• AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. AACE diabetes mellitus guidelines. Glycemic management. Endocr Pract 2007 May-Jun;13(Suppl 1):16-34. [178 references]

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.

Definitions of the classes (1-4) and levels of evidence (A-D) are provided at the end of the "Major Recommendations" field.

Glycemic Management

All Patients With Diabetes Mellitus

• Encourage patients to achieve glycemic levels as near normal as possible without inducing clinically significant hypoglycemia (grade A); glycemic targets include:
  • HbA_1c ≤6.5% (grade B)
  • Fasting plasma glucose concentration <110 mg/dL (grade B)
  • 2-hour postprandial glucose concentration <140 mg/dL (grade B)
• Refer patients for comprehensive, ongoing education in diabetes self-management skills and nutrition therapy (grade A); education should:
  • Be provided by a qualified health care professional
  • Focus on all aspects of diabetes self-management relevant to each patient's treatment plan
  • Promote behavioral changes to support effective and consistent application of the prescribed diabetes treatment plan and an overall healthy lifestyle
  • Be continued as an ongoing intervention to accommodate changes in the treatment plan and patient status
• Initiate self-monitoring of blood glucose levels (grade A)

Patients With Type 1 Diabetes Mellitus

Initiate intensive insulin therapy (grade A) (Table 4.1 describes the pharmacokinetics of available insulin preparations); regimen options include:

• Basal-bolus therapy, using a long-acting insulin analog in combination with a rapid-acting insulin analog or inhaled insulin at meals
• Continuous subcutaneous insulin infusion with an insulin pump; insulin pump therapy is indicated for:
  • Patients who are unable to achieve acceptable control using a regimen of multiple daily injections
  • Patients with histories of frequent hypoglycemia and/or hypoglycemia unawareness
  • Patients who are pregnant
  • Patients with extreme insulin sensitivity (pump therapy facilitates better precision than subcutaneous injections)
  • Patients with a history of dawn phenomenon (these patients can program a higher basal rate for the early morning hours to counteract the rise in blood glucose concentration)
  • Patients who require more intensive diabetes management because of complications including neuropathy, nephropathy, and retinopathy
  • Patients taking multiple daily injections who have demonstrated willingness and ability to comply with prescribed diabetes self-care behavior including frequent glucose monitoring, carbohydrate counting, and insulin adjustment
• Consider adding pramlintide to intensive insulin therapy to enhance glycemic control and to assist with weight management (grade D)
• Consider adding an insulin sensitizer to address insulin resistance as needed (grade C); exercise caution because of the potential for increased fluid retention when thiazolidinediones are used with insulin
• Instruct patients whose glycemic levels are at or above target while receiving multiple daily injections or using an insulin pump to monitor glucose levels at least 3 times daily (grade A)
• Instruct patients whose glycemic levels are above target or who experience frequent hypoglycemia to monitor glucose levels more frequently; monitoring should include both preprandial and 2-hour postprandial glucose levels and occasional 2:00 AM to 3:00 AM glucose levels (grade C)
• Instruct insulin-treated patients to always check glucose levels before administering a dose of insulin by injection or changing the rate of insulin infusion delivered by an insulin pump (grade A)
• Instruct patients to monitor glucose levels anytime there is a suspected (or risk of) low glucose level and/or before driving (grade A)
• Instruct patients to monitor glucose levels more frequently during illness and to perform a ketone test each time a measured glucose concentration is greater than 250 mg/dL (grade C)

Table 4.1 Pharmacokinetics of Available Insulin Preparations

^aMay require 2 daily injections in patients with type 1 diabetes mellitus.

^bAssumes 0.1-0.2 U/kg per injection. Onset and duration may vary significantly greatly by injection site.

^cTime to steady state.

