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NCT07192861Enrolling by invitation

BETA - Pilot Study

Beta-cell Evaluation Through Data-driven Assessments (BETA): Pilot Study in Type 1 Diabetes

Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
28 (estimated)
First submitted
18 Sept 2025
Start date
1 Jul 2025
Primary completion date
30 Nov 2025
Lead sponsor
4YouandMe
NCT number
NCT07192861

What you commit to

  • Study type: Observational
  • Planned participants: 28
  • From 1 Jul 2025 to the primary completion date, 30 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of severe hypoglycemia or diabetes-related ketoacidosis in the prior 6 months or \>2 episodes in the past 12 months.

Other illness

  • 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

Lab values

  • 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.
  • 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.

Other

  • Pregnant or breastfeeding
  • Current tobacco use
  • Overnight hospitalization for any reason in the past 3 months.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Buck Institute for Research on Aging
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.