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NCT01484457 · ClinicalTrials.gov registry record · Early Phase 1
Controlled Insulin Delivery: Combining Technology With Treatment
A Early Phase 1 study, sponsored by Sansum Diabetes Research Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
NCT01484457: Completed Early Phase 1 study, sponsored by Sansum Diabetes Research Institute.
NCT01484457 is a Early Phase 1 study that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 19 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01484457, a Early Phase 1 study, has completed, sponsored by Sansum Diabetes Research Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM) to control blood glucose concentrations. This study seeks to combine real-time continuous glucose sensing with automated insulin delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end result of this line of research will be an artificial pancreas that will provide around-the-clock glucose regulation through controlled insulin delivery in response to detected patterns of change in glucose levels.
Primary Outcome
The primary endpoint of this pilot study is successful restoration of euglycemia from the two perturbed conditions using closed loop control with minimal hypo- and hyperglycemia exposure. The first condition involves restoration of euglycemia when the subject is in a hyperglycemic state. The second condition involves restoration of euglycemia following consumption of a meal containing 25g CHO with no insulin bolus. The patients will be followed for the duration of the 12 hour study.
Interventions
- DEVICE Closed-loop session
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2008-07 |
| Est. Completion | 2010-01 |
| Phase | Early Phase 1 |
What the finished NCT01484457 record still lists
NCT01484457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which Closed-loop session is the first listed.
NCT01484457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01484457 about?
NCT01484457 is a clinical study titled "Controlled Insulin Delivery: Combining Technology With Treatment". Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM) to control blood glucose concentrations. This study seeks to combine real-time continuous glucose...
What is the current status of trial NCT01484457?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2008-07. Estimated completion is 2010-01.
What interventions are being tested in trial NCT01484457?
The interventions under investigation include: Closed-loop session (DEVICE).
Who is sponsoring clinical trial NCT01484457?
This trial is sponsored by Sansum Diabetes Research Institute, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01484457's enrollment target sits among peer trials
19 1292nd of 2000 higher than 686 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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