Skip Navigation
PrintDownload PDFGet Adobe ReaderDownload to WordDownload as HTMLDownload as XMLCitation Manager
Save to Favorites
Guideline Summary
Guideline Title
Standards of medical care in diabetes. V. Diabetes care.
Bibliographic Source(s)
Standards of medical care in diabetes. V. Diabetes care. Diabetes Care. 2013 Jan;36(Suppl 1):S16-28.
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Standards of medical care in diabetes. V. Diabetes care. Diabetes Care 2012 Jan;35(Suppl 1):S16-28.

Scope

Disease/Condition(s)
  • Type 1 diabetes
  • Type 2 diabetes
  • Gestational diabetes
Guideline Category
Counseling
Evaluation
Management
Prevention
Treatment
Clinical Specialty
Cardiology
Endocrinology
Family Practice
Geriatrics
Internal Medicine
Nephrology
Neurology
Nursing
Nutrition
Obstetrics and Gynecology
Ophthalmology
Pediatrics
Preventive Medicine
Psychology
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Dietitians
Health Care Providers
Health Plans
Hospitals
Managed Care Organizations
Nurses
Patients
Pharmacists
Physician Assistants
Physicians
Psychologists/Non-physician Behavioral Health Clinicians
Public Health Departments
Guideline Objective(s)
  • To provide evidence-based principles and recommendations for diabetes management
  • 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
  • Adults and children with type 1 diabetes
  • Adults and children with type 2 diabetes
  • Pregnant women with diabetes
  • Older adults with diabetes
Interventions and Practices Considered
  1. Complete medical evaluation, including medical history, physical examination, appropriate laboratory evaluations, and referrals to specialists
  2. Formulation of a management plan
  3. Patient education regarding self-monitoring of blood glucose (SMBG)
  4. Continuous glucose monitoring (CGM) in selected adults
  5. Glycosylated hemoglobin (A1C) testing
  6. Developing or adjusting management plans to achieve glycemic goals
  7. Pharmacologic management of type 1 and type 2 diabetes
  8. Medical nutrition therapy (MNT)
  9. Diabetes self-management education (DSME)
  10. Physical activity program
  11. Psychosocial assessment and care, including screening for psychosocial problems
  12. Referral for diabetes management
  13. Consideration of intercurrent illness
  14. Bariatric surgery in patients with body mass index (BMI) >35 kg/m2
  15. Glucose for hypoglycemia and glucagon for patients at risk for severe hypoglycemia
  16. Immunization, including influenza, pneumococcal, and hepatitis B vaccines
Major Outcomes Considered
  • Changes in pre- and postprandial blood glucose levels
  • Changes in glycosylated hemoglobin (A1C) levels
  • Duration of glycemic control
  • Incidence of hypoglycemia
  • Incidence of hyperglycemia
  • Changes in blood pressure levels
  • Rates of microvascular events (nephropathy, retinopathy)
  • Rates of major adverse macrovascular events (myocardial infarction, stroke, cardiovascular death)
  • Rates of neuropathic complications
  • Quality of life
  • Mortality rate
  • Cost

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 2011.

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 2013" [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 2013 revision of the standards.

Rating Scheme for the Strength of the Recommendations

Recommendations are 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
  • Several randomized trials have called into question the clinical utility and cost-effectiveness of routine self-monitoring of blood glucose (SMBG) in non–insulin-treated patients.
  • Because medical nutrition therapy (MNT), diabetes self-management education (DSME), and diabetes self-management support (DSMS) can result in cost-savings and improved outcomes, they should be adequately reimbursed by third-party payers.
  • Diabetes education is associated with increased use of primary and preventive services and lower use of acute, inpatient hospital services. Patients who participate in diabetes education are more likely to follow best practice treatment recommendations, particularly among the Medicare population, and have lower Medicare and commercial claim costs.
  • Recent retrospective analyses and modeling studies suggest that bariatric surgery procedures may be cost-effective, when one considers reduction in subsequent health care costs.
  • Centers for Disease Control and Prevention (CDC) economic models suggest that vaccination of adults with diabetes who were aged 20 to 59 years would cost an estimated $75,000 per quality-adjusted life-year saved, while cost per quality-adjusted life-year saved increased significantly at higher ages.
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.

Initial Evaluation

A complete medical evaluation should be performed to classify the diabetes, detect the presence of diabetes complications, review previous treatment and risk factor control in patients with established diabetes, assist in formulating a management plan, and provide a basis for continuing care. Laboratory tests appropriate to the evaluation of each patient's medical condition should be performed. A focus on the components of comprehensive care (see Table 7 in the original guideline document) will assist the health care team to ensure optimal management of the patient with diabetes.

