Diabetes (DM)NCT07192861
BETA - Pilot Study
An observational study of Diabetes (DM), 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 Oura ring and the Empatica EmbracePlus smart wristband to predict the function of beta-cells, the cells in the pancreas that secrete insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (DM)
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 30 Nov 2025
- 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 Type 1 Diabetes
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
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): Pilot Study in Type 1 Diabetes
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.
Read 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 alongside a rich tapestry of health, lifestyle, and behavioral metrics gathered via a smartphone and a smartwatch. In the current pilot study, we will study individuals with Type 1 diabetes (T1D) who have minimal beta-cell function, to assess the feasibility of our methods for application in a subsequent, larger study of individuals with T2D or prediabetes.
To establish a robust foundation for our predictive model, 28 study 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. Participants will also wear and use their own CGM, and will be provided with an Oura ring and Empatica EmbracePlus wristband to wear for up to 6 months. Participants will complete 6 at-home remote stress and meal challenges. From this data, we can calculate clinical measures of beta-cell function, including oral Disposition Index as well as measures of 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 powerful, scalable tool for the early identification of individuals experiencing a decline in beta-cell function.
Coalition and Collaboration partners This project is done by 4YouandMe in collaboration with The Buck Institute, Phenome Health, AgileOps, and Vector Institute and is funded by ARPA-H
- Conditions
- Diabetes (DM)
- Keywords
- wearables, Diabetes, smartphone app, lifestyle, stress, CGM
- Medical subject headings
- 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 months
Feasibility: Adherence
Mean adherence to completing in-app daily study measures
Measured: 6 months
Secondary outcomes (1)
Continuos 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 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Jul 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 4YouandMe
- Sponsor type
- University, hospital or other
- Collaborators
- Buck Institute for Research on Aging, Phenome Health
- Responsible party
- Principal investigator, Stephen Friend, 4YouandMe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192861
- Sponsor's protocol ID
- 4UBETAPILOT
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-cell Evaluation Through Data-driven Assessments (BETA): Pilot Study in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07192861
- Acronym / sponsor ID
- 4UBETAPILOT
- Conditions
- Diabetes (DM)
- Keywords
- wearables, Diabetes, smartphone app, lifestyle, stress, CGM
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- 4YouandMeUniversity, hospital or other
- Collaborators
- Buck Institute for Research on Aging, Phenome Health
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 25 Sep 2025 (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 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.
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 alongside a rich tapestry of health, lifestyle, and behavioral metrics gathered via a smartphone and a smartwatch. In the current pilot study, we will study individuals with Type 1 diabetes (T1D) who have minimal beta-cell function, to assess the feasibility of our methods for application in a subsequent, larger study of individuals with T2D or prediabetes.
To establish a robust foundation for our predictive model, 28 study 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. Participants will also wear and use their own CGM, and will be provided with an Oura ring and Empatica EmbracePlus wristband to wear for up to 6 months. Participants will complete 6 at-home remote stress and meal challenges. From this data, we can calculate clinical measures of beta-cell function, including oral Disposition Index as well as measures of 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 powerful, scalable tool for the early identification of individuals experiencing a decline in beta-cell function.
Coalition and Collaboration partners This project is done by 4YouandMe in collaboration with The Buck Institute, Phenome Health, AgileOps, and Vector Institute and is funded by ARPA-H
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 Type 1 Diabetes
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 months
Proportion of participants retained according to study protocol
Feasibility: Adherence
Time frame: 6 months
Mean adherence to completing in-app daily study measures
1 secondary outcome
Continuos glucose excursions
Time frame: 6 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 25 Sep 2025.
- 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.
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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 Diabetes (DM), 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 11 inclusion and 10 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 25 Sep 2025. 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 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 25 Sep 2025.