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NCT02131766 · ClinicalTrials.gov registry record · NA
USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT02131766: Completed NA study, sponsored by University of Virginia.
NCT02131766 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02131766, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study is to use the USS Virginia Closed-Loop system for overnight insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood glucose levels. This protocol will test the feasibility of "bedside" closed-loop control - an approach comprised of standard sensor-augmented pump therapy during the day using off-the-shelf devices and overnight closed-loop control using experimental devices in an outpatient setting. The rationale for this study is as follows: we anticipate that closed-loop control may ultimately be adopted by patients with T1DM in a selective manner. Patient may choose to start using these systems for overnight control only, e.g. to alleviate the well documented fear of hypoglycemia while asleep. To test this paradigm of "bedside" closed-loop control, subjects will be studied with continuous glucose monitoring (CGM)-augmented usual pump therapy during the day followed by overnight use of USS Virginia Closed Loop Control.
Primary Outcome
Assess the effect size of USS Virginia in increasing time within target (70-180 mg/dL) over a 24-hour period with closed-loop control overnight (23:00 to 07:00) as compared to sensor-augmented pump alone.
Interventions
- OTHER Sensor Augmented Pump Therapy
- DEVICE DiAs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-03 |
| Phase | NA |
What the finished NCT02131766 record still lists
NCT02131766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Sensor Augmented Pump Therapy is the first listed.
NCT02131766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02131766 about?
NCT02131766 is a clinical study titled "USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes". The purpose of this study is to use the USS Virginia Closed-Loop system for overnight insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood glucose levels. This protocol will test the feasibility of "bedside" c...
What is the current status of trial NCT02131766?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2014-06. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02131766?
The interventions under investigation include: Sensor Augmented Pump Therapy (OTHER), DiAs (DEVICE).
Who is sponsoring clinical trial NCT02131766?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02131766's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 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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