440
Participants
Start Date
March 31, 2020
Primary Completion Date
October 30, 2021
Study Completion Date
January 14, 2022
Bionic Pancreas (BP) with Aspart or Lispro
iLet Bionic Pancreas System, which 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 Dexcom G6 sensor using lispro or aspart insulin.
Bionic Pancreas with Fiasp (BPFiasp)
iLet Bionic Pancreas System, which consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls Fiasp insulin delivery based on glucose values obtained by communicating with a Dexcom G6 sensor.
Usual Care (UC)
Using pre-study insulin regimen with the Dexcom G6 CGM
BP Guidance Insulin Dosing
Pre-study insulin delivery method with SMBG and blinded CGM with dosing guidance by the BP
Naomi Berrie Diabetes Center at Columbia University (Pediatrics), New York
Children's National Health System (Pediatrics), Washington D.C.
University of Noth Carolina- Chapel Hill (Adults), Chapel Hill
Emory University (Pediatrics), Atlanta
Nemours Children's Clinic (Pediatrics), Jacksonville
Cleveland Clinic (Adults), Cleveland
Henry Ford Health System (Adults), Detroit
Washington University (Adults), St Louis
University of Texas- Southwestern (Pediatrics and Adults), Dallas
University of Texas Health Science Center (Pediatrics), San Antonio
Barbara Davis Center for Diabetes (Pediatrics and Adults), Aurora
University of California - San Diego (Adults), San Diego
Children's Hospital of Orange County (Pediatrics), Orange
Stanford University (Pediatrics and Adults), Stanford
University of Washington (Adults), Seattle
Massachusetts General Hospital - Diabetes Research Center (Peds and Adults), Boston
Lead Sponsor
Collaborators (1)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Beta Bionics, Inc.
INDUSTRY
Boston University
OTHER
Massachusetts General Hospital
OTHER
Jaeb Center for Health Research
OTHER