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NCT03565666 · ClinicalTrials.gov registry record · Phase 2
The Insulin-Only Bionic Pancreas Bridging Study
A Phase 2 study of Type1 Diabetes Mellitus, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 3
- Study locations
NCT03565666 is a Phase 2 study of Type1 Diabetes Mellitus that has completed, run by Massachusetts General Hospital. The registered enrollment target is 36 participants, below the 753-participant average among 6 other Type1 Diabetes Mellitus trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT03565666, a Phase 2 study of Type1 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03565666
The ClinicalTrials.gov registry entry for NCT03565666 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 753-participant average among 6 other Type1 Diabetes Mellitus trials with a reported enrollment target (95% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Usual care is the first listed.
NCT03565666 reports 3 study locations spanning 3 distinct geographic areas - top geographies include 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: Type1 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.