Management

People with diabetes should receive medical care from a team that may include physicians, nurse practitioners, physician's assistants, nurses, dietitians, pharmacists, and mental health professionals with expertise and a special interest in diabetes. It is essential in this collaborative and integrated team approach that individuals with diabetes assume an active role in their care.

The management plan should be formulated as a collaborative therapeutic alliance among the patient and family, the physician, and other members of the health care team. A variety of strategies and techniques should be used to provide adequate education and development of problem-solving skills in the various aspects of diabetes management. Implementation of the management plan requires that the goals and treatment plan are individualized and take patient preferences into account. The management plan should recognize diabetes self-management education (DSME) and ongoing diabetes support as an integral component of care. In developing the plan, consideration should be given to the patient's age, school or work schedule and conditions, physical activity, eating patterns, social situation and cultural factors, and presence of complications of diabetes or other medical conditions.

Glycemic Control

Assessment of Glycemic Control

Two primary techniques are available for health providers and patients to assess the effectiveness of the management plan on glycemic control: patient self-monitoring of blood glucose (SMBG) or interstitial glucose, and glycosylated hemoglobin (A1C).

Glucose Monitoring

  • Patients on multiple-dose insulin (MDI) or insulin pump therapy should do SMBG at least prior to meals and snacks, occasionally postprandially, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normoglycemic, and prior to critical tasks such as driving. (B)
  • When prescribed as part of a broader educational context, SMBG results may be helpful to guide treatment decisions and/or patient self-management for patients using less frequent insulin injections or noninsulin therapies. (E)
  • When prescribing SMBG, ensure that patients receive initial instruction in and regular evaluation of SMBG technique and SMBG results, as well as their ability to use SMBG data to adjust therapy. (E)
  • Continuous glucose monitoring (CGM) in conjunction with intensive insulin regimens can be a useful tool to lower A1C in selected adults (age ≥25 years) with type 1 diabetes. (A)
  • Although the evidence for A1C lowering is less strong in children, teens, and younger adults, CGM may be helpful in these groups. Success correlates with adherence to ongoing use of the device. (C)
  • CGM may be a supplemental tool to SMBG in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes. (E)

A1C

  • Perform the A1C test at least two times a year in patients who are meeting treatment goals (and who have stable glycemic control). (E)
  • Perform the A1C test quarterly in patients whose therapy has changed or who are not meeting glycemic goals. (E)
  • Use of point-of-care (POC) testing for A1C provides the opportunity for more timely treatment changes. (E)

Glycemic Goals in Adults

  • Lowering A1C to below or around 7% has been shown to reduce microvascular complications of diabetes and, if implemented soon after the diagnosis of diabetes, is associated with long-term reduction in macrovascular disease. Therefore, a reasonable A1C goal for many nonpregnant adults in general is <7%. (B)
  • Providers might reasonably suggest more stringent A1C goals (such as <6.5%) for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease (CVD). (C)
  • Less stringent A1C goals (such as <8%) may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, extensive comorbid conditions, and those with long-standing diabetes in whom the general goal is difficult to attain despite DSME, appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents including insulin. (B)

Table. Summary of Glycemic Recommendations for Many Nonpregnant Adults with Diabetes

Glycosylated hemoglobin (A1C) <7.0%
Preprandial capillary plasma glucose 70 to 130 mg/dL (3.9 to 7.2 mmol/L)
Peak postprandial capillary plasma glucose* <180 mg/dL (<10.0 mmol/L)
  • Goals should be individualized based on:
    • Duration of diabetes
    • Age/life expectancy
    • Comorbid conditions
    • Known cardiovascular disease (CVD) or advanced microvascular complications
    • Hypoglycemia unawareness
    • Individual patient considerations
  • More or less stringent glycemic goals may be appropriate for individual patients
  • Postprandial glucose may be targeted if A1C goals are not met despite reaching preprandial glucose goals.

*Postprandial glucose measurements should be made 1 to 2 hours after the beginning of the meal, generally peak levels in patients with diabetes.

