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NCT02302963 · ClinicalTrials.gov registry record · NA
USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
A NA study, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 85
- Enrollment target
NCT02302963: Completed NA study, sponsored by University of Virginia.
NCT02302963 is a NA study that has completed, run by University of Virginia. The registered enrollment target is 85 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02302963, a NA study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
Study Summary
This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.
Primary Outcome
Change in hypoglycemia during the study on USS Virginia versus Sensor Augmented Pump (SAP) as assessed by Low Blood Glucose Index (LBGI) from Continuous Glucose Monitoring (CGM) during 1 week of baseline blinded use versus during the last week of intervention. The LBGI is a metric of the frequency and severity of hypoglycemia, based on an increasing weighting of progressively low glucose readings. The LBGI will be higher for someone with a higher percentage of low blood glucose readings or more
Interventions
- DEVICE AP System (DiAs or inControl) with USS Virginia
- DEVICE Sensor-Augmented Pump Therapy (placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-01 |
| Phase | NA |
What the finished NCT02302963 record still lists
NCT02302963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which AP System (DiAs or inControl) with USS Virginia is the first listed.
NCT02302963 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02302963 about?
NCT02302963 is a clinical study titled "USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D". This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness and/or risk for hypoglycemia.
What is the current status of trial NCT02302963?
This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2015-06. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02302963?
The interventions under investigation include: AP System (DiAs or inControl) with USS Virginia (DEVICE), Sensor-Augmented Pump Therapy (placebo) (DEVICE).
Who is sponsoring clinical trial NCT02302963?
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 NCT02302963's enrollment target sits among peer trials
85 980th of 2000 higher than 1,018 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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