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Guideline Summary
Guideline Title
American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan.
Bibliographic Source(s)
Handelsman Y, Mechanick JI, Blonde L, Grunberger G, Bloomgarden ZT, Bray GA, Dagogo-Jack S, Davidson JA, Einhorn D, Ganda O, Garber AJ, Hirsch IB, Horton ES, Ismail-Beigi F, Jellinger PS, Jones KL, Jovanovic L, Lebovitz H, Levy P, Moghissi ES, Orzeck EA, Vinik AI, Wyne KL, AACE Task Force for Developing Diabetes Comprehensive Care Plan. American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract. 2011 Mar-Apr;17(Suppl 2):1-53. [375 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. AACE diabetes mellitus guidelines. Endocr Pract 2007 May-Jun;13(Suppl 1).

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.

  • November 25, 2013 – Rosiglitazone-containing Diabetes Medicines External Web Site Policy: The U.S. Food and Drug Administration (FDA) has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010. This decision is based on FDA review of data from a large, long-term clinical trial and is supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute (DCRI).

Scope

Disease/Condition(s)

Diabetes mellitus, including:

  • Type 1 diabetes
  • Type 2 diabetes
  • Gestational diabetes
Guideline Category
Diagnosis
Evaluation
Management
Prevention
Risk Assessment
Screening
Treatment
Clinical Specialty
Cardiology
Endocrinology
Family Practice
Internal Medicine
Nephrology
Nursing
Nutrition
Obstetrics and Gynecology
Ophthalmology
Pediatrics
Podiatry
Preventive Medicine
Psychiatry
Sleep Medicine
Intended Users
Advanced Practice Nurses
Dietitians
Health Care Providers
Nurses
Physician Assistants
Physicians
Podiatrists
Guideline Objective(s)
  • To provide an education resource for the development of a comprehensive care plan for clinical endocrinologists and other clinicians who care for patients with diabetes mellitus (DM)
  • To provide an evidence-based resource developed in 2011 addressing specific problems in DM care
  • To provide a document that can eventually be implemented electronically in clinical practices to assist with decision making for patients with DM
Target Population

Children, adolescents, and adults with or at risk of developing diabetes mellitus

Interventions and Practices Considered

Diagnosis

  1. Fasting plasma glucose (FPG) concentration
  2. Oral glucose tolerance test
  3. Hemoglobin A1C level
  4. Assessment of symptoms of uncontrolled hyperglycemia (e.g., polyuria, polydipsia, polyphagia)

Screening/Prevention

  1. Monitoring patients with prediabetes (annual measurements of FPG, and/or oral glucose tolerance test, A1C levels, cardiovascular disease risk factors)
  2. Lifestyle modifications (weight loss, including pharmacotherapy, laparoscopic-assisted gastric banding, and increased physical activity)
  3. Metformin or thiazolidinediones
  4. Screening for depression

Treatment/Management

  1. Comprehensive treatment program
  2. Multidisciplinary team approach
  3. Patient self-management education
  4. Glucose monitoring
  5. Glucose targets
  6. Pharmacotherapy (insulin, metformin, thiazolidinediones [TZD], sulfonylureas, pramlintide)
  7. Modification of cardiovascular risk factors
    • Blood pressure control (Dietary Approaches to Stop Hypertension [DASH] diet, angiotensin-converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], beta-blockers, calcium channel blockers)
    • Dyslipidemia control (statins, bile acid sequestrants, niacin and/or cholesterol absorption inhibitors)
    • Smoking cessation
    • Therapeutic lifestyle changes (medical nutrition therapy, regular exercise)
  8. Management of microvascular, neuropathic, and other complications
    • Serum creatinine and estimated glomerular filtration rate (eGFR)
    • Retinal examination and treatment of retinopathy
    • Examination and treatment of neuropathies (regular foot inspection, exercise, balance training, orthotics, tricyclic antidepressants, anticonvulsants, serotonin and norepinephrine reuptake inhibitors)
    • Asymptomatic coronary artery disease (measurement of coronary artery calcification, coronary imaging)
    • Assessment for sleep related problem (obstructive sleep apnea, restless leg syndrome)
Major Outcomes Considered
  • Incidence of prediabetes, diabetes mellitus, and gestational diabetes mellitus
  • Rate of progression from prediabetes to diabetes
  • Rate of glycemic control
  • Incidence of cardiovascular and microvascular disease (retinopathy, nephropathy, and neuropathy)
  • Adverse effects of therapy
  • Mortality
  • Quality of life

Methodology

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

Literature Searches

Literature searches are done by primary writers with assistance by American Association of Clinical Endocrinologists (AACE) staff and are guided by middle-range theories to account for complex interactions in patient management. Middle-range theories organize facts or observations into a structurally coherent system that can ultimately explain reality. A middle-range theory lies between detailed descriptions and generalized models.

Selection

Although many highest evidence level (EL) 1 studies consisting of randomized controlled trials (RCTs), and meta-analyses of these trials are cited in this CPG, in the interest of conciseness, there is also a deliberate, preferential, and frequent citation of derivative EL 4 publications that include many primary evidence citations (EL 1, EL 2, and EL 3).

Refer to the AACE Protocol for Standardized Production of Clinical Practice Guidelines—2010 Update for additional methodology information (see the "Availability of Companion Documents" field).

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

2010 American Association of Clinical Endocrinologists Protocol for Production of Clinical Practice Guidelines—Step I: Evidence Ratinga

Numerical Descriptor
(evidence level)b
Semantic Descriptor (reference methodology)
1 Meta-analysis of randomized controlled trials (MRCT)
1 Randomized controlled trials (RCT)
2 Meta-analysis of nonrandomized prospective or case-controlled trials (MNRCT)
2 Nonrandomized controlled trial (NRCT)
2 Prospective cohort study (PCS)
2 Retrospective case-control study (RCCS)
3 Cross-sectional study (CSS)
3 Surveillance study (registries, surveys, epidemiologic study, retrospective chart review, mathematical modeling of database) (SS)
3 Consecutive case series (CCS)
3 Single case reports (SCR)
4 No evidence (theory, opinion, consensus, review, or preclinical study) (NE)

a Adapted from: American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Practice Guidelines--2010 update. Endocr Pract. 2010;16:270-283.

b 1 = strong evidence; 2 = intermediate evidence; 3 = weak evidence; and 4 = no evidence.

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

Comments are provided regarding evidentiary strengths and weaknesses, as follows:

2010 American Association of Clinical Endocrinologists Protocol for Production of Clinical Practice Guidelines—Step II: Evidence Analysis and Subjective Factorsa

Study Design Data Analysis Interpretation of Results

Premise correctness
Allocation concealment (randomization)
Selection bias
Appropriate blinding
Using surrogate end points (especially in
"first-in-its-class" intervention)
Sample size (beta error)
Null hypothesis versus Bayesian statistics

Intent-to-treat
Appropriate statistics

Generalizability
Logical
Incompleteness
Validity

aAdapted from: American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Practice Guidelines--2010 update. Endocr Pract. 2010;16:270-283.