Glycemic Goals in Gestational Diabetes Mellitus (GDM)

Regarding goals for glycemic control for women with GDM, recommendations from the Fifth International Workshop-Conference on Gestational Diabetes are to target maternal capillary glucose concentrations of:

  • Preprandial ≤95 mg/dL (5.3 mmol/L) and either
    • 1-h postmeal ≤140 mg/dL (7.8 mmol/L)

      or

    • 2-h postmeal ≤120 mg/dL (6.7 mmol/L)

For women with pre-existing type 1 or type 2 diabetes who become pregnant, a recent consensus statement recommended the following as optimal glycemic goals, if they can be achieved without excessive hypoglycemia:

  • Premeal, bedtime, and overnight glucose 60 to 99 mg/dL (3.3 to 5.4 mmol/L)
  • Peak postprandial glucose 100 to 129 mg/dL (5.4 to 7.1 mmol/L)
  • A1C <6.0%

Pharmacologic and Overall Approaches to Treatment

Insulin Therapy for Type 1 Diabetes

  • Most people with type 1 diabetes should be treated with MDI injections (three to four injections per day of basal and prandial insulin) or continuous subcutaneous insulin infusion (CSII). (A)
  • Most people with type 1 diabetes should be educated in how to match prandial insulin dose to carbohydrate intake, premeal blood glucose, and anticipated activity. (E)
  • Most people with type 1 diabetes should use insulin analogs to reduce hypoglycemia risk. (A)
  • Consider screening those with type 1 diabetes for other autoimmune diseases (thyroid, vitamin B12 deficiency, celiac) as appropriate. (B)

Recommended therapy for type 1 diabetes consists of the following components: 1) use of MDI injections (three to four injections per day of basal and prandial insulin) or CSII therapy; 2) matching prandial insulin to carbohydrate intake, premeal blood glucose, and anticipated activity; and 3) for many patients (especially if hypoglycemia is a problem), use of insulin analogs. There are excellent reviews available that guide the initiation and management of insulin therapy to achieve desired glycemic goals.

Because of the increased frequency of other autoimmune diseases in type 1 diabetes, screening for thyroid dysfunction, vitamin B12 deficiency, or celiac disease should be considered based on signs and symptoms. Periodic screening in the absence of symptoms has been recommended, but the effectiveness and optimal frequency are unclear.

Pharmacological Therapy for Hyperglycemia in Type 2 Diabetes

  • Metformin, if not contraindicated and if tolerated, is the preferred initial pharmacological agent for type 2 diabetes. (A)
  • In newly diagnosed type 2 diabetic patients with markedly symptomatic and/or elevated blood glucose levels or A1C, consider insulin therapy, with or without additional agents, from the outset. (E)
  • If noninsulin monotherapy at maximal tolerated dose does not achieve or maintain the A1C target over 3 to 6 months, add a second oral agent, a glucagon-like peptide-1 (GLP-1) receptor agonist, or insulin. (A)
  • A patient-centered approach should be used to guide choice of pharmacological agents. Considerations include efficacy, cost, potential side effects, effects on weight, comorbidities, hypoglycemia risk, and patient preferences. (E)
  • Due to the progressive nature of type 2 diabetes, insulin therapy is eventually indicated for many patients with type 2 diabetes. (B)

For information about currently approved classes of medications for treating hyperglycemia in type 2 diabetes, see the ADA-European Association for the Study of Diabetes (EASD) position statement.

Medical Nutrition Therapy (MNT)

General Recommendations

  • Individuals who have prediabetes or diabetes should receive individualized MNT as needed to achieve treatment goals, preferably provided by a registered dietitian familiar with the components of diabetes MNT. (A)
  • Because MNT can result in cost savings and improved outcomes (B), MNT should be adequately covered by insurance and other payers. (E)

Energy Balance, Overweight, and Obesity

  • Weight loss is recommended for all overweight or obese individuals who have or are at risk for diabetes. (A)
  • For weight loss, either low-carbohydrate, low-fat calorie-restricted, or Mediterranean diets may be effective in the short term (up to 2 years). (A)
  • For patients on low-carbohydrate diets, monitor lipid profiles, renal function, and protein intake (in those with nephropathy), and adjust hypoglycemic therapy as needed. (E)
  • Physical activity and behavior modification are important components of weight loss programs and are most helpful in maintenance of weight loss. (B)

Primary Prevention of Type 2 Diabetes

  • Among individuals at high risk for developing type 2 diabetes, structured programs that emphasize lifestyle changes that include moderate weight loss (7% body weight) and regular physical activity (150 min/week), with dietary strategies including reduced calories and reduced intake of dietary fat, can reduce the risk for developing diabetes and are therefore recommended. (A)
  • Individuals at high risk for type 2 diabetes should be encouraged to achieve the U.S. Department of Agriculture (USDA) recommendation for dietary fiber (14 g fiber/1,000 kcal) and foods containing whole grains (one-half of grain intake). (B)
  • Individuals at risk for type 2 diabetes should be encouraged to limit their intake of sugar-sweetened beverages. (B)

