Schleicher Erwin, Kabytaev Kuanysh, Nauck Matthias, Müller-Wieland Dirk, Peter Andreas, Little Randie R, Heinemann Lutz
Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tuebingen, Tuebingen, Germany.
Institute for Diabetes Research and Metabolic Diseases, Helmholtz Centre Munich, University of Tuebingen, Tuebingen, Germany.
J Diabetes Sci Technol. 2025 Aug 8:19322968251362848. doi: 10.1177/19322968251362848.
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.
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.
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.
β细胞功能受损是糖尿病病理生理学的关键因素，可通过生物标志物C肽进行评估。因此，C肽测量可用于糖尿病的预测、诊断和亚分类。此外，C肽有助于预测治疗反应并指导治疗决策。为支持糖尿病分类，美国糖尿病协会（ADA）和欧洲糖尿病研究协会（EASD）最近在其指南中引入了血清C肽临界值：C肽水平<0.2 nmol/L提示1型糖尿病，而C肽水平>0.6 nmol/L表明2型糖尿病。然而，由于C肽测量的标准化尚未实现，分析方面限制了这些定义临界值的临床应用。不同检测制造商的结果仍显示出显著差异。
这种差异可能会产生重大后果，因为近年来，依靠C肽检测进行糖尿病分类和治疗决策的情况一直在稳步增加。尽管越来越多的人呼吁对C肽检测进行标准化，并且已经建立了标准化流程，但遗憾的是，标准化尚未在实践中实施。
因此，医疗保健提供者倡导进行标准化的C肽测量似乎是合适的，这或多或少掌握在C肽检测制造商手中，以提高诊断准确性和患者安全性。