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

The entire American Association of Clinical Endocrinologists (AACE) clinical practice guideline (CPG) development process is conducted free of industry involvement. Once the CPG topic is assigned, the chairperson and primary writers are identified. Then middle-range theories are generated that will guide the systematic literature search. Once this has been completed, there are four sequential steps in the integration of clinical evidence into recommendation grades:

  • Step I: Evidence rating based on methodology
  • Step II: Analysis of evidence and identification of subjective factors
  • Step III: Phrasing, determining level of consensus, and alphabetic grading of recommendations
  • Step IV: Appending qualifiers to recommendations

The AACE Board of Directors mandated a new CPG for the development of a diabetes mellitus (DM) comprehensive care plan. This CPG was developed in accordance with the "AACE Protocol for Standardized Production of Clinical Practice Guidelines—2010 Update" (see the "Availability of Companion Documents" field). Reference citations in the text of the original guideline document include the reference number, numerical descriptor (evidence level [EL] 1-4), and semantic descriptor (see the "Rating Scheme for the Strength of the Evidence" field). Recommendations are assigned EL ratings on the basis of the quality of supporting evidence, all of which have also been rated for strength (see the "Rating Scheme for the Strength of the Recommendations"). The format of this CPG is based on specific and relevant clinical questions.

Rating Scheme for the Strength of the Recommendations

2010 American Association of Clinical Endocrinologists Protocol for Production of Clinical Practice Guidelines—Step III: Grading of Recommendations; How Different Evidence Levels Can Be Mapped to the Same Recommendation Gradea,b

Best Evidence Level Subjective Factor Impact Two-thirds Consensus Mapping Recommendation Grade
1 None Yes Direct A
2 Positive Yes Adjust up A
2 None Yes Direct B
1 Negative Yes Adjust down B
3 Positive Yes Adjust up B
3 None Yes Direct C
2 Negative Yes Adjust down C
4 Positive Yes Adjust up C
4 None Yes Direct D
3 Negative Yes Adjust down D
1, 2, 3, 4 NA No Adjust down D

a Starting with the left column, best evidence levels (BELs), subjective factors, and consensus map to recommendation grades in the right column. When subjective factors have little or no impact ("none"), then the BEL is directly mapped to recommendation grades. When subjective factors have a strong impact, then recommendation grades may be adjusted up ("positive" impact) or down ("negative" impact). If a two-thirds consensus cannot be reached, then the recommendation grade is D. NA, not applicable (regardless of the presence or absence of strong subjective factors, the absence of a two-thirds consensus mandates a recommendation grade D).

b Adapted from: American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Practice Guidelines--2010 update. Endocr Pract. 2010;16:270-283.

Cost Analysis
  • Surgical intervention in obesity significantly reduces the risk of diabetes mellitus and the risk of future mortality and is cost-effective.
  • Concerns have been raised about the costs incurred by continuous subcutaneous insulin injection (CSII). However, recent evidence indicates that CSII is a cost-effective treatment option, both in general and compared with multiple daily injections (MDI) for children and adults with type 1 diabetes mellitus. Table 10 in the original guideline document summarizes the key assumptions and findings of 5 recent representative cost-effectiveness analyses comparing CSII with MDI in specific patient populations.
  • Evidence suggests that referral of patients with stage 4 chronic kidney disease to a nephrologist is cost-effective and delays the time to dialysis treatment.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

This clinical practice guideline (CPG) has been reviewed and approved by the primary writers, other invited experts, the American Association of Clinical Endocrinologists (AACE) Publications Committee, and the AACE Board of Directors before submission for peer review by Endocrine Practice.

Recommendations

Major Recommendations

The levels of evidence (1 to 4) and the recommendation grades (A to D) are defined at the end of the "Major Recommendations" field.

Executive Summary of Recommendations

The following recommendations (labeled "R") are evidence based (Grades A, B, and C) or are based on expert opinion because of a lack of conclusive clinical evidence (Grade D). The best evidence level (BEL), which corresponds to the best conclusive evidence found, accompanies the recommendation grade in this Executive Summary.

How is Diabetes Mellitus (DM) Diagnosed and Classified?

Diagnosis of DM

R1. The following criteria may be used to diagnose DM (see Table below) (Grade A; BEL 1):

  • Fasting plasma glucose (FPG) concentration (after 8 or more hours of no caloric intake) of 126 mg/dL or greater, or
  • Plasma glucose concentration of 200 mg/dL or greater 2 hours after ingesting 75-g oral glucose load in the morning after an overnight fast of at least 8 hours, or
  • Symptoms of uncontrolled hyperglycemia (e.g., polyuria, polydipsia, polyphagia) and a random (casual, nonfasting) plasma glucose concentration of 200 mg/dL or greater, or
  • Hemoglobin A1C (A1C) level of 6.5% or higher.

In the absence of unequivocal hyperglycemia or severe metabolic stress, the same test (glucose or A1C measurement) should be repeated on a different day to confirm the diagnosis of DM (Grade D; BEL 4). Screening should be considered in the presence of risk factors for DM (see Table below) (Grade D; BEL 4).

R2. There is a continuum of risk for poor patient outcomes in the progression from normal glucose tolerance to overt type 2 DM (T2DM) (Grade D; BEL 4). Prediabetes can be identified by the presence of impaired glucose tolerance, which is an oral glucose tolerance test glucose value of 140 to 199 mg/dL, 2 hours after ingesting 75 g of glucose, and/or impaired fasting glucose, which is a fasting glucose value of 100 to 125 mg/dL (see Table below) (Grade D; BEL 4). A1C values between 5.5% and 6.4% should be a signal to do more specific glucose testing (Grade D; BEL 4). A1C testing should be used as a screening tool only; FPG measurement or an oral glucose tolerance test should be used for definitive diagnosis (Grade D; BEL 4). Metabolic syndrome based on National Cholesterol Education Program IV Adult Treatment Panel III criteria is a prediabetes equivalent (Grade C; BEL 3).

R3. In pregnancy, elevated plasma glucose levels (FPG concentration >92 mg/dL; 1-hour postchallenge glucose value ≥180 mg/dL; or 2-hour value ≥153 mg/dL) satisfy the criteria for a diagnosis of gestational DM (GDM) (Grade C; BEL 3). All pregnant women should be screened for GDM at 24 to 28 weeks' gestation, using a 75-g (glucose), 2-hour oral glucose tolerance test.

Table. Glucose Testing and Interpretation

Test Result Diagnosis
Fasting plasma glucose, mg/dL ≤99 Normal
100-125 Impaired fasting glucose
≥126 Diabetes, confirmed by repeating the test on a different day
Glucose, mg/dL (oral glucose tolerance test, 2 hours after ingestion of 75-g glucose load) ≤139 Normal
140-199 Impaired glucose tolerance
≥200 Diabetes, confirmed by repeating the test on a different day
Hemoglobin A1C, % (as a screening test) ≤5.4 Normal
5.5-6.4 High risk/prediabetes; requires screening by glucose criteria
≥6.5 Diabetes, confirmed by repeating the test on a different day

Classification of DM

DM represents a group of heterogeneous metabolic disorders that develop when insulin secretion is insufficient to maintain normal plasma glucose levels.