Management of Diabetes

Macronutrients in Diabetes Management

  • The mix of carbohydrate, protein, and fat may be adjusted to meet the metabolic goals and individual preferences of the person with diabetes. (C)
  • Monitoring carbohydrate, whether by carbohydrate counting, choices, or experience-based estimation, remains a key strategy in achieving glycemic control. (B)
  • Saturated fat intake should be <7% of total calories. (B)
  • Reducing intake of trans fat lowers low-density lipoprotein (LDL) cholesterol and increases high-density lipoprotein (HDL) cholesterol (A); therefore, intake of trans fat should be minimized (E).

Other Nutrition Recommendations

  • If adults with diabetes choose to use alcohol, they should limit intake to a moderate amount (one drink per day or less for adult women and two drinks per day or less for adult men) and should take extra precautions to prevent hypoglycemia. (E)
  • Routine supplementation with antioxidants, such as vitamins E and C and carotene, is not advised because of lack of evidence of efficacy and concern related to long-term safety. (A)
  • It is recommended that individualized meal planning include optimization of food choices to meet recommended daily allowance (RDA)/dietary reference intakes (DRI) for all micronutrients. (E)

Achieving nutrition-related goals requires a coordinated team effort that includes the active involvement of the person with prediabetes or diabetes. Because of the complexity of nutrition issues, it is recommended that a registered dietitian who is knowledgeable and skilled in implementing nutrition therapy into diabetes management and education be the team member who provides MNT.

Diabetes Self-management Education and Support

  • People with diabetes should receive DSME and diabetes self-management support (DSMS) according to National Standards for Diabetes Self-management Education and Support when their diabetes is diagnosed and as needed thereafter. (B)
  • Effective self-management and quality of life are the key outcomes of DSME and DSMS and should be measured and monitored as part of care. (C)
  • DSME and DSMS should address psychosocial issues, since emotional well-being is associated with positive diabetes outcomes. (C)
  • DSME and DSMS programs are appropriate venues for people with prediabetes to receive education and support to develop and maintain behaviors that can prevent or delay the onset of diabetes. (C)
  • Because DSME and DSMS can result in cost-savings and improved outcomes (B), DSME and DSMS should be adequately reimbursed by third-party payers. (E)

Physical Activity

  • Adults with diabetes should be advised to perform at least 150 min/week of moderate-intensity aerobic physical activity (50% to 70% of maximum heart rate), spread over at least 3 days per week with no more than 2 consecutive days without exercise. (A)
  • In the absence of contraindications, people with type 2 diabetes should be encouraged to perform resistance training three times per week. (A)

Psychosocial Assessment and Care

  • It is reasonable to include assessment of the patient's psychological and social situation as an ongoing part of the medical management of diabetes. (E)
  • Psychosocial screening and follow-up may include, but is not limited to, attitudes about the illness, expectations for medical management and outcomes, affect/mood, general and diabetes-related quality of life, resources (financial, social, and emotional) and psychiatric history. (E)
  • Screen for psychosocial problems such as depression and diabetes-related distress, anxiety, eating disorders, and cognitive impairment when self-management is poor. (B)

When Treatment Goals Are Not Met

For a variety of reasons, some people with diabetes and their health care providers do not achieve the desired goals of treatment (see the table above). Rethinking the treatment regimen may require assessment of barriers including income, health literacy, diabetes distress, depression, and competing demands, including those related to family responsibilities and dynamics. Other strategies may include culturally appropriate and enhanced DSME and DSMS, co-management with a diabetes team, referral to a medical social worker for assistance with insurance coverage, or change in pharmacological therapy. Initiation of or increase in SMBG, utilization of CGM, frequent contact with the patient, or referral to a mental health professional or physician with special expertise in diabetes may be useful.

Intercurrent Illness

The stress of illness, trauma, and/or surgery frequently aggravates glycemic control and may precipitate diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state, life-threatening conditions that require immediate medical care to prevent complications and death. Any condition leading to deterioration in glycemic control necessitates more frequent monitoring of blood glucose and (in ketosis-prone patients) urine or blood ketones. Marked hyperglycemia requires temporary adjustment of the treatment program and, if accompanied by ketosis, vomiting, or alteration in the level of consciousness, immediate interaction with the diabetes care team. The patient treated with noninsulin therapies or MNT alone may temporarily require insulin. Adequate fluid and caloric intake must be assured. Infection or dehydration is more likely to necessitate hospitalization of the person with diabetes than the person without diabetes.

