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Schleicher, E. ; Kabytaev, K.* ; Nauck, M.* ; Müller-Wieland, D.* ; Peter, A. ; Little, R.R.* ; Heinemann, L.*

Call for standardization of C-peptide measurement.

J. Diabetes Sci. Technol.:19322968251362848 (2025)

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BACKGROUND: An impaired β-cell function is a key contributor to the pathophysiology of diabetes mellitus that can be estimated by the biomarker C-peptide. Measurement of C-peptide can therefore be used for prediction, diagnosis, and subclassification of diabetes. Furthermore, C-peptide assists in the prediction of therapeutic response and guiding therapeutic decisions. To support diabetes classification, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have recently introduced serum C-peptide cut-off values in their guidelines: <0.2 nmol/L C-peptide levels suggest the presence of type 1 DM while C-peptide levels >0.6 nmol/L indicate type 2 DM. However, analytical aspects limit the clinical utility of these defined cut-off values since standardization of C-peptide measurements has not been achieved. Results from different assay manufacturers still show significant variability. RESULTS: This discrepancy can have significant consequences, as reliance on C-peptide testing for diabetes classification and therapeutic decisions has steadily increased in recent years. Although there have been growing calls to standardize C-peptide testing and a process for standardization has been established, standardization has unfortunately yet to be implemented in practice. CONCLUSION: It therefore seems appropriate for health care providers to advocate for standardized C-peptide measurements, which is more or less in the hands of the manufacturer of the C-peptide assays, to improve diagnostic accuracy and patient safety.

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