BETA - Pilot Study

Enrolling by invitation

Conditions studied: Diabetes (DM)

In brief

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 function of beta-cells, the cells in the pancreas that secrete insulin. This study is being initially done with individuals with Type 1 diabetes, so that in the future these methods can be tested in a larger study of individuals with Type 2 diabetes or prediabetics. The eventual aim of this work is to develop remote digital tools that can predict the health and functioning of the pancreas in people with prediabetes and Type 2 diabetes, allowing personalized treatment approaches to preserve insulin secretion.

Key facts

Study ID

NCT07192861

Run by

4YouandMe

People needed

28

Starts

2025-07-01

Expected to finish

2025-11-30

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Buck Institute for Research on Aging — San Francisco, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.