The hospitalized patient should be treated by a physician with expertise in the management of diabetes. For further information on management of patients with hyperglycemia in the hospital, see the National Guideline Clearinghouse (NGC) summary of the ADA position statement Standards of medical care in diabetes. IX. Diabetes care in specific settings. For further information on management of DKA or hyperglycemic nonketotic hyperosmolar state, refer to the ADA consensus statement on hyperglycemic crises.

Hypoglycemia

  • Individuals at risk for hypoglycemia should be asked about symptomatic and asymptomatic hypoglycemia at each encounter. (C)
  • Glucose (15 to 20 g) is the preferred treatment for the conscious individual with hypoglycemia, although any form of carbohydrate that contains glucose may be used. If SMBG 15 min after treatment shows continued hypoglycemia, the treatment should be repeated. Once SMBG glucose returns to normal, the individual should consume a meal or snack to prevent recurrence of hypoglycemia. (E)
  • Glucagon should be prescribed for all individuals at significant risk of severe hypoglycemia, and caregivers or family members of these individuals should be instructed in its administration. Glucagon administration is not limited to health care professionals. (E)
  • Hypoglycemia unawareness or one or more episodes of severe hypoglycemia should trigger re-evaluation of the treatment regimen. (E)
  • Insulin-treated patients with hypoglycemia unawareness or an episode of severe hypoglycemia should be advised to raise their glycemic targets to strictly avoid further hypoglycemia for at least several weeks, to partially reverse hypoglycemia unawareness, and to reduce risk of future episodes. (A)
  • Ongoing assessment of cognitive function is suggested with increased vigilance for hypoglycemia by the clinician, patient, and caregivers if low cognition and/or declining cognition is found. (B)

Bariatric Surgery

  • Bariatric surgery may be considered for adults with BMI ≥35 kg/m2 and type 2 diabetes, especially if the diabetes or associated comorbidities are difficult to control with lifestyle and pharmacologic therapy. (B)
  • Patients with type 2 diabetes who have undergone bariatric surgery need lifelong lifestyle support and medical monitoring. (B)
  • Although small trials have shown glycemic benefit of bariatric surgery in patients with type 2 diabetes and BMI of 30 to 35 kg/m2, there is currently insufficient evidence to generally recommend surgery in patients with BMI <35 kg/m2 outside of a research protocol. (E)
  • The long-term benefits, cost-effectiveness, and risks of bariatric surgery in individuals with type 2 diabetes should be studied in well-designed controlled trials with optimal medical and lifestyle therapy as the comparator. (E)

Immunization

  • Annually provide an influenza vaccine to all diabetic patients ≥6 months of age. (C)
  • Administer pneumococcal polysaccharide vaccine to all diabetic patients ≥2 years of age. A one-time revaccination is recommended for individuals >64 years of age previously immunized when they were <65 years of age if the vaccine was administered >5 years ago. Other indications for repeat vaccination include nephrotic syndrome, chronic renal disease, and other immunocompromised states, such as after transplantation. (C)
  • Administer hepatitis B vaccination to unvaccinated adults with diabetes who are aged 19 through 59 years. (C)
  • Consider administering hepatitis B vaccination to unvaccinated adults with diabetes who are aged ≥60 years. (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 most recommendations (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

A focus on the components of comprehensive care will assist the health care team to ensure optimal management of the patient with diabetes.

Potential Harms
  • Intensive insulin therapy was associated with a high rate of severe hypoglycemia in the Diabetes Control and Complications Trial (DCCT). However, a number of rapid-acting and long-acting insulin analogs have been developed that are associated with less hypoglycemia with equal glycosylated hemoglobin (A1C)-lowering in type 1 diabetes.
  • Bariatric surgery is costly in the short term and has some risks. Rates of morbidity and mortality directly related to the surgery have been reduced considerably in recent years, with 30-day mortality rates now 0.28%, similar to those of laparoscopic cholecystectomy. Longer-term concerns include vitamin and mineral deficiencies, osteoporosis, and rare but often severe hypoglycemia from insulin hypersecretion.
  • In individuals taking insulin and/or insulin secretagogues, physical activity can cause hypoglycemia if medication dose or carbohydrate consumption is not altered.
  • When people with type 1 diabetes are deprived of insulin for 12–48 h and are ketotic, exercise can worsen hyperglycemia and ketosis; therefore, vigorous activity should be avoided in the presence of ketosis. However, it is not necessary to postpone exercise based simply on hyperglycemia, provided the patient feels well and urine and/or blood ketones are negative.
  • People with diabetic autonomic neuropathy should undergo cardiac investigation before beginning physical activity more intense than that to which they are accustomed.

