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NOT YET RECRUITING
NCT07911566
NA

Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes

Sponsor: Beta Bionics, Inc.

View on ClinicalTrials.gov

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

DEVICE

iLet FCL

iLet FCL