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

Inclusion criteria

• 18 years of age or older
• An established diagnosis of Type 1 diabetes
• Self-reported glycated hemoglobin (HbA1c) below 8% (64 mmol/mol)
• Body Mass Index 18-40 kg/m2
• Fluent in written and spoken English
• Own a personal iPhone 6s or later (iOS 15+ or newer) or Android smartphone (version 12 or newer) and willing to use this phone to download and use the app for the study
• Own a personal Dexcom CGM and willing to provide the study researchers access to it's data during the study.
• Willing to use the study wearable devices (Oura ring, Empatica wristband)
• Resides in the San Francisco Bay area and willing to travel to Novato, CA on at least two occasions for the in person assessments at the Buck Institute.
• If using long-acting insulin (e.g. Basaglar, Lantus, Levemir, Toujeo, Tresiba), must be on a dosing schedule that involves administration of insulin only at bedtime and no other times of day
• Willing to stop use of prescription or over-the-counter medications containing acetaminophen (e.g. Tylenol, Percocet, Nyquil and other common medications for cold and flu, etc.) due to potential interference with the study-provided continuous glucose monitor.

Exclusion criteria

• Pregnant or breastfeeding
• Current tobacco use
• Allergy to dairy or soy
• History of pancreatic disease (other than diabetes) or pancreatic transplantation
• Active malignancy or chemotherapy for malignancy within the past year
• History of bariatric surgery or other gastrointestinal surgery anticipated to affect glucose metabolism, or any cause of gastroparesis
• Renal, hepatic, cardiovascular, or other systemic disease likely to interfere with glucose metabolism or study participation.
• History of severe hypoglycemia or diabetes-related ketoacidosis in the prior 6 months or >2 episodes in the past 12 months.
• Overnight hospitalization for any reason in the past 3 months.
• Current use of the following medications: Calcium channel blockers (e.g., verapamil), glucocorticoids, non-selective beta blockers (e.g., propranolol), GLP-1 receptor agonists, SGLT inhibitors, DPP-4 inhibitors, sulfonylureas, meglitinides, metformin, or thiazolidinediones.