Status:
ENROLLING_BY_INVITATION
BETA - Pilot Study
Lead Sponsor:
4YouandMe
Collaborating Sponsors:
Buck Institute for Research on Aging
Phenome Health
Conditions:
Diabetes (DM)
Eligibility:
All Genders
18+ years
Brief Summary
This study is testing the feasibility of using non-invasive, remote digital tools including continuous glucose monitors (CGMs) and Oura ring and the Empatica EmbracePlus smart wristband to predict the...
Detailed Description
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 along...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT07192861
Start Date
July 1 2025
End Date
November 30 2025
Last Update
September 25 2025
Active Locations (1)
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1
Buck Institute for Research on Aging
San Francisco, California, United States, 94102