R4. T2DM is the most common form of DM, accounting for more than 90% of cases. It is typically identified in patients older than 30 years who are overweight or obese and/or have a positive family history, but do not have autoantibodies characteristic of type 1 DM (T1DM). Most persons with T2DM have evidence of insulin resistance (such as high triglycerides or low high-density lipoprotein cholesterol [HDL-C]) (Grade A; BEL 1).

R5. T1DM is usually characterized by absolute insulin deficiency and may be confirmed by the presence of autoantibodies to glutamic acid decarboxylase, pancreatic islet b cells (tyrosine phosphatase IA-2), and/or insulin (Grade A; BEL 1). Some forms of T1DM have no evidence of autoimmunity and have been termed idiopathic. T1DM or monogenic DM can also occur in obese children and adolescents. Therefore, documenting the levels of insulin and C-peptide and the presence or absence of immune markers and obtaining a careful family history in addition to the clinical presentation may be useful in establishing the correct diagnosis, determining treatment, and helping to distinguish between T1DM and T2DM in children (Grade A; BEL 1).

R6. GDM is a condition in which women without previously diagnosed DM exhibit elevated plasma glucose levels (see R3 above) (Grade C; BEL 3).

R7. Evaluation for monogenic DM (formerly maturity-onset diabetes of the young) is recommended for any child with an atypical presentation, course, or response to therapy. Diagnostic likelihood is strengthened by a family history over 3 generations suggesting autosomal dominant inheritance. This type of DM can occur in the child before appearing in the parent or other relatives (Grade A; BEL 1).

How Can DM Be Prevented?

R8. T2DM can be prevented or at least delayed by intervening in persons who have prediabetes (see Table below for prediabetes risk factors suggesting a need for screening). Monitoring of patients with prediabetes to assess their glycemic status should include at least annual measurement of FPG and/or an oral glucose tolerance test (see Table above) (Grade D; BEL 4). A1C should be for screening use only (Grade D; BEL 4). Cardiovascular disease (CVD) risk factors (especially elevated blood pressure and/or dyslipidemia) and excessive weight should be addressed and monitored at regular intervals (Grade D; BEL 4).

R9. Persons with prediabetes should modify their lifestyle, including initial attempts to lose 5% to 10% of body weight if overweight or obese and participation in moderate physical activity (e.g., walking) at least 150 minutes per week (Grade D; BEL 4). Organized programs with follow-up appear to benefit these efforts (Grade A; BEL 1).

R10. In addition to lifestyle measures, metformin or perhaps thiazolidinediones (TZDs) should be considered for younger patients who are at moderate to high risk for developing DM; for patients with additional CVD risk factors including hypertension, dyslipidemia, or polycystic ovarian syndrome; for patients with a family history of DM in a first-degree relative; and/or for patients who are obese (Grade A; BEL 1).

R11. Obesity is a major risk factor for T2DM and for CVD. Lifestyle modification (primarily calorie reduction and appropriately prescribed physical activity) is the cornerstone in the control of obesity in T2DM (Grade A; BEL 1). Pharmacotherapy for weight loss may be considered when lifestyle modification fails to achieve the targeted goal in patients with T2DM and a body mass index greater than 27 kg/m2 (Grade D; BEL 4). Consideration may be given to laparoscopic-assisted gastric banding in patients with T2DM who have a body mass index greater than 30 kg/m2 or Roux-en-Y gastric bypass for patients with a body mass index greater than 35 kg/m2 to achieve at least short-term weight reduction (Grade A; BEL 1). Patients with T2DM who undergo Roux-en-Y gastric bypass must have meticulous metabolic postoperative follow-up because of a risk of vitamin and mineral deficiencies and hypoglycemia (Grade D; BEL 4).

Table. Prediabetes Risk Factors Suggesting a Need for Screening (2 [EL 4; consensus no evidence (NE)])

Family history of diabetes mellitus
Cardiovascular disease
Being overweight or obese
Sedentary lifestyle
Nonwhite ancestry
Previously identified impaired glucose tolerance, impaired fasting glucose, and/or metabolic syndrome
Hypertension
Increased levels of triglycerides, low concentrations of high-density lipoprotein cholesterol, or both
History of gestational diabetes mellitus
Delivery of a baby weighing more than 4 kg (9 lb)
Polycystic ovary syndrome
Antipsychotic therapy for schizophrenia and/or severe bipolar disease

What Is the Role of a DM Comprehensive Care Plan?

R12. Every patient with documented DM requires a comprehensive treatment program, which takes into account the patient's unique medical history, behaviors and risk factors, ethnocultural background, and environment (Grade A; BEL 4; upgraded by unanimous consensus as prime importance in this CPG).

Multidisciplinary Team Approach

R13. An organized multidisciplinary team may best deliver care for patients with DM. Members of such a team can include a primary care physician, endocrinologist, physician assistant, nurse practitioner, registered nurse, certified diabetes educator (CDE), dietitian, exercise specialist, and mental health care professional. The educational, social, and logistical elements of therapy and the variation in successful care delivery associated with age and maturation present additional complexity when caring for children with DM (Grade D; BEL 4).

DM Self-Management Education

R14. Persons with DM should receive comprehensive DM self-management education at the time of DM diagnosis and subsequently as appropriate. Therapeutic lifestyle management must be discussed with all patients with DM and prediabetes at the time of diagnosis and throughout their lifetime. This includes medical nutrition therapy (with reduction and modification of caloric and fat intake to achieve weight loss in those who are overweight or obese), appropriately prescribed physical activity, avoidance of tobacco products, and adequate quantity and quality of sleep (Grade D; BEL 4).

See Appendix in the original guideline document for Q4: What is the Imperative for Education and Team Approach in DM Management?

What Are the Comprehensive Treatment Goals for Persons With DM?

Glycemic and A1C Goals

Outpatient Glucose Targets for Nonpregnant Adults

R15. Glucose targets should be individualized and take into account residual life expectancy, duration of disease, presence or absence of microvascular and macrovascular complications, CVD risk factors, comorbid conditions and risk for severe hypoglycemia. Glucose targets should also be formulated in the context of the patient's psychological, social, and economic status (Grade A; BEL 1). In general, therapy should target a A1C level of 6.5% or less for most nonpregnant adults, if it can be achieved safely (Grade D; BEL 4) (see Table 7 in the original guideline document). To achieve this target A1C level, FPG should usually be less than 110 mg/dL and the 2-hour postprandial glucose concentration should be less than 140 mg/dL (Grade B; BEL 2) (see Table 7 in the original guideline document).

In adults with recent onset of T2DM and no clinically significant CVD, glycemic control aimed at normal (or near-normal) glycemia may be considered, with the aim of preventing the development of microvascular (Grade A; BEL 1) and macrovascular complications over a lifetime, if it can be achieved without substantial hypoglycemia or other unacceptable adverse consequences. Although it is uncertain that the clinical course of established CVD is improved by strict glycemic control, the progression of microvascular complications clearly is benefitted (Grade A; BEL 1). In certain patients, a less stringent goal may be considered (A1C 7%-8%) (Grade A; BEL 1). Such individuals those with history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, extensive comorbid conditions, or long-standing DM in which the general goal has been difficult to attain despite intensive efforts (Grade A; BEL 1).

Inpatient Glucose Targets for Nonpregnant Adults

R16. For most hospitalized persons with hyperglycemia, a glucose range of 140 to 180 mg/dL is recommended, provided these targets can be safely achieved (see Table 7 in the original guideline document) (Grade D; BEL 4).

