At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 12 enrolled
Drug / intervention
Dasiglucagon +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Bihormonal iLet Bionic Pancreas Feasibility Study
In Brief
A Phase 3 clinical trial evaluating Bihormonal iLet Bionic Pancreas, Insulin-only Bionic Pancreas, and 1 other intervention for Type 1 Diabetes Mellitus. Completed, enrolled 12 participants across 1 site.
Detailed Summary
Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsBeta Bionics, Inc., Zealand Pharma
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartMay 2019
Primary CompletionJul 2019
TodayJul 2026
First PostedFeb 15, 2019
Enrollment StartMay 15, 2019
Primary CompletionJul 3, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.4 years ago
Interventions
Bihormonal iLet Bionic Pancreasdevice
Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
Insulin-only Bionic Pancreasdevice
Insulin-only iLet Bionic Pancreas using just insulin
Dasiglucagondrug
Experimental stable glucagon for use in the iLet Bionic Pancreas