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Brief Summary

GUIDELINE TITLE

American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Screening and diagnosis.

BIBLIOGRAPHIC SOURCE(S)

  • AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. AACE diabetes mellitus guidelines. Screening and diagnosis. Endocr Pract 2007 May-Jun;13(Suppl 1):10-2. [5 references]

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previously published version: American Association of Clinical Endocrinologists, American College of Endocrinology. Medical guidelines for the management of diabetes mellitus: the AACE system of intensive diabetes self-management--2002 update. Endocr Pract 2002 Jan-Feb;8(Suppl 1):40-82.

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

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.

  • Annually screen all individuals 30 years or older who are at risk for having or developing type 2 diabetes mellitus (grade B) (See Table 2.1 below for a list of risk factors and Table 2.2 for clinical interpretations of plasma glucose concentrations)
  • Use 1 of the 3 diagnostic criteria presented in the Table 2.3 to diagnose diabetes mellitus (grade B)
  • American College of Endocrinology/American Association of Clinical Endocrinologists does not recommend using HbA1c measurement to diagnose diabetes mellitus (grade C)
  • Screen all pregnant women for gestational diabetes mellitus (GDM) (grade A); women at low risk should be screened at 24 to 28 weeks' gestation; women at high risk should be screened at 20 weeks' gestation (grade B) (See Table 2.4 for Gestational Diabetes Mellitus (GDM) risk factors and Table 2.5 for diagnostic criteria using a 75-g oral glucose tolerance test).

Table 2.1 Risk Factors for Prediabetes and Diabetes Mellitus

Risk Factors
Family history of diabetes

Cardiovascular disease

Overweight or obese state

Sedentary lifestyle

Latino/Hispanic, Non-Hispanic black, Asian American, Native American, or Pacific Islander ethnicity

Previously identified impaired glucose tolerance or impaired fasting glucose

Hypertension

Increased levels of triglycerides, low concentrations of high-density lipoprotein cholesterol, or both

History of gestational diabetes

History of delivery of an infant with a birth weight >9 pounds

Polycystic ovary syndrome

Psychiatric illness

 

Table 2.2 Clinical Interpretations of Plasma Glucose Concentrations

Glucose Concentration, mg/dL Clinical Interpretation
Fasting

<100

Within the reference range

100-125

Impaired fasting glucose/prediabetes mellitus

>126

Overt diabetes mellitus
2-hour postchallenge load (75-g oral glucose tolerance test)

<140

Within the reference range

140-199

Impaired fasting glucose/prediabetes mellitus

>200

Overt diabetes mellitus

 

Table 2.3 Diagnostic Criteria for Diabetes Mellitusa

Diagnostic Criteria
Symptoms of diabetes (polyuria, polydipsia, unexplained weight loss) plus casual plasma glucose concentration ≥200 mg/dL
or
Fasting plasma glucose concentration ≥126 mg/dL
or
2-hour postchallenge glucose concentration ≥200 mg/dL during a 75-g oral glucose tolerance test

aOne of the 3 criteria listed is sufficient to establish the diagnosis of diabetes mellitus. These assessments should be confirmed by repeated testing on a subsequent day in the absence of unequivocal hyperglycemia.

 

Table 2.4 Risk Factors for Gestational Diabetes Mellitus

Risk Factors
> 25 years of age

Overweight or obese state

Family history of diabetes mellitus (i.e., in a first-degree relative)

History of abnormal glucose metabolism

History of poor obstetric outcome

History of delivery of an infant with a birth weight >9 pounds

History of polycystic ovary syndrome

Latino/Hispanic, non-Hispanic black, Asian American, Native American, or Pacific Islander ethnicity

Fasting (no energy intake for at least 8 hours) plasma glucose concentration >85 mg/dL or 2-hour postprandial glucose concentration >140 mg/dL (indicates need to perform a 75-g oral glucose tolerance test)

Table 2.5 Diagnostic Criteria for Gestational Diabetes Mellitus Using a 75-g Oral Glucose Tolerance Testa

State at Plasma Glucose Measurement Plasma Glucose Concentration, mg/dL
Fasting >95
1-hour postglucose administration >180
2-hour postglucose administration >155

aTwo or more of the listed venous plasma glucose concentrations must be met or exceeded for a positive diagnosis. The test should be performed after an overnight fast of 8 to 14 hours and after at least 3 days of unrestricted diet (i.e., ≥150 g carbohydrate per day) and unlimited physical activity.