Outpatient Glucose Targets for Pregnant Women

R17. For women with GDM, treatment goals are a preprandial glucose concentration of 95 mg/dL or lower and either a 1-hour postmeal glucose value of 140 mg/dL or less or a 2-hour postmeal glucose value of 120 mg/dL or less (Grade D; BEL 4). For women with preexisting T1DM or T2DM who become pregnant, glycemic goals are a premeal, bedtime, and overnight glucose values of 60 to 99 mg/dL; a peak postprandial glucose value of 100 to 129 mg/dL; and a A1C value of 6.0% or less—only if they can be achieved safely (Grade D; BEL 4).

CVD Risk Reduction Targets

R18. CVD is the primary cause of death for most persons with DM; therefore a DM comprehensive care plan should include modification of CVD risk factors (Grade A; BEL 1). Cardiovascular risk reduction targets are summarized in Table 7 in the original guideline document.

Blood Pressure

R19. The blood pressure goal for persons with DM or prediabetes is less than 130/80 mm Hg (see Table 7 in the original guideline document) (Grade D; BEL 4).

Lipids

R20. Treatment targets for dyslipidemia are based on established CVD risk reduction recommendations. In persons with DM or prediabetes and no CVD or minimal CV risk, the low-density lipoprotein cholesterol (LDL-C) goal of less than 100 mg/dL is the primary target for therapy. The goal for non–HDL-C is less than 130 mg/dL. The highest-risk patients are those with established CVD or more than 2 major CVD risk factors. For these patients, LDL-C remains the primary target for therapy with a goal of less than 70 mg/dL. The non–HDL-C treatment goal is less than 100 mg/dL (see Table 7 in the original guideline document) (Grade A; BEL 1). HDL-C values greater than 40 mg/dL in men and greater than 50 mg/dL in women are desirable. If the triglyceride concentration is 200 mg/dL or greater, non–HDL-C becomes a secondary target (Grade C; BEL 3).

How Can DM Comprehensive Care Plan Guideline Targets Be Achieved?

Therapeutic Lifestyle Changes

R21. Medical nutritional therapy must be individualized, and this generally means evaluation and teaching by a trained nutritionist/registered dietitian or knowledgeable physician (Grade D; BEL 4). Insulin dosage adjustments to match carbohydrate intake (e.g., use of carbohydrate counting), sucrose-containing or high glycemic index food limitations, adequate protein intake, "heart healthy" diet use, weight management, and sufficient physical activity are recommended.

R22. Regular physical activity, both aerobic and strength training, are important to improve a variety of CVD risk factors, decrease risk of falls and fractures, improve functional capacity and sense of well-being, and improve glucose control in persons with T2DM. Increased physical activity is also a major component in weight loss and weight maintenance programs. The current recommendations of at least 150 minutes per week of moderate-intensity exercise, such as brisk walking or its equivalent, are now well accepted and part of the nationally recommended guidelines. For persons with T2DM, it is also recommended to incorporate flexibility and strength training exercises. Patients must be evaluated initially for contraindications and/or limitations to physical activity, and then an exercise prescription should be developed for each patient according to both their goals and exercise limitations. Physical activity programs should begin slowly and build up gradually (Grade D; BEL 4).

Antihyperglycemic Pharmacotherapy

The choice of therapeutic agents should be based on their differing metabolic actions and adverse effect profiles as described in the 2009 American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) Diabetes Algorithm for Glycemic Control (Grade D; BEL 4).

R23. Insulin is required in all patients with T1DM, and it should be considered for patients with T2DM when noninsulin antihyperglycemic therapy fails to achieve target glycemic control or when a patient, whether drug naïve or not, has symptomatic hyperglycemia (Grade A; BEL 1).

R24. Antihyperglycemic agents may be broadly categorized by whether they predominantly target FPG or PPG levels. These effects are not exclusive; drugs acting on FPG passively reduce PPG, and drugs acting on PPG passively reduce FPG, but these broad categories can aid in therapeutic decision-making. TZDs and sulfonylureas are examples of oral agents primarily affecting FPG. Metformin and incretin enhancers (dipeptidyl-peptidase 4 inhibitors [DPP-4 inhibitors]) also favorably affect FPG. When insulin therapy is indicated in patients with T2DM to target FPG, therapy with long-acting basal insulin should be the initial choice in most cases; insulin analogues glargine and detemir are preferred over intermediate-acting neutral protamine Hagedorn (NPH) because they are associated with less hypoglycemia (Grade A; BEL 1). The initial choice of an agent targeting FPG or PPG involves comprehensive patient assessment with emphasis given to the glycemic profile obtained by self-monitoring of blood glucose (SMBG).

R25. When postprandial hyperglycemia is present, glinides and/or a-glucosidase inhibitors, short- or rapid-acting insulin, and metformin should be considered (Grade A; BEL 1). Incretin-based therapy (DPP-4 inhibitors and glucagon-like peptide 1 [GLP-1] receptor agonists, especially short-acting GLP-1 agonists) also target postprandial hyperglycemia in a glucose-dependent fashion, which reduces the risks of hypoglycemia. When control of postprandial hyperglycemia is needed and insulin is indicated, rapid-acting insulin analogues are preferred over regular human insulin because they have a more rapid onset and offset of action and are associated with less hypoglycemia (Grade A; BEL 1). Pramlintide can be used as an adjunct to prandial insulin therapy to reduce postprandial hyperglycemia, A1C, and weight (Grade A; BEL 1).

R26. Premixed insulin (fixed combination of shorter- and longer-acting components) analogue therapy may be considered for patients in whom adherence to a drug regimen is an issue; however, these preparations lack component dosage flexibility and may increase the risk for hypoglycemia compared with basal insulin or basal-bolus insulin (Grade D; BEL 4). Basal-bolus insulin therapy is flexible and is recommended for intensive insulin therapy (Grade B; BEL 3).

R27. Intensification of pharmacotherapy requires glucose monitoring and medication adjustment at appropriate intervals when treatment goals are not achieved or maintained (Grade D; BEL 4). Most patients with an initial A1C level greater than 7.5% will require combination therapy using agents with complementary mechanisms of action (Grade D; BEL 4). The AACE algorithm outlines treatment choices on the basis of the current A1C level (Grade D; BEL 4).

What Are Some Special Considerations for Treatment of Hyperglycemia?

Treatment of Hyperglycemia in T1DM

R28. Physiologic insulin regimens, which provide both basal and prandial insulin, are recommended for most patients with T1DM (Grade A; BEL 1). These regimens include (a) use of multiple daily injections (MDI), which usually provide 1 or 2 injections daily of basal insulin to control glycemia between meals and overnight and injections of prandial insulin before each meal to control meal-related glycemia; (b) the use of continuous subcutaneous insulin infusion (CSII) to provide a more physiologic way to deliver insulin, which may improve glucose control while reducing risks of hypoglycemia; and (c) for other patients (especially if hypoglycemia is a problem), the use of insulin analogues (Grade A; BEL 1).

