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NCT04200313 · ClinicalTrials.gov registry record · NA
The Insulin-Only Bionic Pancreas Pivotal Trial
A NA study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- NA
- Development phase
- 440
- Enrollment target
NCT04200313: Completed NA study, sponsored by Jaeb Center for Health Research.
NCT04200313 is a NA study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 440 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04200313, a NA study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- NA
- Development phase
- 440 participants
- Enrollment target
Study Summary
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).
Primary Outcome
The primary outcome is superiority for central lab hemoglobin A1c at 13 weeks. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.
Interventions
- OTHER Usual Care (UC)
- COMBINATION_PRODUCT Bionic Pancreas (BP) with Aspart or Lispro
- COMBINATION_PRODUCT Bionic Pancreas with Fiasp (BPFiasp)
- OTHER BP Guidance Insulin Dosing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2020-03-31 |
| Est. Completion | 2022-01-14 |
| Phase | NA |
What the finished NCT04200313 record still lists
NCT04200313 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 4 interventions - of which Usual Care (UC) is the first listed.
NCT04200313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04200313 about?
NCT04200313 is a clinical study titled "The Insulin-Only Bionic Pancreas Pivotal Trial". 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 tra...
What is the current status of trial NCT04200313?
This trial is currently completed. It is a NA study. The enrollment target is 440 participants. The study started on 2020-03-31. Estimated completion is 2022-01-14.
What interventions are being tested in trial NCT04200313?
The interventions under investigation include: Usual Care (UC) (OTHER), Bionic Pancreas (BP) with Aspart or Lispro (COMBINATION_PRODUCT), Bionic Pancreas with Fiasp (BPFiasp) (COMBINATION_PRODUCT), BP Guidance Insulin Dosing (OTHER).
Who is sponsoring clinical trial NCT04200313?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04200313's enrollment target sits among peer trials
440 233rd of 2000 higher than 1,766 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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