Definitions:

Levels of Substantiation in Evidence-Based Medicinea

Level-of-Evidence Categoryb Study Design or Information Type Comments
1 Randomized controlled trials

Multicenter trials

Large meta-analyses with quality ratings
Well-conducted, well-controlled trials at 1 or more medical centers

Data derived from a substantial number of trials with adequate power; substantial number of subjects and outcome data

Consistent pattern of findings in the population for which the recommendation is made – generalizable results

Compelling nonexperimental, clinically obvious evidence (e.g., use of insulin in diabetic ketoacidosis); "all or none" evidence
2 Randomized controlled trials

Prospective cohort studies

Meta-analyses of cohort studies

Case-control studies
Limited number of trials, small number of subjects

Well-conducted studies

Inconsistent findings or results not representative for the target population
3 Methodologically flawed randomized controlled trials

Nonrandomized controlled trials

Observational studies

Case series or case reports
Trials with 1 or more major or 3 or more minor methodologic flaws

Uncontrolled or poorly controlled trials

Retrospective or observational data

Conflicting data with weight of evidence unable to support a final recommendation
4 Expert consensus

Expert opinion based on experience

Theory-driven conclusions

Unproven claims

Experience-based information
Inadequate data for inclusion in level-of-evidence categories 1, 2, or 3; data necessitates an expert panel's synthesis of the literature and a consensus

aAdapted from the American Association of Clinical Endocrinologists Protocol for the Standardized Production of Clinical Practice Guidelines.

bLevel-of-evidence categories 1 through 3 indicate scientific substantiation or proof; level-of-evidence category 4 indicates unproven claims.

Recommendation Grades in Evidence-Based Medicinea

Grade Description
A Homogeneous evidence from multiple well-designed randomized controlled trials with sufficient statistical power

Homogeneous evidence from multiple well-designed cohort controlled trials with sufficient statistical power

>1 conclusive level of evidence category 1 publications demonstrating benefit >> outweighs risk
B Evidence from at least one large well-designed clinical trial, cohort or case-controlled analytic study, or meta-analysis

No conclusive level of evidence category 1 publication; >1 conclusive level of evidence category 2 publications demonstrating benefit >> risk
C Evidence based on clinical experience, descriptive studies, or expert consensus opinion

No conclusive level 1 or 2 publication; >1 conclusive level of evidence category 3 publications demonstrating benefit >> risk

No conclusive risk at all and no conclusive benefit demonstrated by evidence
D Not rated

No conclusive level of evidence category 1, 2, or 3 publication demonstrating benefit >> risk

Conclusive level of evidence category 1, 2, or 3 publication demonstrating risk >> benefit

aAdapted from the American Association of Clinical Endocrinologists Protocol for the Standardized Production of Clinical Practice Guidelines.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. AACE diabetes mellitus guidelines. Screening and diagnosis. Endocr Pract 2007 May-Jun;13(Suppl 1):10-2. [5 references]

ADAPTATION

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

DATE RELEASED

2000 Jan (revised 2007)

GUIDELINE DEVELOPER(S)

American Association of Clinical Endocrinologists - Medical Specialty Society
American College of Endocrinology - Medical Specialty Society

SOURCE(S) OF FUNDING

American Association of Clinical Endocrinologists (AACE)

GUIDELINE COMMITTEE

American Association of Clinical Endocrinologists (AACE) Diabetes Mellitus Clinical Practice Guidelines Task Force

