Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

David B Sacks; Mark Arnold; George L Bakris; David E Bruns; Andrea R Horvath; Åke Lernmark; Boyd E Metzger; David M Nathan; M Sue Kirkman

doi:10.1093/clinchem/hvad080

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Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

Journal article

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Peer reviewed

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

David B Sacks, Mark Arnold, George L Bakris, David E Bruns, Andrea R Horvath, Åke Lernmark, Boyd E Metzger, David M Nathan and M Sue Kirkman

Clinical chemistry (Baltimore, Md.), Vol.69(8), pp.808-868

08/02/2023

DOI: 10.1093/clinchem/hvad080

PMCID: PMC12376302

PMID: 37473453

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Abstract

Numerous laboratory tests are used in the diagnosis and management of diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for laboratory analysis in screening, diagnosis, or monitoring of diabetes. The overall quality of the evidence and the strength of the recommendations were evaluated. The draft consensus recommendations were evaluated by invited reviewers and presented for public comment. Suggestions were incorporated as deemed appropriate by the authors (see Acknowledgments). The guidelines were reviewed by the Evidence Based Laboratory Medicine Committee and the Board of Directors of the American Association of Clinical Chemistry and by the Professional Practice Committee of the American Diabetes Association. Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A1c (Hb A1c) in the blood. Glycemic control is monitored by the people with diabetes measuring their own blood glucose with meters and/or with continuous interstitial glucose monitoring (CGM) devices and also by laboratory analysis of Hb A1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide are addressed. 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.

Insulin

Blood Glucose - analysis

Blood Glucose Self-Monitoring

Diabetes Mellitus - diagnosis

Diabetes Mellitus - therapy

Diabetes Mellitus, Type 1

Glycated Hemoglobin

Humans

Details

Title: Subtitle: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus
Creators: David B Sacks - National Institutes of Health
Mark Arnold - University of Iowa, Fraternal Order of Eagles Diabetes Research Center
George L Bakris - University of Chicago
David E Bruns - University of Virginia
Andrea R Horvath - Prince of Wales Hospital
Åke Lernmark - Skåne University Hospital
Boyd E Metzger - Northwestern University
David M Nathan - Massachusetts General Hospital
M Sue Kirkman - Department of Medicine, University of North Carolina, Chapel Hill, NC, United States
Resource Type: Journal article
Publication Details: Clinical chemistry (Baltimore, Md.), Vol.69(8), pp.808-868
DOI: 10.1093/clinchem/hvad080
PMID: 37473453
PMCID: PMC12376302
NLM abbreviation: Clin Chem
ISSN: 1530-8561
eISSN: 1530-8561
Language: English
Date published: 08/02/2023
Academic Unit: Pharmaceutical Sciences and Experimental Therapeutics; Center for Biocatalysis and Bioprocessing; Fraternal Order of Eagles Diabetes Research Center; Chemistry
Record Identifier: 9984473208702771

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