The Insulin-Only Bionic Pancreas Pivotal Trial
Public ClinicalTrials.gov record NCT04200313. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Insulin-Only Bionic Pancreas Pivotal Trial: Testing the iLet in Adults and Children With Type 1 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multi-center randomized control trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual Care (UC) during a 13-week study period. Participants may be enrolled initially into a screening protocol and then transfer into the RCT protocol, or they may enter directly into the RCT protocol. The RCT will be followed by an Extension Phase in which the RCT Usual Care (UC) Group will use the insulin-only configuration of the iLet Bionic Pancreas (BP) System for 3 months. At the completion of use of the BP system in the RCT only, participants will enter a 2-4 day Transition Phase and be randomly assigned to either transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP System or transition back to their usual mode of therapy based on what their own insulin regimens were prior to enrolling in the RCT. There is an optional ancillary study to assess the safety of utilizing self-monitored blood glucose (SMBG) measurements instead of continuous glucose monitor (CGM) measurements as input into the iLet for \~48-60 hours. The Study is intended to mirror a real-world situation where CGM may not be available for an extended period of time (eg, user runs out of sensors and is awaiting new shipment).
Study identification
- NCT ID
- NCT04200313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 440 participants
Conditions and interventions
Interventions
- Bionic Pancreas (BP) with Aspart or Lispro Combination Product
- Bionic Pancreas with Fiasp (BPFiasp) Combination Product
- Usual Care (UC) Other
- BP Guidance Insulin Dosing Other
Combination Product · Other
Eligibility (public fields only)
- Age range
- 6 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 30, 2020
- Primary completion
- Oct 29, 2021
- Completion
- Jan 13, 2022
- Last update posted
- Feb 19, 2025
2020 – 2022
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Orange County (Pediatrics) | Orange | California | 92868 | — |
| University of California - San Diego (Adults) | San Diego | California | 92037 | — |
| Stanford University (Pediatrics and Adults) | Stanford | California | 94305 | — |
| Barbara Davis Center for Diabetes (Pediatrics and Adults) | Aurora | Colorado | 80045 | — |
| Children's National Health System (Pediatrics) | Washington D.C. | District of Columbia | 20010 | — |
| Nemours Children's Clinic (Pediatrics) | Jacksonville | Florida | 32207 | — |
| Emory University (Pediatrics) | Atlanta | Georgia | 30322 | — |
| Massachusetts General Hospital - Diabetes Research Center (Peds and Adults) | Boston | Massachusetts | 02114 | — |
| Henry Ford Health System (Adults) | Detroit | Michigan | 48202 | — |
| Washington University (Adults) | St Louis | Missouri | 63110 | — |
| Naomi Berrie Diabetes Center at Columbia University (Pediatrics) | New York | New York | 10032 | — |
| University of Noth Carolina- Chapel Hill (Adults) | Chapel Hill | North Carolina | 27517 | — |
| Cleveland Clinic (Adults) | Cleveland | Ohio | 44195 | — |
| University of Texas- Southwestern (Pediatrics and Adults) | Dallas | Texas | 75390 | — |
| University of Texas Health Science Center (Pediatrics) | San Antonio | Texas | 78229 | — |
| University of Washington (Adults) | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04200313, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 19, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04200313 live on ClinicalTrials.gov.