NPH, neutral protamine Hagedorn; h, hour; min, minutes

Patients With Type 2 Diabetes Mellitus

• Aggressively implement all appropriate components of care (medical nutrition therapy, physical activity, weight management regimen, pharmacologic interventions, diabetes self-management education) at the time of diagnosis (grade A)
• Persistently monitor and titrate pharmacologic therapy until all glycemic goals are achieved (grade A)
  • First assess the patient's current HbA_1c level, fasting/preprandial glycemic profile, and 2-hour postprandial glycemic profile to evaluate the level of control and to identify patterns; this will require the patient to obtain comprehensive fasting, preprandial, and postprandial glucose readings over a 7-day period (grade A)
  • After initiating pharmacologic therapy based on the patterns identified in the profile, persistently monitor and titrate therapy over the next 2 to 3 months until all American College of Endocrinology/American Association of Clinical Endocrinologists (ACE/AACE) glycemic goals are achieved (grade A) (Table 4.2 below shows examples of pharmacologic regimens that are intended to serve as starting points for selecting appropriate therapies. Tables 4.3, 4.4, 4.5, and 4.6 in the original guideline document present information about new medications and currently available oral therapies.)
  • If glycemic goals are not achieved at the end of 2 to 3 months of therapy, initiate a more intensive regimen and persistently monitor and titrate therapy over the next 2 to 3 months until all ACE/AACE glycemic goals are achieved (grade A)
  • Recognize that patients currently treated with monotherapy or combination therapy who have not achieved glycemic goals will require either increased dosages of their current medications or the addition of a second or third medication (grade A)
  • Consider insulin therapy in patients with HbA_1c levels greater than 8% and symptomatic hyperglycemia and in patients with elevated fasting blood glucose levels or exaggerated postprandial glucose excursions regardless of HbA_1c levels (grade A)
  • Initiate insulin therapy to control hyperglycemia and to reverse glucose toxicity when the HbA_1c level is greater than 10%; insulin treatment can then be modified or discontinued once glucose toxicity is reversed (grade A)
  • Consider use of continuous subcutaneous insulin infusion in insulin-treated patients (grade C)

Table 4.2 Examples of Pharmacologic Regimens for Treating Type 2 Diabetes Mellitus^a

Abbreviations: HbA1c, hemoglobin A1c; NPH, neutral protamine Hagedorn.

^aThe options listed are in no order of preference.

• Instruct patients whose glycemic levels are at or above target while receiving multiple daily injections or using an insulin pump to monitor glucose levels at least 3 times daily (grade B); although monitoring glucose levels at least 3 times daily is recommended, there is no supporting evidence regarding optimal frequency of glucose monitoring with or without insulin pump therapy
  • Instruct insulin-treated patients to always check glucose levels before administering a dose of insulin by injection or changing the rate of insulin infusion delivered by an insulin pump (grade B)
  • Instruct patients whose glycemic levels are above target while being treated with oral agents alone, oral agents plus once-daily insulin, or once-daily insulin alone to monitor glucose levels at least 2 times daily (grade C); there is no supporting evidence regarding optimal frequency of glucose monitoring in these patients
  • Instruct patients who are meeting target glycemic levels (including those treated nonpharmacologically) to monitor glucose levels at least once daily (grade D)
  • Instruct patients whose glycemic levels are above target or who experience frequent hypoglycemia to monitor glucose levels more frequently; monitoring should include both preprandial and 2-hour postprandial glucose levels and occasional 2:00 AM to 3:00 AM glucose levels (grade B)
  • Instruct patients to obtain comprehensive preprandial and 2-hour postprandial glucose measurements to create a weekly profile periodically and before clinician visits to guide nutrition and physical activity, to detect postprandial hyperglycemia, and to prevent hypoglycemia (grade B)
  • Instruct patients to monitor glucose levels anytime there is a suspected (or risk of) low glucose level and/or before driving (grade A)
  • Instruct patients to monitor glucose levels more frequently during illness and to perform a ketone test each time a measured glucose concentration is greater than 250 mg/dL (grade C)

Definitions:

Levels of Substantiation in Evidence-Based Medicine^a

^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 Medicine^a

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

None provided

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

• AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. AACE diabetes mellitus guidelines. Glycemic management. Endocr Pract 2007 May-Jun;13(Suppl 1):16-34. [178 references]

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

2000 Jan (revised 2007)

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

American Association of Clinical Endocrinologists (AACE)

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

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

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.

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.

None available

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 summary was updated by ECRI Institute on November 28, 2007 following the U.S. Food and Drug Administration advisory on the Avandia (rosiglitazone maleate) Tablets. This summary was updated by ECRI Institute on March 10, 2008 following the U.S. Food and Drug Administration advisory on Avandia (rosiglitazone maleate). This summary was updated by ECRI Institute on April 21, 2008 following the U.S. Food and Drug Administration advisory on Exubera (insulin human rDNA origin) Inhalation Powder.

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).