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Task Force Members: Helena W. Rodbard, MD, FACP, MACE (Chairperson) Medical Director, Endocrine and Metabolic Consultants Past President, American Association of Clinical Endocrinologists Past President, American College of Endocrinology, Rockville, Maryland; Lawrence Blonde, MD, FACP, FACE, Director, Ochsner Diabetes Clinical Research Unit; Section on Endocrinology, Diabetes, and Metabolic Diseases Associate Residency Program Director, Department of Internal Medicine, New Orleans, Louisiana; Susan S. Braithwaite, MD, FACP, FACE, Clinical Professor of Medicine, University of North Carolina, Division of Endocrinology, Chapel Hill, NC; Elise M. Brett, MD, FACE, Assistant Clinical Professor of Medicine; Division of Endocrinology, Diabetes, and Bone Disease; Mount Sinai School of Medicine, New York, New York; Rhoda H. Cobin, MD, MACE, Clinical Professor of Medicine; Division of Endocrinology, Diabetes, and Bone Disease; Mount Sinai School of Medicine, Immediate Past President, American College of Endocrinology, Past President, American Association of Clinical Endocrinologists, New York, New York; Yehuda Handelsman, MD, FACP, FACE, Medical Director, Metabolic Institute of America, Senior Scientific Consultant, Metabolic Endocrine Education Foundation, Tarzana, California; Richard Hellman, MD, FACP, FACE, Clinical Professor of Medicine, University of Missouri-Kansas City School of Medicine, President, American Association of Clinical Endocrinologists, North Kansas City, Missouri; Paul S. Jellinger, MD, MACE, Professor of Medicine and Voluntary Faculty, University of Miami School of Medicine, Past President, American College of Endocrinology Past President, American Association of Clinical Endocrinologists, Hollywood, Florida; Lois G. Jovanovic, MD, FACE, CEO & Chief Scientific Officer, Sansum Diabetes Research Institute, Adjunct Professor Biomolecular Science and Engineering, University of California-Santa Barbara, Clinical Professor of Medicine, University of Southern California, Keck School of Medicine, Santa Barbara, CA; Philip Levy, MD, FACE, Clinical Professor of Medicine, University of Arizona College of Medicine, Past President, American College of Endocrinology, Phoenix, Arizona; Jeffrey I. Mechanick, MD, FACP, FACE, FACN, Associate Clinical Professor of Medicine and Director of Metabolic Support; Division of Endocrinology, Diabetes, and Bone Disease; Mount Sinai School of Medicine, New York, New York; Farhad Zangeneh, MD, FACP, FACE, Assistant Clinical Professor of Medicine, George Washington University School of Medicine, Washington, DC, Endocrine, Diabetes and Osteoporosis Clinic (EDOC), Sterling, Virginia

Medical Writer: Christopher G. Parkin, MS

Reviewers: Lewis E. Braverman, MD; Samuel Dagogo-Jack, MD, FACE; Vivian A. Fonseca, MD, FACE; Martin M. Grajower, MD, FACP, FACE; Virginia A. LiVolsi, MD; Fernando Ovalle, MD, FACE; Herbert I. Rettinger, MD, FACE; Talla P. Shankar, MD, FACE; Joseph J. Torre, MD, FACP, FACE; Dace L. Trence, MD, FACE

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Dr. Lawrence Blonde reports that he has received grant/research support from Amylin Pharmaceuticals, Inc.; AstraZeneca LP; Bristol-Myers Squibb Company; Eli Lilly and Company; MannKind Corporation; Merck & Co., Inc.; Novo Nordisk Inc.; Novartis Corporation; Pfizer Inc.; and sanofi-aventis U.S. He has received speaker and consultant honoraria from Abbott Laboratories; Amylin Pharmaceuticals, Inc.; Eli Lilly and Company; GlaxoSmithKline; LifeScan, Inc.; Merck & Co., Inc.; Novartis, Novo Nordisk Inc.; Pfizer Inc.; and sanofi-aventis U.S. He has received consultant honoraria from Kos Pharmaceuticals, Inc. and U.S. Surgical. Dr. Blonde has also disclosed that his spouse is a stock shareholder of Amylin Pharmaceuticals, Inc. and Pfizer Inc., in an account that is not part of their community property.

