150
Participants
Start Date
September 24, 2024
Primary Completion Date
November 30, 2025
Study Completion Date
March 31, 2026
iLet Bionic Pancreas System (BP)
The iLet Bionic Pancreas System (BP) consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls insulin delivery based on glucose values obtained by communicating with a CGM sensor.
Usual Care (UC)
Usual Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump.
RECRUITING
Columbia University Medical Center, New York
ACTIVE_NOT_RECRUITING
Children's Hospital of Philadelphia, Philadelphia
RECRUITING
Johns Hopkins University School of Medicine, Baltimore
RECRUITING
University of Virginia-Center for Diabetes Technology, Charlottesville
RECRUITING
Emory University, Atlanta
RECRUITING
University Hospitals of Cleveland, Cleveland
RECRUITING
Indiana University School of Medicine, Indianapolis
RECRUITING
University of Minnesota, Minneapolis
RECRUITING
Children's Mercy Hospital, Kansas City
RECRUITING
UT Southwestern Medical Center, Dallas
RECRUITING
Baylor College of Medicine, Houston
RECRUITING
University of Texas Health San Antonio, San Antonio
RECRUITING
University of Colorado-Barbara Davis Center for Diabetes, Aurora
RECRUITING
University of Utah, Salt Lake City
RECRUITING
Yale University School of Medicine, New Haven
RECRUITING
Massachusetts General Hospital, Boston
Lead Sponsor
Collaborators (1)
Cystic Fibrosis Foundation
OTHER
Massachusetts General Hospital
OTHER
Beta Bionics, Inc.
INDUSTRY
Jaeb Center for Health Research
OTHER