BETA - Pilot Study

The ultimate objective of our research program is to construct a real-time, non-invasive predictor of pancreatic beta-cell function for individuals with T2D or prediabetes, using data from a CGM alongside a rich tapestry of health, lifestyle, and behavioral metrics gathered via a smartphone and a smartwatch. In the current pilot study, we will study individuals with Type 1 diabetes (T1D) who have minimal beta-cell function, to assess the feasibility of our methods for application in a subsequent, larger study of individuals with T2D or prediabetes. To establish a robust foundation for our predictive model, 28 study participants will undergo detailed evaluations of pancreatic beta-cell function at the Buck Institute's Clinical Research Unit (CRU) using the Minimal Model Oral Glucose Tolerance Test (OGTT) with analysis of C-peptide, glucose, and insulin levels. Participants will also wear and use their own CGM, and will be provided with an Oura ring and Empatica EmbracePlus wristband to wear for up to 6 months. Participants will complete 6 at-home remote stress and meal challenges. From this data, we can calculate clinical measures of beta-cell function, including oral Disposition Index as well as measures of the Homeostatic Model Assessment of beta-cell function (HOMA-B), and beta-cell glucose sensitivity. This hybrid approach, blending advanced digital data acquisition with traditional clinical assessments, will facilitate the identification of critical data patterns and biomarkers correlating with beta-cell function. The envisioned outcome is a powerful, scalable tool for the early identification of individuals experiencing a decline in beta-cell function. Coalition and Collaboration partners This project is done by 4YouandMe in collaboration with The Buck Institute, Phenome Health, AgileOps, and Vector Institute and is funded by ARPA-H