnant should have a comprehensive eye examination and be counseled on the risk of development and/or progression of diabetic retinopathy. Eye examination should occur in the first trimester with close follow-up throughout pregnancy and for 1 year postpartum. (B)

Treatment

  • Promptly refer patients with any level of macular edema, severe nonproliferative diabetic retinopathy (NPDR), or any proliferative diabetic retinopathy (PDR) to an ophthalmologist who is knowledgeable and experienced in the management and treatment of diabetic retinopathy. (A)
  • Laser photocoagulation therapy is indicated to reduce the risk of vision loss in patients with high-risk PDR, clinically significant macular edema, and in some cases of severe NPDR. (A)
  • The presence of retinopathy is not a contraindication to aspirin therapy for cardioprotection, as this therapy does not increase the risk of retinal hemorrhage. (A)

Neuropathy Screening and Treatment

  • All patients should be screened for distal symmetric polyneuropathy (DPN) starting at diagnosis of type 2 diabetes, 5 years after the diagnosis of type 1 diabetes, and at least annually thereafter, using simple clinical tests. (B)
  • Electrophysiological testing is rarely needed, except in situations where the clinical features are atypical. (E)
  • Screening for signs and symptoms of cardiovascular autonomic neuropathy should be instituted at diagnosis of type 2 diabetes and 5 years after the diagnosis of type 1 diabetes. Special testing is rarely needed and may not affect management or outcomes. (E)
  • Medications for the relief of specific symptoms related to painful DPN and autonomic neuropathy are recommended, as they improve the quality of life of the patient. (E)

Foot Care

  • For all patients with diabetes, perform an annual comprehensive foot examination to identify risk factors predictive of ulcers and amputations. The foot examination should include inspection, assessment of foot pulses, and testing for loss of protective sensation (LOPS) (10-g monofilament plus testing any one of the following: vibration using 128-Hz tuning fork, pinprick sensation, ankle reflexes, or vibration perception threshold). (B)
  • Provide general foot self-care education to all patients with diabetes. (B)
  • A multidisciplinary approach is recommended for individuals with foot ulcers and high-risk feet, especially those with a history of prior ulcer or amputation. (B)
  • Refer patients who smoke, have loss of protective sensation and structural abnormalities, or have history of prior lower-extremity complications to foot care specialists for ongoing preventive care and life-long surveillance. (C)
  • Initial screening for peripheral arterial disease (PAD) should include a history for claudication and an assessment of the pedal pulses. Consider obtaining an ankle-brachial index (ABI), as many patients with PAD are asymptomatic. (C)
  • Refer patients with significant claudication or a positive ABI for further vascular assessment and consider exercise, medications, and surgical options. (C)

Definitions:

American Diabetes Association's Evidence Grading System for Clinical Practice Recommendations

A

Clear evidence from well-conducted, generalizable randomized controlled trials (RCTs) that are adequately powered, including:

  • Evidence from a well-conducted multicenter trial
  • Evidence from a meta-analysis that incorporated quality ratings in the analysis

Compelling nonexperimental evidence (i.e., "all or none" rule developed by the Centre for Evidence-Based Medicine at Oxford)

Supportive evidence from well-conducted RCTs that are adequately powered, including:

  • Evidence from a well-conducted trial at one or more institutions
  • Evidence from a meta-analysis that incorporated quality ratings in the analysis

B

Supportive evidence from well-conducted cohort studies, including:

  • Evidence from a well-conducted prospective cohort study or registry
  • Evidence from a well-conducted meta-analysis of cohort studies

Supportive evidence from a well-conducted case-control study

C

Supportive evidence from poorly controlled or uncontrolled studies, including:

  • Evidence from RCTs with one or more major or three or more minor methodological flaws that could invalidate the results
  • Evidence from observational studies with high potential for bias (such as case series with comparison to historical controls)
  • Evidence from case series or case reports

Conflicting evidence with the weight of evidence supporting the recommendation

E

Expert consensus or clinical experience

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Prevention and appropriate management of diabetes complications

Potential Harms
  • Chronic diuretic use during pregnancy has been associated with restricted maternal plasma volume, which might reduce uteroplacental perfusion.
  • Combination therapy with a statin and a fibrate or statin and niacin may be efficacious for patients needing treatment for all three lipid fractions, but this combination is associated with an increased risk for abnormal transaminase levels, myositis, or rhabdomyolysis. The risk of rhabdomyolysis is higher with higher doses of statins and with renal insufficiency and seems to be lower when statins are combined with fenofibrate than gemfibrozil.
  • The main adverse effect of aspirin appears to be an increased risk of gastrointestinal bleeding. The excess risk may be as high as 1 to 5 per 1,000 per year in real-world settings.
  • Measurement of spot urine for albumin only, whether by immunoassay or by using a dipstick test specific for microalbumin, without simultaneously measuring urine creatinine, is somewhat less expensive but susceptible to false-negative and false-positive determinations as a result of variation in urine concentration due to hydration and other factors.

