BETA - Pilot Study

NCT07192861 | Enrolling By Invitation

• 1 other identifier: 4UBETAPILOT
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes (DM)

Keywords

wearables; Diabetes; smartphone app; lifestyle; stress; CGM

Outcome Measures

Primary Outcomes (2)

• Feasibility: Retention

  Proportion of participants retained according to study protocol

  6 months

• Feasibility: Adherence

  Mean adherence to completing in-app daily study measures

  6 months

Secondary Outcomes (1)

• Continuos glucose excursions

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with Type 1 Diabetes

You may qualify if:

• 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.

Sponsors & Collaborators

• 4YouandMe: lead
• Buck Institute for Research on Aging: collaborator
• Phenome Health: collaborator

Study Sites (1)

Buck Institute for Research on Aging

San Francisco, California, 94102, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frequently sampled Oral Glucose Tolerance Test (OGTT) with glucose, insulin and C-peptide at each time point; fasting HbA1c and lipid profile

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 25, 2025
• Study Start: July 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE

Locations

US (1)