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Review
. 2023 Oct 1;46(10):e151-e199.
doi: 10.2337/dci23-0036.

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

David B Sacks  1 , Mark Arnold  2 , George L Bakris  3 , David E Bruns  4 , Andrea R Horvath  5 , Åke Lernmark  6 , Boyd E Metzger  7 , David M Nathan  8 , M Sue Kirkman  9
Affiliations
Review

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

David B Sacks et al. Diabetes Care. .

Abstract

Background: 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.

Approach: 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 for Clinical Chemistry and by the Professional Practice Committee of the American Diabetes Association.

Content: Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A1c (HbA1c) 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 HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of ketones, autoantibodies, urine albumin, insulin, proinsulin, and C-peptide 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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Conflict of interest statement

Duality of Interest. D.B.S., Associate Editor for Clinical Chemistry, American Association for Clinical Chemistry, and Chair, Scientific Review Committee on Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus. M.A.A., travel expenses paid by American Diabetes Association for attendance at the in-person manuscript review meeting, consulting for Rockley Photonics, a for-profit company working to develop wearable technology for fitness and wellness applications, including noninvasive glucose measurements, consulting for Foundation for Innovative New Diagnostics concerning the development of glucose sensing technologies for low- and middle-income countries, consulting for LifePlus concerning their interest in the development of a noninvasive glucose sensor for management of diabetes, and patent application filed (Olesberg, JT, Arnold, MA, Urea monitoring during dialysis for improved quality control and treatment guidance, U.S. Provisional Application 63/087,600 filed on 5 October 2020, International Patent Application No. PCT/US2021/053598 filed on 5 October 2021, U.S. Patent Application 18/030,339 filed on 5 April 2023). G.L.B., consultant or member of clinical trial steering committee for Bayer, KBP Biosciences, Ionis, Alnylam, AstraZeneca, Novo Nordisk, Janssen InREGEN and consulted for DiaMedica and Quantum Genomics. A.R.H., Elsevier, royalty for Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 6th edition, and Tietz Fundamentals of Clinical Chemistry and Molecular Diagnostics, Chair of the Preanalytical glucose working party of the Australasian Association of Clinical Biochemistry and Laboratory Medicine, Chair of the Analytical Performance Specifications based on Outcomes Task Force Group of the European Federation of Clinical Chemistry and Laboratory Medicine. Å.L., DiaMyd AB, Stockholm, Sweden, consulting fee. No other potential conflicts of interest relevant to this article were reported.

Figures

Figure 1
Figure 1
The KDIGO heatmap of staging and CKD/cardiovascular risk. Both eGFR and albuminuria are needed to properly stage kidney disease. The colors signify both risk of progression to dialysis as well as cardiovascular risk. Green, very low or no risk; yellow, moderate risk; orange, moderate to high risk; and red, highest risk. Reprinted from the ADA (451).
See this image and copyright information in PMC

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