Contraindications

Contraindications
  • Providers should assess patients for conditions that might contraindicate certain types of exercise or predispose to injury, such as uncontrolled hypertension, severe autonomic neuropathy, severe peripheral neuropathy or history of foot lesions, and unstable proliferative retinopathy. The patient's age and previous physical activity level should be considered.
  • In the presence of proliferative diabetic retinopathy (PDR) or severe nonproliferative diabetic retinopathy (NPDR), vigorous aerobic or resistance exercise may be contraindicated because of the risk of triggering vitreous hemorrhage or retinal detachment.

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 multiple risk factor control, the optimal way to achieve this result is less clear. It is difficult to assess each component of such a complex intervention.
  • Although 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

Although 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) has been shown in numerous studies to be an effective framework for improving the quality of diabetes care. The 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.

The 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; 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
Resources
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

Identifying Information and Availability

Bibliographic Source(s)
Standards of medical care in diabetes. V. Diabetes care. Diabetes Care. 2013 Jan;36(Suppl 1):S16-28.
Adaptation

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

Date Released
1998 (revised 2013 Jan)
Guideline Developer(s)
American Diabetes Association - Professional Association
Source(s) of Funding

The American Diabetes Association (ADA) funds development of the standards and all its position statements out of its general revenues and does not use industry support for these purposes.

Guideline Committee

Professional Practice Committee

Composition of Group That Authored the Guideline

Committee Members: Roger Austin, MS, RPH, CDE; Nathaniel G. Clark, MD, RD; Cyrus V. Desouza, MD; Martha Funnell, MSN, RN, CDE; Allison B. Goldfine, MD; Richard Grant, MD, MPH; James Lenard, MD; Jennifer B. Marks, MD; Anthony L. McCall, MD, PhD; Janis R. McWilliams, RN, MSN, CDE, BC-ADM; R. Harsha Rao, MD; Andrew Rhinehart, MD, CDE, BC-ADM, FACP; Henry Rodriguez, MD; Debra L. Simmons, MD, MS; Patricia Urbanski, MEd, RD, LD, CDE; Carol Wysham, MD (Chair); 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. These disclosures were discussed at the onset of the standards revision meeting.

Members of the committee, their employer, and their disclosed conflicts of interest are listed in the "Professional Practice Committee for the 2013 Clinical Practice Recommendations" 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: Standards of medical care in diabetes. V. Diabetes care. Diabetes Care 2012 Jan;35(Suppl 1):S16-28.

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 2013 Jan;36(Suppl 1):S1-S2.
  • Summary of revisions for the 2013 clinical practice recommendations. Diabetes Care 2013 Jan;36(Suppl 1):S3.
  • Executive summary: standards of medical care in diabetes. Diabetes Care 2013 Jan;36(Suppl 1):S4-S10.
  • Diagnosis and classification of diabetes mellitus. Diabetes Care 2013 Jan;36(Suppl 1):S67-S74.
  • Third-party reimbursement for diabetes care, self-management education, and supplies. Diabetes Care 2013 Jan;36(Suppl 1):S98-99.
  • Professional Practice Committee 2013 (includes conflict of interest disclosure). Diabetes Care 2013 Jan;36(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:

  • 2013 Standards of medical care in diabetes. Clinical practice recommendations. Slide set. American Diabetes Association; 2013 Jan. 146 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 May 10, 2002. This summary was updated on July 29, 2003, March 23, 2004, July 1, 2005, and March 16, 2006. This summary was updated most recently by ECRI Institute on April 25, 2007. The updated information was verified by the guideline developer on April 30, 3007. 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 May 20, 2010. The information was verified by the guideline developer on May 25, 2010. This summary was updated by ECRI Institute on November 12, 2010 following the U.S. Food and Drug Administration (FDA) advisory on Afluria (influenza virus vaccine). This summary was updated by ECRI Institute on February 25, 2011, May 10, 2012, and on June 12, 2013.

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.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouseâ„¢ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

Read full disclaimer...