At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Insulin-Only Bionic Pancreas Bridging Study
In Brief
A Phase 3 clinical trial evaluating iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog, iLet Bionic Pancreas insulin-only configuration with Fiasp, and 1 other intervention for Type1 Diabetes Mellitus. Completed, enrolled 36 participants across 3 sites.
Detailed Summary
The iLet is a closed-loop delivery system that can be used in insulin-only, bihormonal, or glucagon-only configurations. Previous studies have utilized a phone-based bionic pancreas. The iLet consists of a touchscreen-enabled, menu-driven user interface and an onboard microprocessor that provides a comprehensive and standalone platform, which allows the iLet to operate independently of smartphones or other devices and without the need for internet support during routine operation. This is a multicenter study of adult participants with type 1 diabetes, who will manage their diabetes with the iLet bionic pancreas compared to usual care.
Study Details
Timeline
Interventions
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
iLet Bionic Pancreas insulin-only configuration with Fiasp (faster insulin aspart)
Usual care