The Insulin-Only Bionic Pancreas Pivotal Trial: Testing the iLet in Adults and Children with Type 1 Diabetes
Study ID: STU-2019-1241
The study is a randomized, parallel trial comparing the bionic pancreas in the insulin-only configuration (using FDa-approved insulin analogs in both children and adults, and Fiasp in adults) to usual care with a 2:1 randomization (insulin-only BP : usual care) in children and a 2:2:1 randomization in adults (insulin-only BP with lispro/aspart : insulin-only BP with Fiasp : usual care). The study has three major parts: (1) the Test Run Period, (2) the RCT Period, and (3) the extension Studies. Site Test Runs (STRs) will be conducted during the Test Run (TR) Period. The results of this TR Period will be evaluated for safety prior to beginning the RCT Period at any of the clinical sites. The three-month, parallel-group, multi-center, randomized control trial (RCT) is designed to compare the insulin-only iLet BP group using insulin lispro or insulin aspart (adults and pediatrics, BP Group), a BP group using Fiasp (adults only, BP Fiasp Group), and a control group follo[See protocol for complete text]
To compare the efficacy of the insulin-only configuration of the iLet BP System using insulin lispro, insulin aspart, and (in adults only) Fiasp, in maintaining near-normal glycemia relative to usual care in a long-term, home-use study in adults and children with T1D.