Using wearable devices to track insulin-making cells in prediabetes and type 2 diabetes

Trial details

Who runs it

4YouandMe

Trial code

NCT07598773

Record updated

20 May 2026

Original description

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 full original descriptionShow less

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.

Inclusion: 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; 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.

Exclusion: 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.); Dairy or soy allergy; Diagnosed with Type 1 diabetes or MODY (Maturity-Onset Diabetes of the Young); 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; Using any Abbott CGM (prescribed or OTC); BMI <18 kg/m2 or >40 kg/m2; Currently pregnant or breastfeeding; Using an insulin pump; Hospitalized overnight for any reason in the last 3 months.

ClinicalTrials.gov NCT07598773