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NCT03674281 · ClinicalTrials.gov registry record · NA
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
A NA study of Type 1 Diabetes Mellitus and Cognitive Change, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03674281: Completed NA study of Type 1 Diabetes Mellitus and Cognitive Change, sponsored by University of Virginia.
NCT03674281 is a NA study of Type 1 Diabetes Mellitus and Cognitive Change that has completed, run by University of Virginia. The registered enrollment target is 50 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03674281, a NA study of Type 1 Diabetes Mellitus and Cognitive Change, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.
Primary Outcome
Percentage of time of blood glucose in range 70-180 mg/dL as measured by the continuous glucose monitor.
Conditions Studied
Interventions
- DEVICE SAP
- DEVICE CLC
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-09-24 |
| Est. Completion | 2019-11-21 |
| Phase | NA |
What the finished NCT03674281 record still lists
NCT03674281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which SAP is the first listed.
NCT03674281 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03674281 about?
NCT03674281 is a clinical study titled "The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System". The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and e...
What is the current status of trial NCT03674281?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2018-09-24. Estimated completion is 2019-11-21.
What conditions does trial NCT03674281 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus, Cognitive Change.
What interventions are being tested in trial NCT03674281?
The interventions under investigation include: SAP (DEVICE), CLC (DEVICE).
Who is sponsoring clinical trial NCT03674281?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03674281 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03674281's enrollment target sits among peer trials
50 52nd of 112 higher than 57 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus 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.
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