Clinical trial
The Insulin-Only Bionic Pancreas Pivotal Trial
NCT04200313 · Jaeb Center for Health Research, Other · Completed
Key facts
| NCT number | NCT04200313 |
|---|---|
| Title | The Insulin-Only Bionic Pancreas Pivotal Trial |
| Official title | The Insulin-Only Bionic Pancreas Pivotal Trial: Testing the iLet in Adults and Children With Type 1 Diabetes |
| Lead sponsor | Jaeb Center for Health Research, Other |
| Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) NIH Beta Bionics, Inc. Industry Boston University Massachusetts General Hospital |
| Status | Completed |
| Study type | Interventional |
| Conditions | Diabetes Mellitus, Type 1 Diabetes, Type 1 |
| Intervention type | Combination Product, Other |
| Interventions | Bionic Pancreas (BP) with Aspart or Lispro, Bionic Pancreas with Fiasp (BPFiasp), Usual Care (UC), BP Guidance Insulin Dosing |
| Enrollment | 440 |
| Start date | Mar 31, 2020 |
| Primary completion | Oct 30, 2021 |
| Completion | Jan 14, 2022 |
| First posted | Dec 16, 2019 |
| Last update posted | Feb 20, 2025 |
| Countries | United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- 1–9 Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: