Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT07192861
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07192861
Study Brief:
Protocol Section:
NCT07192861