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

内容摘要

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. 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. 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. 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. This study focused on finding an easier way to collect blood samples for measuring C-peptide, a marker used in diabetes research, without needing a traditional needle stick in a vein (venipuncture). Instead, researchers tested a small, easily applied device that collects a small amount of blood from the upper arm. Healthy volunteer participants gave blood samples from both this device (called the Tasso+) and from the standard way (venipuncture). Some of these samples were collected away from a doctor’s office. The researchers checked to see if the small device gave accurate and reliable results for C-peptide, even if the samples were handled in different ways. These different ways included delays before processing and being stored in a fridge or freezer. They also asked participants about their experience with using the device.The study showed that transdermal micro-sampling devices, such as the Tasso+, provided C-peptide measurements similar to those from standard blood draws. The C-peptide in the samples stayed stable for up to 3 days in the refrigerator, even if not processed right away. Participants found the device easy and comfortable to use.In summary, using this device to collect small amounts of blood is a reliable way for samples related to diabetes to be collected and can help with research with less stress. This can make taking part in studies easier, allow for sample collection at home, and help researchers to include more people in studies while still getting trustworthy results.