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The Insulin-Only Bionic Pancreas Bridging Study
NCT03565666 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03565666 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03565666?
This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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