Dr. Susan S. Braithwaite reports that she does not have any financial relationships with any commercial interests.

Dr. Elise M. Brett reports that her spouse is an employee of Novo Nordisk Inc.

Dr. Rhoda H. Cobin reports that she has received speaker honoraria from GlaxoSmithKline; Pfizer Inc.; sanofi-aventis U.S.; and Novartis and consultant honoraria from Abbott Laboratories.

Dr. Yehuda Handelsman reports that he has received speaker honoraria from Abbott Laboratories; Amylin Pharmaceuticals, Inc.; AstraZeneca LP; Bristol-Myers Squibb Company; GlaxoSmithKline; Merck & Co., Inc.; Novartis; and sanofi-aventis U.S. and consultant honoraria from Abbott Laboratories; Daiichi Sankyo, Inc.; Novartis; and sanofi-aventis U.S.

Dr. Richard Hellman reports that he has received speaker honoraria from Daiichi Sankyo, Inc. and Pfizer Inc. and research grants for his role as an independent contractor from Abbott Laboratories; Pfizer Inc.; and Medtronic, Inc.

Dr. Paul S. Jellinger reports that he has received speaker honoraria from Eli Lilly and Company; Merck & Co., Inc.; Novartis; Novo Nordisk Inc.; and Takeda Pharmaceuticals North America, Inc.

Dr. Lois G. Jovanovic reports that she has received research grants for her role as investigator from Eli Lilly and Company; DexCom Inc.; LifeScan, Inc.; Novo Nordisk Inc.; Pfizer Inc.; Roche Pharmaceuticals; sanofi-aventis U.S.; and Sensys Medical, Inc.

Dr. Philip Levy reports that he has received speaker honoraria from Abbott Laboratories; Amylin Pharmaceuticals, Inc.; GlaxoSmithKline; Eli Lilly and Company; Merck & Co., Inc.; Novo Nordisk Inc.; Novartis; Pfizer Inc.; and sanofi-aventis U.S. and research grants from Amylin Pharmaceuticals, Inc.; MannKind Corporation; Novo Nordisk Inc.; Pfizer Inc.; and sanofi-aventis U.S.

Dr. Jeffrey I. Mechanick reports that he does not have any financial relationships with any commercial interests.

Dr. Helena W. Rodbard reports that she has received consultant honoraria from Ortho-McNeil, Inc.; Pfizer Inc.; sanofi-aventis U.S.; and Takeda Pharmaceuticals North America, Inc.; speaker honoraria from Abbott; GlaxoSmithKline; Merck & Co., Inc.; Novo Nordisk; Pfizer Inc.; and sanofi-aventis U.S. and research support from Biodel, Inc. and sanofi-aventis U. S.

Dr. Farhad Zangeneh reports that he has received speaker honoraria from Eli Lilly and Company; GlaxoSmithKline; Novartis; Novo Nordisk Inc.; Pfizer Inc.; Roche Pharmaceuticals; sanofi-aventis U.S.; and Takeda Pharmaceuticals North America, Inc.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previously published version: American Association of Clinical Endocrinologists, American College of Endocrinology. Medical guidelines for the management of diabetes mellitus: the AACE system of intensive diabetes self-management--2002 update. Endocr Pract 2002 Jan-Feb;8(Suppl 1):40-82.

GUIDELINE AVAILABILITY

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

Print copies: Available from the American Association of Clinical Endocrinologists (AACE), 1000 Riverside Avenue, Suite 205, Jacksonville, FL 32204.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

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.

COPYRIGHT STATEMENT

All rights reserved. No part of these materials may be reproduced or retransmitted in any manner without the prior written permission of American Association of Clinical Endocrinologists (AACE)/American College of Endocrinology (ACE).

DISCLAIMER

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