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NCT03565666 · ClinicalTrials.gov registry record · Phase 2
The Insulin-Only Bionic Pancreas Bridging Study
A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 3
- Study locations
NCT03565666: Completed Phase 2 study of Type 1 Diabetes Mellitus, sponsored by Massachusetts General Hospital.
NCT03565666 is a Phase 2 study of Type 1 Diabetes Mellitus that has completed, run by Massachusetts General Hospital. The registered enrollment target is 36 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (79% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03565666, a Phase 2 study of Type 1 Diabetes Mellitus, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Usual care
- DEVICE iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
- DRUG iLet Bionic Pancreas insulin-only configuration with Fiasp
Study Locations (3)
California
- Stanford University - Palo Alto
Colorado
- Barbara Davis Center for Childhood Diabetes - Aurora
Florida
- Nemours Children's Specialty Care - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2018-07-09 |
| Est. Completion | 2018-11-19 |
| Phase | Phase 2 |
What the finished NCT03565666 record still lists
NCT03565666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Usual care is the first listed.
NCT03565666 reports a single indexed study location in California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT03565666 about?
NCT03565666 is a clinical study titled "The Insulin-Only Bionic Pancreas Bridging Study". 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 ...
What is the current status of trial NCT03565666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2018-07-09. Estimated completion is 2018-11-19.
What conditions does trial NCT03565666 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03565666?
The interventions under investigation include: Usual care (OTHER), iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog (DEVICE), iLet Bionic Pancreas insulin-only configuration with Fiasp (DRUG).
Who is sponsoring clinical trial NCT03565666?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03565666 being conducted?
This trial has 3 study locations across California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03565666's enrollment target sits among peer trials
36 64th of 112 higher than 47 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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