Potential remote measurement of C-peptide using a minimally invasive and convenient sampling technique.

Abstract

Background: In clinical research, alternatives to venipuncture can reduce participant burden and increase accessibility and sampling opportunities for biomarkers. Residual pancreatic beta-cell function is assessed in clinical research and in diabetes care using fasting and stimulated C-peptide measurements, and changes are assessed over time. Operational, technical, and acceptability considerations of utilizing Tasso+ SST devices for C-peptide collection compared to venipuncture-derived serum samples were investigated.

Methodology: Samples were collected from prospectively enrolled healthy participants via Third Generation Tasso+ SST micro-sampling devices and phlebotomy. Eleven fasted Tasso+ samples collected on-site or remote underwent alternative handling conditions and were evaluated for consistency, quality, and stability. Participants responded to device acceptability questionnaires.

Results: The Tasso+ SST micro-sampling device showed excellent concordance with simultaneous venipuncture-derived fasted C-Peptide, with concentration being largely conserved in healthy volunteers despite alternative sample handling. Delayed centrifugation over 72 hours caused no consequential degradation of C-peptide when kept at 4°C. Questionnaire responses indicate acceptable device usability and associated comfort levels.

Conclusion: Fasting C-peptide levels can be accurately collected using micro-sampling collection techniques. Tasso+ C-peptide stability is seen when kept at 4°C. Micro-sampling devices can be used with shipping mechanisms (without centrifugation) to decrease participant burden, expand trial populations, and aid biomarker measurements.