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Early Detection of Beta-Cell Decline using Home Dried Blood Spot C-Peptide Levels in New-Onset Type 1 Diabetes

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posted on 2025-05-22, 14:04 authored by A Emile J Hendriks, M Loredana Marcovecchio, Mark L Evans, Peter Barker, Keith Burling, Lut Overbergh, Chantal Mathieu

Objective: There is a need for early detection of beta-cell decline in people with newly diagnosed (ND) type 1 diabetes. The gold standard mixed-meal tolerance test (MMTT) is an invasive and time-consuming procedure, that requires participants to travel to clinical sites. We assessed the feasibility of measuring dried blood spot (DBS) C-peptide levels collected at home as an alternative to the MMTT to detect early beta-cell decline.

Research Design and Methods: Individuals with ND type 1 diabetes recruited within six weeks of diagnosis as part of the INNODIA cohort, collected finger-prick DBS C-peptide at home, both fasting and 60 minutes post liquid meal. At 12 months, an MMTT was conducted to measure venous C-peptide area under the curve (AUC).

Results: A total of 292 people were analysed, mean age was 12.7 years (range 1.2–43.8 years). The median [IQR] number of DBS card pairs per participant was 6.5 [2–9] over 12 months. The slopes of stimulated DBS C-peptide in the first six months significantly predicted venous MMTT AUC C-peptide and peak C-peptide at 12 months (p<0.01). The models were adjusted for simultaneous glucose levels, age, and baseline fasting C-peptide. However, the six-month fasting DBS C-peptide slope did not predict 12-month MMTT AUC C-peptide.

Conclusions: Home DBS C-peptide assessment is a feasible method to monitor beta-cell function in ND type 1 diabetes. The early prognostic utility of stimulated DBS C-peptide highlights its potential for optimising trial design. However, further validation is needed to confirm its reliability and broader applicability.

Funding

This study has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement no. 115797 (INNODIA). This Joint Undertaking receives support from the Union’s Horizon 2020 research and innovation programme, ‘EFPIA’, ‘JDRF’ and ‘The Leona M. and Harry B. Helmsley Charitable Trust’. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of IMI2-JU. IMI2-JU cannot be held responsible for them. The University of Cambridge has received salary support for MLE through the National Health Service in the East of England through the Clinical Academic Reserve. The funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

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