CSII (Insulin Pump Therapy)

R29. CSII is useful in motivated and DM-educated patients with T1DM and in certain insulinopenic patients with T2DM who are unable to achieve optimal glycemic control with MDI. Thorough education and periodic reevaluation of CSII users, as well as CSII expertise of the prescribing physician, is necessary to ensure patient safety (Grade D; BEL 4). Sensor-augmented CSII should be considered in patients in whom it is deemed appropriate (Grade B; BEL 2).

Treatment of Hyperglycemia in Children and Adolescents

R30. The pharmacologic treatment of any form of DM in children does not, at this stage of our knowledge, differ in substance from treatment in adults (Grade D; BEL 4). In children or adolescents with T1DM, insulin regimens should be MDI or CSII (Grade D; BEL 4), but injection frequencies may become problematic in some school settings. Higher insulin to carbohydrate ratios may be needed during puberty (Grade D; BEL 4). In children or adolescents with T2DM, diet and lifestyle modification are implemented first; addition of metformin and/or insulin should be considered when glycemic targets are not achievable with lifestyle measures alone (Grade C; BEL 3). An extensive review of guidelines for the care of children with DM from the International Society of Pediatric and Adolescent Diabetes was published in 2009 and is available on their Web site (http://www.ispad.org External Web Site Policy).

Treatment of Hyperglycemia in Pregnancy

R31. All women with preexisting DM (T1DM, T2DM, or previous GDM) should have access to preconception care to ensure adequate nutrition and glucose control before conception, during pregnancy, and in the postpartum period (Grade B; BEL 2). Regular or rapid-acting insulin analogues are the preferred treatment for postprandial hyperglycemia in pregnant women. Basal insulin needs can be provided by using rapid-acting insulin via CSII or by using long-acting insulin (e.g., NPH; US Food and Drug Administration [FDA] pregnancy category B) (Grade B; BEL 2). Although insulin is the preferred treatment approach, metformin and glyburide have been shown to be effective alternatives and without adverse effects in some women.

Treatment of Hyperglycemia in Hospitalized Patients

R32. Insulin can rapidly control hyperglycemia and, therefore, is the drug of choice for hospitalized patients with hyperglycemia (Grade D; BEL 4). Subcutaneous insulin orders should be specified as "basal," "prandial," or "correction" (Grade D; BEL 4). Insulin dosing should be synchronized with provision of enteral or parenteral nutrition (Grade D; BEL 4). Exclusive use of "sliding scale insulin" should be discouraged (Grade D; BEL 4). Oral antihyperglycemic agents have a limited role in acute care settings, and practitioners should consider discontinuing them in favor of insulin during acute illness that might reasonably be expected to affect glucose levels and/or increase the risk for medication-related adverse events (Grade D; BEL 4). Regular insulin is acceptable for intravenous administration, but insulin analogues are preferred for subcutaneous administration. Intravenous insulin is preferred for critically ill patients.

When and How Should Glucose Monitoring Be Used?

R33. A1C should be measured at least twice yearly in all patients with DM and at least 4 times yearly in patients not at target (Grade D; BEL 4).

R34. SMBG should be performed by all patients using insulin (minimum of twice daily and ideally at least before any injection of insulin) (Grade D; BEL 4). More frequent SMBG after meals or in the middle of the night may be required for insulin-taking patients with frequent hypoglycemia, patients not at A1C targets, or those with symptoms (Grade D; BEL 4). Patients not requiring insulin therapy may benefit from SMBG, especially to provide feedback about the effects of their lifestyle and pharmacologic therapy; testing frequency must be personalized (Grade D; BEL 4). Although still early in its development, continuous glucose monitoring (CGM) can be useful for many patients to improve A1C levels and reduce hypoglycemia (Grade D; BEL 4).

How Should Hypoglycemia Be Prevented, Identified, and Managed in Patients With DM?

R35. Hypoglycemia treatment requires oral administration of rapidly absorbed glucose (Grade D; BEL 4). If the patient is unable to swallow, parenteral glucagon may be given by a trained family member or by medical personnel (Grade D; BEL 4). In unresponsive patients, intravenous glucose should be given (Grade D; BEL 4). Patients may need to be hospitalized for observation if a sulfonylurea or a very large dose of insulin is the cause of the hypoglycemia because prolonged hypoglycemia can occur (Grade D; BEL 4). If the patient has hypoglycemic unawareness and hypoglycemia-associated autonomic failure, several weeks of hypoglycemia avoidance may reduce the risk or prevent the recurrence of severe hypoglycemia (Grade A; BEL 1). In patients with T2DM who become hypoglycemic and have been treated with an alpha-glucosidase inhibitor in addition to insulin or an insulin secretagogue, oral glucose must be given because alpha-glucosidase inhibitors inhibit the breakdown and absorption of complex carbohydrates and disaccharides (Grade D; BEL 4).

How Should Microvascular and Neuropathic Disease Be Prevented, Diagnosed, and Treated in Patients With DM?

Microvascular and neuropathic complications are most closely associated with glycemic status; the risk for and progression of these complications are reduced by improving glycemic control.

Diabetic Nephropathy

R36. Beginning 5 years after diagnosis in patients with T1DM and at diagnosis in patients with T2DM, an annual assessment of serum creatinine to estimate the glomerular filtration rate (GFR) and urine albumin excretion should be performed to identify, stage, and monitor progression of diabetic nephropathy (Grade D; BEL 4). Patients with diabetic nephropathy should be counseled regarding the increased need for optimal glycemic control, blood pressure control, dyslipidemia control, and smoking cessation (Grade A; BEL 1). When therapy with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers is initiated, renal function and serum potassium levels must be closely monitored (Grade A; BEL 1).

Diabetic Retinopathy

R37. At the time of diagnosis, patients with T2DM should be referred to an experienced ophthalmologist or optometrist for annual dilated eye examination (Grade D; BEL 4). In patients with T1DM, a referral should be made within 5 years of diagnosis (Grade B; BEL 2). Women who are pregnant and have DM should be referred for frequent/repeated eye examinations during pregnancy and 1 year postpartum (Grade C; BEL 3). Patients with active retinopathy should have examinations more frequently than once a year, as should patients receiving vascular endothelial growth factor therapy (Grade D; BEL 4). Optimal glucose, blood pressure, and lipid control should be implemented to slow the progression of retinopathy (Grade D; BEL 4).

Diabetic Neuropathy

R38. Diabetic painful neuropathy is diagnosed clinically and must be differentiated from other painful conditions (Grade D; BEL 4). Interventions that reduce oxidative stress, improve glycemic control, and/or improve dyslipidemia and hypertension might have a beneficial effect on diabetic neuropathy (Grade A; BEL 1). Exercise and balance training may also be beneficial (Grade C; BEL 3). Tricyclic antidepressants, anticonvulsants, and serotonin and norepinephrine reuptake inhibitors are useful treatments (Grade A; BEL 1). Large-fiber neuropathies are managed with strength, gait, and balance training; pain management; orthotics to treat and prevent foot deformities; tendon lengthening for pes equinus from Achilles tendon shortening; and/or surgical reconstruction and full contact casting as needed (Grade A; BEL 1). Small-fiber neuropathies are managed with foot protection (e.g., padded socks), supportive shoes with orthotics if necessary, regular foot and shoe inspection, prevention of heat injury, and use of emollient creams; however, for pain management, the medications mentioned above must be used (Grade A; BEL 1).

