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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 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 33 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02131766
The ClinicalTrials.gov registry entry for NCT02131766 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sensor Augmented Pump Therapy is the first listed.
NCT02131766 reports 0 study locations.
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.
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