drugset / Trial / NCT03565666

The Insulin-Only Bionic Pancreas Bridging Study

NCT03565666

Phase 2/3 Completed 36 enrolled Massachusetts General Hospital
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2018-07-09
Primary completion
2018-11-19
Completion
2018-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin aspart Protein / enzyme biologic