How Should Macrovascular Disease Be Prevented, Diagnosed, and Treated in Patients With Prediabetes or DM?

Antiplatelet Therapy

R39. The use of low-dosage aspirin (75-162 mg daily) is recommended for secondary prevention of CVD (Grade A; BEL 1). For primary prevention of CVD, its use may be considered for those at high risk (10-year risk >10%) (Grade D; BEL 4).

Hypertension

R40. Therapeutic recommendations for hypertension should include lifestyle modification to include DASH diet (Dietary Approaches to Stop Hypertension), in particular reduced salt intake, physical activity, and, as needed, consultation with a registered dietician and/or CDE (Grade A; BEL 1). Pharmacologic therapy is used to achieve targets unresponsive to therapeutic lifestyle changes alone. Initially, antihypertensive agents are selected on the basis of their ability to reduce blood pressure and to prevent or slow the progression of nephropathy and retinopathy; angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers are considered the preferred choice in patients with DM (Grade D; BEL 4). The use of combination therapy is likely required to achieve blood pressure targets, including calcium channel antagonists, diuretics, combined a/b-adrenergic blockers, and newer-generation beta-adrenergic blockers in addition to agents that block the renin-angiotensin system (Grade A; BEL 1).

Dyslipidemia

R41. All patients with DM should be screened for dyslipidemia (Grade A; BEL 1). Therapeutic recommendations should include therapeutic lifestyle changes and, as needed, consultation with a registered dietitian and/or CDE (Grade A; BEL 1). Pharmacologic therapy is used to achieve targets unresponsive to therapeutic lifestyle changes alone. LDL-C is the primary target for therapy. Statins are the treatment of choice in the absence of contraindications. Combinations of statins (Grade A; BEL 1) with bile acid sequestrants, niacin, and/or cholesterol absorption inhibitors should be considered in situations of inadequate goal attainment. These agents may be used instead of statins in cases of statin-related adverse events or intolerance (Grade A; BEL 2). In patients with LDL-C at goal, but with triglyceride concentrations of 200 mg/dL or higher or low HDL-C (<35 mg/dL), treatment protocols including the use of fibrates or niacin are used to achieve non–HDL-C goal (<100 mg/dL when at highest risk; <130 mg/dL when at high risk) (Grade A; BEL 1). Apolipoprotein B targets are less than 80 mg/dL in patients with CVD and less than 90 mg/dL in patients without CVD.

Asymptomatic Coronary Artery Disease

R42. Measurement of coronary artery calcification or coronary imaging may be used to assess whether a patient is a reasonable candidate for intensification of glycemic, lipid, and/or blood pressure control (Grade C; BEL 3). Screening for asymptomatic coronary artery disease with various stress tests in patients with T2DM has not been clearly demonstrated to improve cardiac outcomes and is therefore not recommended (Grade D; BEL 4).

How Should Other Common Comorbidities of DM Be Addressed?

Sleep-Related Problems

R43. Obstructive sleep apnea is common and should be screened for in adults with T2DM, especially in men older than 50 years (Grade D; BEL 4). Continuous positive airway pressure should be considered for treating patients with obstructive sleep apnea (Grade A; BEL 1). This condition can be diagnosed by history or by home monitoring, but referral to a sleep specialist should be considered in patients suspected of having obstructive sleep apnea or restless leg syndrome (Grade D; BEL 4).

Depression

R44. Routine depression screening is recommended for adults with DM. Untreated comorbid depression can have serious clinical implications for patients with DM (Grade A; BEL 1).

Definitions:

2010 American Association of Clinical Endocrinologists Protocol for Production of Clinical Practice Guidelines—Step I: Evidence Ratinga

Numerical Descriptor
(evidence level)b
Semantic Descriptor (reference methodology)
1 Meta-analysis of randomized controlled trials (MRCT)
1 Randomized controlled trials (RCT)
2 Meta-analysis of nonrandomized prospective or case-controlled trials (MNRCT)
2 Nonrandomized controlled trial (NRCT)
2 Prospective cohort study (PCS)
2 Retrospective case-control study (RCCS)
3 Cross-sectional study (CSS)
3 Surveillance study (registries, surveys, epidemiologic study, retrospective chart review, mathematical modeling of database) (SS)
3 Consecutive case series (CCS)
3 Single case reports (SCR)
4 No evidence (theory, opinion, consensus, review, or preclinical study) (NE)

a Adapted from: American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Practice Guidelines--2010 update. Endocr Pract. 2010;16:270-283.

b 1 = strong evidence; 2 = intermediate evidence; 3 = weak evidence; and 4 = no evidence.

2010 American Association of Clinical Endocrinologists Protocol for Production of Clinical Practice Guidelines—Step III: Grading of Recommendations; How Different Evidence Levels Can Be Mapped to the Same Recommendation Gradea,b

Best Evidence Level Subjective Factor Impact Two-thirds Consensus Mapping Recommendation Grade
1 None Yes Direct A
2 Positive Yes Adjust up A
2 None Yes Direct B
1 Negative Yes Adjust down B
3 Positive Yes Adjust up B
3 None Yes Direct C
2 Negative Yes Adjust down C
4 Positive Yes Adjust up C
4 None Yes Direct D
3 Negative Yes Adjust down D
1, 2, 3, 4 NA No Adjust down D

a Starting with the left column, best evidence levels (BELs), subjective factors, and consensus map to recommendation grades in the right column. When subjective factors have little or no impact ("none"), then the BEL is directly mapped to recommendation grades. When subjective factors have a strong impact, then recommendation grades may be adjusted up ("positive" impact) or down ("negative" impact). If a two-thirds consensus cannot be reached, then the recommendation grade is D. NA, not applicable (regardless of the presence or absence of strong subjective factors, the absence of a two-thirds consensus mandates a recommendation grade D).

b Adapted from: American Association of Clinical Endocrinologists Protocol for Standardized Production of Clinical Practice Guidelines--2010 update. Endocr Pract. 2010;16:270-283.

Clinical Algorithm(s)

An algorithm for treatment of neuropathic pain after exclusion of nondiabetic etiologies and stabilization of glycemic control is provided in the original guideline document.

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

Intensive treatment of diabetes mellitus and conditions known to be risk factors can significantly decrease the development and/or progression of chronic complications.

Potential Harms
  • Adverse effects associated with pharmacotherapy
  • Perioperative complications from bariatric surgery

Contraindications

Contraindications
  • Liraglutide use is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2.
  • Metformin use is contraindicated in stage 4 and 5 chronic kidney disease.
  • Thiazolidinediones (TZDs) are contraindicated in patients with New York Heart Association class 3 and 4.
  • Valsalva maneuver must not be performed in patients with proliferative retinopathy.

Qualifying Statements

Qualifying Statements
  • These guidelines are a working document that reflects the state of the field at the time of publication. Because rapid changes in this area are expected, periodic revisions are inevitable. The American Association of Clinical Endocrinologists (AACE) encourages medical professionals to use this information in conjunction with their best clinical judgment. The presented recommendations may not be appropriate in all situations. Any decision by practitioners to apply these guidelines must be made in light of local resources and individual patient circumstances.
  • This document represents only a guideline. Individual patient circumstances and presentations differ, and the ultimate clinical management is based on what is in the best interest of the individual patient, involving patient input and reasonable clinical judgment by the treating clinicians.