Contraindications

Contraindications
  • During pregnancy, treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) is contraindicated, since they can cause fetal damage.
  • Statin therapy is contraindicated in pregnancy.
  • Thiazolidinedione treatment should be avoided in patients with symptomatic heart failure.
  • Metformin should be avoided in unstable or hospitalized patients with congestive heart failure (CHF).
  • Aspirin therapy is contraindicated in patients under the age of 21 years because of the associated risk of Reye's syndrome.

Qualifying Statements

Qualifying Statements
  • Evidence is only one component of clinical decision-making. Clinicians care for patients, not populations; guidelines must always be interpreted with the needs of the individual patient in mind. Individual circumstances, such as comorbid and coexisting diseases, age, education, disability, and, above all, patients' values and preferences, must also be considered and may lead to different treatment targets and strategies. Also, conventional evidence hierarchies, such as the one adapted by the American Diabetes Association, may miss some nuances that are important in diabetes care. For example, while there is excellent evidence from clinical trials supporting the importance of achieving glycemic control, the optimal way to achieve this result is less clear. It is difficult to assess each component of such a complex intervention.
  • While individual preferences, comorbidities, and other patient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to preclude clinical judgment or more extensive evaluation and management of the patient by other specialists as needed.

Implementation of the Guideline

Description of Implementation Strategy

While numerous interventions to improve adherence to the recommended standards have been implemented, a major barrier to optimal care is a delivery system that too often is fragmented, lacks clinical information capabilities, often duplicates services, and is poorly designed for the coordinated delivery of chronic care. The Chronic Care Model (CCM) includes six core elements for the provision of optimal care of patients with chronic disease: 1) delivery system design (moving from a reactive to a proactive care delivery system, where planned visits are coordinated through a team-based approach; 2) self-management support; 3) decision support (basing care on evidence-based, effective care guidelines); 4) clinical information systems (using registries that can provide patient-specific and population-based support to the care team); 5) community resources and policies (identifying or developing resources to support healthy lifestyles); and 6) health systems (to create a quality-oriented culture). Redefinition of the roles of the clinic staff and promoting self-management on the part of the patient are fundamental to the successful implementation of the CCM. Collaborative, multidisciplinary teams are best suited to provide such care for people with chronic conditions like diabetes and to facilitate patients' performance of appropriate self-management.

National Diabetes Education Program (NDEP) maintains an online resource (www.betterdiabetescare.nih.gov External Web Site Policy) to help health care professionals design and implement more effective health care delivery systems for those with diabetes.

Three specific objectives are outlined below.

Objective 1: Optimize Provider and Team Behavior

The care team should prioritize timely and appropriate intensification of lifestyle and/or pharmaceutical therapy of patients who have not achieved beneficial levels of blood pressure, lipid, or glucose control. Strategies such as explicit goal setting with patients; identifying and addressing language, numeracy, or cultural barriers to care; integrating evidence-based guidelines and clinical information tools into the process of care; and incorporating care management teams including nurses, pharmacists, and other providers have each been shown to optimize provider and team behavior and thereby catalyze reduction in glycosylated hemoglobin (A1C), blood pressure, and low-density lipoprotein (LDL) cholesterol.

Objective 2: Support Patient Behavior Change

Successful diabetes care requires a systematic approach to supporting patients' behavior change efforts, including (a) healthy lifestyle changes (physical activity, healthy eating, nonuse of tobacco, weight management, effective coping), (b) disease self-management (medication taking and management, self-monitoring of glucose and blood pressure when clinically appropriate); and (c) prevention of diabetes complications (self-monitoring of foot health, active participation in screening for eye, foot, and renal complications, and immunizations). High-quality diabetes self-management education (DSME) has been shown to improve patient self-management, satisfaction, and glucose control, as has delivery of ongoing diabetes self-management support (DSMS) so that gains achieved during DSME are sustained. National DSME standards call for an integrated approach that includes clinical content and skills and behavioral strategies (goal-setting, problem solving) and addresses emotional concerns in each needed curriculum content area.

Objective 3: Change the System of Care

The most successful practices have an institutional priority for providing high quality of care. Changes that have been shown to increase quality of diabetes care include basing care on evidence-based guidelines, expanding the role of teams and staff, redesigning the processes of care, implementing electronic health record tools, activating and educating patients, and identifying and/or developing and engaging community resources and public policy that support healthy lifestyles. Recent initiatives such as the Patient Centered Medical Home show promise to improve outcomes through coordinated primary care and offer new opportunities for team-based chronic disease care. Alterations in reimbursement that reward the provision of appropriate and high quality care rather than visit-based billing, and that can accommodate the need to personalize care goals, may provide additional incentives to improve diabetes care.

