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Brief Summary

GUIDELINE TITLE

American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Patient safety in diabetes care.

BIBLIOGRAPHIC SOURCE(S)

  • AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. AACE diabetes mellitus guidelines. Patient safety in diabetes care. Endocr Pract 2007 May-Jun;13(Suppl 1):63-8. [34 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 (1–4) and the recommendation grades (A–D) are defined at the end of the "Major Recommendations" field.

Patient Safety In Diabetes Care

Systems Issues

  • Medical errors are common and adversely affect important outcomes in diabetes care (grade A)
  • Most medical errors are not injurious because they are discovered and corrected by the health care team before they cause harm (grade A)
  • A high level of patient safety is not a predictable outcome of complex medical systems and is usually achievable only with considerable and continuous effort (grade C)
  • Create a nonpunitive environment to encourage learning from mistakes and involve all members of the health care team who are responsible for the care of the diabetic patient in the clinical setting (grade B)
  • Schedule regular health care team meetings to address patient safety as a priority and insert a line item into the annual budget to pay for needed changes (grade B)
  • Encourage voluntary sharing of error data and address them using an analytic method to improve the system of care and to reduce the frequency of injurious medical errors (grade B)
  • As part of diabetes care coordination, develop a culture of safety, a group of health care workers who function as a team to protect the patient from injurious medical errors (grade B)
  • Use algorithms to address complex medical procedures and provide ample time for relevant staff to learn and practice how to use the algorithms (grade B)
  • Always balance profitability with safety concerns (grade A)
  • Implement and use an electronic health record or information sharing system; a well-designed system may significantly reduce the frequency of medical errors (grade A)
  • Implement and use well-designed computerized physician order entry systems to reduce medication errors (grade A)
  • Although comorbid conditions, economic conditions, and patient preferences often cause necessary and appropriate variations in care practice, wherever possible, reduce variations in care that are not evidence-based to decrease the occurrence of errors; allow others (peers, allied health professionals, patients, and families of patients) to facilitate best practices. Also, monitoring of desired clinical performance standards becomes easier (grade A)

Patient Issues

  • Give explicit, clear insulin orders to anticipate each of the common or important situations that patients must confront (grade A)
  • Use written algorithms for insulin therapy; if possible, they should be typed or printed (grade A)
  • Provide frequent glucose monitoring according to the medical needs of the patient (grade A)
  • Routinely recheck patient understanding of basic concepts of self-care at appropriate intervals (grade A)
  • Assess for coronary heart disease in patients with diabetes mellitus (grade A)
  • Evaluate all patients for their relative risk of hypoglycemia (grade A)
  • Use diabetes education programs that are evidence-based and focused on issues of patient safety (grade C)
  • Encourage all patients who drive motor vehicles, who have high-risk occupations, or whose leisure time involves high-risk activities to participate in an education program with emphasis on hypoglycemia recognition, prevention, and treatment (grade A)

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. Patient safety in diabetes care. Endocr Pract 2007 May-Jun;13(Suppl 1):63-8. [34 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

NGC DISCLAIMER

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Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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