Implementation of the Guideline

Description of Implementation Strategy

Implementation of clinical practice guidelines (CPGs) adherent with the 2010 American Association of Clinical Endocrinologists (AACE) protocol will include the following factors:

  1. Development of continuing medical education credit linked to the reading of and correct responses to questions on the content of the CPG
  2. Distribution of surveys to AACE membership regarding the relevance and utility of the CPG and then incorporation of responses into CPG updates
  3. Development of electronic implementation of clinical knowledge management systems that are evidence-based and can be integrated with electronic medical records and other health care information systems
Implementation Tools
Clinical Algorithm
Patient Resources
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
Getting Better
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Handelsman Y, Mechanick JI, Blonde L, Grunberger G, Bloomgarden ZT, Bray GA, Dagogo-Jack S, Davidson JA, Einhorn D, Ganda O, Garber AJ, Hirsch IB, Horton ES, Ismail-Beigi F, Jellinger PS, Jones KL, Jovanovic L, Lebovitz H, Levy P, Moghissi ES, Orzeck EA, Vinik AI, Wyne KL, AACE Task Force for Developing Diabetes Comprehensive Care Plan. American Association of Clinical Endocrinologists medical guidelines for clinical practice for developing a diabetes mellitus comprehensive care plan. Endocr Pract. 2011 Mar-Apr;17(Suppl 2):1-53. [375 references] PubMed External Web Site Policy
Adaptation

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

Date Released
2000 Jan (revised 2011 Mar)
Guideline Developer(s)
American Association of Clinical Endocrinologists - Medical Specialty Society
Source(s) of Funding

American Association of Clinical Endocrinologists (AACE)

Guideline Committee

American Association of Clinical Endocrinologists (AACE) Task Force for Developing a Diabetes Comprehensive Care Plan

Composition of Group That Authored the Guideline

Writing Committee

Cochairpersons: Yehuda Handelsman, MD, FACP, FACE, FNLA; Jeffrey I. Mechanick, MD, FACP, FACE, FACN, ECNU; Lawrence Blonde, MD, FACP, FACE; George Grunberger, MD, FACP, FACE

Task Force Members: Zachary T. Bloomgarden, MD, FACE; George A. Bray, MD, MACP, MACE; Samuel Dagogo-Jack, MD, FACE; Jaime A. Davidson, MD, FACP, MACE; Daniel Einhorn, MD, FACP, FACE; Om Ganda, MD, FACE; Alan J. Garber, MD, PhD, FACE; Irl B. Hirsch, MD; Edward S. Horton, MD, FACE; Faramarz Ismail-Beigi, MD, PhD; Paul S. Jellinger, MD, MACE; Kenneth L. Jones, MD; Lois Jovanovič, MD, MACE; Harold Lebovitz, MD, FACE; Philip Levy, MD, MACE; Etie S. Moghissi, MD, FACP, FACE; Eric A. Orzeck, MD, FACP, FACE; Aaron I. Vinik, MD, PhD, FACP, MACP; Kathleen L. Wyne, MD, PhD, FACE

Reviewers

Alan J. Garber, MD, PhD, FACE; Daniel L. Hurley, MD; Farhad Zangeneh, MD, FACP, FACE

Financial Disclosures/Conflicts of Interest

Cochairpersons

Dr. Yehuda Handelsman reports that he has received speakers' bureau honoraria from AstraZeneca, Bristol-Myers Squibb/AstraZeneca, Daiichi Sankyo, Inc, GlaxoSmithKline plc, Merck & Co, Inc, and Novartis AG; consultant honoraria from Bristol-Myers Squibb/AstraZeneca, Daiichi Sankyo, Inc, Gilead, Genentech, Inc, GlaxoSmithKline plc, Merck & Co, Inc, XOMA, Tethys Bioscience, Inc, and Tolerx, Inc; and research grant support from Daiichi Sankyo, Inc, GlaxoSmithKline plc, Novartis AG, NovoNordisk A/S, Takeda Pharmaceuticals North America, Inc, sanofi-aventis U.S., LLC, XOMA, and Tolerx, Inc.

Dr. Jeffrey I. Mechanick reports that he has received speaker honoraria and consultant fees from Abbott Nutrition.

Dr. Lawrence Blonde reports that he has received speaker honoraria from AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc, Bristol-Myers Squibb, Daiichi Sankyo, Inc, Merck & Co, Inc, Santarus, VeroScience, LLC, and NovoNordisk A/S and that he has received consultant honoraria from Amylin Pharmaceuticals, Inc, AstraZeneca, Boehinger Ingelheim Pharmaceuticals, Inc, Bristol-Myers Squibb, Daiichi Sankyo, Inc, GlaxoSmithKline plc, Halozyme Therapeutics, Johnson & Johnson Services, Inc, MannKind Corporation, Merck & Co, Inc, NovoNordisk A/S, Orexigen Therapeutics, Inc, F. Hoffmann-La Roche Ltd, sanofi-aventis U.S., LLC, Santarus, and VeroScience, LLC. He also reports that his institution has received research grant support for his role as investigator from Boehinger Ingelheim Pharmaceuticals, Inc, Eli Lilly and Company, Johnson & Johnson Services, Inc, NovoNordisk A/S, F. Hoffmann-La Roche Ltd, and sanofi-aventis U.S., LLC. He reports that his late spouse's estate contains shares of Amylin Pharmaceuticals, Inc, and Pfizer, Inc.

Dr. George Grunberger reports that he has received speaker honoraria from Eli Lilly and Company, NovoNordisk A/S, Merck & Co, Inc, sanofi-aventis U.S., LLC, AstraZeneca, Bristol-Myers Squibb, Takeda Pharmaceuticals North America, Inc, and GlaxoSmithKline plc and research grant support for his role as investigator from Eli Lilly and Company, NovoNordisk A/S, GlaxoSmithKline plc, and Johnson & Johnson Services, Inc.

Task Force Members

Dr. Zachary T. Bloomgarden reports that he has received speaker honoraria from GlaxoSmithKline plc, Merck & Co, Inc, and NovoNordisk A/S; advisory board/consultant honoraria from Bristol-Myers Squibb/AstraZeneca, Boehinger Ingelheim Pharmaceuticals, Inc, Merck & Co, Inc, Novartis AG, and NovoNordisk A/S; and stockholder dividends from CR Bard Inc, CVS Caremark, F. Hoffmann-La Roche Ltd, and St. Jude Medical, Inc.

Dr. George A. Bray reports that he does not have any relevant financial relationships with any commercial interests.

Dr. Samuel Dagogo-Jack reports that he has received consultant/speaker honoraria from Eli Lilly and Company, GlaxoSmithKline plc, and Merck & Co, Inc; consultant honoraria from F. Hoffmann-La Roche Ltd; and research grant support for his role as principal investigator from AstraZeneca and NovoNordisk A/S.