It is clear that optimal diabetes management requires an organized, systematic approach and involvement of a coordinated team of dedicated health care professionals working in an environment where patient-centered high-quality care is a priority.

Implementation Tools
Quick Reference Guides/Physician Guides
Slide Presentation
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Standards of medical care in diabetes. VI. Prevention and management of diabetes complications. Diabetes Care 2012 Jan;35(Suppl 1):S28-38.
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
1998 (revised 2012 Jan)
Guideline Developer(s)
American Diabetes Association - Professional Association
Source(s) of Funding

American Diabetes Association (ADA)

Guideline Committee

Professional Practice Committee

Composition of Group That Authored the Guideline

Committee Members: Roger Anderson, MS, RPH, CDE; Susan Braithwaite, MD; Martha Funnell, MSN, RN, CDE; Robert Gabbay, MD; Richard Grant, MD, MPH; Jane Kadohiro, DrPH, APRN, CDE; James Lenard, MD; Daniel Lorber, MD; Michelle Magee, MD; Sunder Mudaliar, MD; Patrick O'Connor, MD, MPH; R. Harsha Rao, MD; Andrew Rhinehart, MD, CDE; Stuart Weinzimer, MD; Carol Wysham, MD (Chair); Gretchen Youssef, MS, RD, CDE; Judy Fradkin, MD (Ex officio); Stephanie Dunbar, RD, MPH (Staff); Sue Kirkman, MD (Staff)

Financial Disclosures/Conflicts of Interest

Members of the Professional Practice Committee disclose all potential financial conflicts of interest with industry.

Members of the committee, their employer, and their disclosed conflicts of interest are listed in the "Professional Practice Committee Members" table and are available from the American Diabetes Association (ADA) Web site (see the "Availability of Companion Documents" field).

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: American Diabetes Association (ADA). Standards of medical care in diabetes. VI. Prevention and management of diabetes complications. Diabetes Care 2011 Jan;34(Suppl 1):S27-38.

Guideline Availability

Electronic copies: Available from the Diabetes Care Journal Web site External Web Site Policy.

Print copies: Available from the American Diabetes Association, 1701 North Beauregard Street, Alexandria, VA 22311.

Availability of Companion Documents

The following are available:

  • Introduction. Diabetes Care 2012 Jan;35(Suppl 1):S1-S2.
  • Summary of revisions for the 2012 clinical practice recommendations. Diabetes Care 2012 Jan;35(Suppl 1):S3.
  • Executive summary: standards of medical care in diabetes. Diabetes Care 2012 Jan;35(Suppl 1):S4-S10.
  • Diagnosis and classification of diabetes mellitus. Diabetes Care 2012 Jan;35(Suppl 1):S64-S71.
  • Third-party reimbursement for diabetes care, self-management education, and supplies. Diabetes Care 2012 Jan;35(Suppl 1):S99-100.
  • Professional Practice Committee 2012 (includes conflict of interest disclosure). Diabetes Care 2012 Jan;35(Suppl 1):S109-S110.

Electronic copies: Available from the Diabetes Care Journal Web site External Web Site Policy.

Print copies: Available from the American Diabetes Association, 1701 North Beauregard Street, Alexandria, VA 22311.

The following is also available:

  • 2012 Standards of medical care in diabetes. Clinical practice recommendations. Slide set. American Diabetes Association; 2012 Jan. 150 p. Electronic copies: Available from the American Diabetes Association (ADA) Web site External Web Site Policy.
Patient Resources

None available

NGC Status

This summary was completed by ECRI on November 1, 1998. The information was verified by the guideline developer on December 15, 1998. It was updated by ECRI on April 1, 2000, April 2, 2001, March 14, 2002, July 29, 2003, May 26, 2004, July 1, 2005, and March 17, 2006, and April 25, 2007. This summary was updated by ECRI Institute on March 31, 2008. The updated information was verified by the guideline developer on May 15, 2008. This summary was updated by ECRI Institute on January 5, 2010 following the U.S. Food and Drug Administration advisory on Plavix (Clopidogrel). This summary was updated by ECRI Institute on May 20, 2010. The information was verified by the guideline developer on May 25, 2010. This summary was updated by ECRI Institute on February 25, 2011. This summary was updated by ECRI Institute on June 27, 2011 following the U.S. Food and Drug Administration advisory on Zocor (simvastatin). This summary was updated by ECRI Institute on November 22, 2011 following the U.S. Food and Drug Administration (FDA) advisory on Trilipix (fenofibric acid). This NGC summary was updated by ECRI Institute on May 10, 2012.

Copyright Statement

This NGC summary is based on the original guideline, which is copyrighted by the American Diabetes Association (ADA).

For information on guideline reproduction, please contact Alison Favors, Manager, Rights and Permissions by e-mail at permissions@diabetes.org.

For information about the use of the guidelines, please contact the Clinical Affairs Department at (703) 549-1500 ext. 1692.

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