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NCT03859401 · ClinicalTrials.gov registry record · NA
Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas
A NA study, sponsored by Marc Breton.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT03859401: Completed NA study, sponsored by Marc Breton.
NCT03859401 is a NA study that has completed, run by Marc Breton. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03859401, a NA study, has completed, sponsored by Marc Breton.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a randomized crossover trial with 1:1 randomization to the admission sequence of using the Control AP system (rMPC - Naïve Model Predictive Control) vs. Experimental AP system (EnMPC - Ensemble Model Predictive Control) over approximately 4 months. Eligible participants will proceed to the Data Collection Phase for approximately 28 days, during which they will participate in regimented exercise activities. If the participant collected adequate data during the Data Collection Phase, they will be randomized and undergo the study admissions in the assigned sequence. Each admission is approximately 36 hours in length and will consist of one afternoon of exercise and one without.
Primary Outcome
Number of hypoglycemic occurrences immediately before, during, and immediately after exercise (\~5-7pm) as defined by more than one consecutive CGM values below 70 mg/dL or hypoglycemic treatment per glycemic guidelines.
Interventions
- DEVICE EnMPC (Ensemble Model Predictive Control) AP Controller
- DEVICE rMPC (Naïve Model Predictive Control) AP Controller
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-04-12 |
| Est. Completion | 2020-01-13 |
| Phase | NA |
What the finished NCT03859401 record still lists
NCT03859401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which EnMPC (Ensemble Model Predictive Control) AP Controller is the first listed.
NCT03859401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03859401 about?
NCT03859401 is a clinical study titled "Exercise-Induced Hypoglycemia Prevention in Adults With Type 1 Diabetes Using an Artificial Pancreas". This is a randomized crossover trial with 1:1 randomization to the admission sequence of using the Control AP system (rMPC - Naïve Model Predictive Control) vs. Experimental AP system (EnMPC - Ensemble Model Predictive Control) over approximately 4 months. Eligible participants will proceed to the D...
What is the current status of trial NCT03859401?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2019-04-12. Estimated completion is 2020-01-13.
What interventions are being tested in trial NCT03859401?
The interventions under investigation include: EnMPC (Ensemble Model Predictive Control) AP Controller (DEVICE), rMPC (Naïve Model Predictive Control) AP Controller (DEVICE).
Who is sponsoring clinical trial NCT03859401?
This trial is sponsored by Marc Breton, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03859401's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 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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