NCT07192861
BETA - Pilot Study
Enrolling by Invitation
Not specifiedAges 18+Observational4YouandMeInvestigator-initiated
~28 participants
Updated 2025-09-25 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility: Retention
Measured over 6 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Exclusion
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
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.
What this trial measures
- Feasibility: Retention6 months
Proportion of participants retained according to study protocol
- Feasibility: Adherence6 months
Mean adherence to completing in-app daily study measures