PrediabetesBETATrackNCT07598773
BETA: Study in Prediabetes Type 2 Diabetes
An observational study of Prediabetes and Type 2 Diabetes, run by 4YouandMe at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes, Type 2 Diabetes
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with prediabetes or Type 2 diabetes
Who may be able to join
- 18+ 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Buck Institute for Research on Aging
San Francisco, California, 94102
About this study
Official title: Beta-cell Evaluation Through Data-driven Assessments (BETA): Study in Prediabetes Type 2 Diabetes
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.
Read the detailed description
The objective of this research 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 diverse array of health, lifestyle, and behavioral metrics gathered via a smartphone app and Oura Ring. Investigators will study individuals with T2D or prediabetes using remote digital tools to determine the risk of conversion from prediabetes to T2D as it relates to beta-cell function, as well as personalized treatment options for individuals with Type 2 diabetes. 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, and a Meal Tolerance Test (MTT) at the end of the study. Participants will complete 4 at-home real-world challenges that will also involved MTTs with or without a controlled psychological stress test that will be administered to you by research staff. From this data, the investigators can calculate clinical measures of beta-cell function, including oral Disposition Index as well as 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 scalable tool for early identification of individuals experiencing a decline in beta-cell function.
- Conditions
- Prediabetes, Type 2 Diabetes
- Keywords
- Prediabetes, Type 2 diabetes, Diabetes, wearables, smartphone app, lifestyle, stress, CGM
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Retention
Proportion of participants retained according to study protocol
Measured: 6-8 months
Feasibility: Adherence
Mean adherence to completing in-app daily study measures
Measured: 6-8 months
Secondary outcomes (1)
Continuous Glucose Excursions
Participants glucose excursions will be collected from personal CGMs. A glucose excursion is defined as a change (+/- 25mg/dl) since the last CGM reading. Associations between glucose excursions and factors relating to diet, stress, sleep and activity will be estimated.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start25 Mar 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 4YouandMe
- Sponsor type
- University, hospital or other
- Collaborators
- Buck Institute for Research on Aging, Phenome Health, AgileOps, Oregon State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598773
- Sponsor's protocol ID
- 4BETA2
- Acronym
- BETATrack
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-cell Evaluation Through Data-driven Assessments (BETA): Study in Prediabetes Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07598773
- Acronym / sponsor ID
- BETATrack / 4BETA2
- Conditions
- Prediabetes, Type 2 Diabetes
- Keywords
- Prediabetes, Type 2 diabetes, Diabetes, wearables, smartphone app, lifestyle, stress, CGM
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- 4YouandMeUniversity, hospital or other
- Collaborators
- Buck Institute for Research on Aging, Phenome Health, AgileOps, Oregon State University
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this research 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 diverse array of health, lifestyle, and behavioral metrics gathered via a smartphone app and Oura Ring. Investigators will study individuals with T2D or prediabetes using remote digital tools to determine the risk of conversion from prediabetes to T2D as it relates to beta-cell function, as well as personalized treatment options for individuals with Type 2 diabetes. 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, and a Meal Tolerance Test (MTT) at the end of the study. Participants will complete 4 at-home real-world challenges that will also involved MTTs with or without a controlled psychological stress test that will be administered to you by research staff. From this data, the investigators can calculate clinical measures of beta-cell function, including oral Disposition Index as well as 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 scalable tool for early identification of individuals experiencing a decline in beta-cell function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with prediabetes or Type 2 diabetes
Key inclusion criteria (12 listed)
- 18+ 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility: Retention
Time frame: 6-8 months
Proportion of participants retained according to study protocol
Feasibility: Adherence
Time frame: 6-8 months
Mean adherence to completing in-app daily study measures
1 secondary outcome
Continuous Glucose Excursions
Time frame: 6-8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Prediabetes
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
Nutritional and Metabolic Diseases, Prediabetes
Active, not recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
RecruitingObservational study
AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
Overweight and Obesity, Diabetes Mellitus, Type 2
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Active, not recruitingEarly Phase 1
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetes and Type 2 Diabetes, run by 4YouandMe at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Retention (time frame: 6-8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.