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Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Sponsor: Beta Bionics, Inc.
Summary
The goal of this clinical trial is to evaluate the safety and efficacy of the fully closed loop (FCL) iLet automated insulin delivery (AID) System in people ≥18 years old with type 1 diabetes or type 2 diabetes requiring insulin therapy. The main questions it aims to answer are: Do HbA1c levels decrease when using the iLet FCL algorithm? What medical problems do participants have when using the iLet FCL algorithm? Participants will use the iLet FCL for 13 weeks, undergo bloodwork, and complete psychosocial questionnaires.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-11
Completion Date
2027-07
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
iLet FCL
iLet FCL