Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus
- PMID: 37473453
- PMCID: PMC12376302
- DOI: 10.1093/clinchem/hvad080
Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus
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 of 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 (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.
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.
This article has been co-published with permission in Clinical Chemistry by Oxford University Press on behalf of the American Association for Clinical Chemistry and in Diabetes Care by the American Diabetes Association. © This work is written by (a) US Government employee(s) and is in the public domain in the US (2023).
Conflict of interest statement
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Comment in
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Laboratory Guidelines Are Needed for Diagnostic Genetic Testing for Monogenic Diabetes.Clin Chem. 2023 Aug 2;69(8):788-790. doi: 10.1093/clinchem/hvad093. Clin Chem. 2023. PMID: 37473454 No abstract available.
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New Laboratory Guidelines for Diabetes: Continuing the Collaboration between Clinical and Laboratory Medicine.Clin Chem. 2023 Aug 2;69(8):785-787. doi: 10.1093/clinchem/hvad092. Clin Chem. 2023. PMID: 37473456 No abstract available.
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