Lab Med Online.  2011 Oct;1(4):173-178. 10.3343/lmo.2011.1.4.1.

Translation: Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

  • 1Department of Laboratory Medicine, National Institutes of Health, Bethesda, MD, USA.
  • 2Department of Chemistry, University of Iowa, Iowa City, IA, USA.
  • 3Department of Medicine, Hypertensive Disease Unit, Section of Endocrinology, Diabetes and Metabolism, University of Chicago, Chicago, IL, USA.
  • 4Department of Pathology, University of Virginia Medical School, Charlottesville, VA, USA.
  • 5Screening and Test Evaluation Program, School of Public Health, University of Sydney, SEALS Department of Clinical Chemistry, Prince of Wales Hospital, Sydney, Australia.
  • 6American Diabetes Association, Alexandria, VA, USA.
  • 7Department of Clinical Sciences, Lund University/CRC, Skane University Hospital Malmo, Malmo, Sweden.
  • 8Division of Endocrinology, Northwestern University, The Feinberg School of Medicine, Chicago, IL, USA.
  • 9Massachusetts General Hospital and Harvard Medical School, Diabetes Center, Boston, MA, USA.


Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. APPROACH: An expert committee compiled evidencebased recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. CONTENT: In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A1c (HbA1c) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of Hb A1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY: The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

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