Dr. Jaime A. Davidson reports that he has received speaker honoraria from Eli Lilly and Company and Takeda Pharmaceuticals North America, Inc; consultant honoraria from Eli Lilly and Company, Generex Biotechnology Corp, NovoNordisk A/S, Merck Sharp & Dohme Corp, and Boehinger Ingelheim Pharmaceuticals, Inc; and data safety monitoring board honoraria from Eli Lilly and Company.

Dr. Daniel Einhorn reports that he has received shares for his role as an advisor from Halozyme Therapeutics, MannKind Corporation, and Freedom Meditech, Inc; consulting fees for his role as chair of the data management committee from Eli Lilly and Company; and consulting fees for his role as executive committee member on the NAVIGATOR Clinical Trial from Novartis AG.

Dr. Om Ganda reports that he has received speaker honoraria from Abbott Laboratories, AstraZeneca, and GlaxoSmithKline plc.

Dr. Alan J. Garber reports that he has received consultant honoraria from F. Hoffmann-La Roche Ltd; speakers' bureau and advisory board honoraria from GlaxoSmithKline plc, Merck & Co, Inc, Daiichi Sankyo, Inc, and NovoNordisk A/S; and clinical research support from Bristol-Myers Squibb, GlaxoSmithKline plc, Merck & Co, Inc, and NovoNordisk A/S.

Dr. Irl B. Hirsch reports that he has received consultant honoraria from Abbott Diabetes Care, Bayer AG, Boehinger Ingelheim Pharmaceuticals, Inc, Johnson & Johnson Services, Inc, and F. Hoffmann-La Roche Ltd and grant support for his role as principal investigator from Halozyme Therapeutics, MannKind Corporation, and NovoNordisk A/S.

Dr. Edward S. Horton reports that he has received speaker honoraria from Merck & Co, Inc; steering committee honoraria from Medtronic, Inc; data and safety monitoring board honoraria from ChemoCentryx, Inc, Takeda Pharmaceuticals North America, Inc, and Boehringer-Ingelheim Pharmaceuticals, Inc; and advisory board honoraria from Merck & Co, Inc, Tethys Bioscience, Inc, Amylin Pharmaceuticals, Inc, Bristol-Myers Squibb, GlaxoSmithKline plc, Metabasis Therapeutics, Inc, NovoNordisk A/S, F. Hoffmann-La Roche Ltd, sanofi-aventis U.S., LLC, and Gilead.

Dr. Faramarz Ismail-Beigi reports that he has received consultant honoraria from Eli Lilly and Company.

Dr. Paul S. Jellinger reports that he has received speaker honoraria from Amylin Pharmaceuticals, Inc, Eli Lilly and Company, Merck & Co, Inc, and NovoNordisk A/S.

Dr. Kenneth L. Jones reports that he does not have any relevant financial relationships with any commercial interests.

Dr. Lois Jovanovič reports that she has received research grant support for her role as investigator from Eli Lilly and Company and NovoNordisk A/S.

Dr. Harold Lebovitz reports that he has received speaker honoraria from Amylin Pharmaceuticals, Inc, Bristol-Myers Squibb, GlaxoSmithKline plc, Merck & Co, Inc, and Biocon.

Dr. Philip Levy reports that he has received speaker honoraria from Bristol-Myers Squibb/AstraZeneca, NovoNordisk A/S, Merck & Co, Inc, Pfizer, Inc, Bristol-Myers Squibb, Amylin Pharmaceuticals, Inc, Daiichi Sankyo, Inc, GlaxoSmithKline plc, Eli Lilly and Company, and sanofi-aventis U.S., LLC; and research grant support from Bristol-Myers Squibb/AstraZeneca, NovoNordisk A/S, Merck & Co, Inc, Pfizer, Inc, and Boehringer-Ingelheim Pharmaceuticals, Inc.

Dr. Etie S. Moghissi reports that she has received speaker honoraria from AstraZeneca, Bristol-Myers Squibb, and NovoNordisk A/S and consultant honoraria from Eli Lilly and Company and NovoNordisk A/S.

Dr. Eric A. Orzeck reports that he has received speaker honoraria from Abbott Laboratories, Eli Lilly and Company, GlaxoSmithKline plc, and NovoNordisk A/S.

Dr. Aaron I. Vinik reports that he has received speakers' bureau/consultant honoraria from Abbott Laboratories, The Ansar Group, Inc, AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline plc, Beecham Pharmaceuticals Pte Ltd, Merck & Co, Inc, Novartis AG, Pfizer, Inc, RW Johnson Pharmaceutical Research Institute, sanofi-aventis U.S., LLC, Takeda Pharmaceuticals North America, Inc, and Tercica, Inc, and research grant support from Abbott Laboritories, GlaxoSmithKline plc, sanofi-aventis U.S., LLC, Arcion Therapeutics, Inc, Eli Lilly and Company, Merck Research Labs, Pfizer, Inc, NIH/NIA, and the American Diabetes Association.

Dr. Kathleen L. Wyne reports that she has received speaker honoraria from Abbott Laboratories and NovoNordisk A/S.

Reviewers

Dr. Alan J. Garber reports that he has received consultant honoraria from F. Hoffmann-La Roche Ltd; speakers' bureau and advisory board honoraria from GlaxoSmithKline plc, Merck & Co, Inc, Daiichi Sankyo, Inc, and NovoNordisk A/S; and clinical research support from Bristol-Myers Squibb, GlaxoSmithKline plc, Merck & Co, Inc, and NovoNordisk A/S.

Dr. Daniel L. Hurley reports that he does not have any relevant financial relationships with any commercial interests.

Dr. Farhad Zangeneh reports that he has received speaker honoraria from Auxilium Pharmaceuticals, Inc, Daiichi Sankyo, Inc, Eli Lilly and Company, Kowa Pharmaceuticals America, Inc, Novartis AG, NovoNordisk A/S, Pfizer, Inc, Santarus, Inc, sanofi-aventis U.S., LLC, and Takeda Pharmaceuticals North America, Inc.

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. AACE diabetes mellitus guidelines. Endocr Pract 2007 May-Jun;13(Suppl 1).

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the American Association of Clinical Endocrinologists (AACE) Web site External Web Site Policy.

Print copies: Available from the American Association of Clinical Endocrinologists (AACE), 245 Riverside Avenue, Suite 200, Jacksonville, FL 32202.

Availability of Companion Documents

The following is available:

Print copies: Available from the American Association of Clinical Endocrinologists (AACE), 245 Riverside Avenue, Suite 200, Jacksonville, FL 32202.

Patient Resources

Patient education information materials, including a diabetes disaster plan and poster, as well as a DVD on type 1 diabetes, are available from the American Association of Clinical Endocrinologists Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI on March 1, 2000. The summary was verified by the guideline developer as of March 8, 2000. This summary was updated on April 16, 2002. The information was verified by the guideline developer on November 11, 2002. This summary was updated by ECRI Institute on September 27, 2007. The updated information was verified by the guideline developer on November 12, 2007. This NGC summary was updated by ECRI Institute on September 9, 2011. This summary was updated by ECRI Institute on April 13, 2012 following the U.S. Food and Drug Administration advisories on Statin Drugs and Statins and HIV or Hepatitis C drugs. This summary was updated by ECRI Institute on April 4, 2014 following the U.S. Food and Drug Administration (FDA) advisory on Rosiglitazone-containing Diabetes Medicines.

Copyright Statement

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