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
Study identification
- NCT ID
- NCT04200313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Jaeb Center for Health Research
- Other
- Enrollment
- 440 participants
Conditions and interventions
Interventions
- BP Guidance Insulin Dosing Other
- Bionic Pancreas (BP) with Aspart or Lispro Combination Product
- Bionic Pancreas with Fiasp (BPFiasp) Combination Product
- Usual Care (UC) Other
Other · Combination Product
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.
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 May 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04200313 live on ClinicalTrials.gov.