BETA: Study in Prediabetes Type 2 Diabetes
BETATrack
Beta-cell Evaluation Through Data-driven Assessments (BETA): Study in Prediabetes Type 2 Diabetes
1 other identifier
observational
130
1 country
1
Brief Summary
This study is testing the feasibility of using non-invasive, remote digital tools including continuous glucose monitors (CGMs) and the Oura Ring to predict the function of beta-cells, the cells in the pancreas that secrete insulin. This study is being done in individuals with prediabetes or Type 2 diabetes. The aim is to develop remote digital tools that can predict the health and functioning of the pancreas in people with prediabetes or Type 2 diabetes, allowing personalized treatment approaches to preserve insulin secretion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2026
CompletedFirst Submitted
Initial submission to the registry
May 14, 2026
CompletedFirst Posted
Study publicly available on registry
May 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
May 20, 2026
May 1, 2026
10 months
May 14, 2026
May 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility: Retention
Proportion of participants retained according to study protocol
6-8 months
Feasibility: Adherence
Mean adherence to completing in-app daily study measures
6-8 months
Secondary Outcomes (1)
Continuous Glucose Excursions
6-8 months
Eligibility Criteria
Individuals with prediabetes or Type 2 diabetes
You may qualify if:
- + years old
- Have an established diagnosis of Prediabetes or Type 2 diabetes
- Have a glycated hemoglobin (HbA1c) below 8% (64 mmol/mol) and a body mass index (BMI) between 18-40 kg/m2 that will be determined from your height and weight
- Are willing to use an Abbott FreeStyle Libre 3/3+ Continuous Glucose Monitor (CGM) supplied by the study and provide the study investigators access to the CGM data
- Are willing to use the study wearable devices (e.g., Oura Ring)
- Are able to read, write, and speak in English
- If you use long-acting insulin, you must be on a prescribed regimen where you administer it at bedtime only and no other time of day (bolus short-acting may be used at any time as needed)
- All medication regimens must have a minimum of 30 days supply, and no new medications started within 30 days of enrollment
- Weight must be stable (± 10 pounds) for 2 months prior to enrollment
- Must have a personally owned iPhone 6s or newer (iOS 16.4+) or Android smartphone (version 12 or newer) and use this phone to download and use the study app and use the provided study devices
- Must have a personally owned computer or tablet or have access to these devices at home
- Must reside in the North San Francisco Bay area and be willing to travel to Novato, CA to attend two morning clinic assessments at the Buck Institute
You may not qualify if:
- Using any Abbott CGM (prescribed or OTC)
- BMI \<18 kg/m2 or \>40 kg/m2
- Dairy or soy allergy
- Currently pregnant or breastfeeding
- Diagnosed with Type 1 diabetes or MODY (Maturity-Onset Diabetes of the Young)
- Using an insulin pump
- Using any of the following medications: Glucocorticoids, Non-Selective Beta Blockers (e.g., propranolol), Thiazide Diuretics
- Currently using tobacco products (cigarettes, vapes, chew, dip, etc.)
- Hospitalized overnight for any reason in the last 3 months
- History of pancreatic disease (other than diabetes) or pancreatic transplantation
- Have any active malignancy within the last 12 months
- History of bariatric / other gastrointestinal surgery anticipated to affect glucose metabolism / cause gastroparesis
- History of systemic disease (hepatic, cardiovascular, other) likely to interfere with glucose metabolism or study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 4YouandMelead
- Buck Institute for Research on Agingcollaborator
- Phenome Healthcollaborator
- AgileOpscollaborator
- Oregon State Universitycollaborator
Study Sites (1)
Buck Institute for Research on Aging
San Francisco, California, 94102, United States
Biospecimen
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
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2026
First Posted
May 20, 2026
Study Start
March 25, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
Deidentified study data will be shared beyond the internal research team by 4YouandMe with external qualified researchers using an ARPA-H approved data sharing platforms such as the Synapse Data Sharing Platform at Sage Bionetworks. This data sharing will occur 1 year after the last participant has exited the study. Researchers from other institutions, and other third parties will be able to apply for access to the deidentified dataset by presenting a research study plan for analysis that has been reviewed by an IRB or ethics committee. Data released through these ARPA-H approved data sharing platforms will be stored indefinitely.