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NCT05251116 · ClinicalTrials.gov registry record · NA
Study of an Interstitial Fluid Glucose Sensor
A NA study of Diabete Mellitus, sponsored by Abbott Diabetes Care.
- Completed
- Registry status
- NA
- Development phase
- 332
- Enrollment target
- 5
- Study locations
NCT05251116: Completed NA study of Diabete Mellitus, sponsored by Abbott Diabetes Care.
NCT05251116 is a NA study of Diabete Mellitus that has completed, run by Abbott Diabetes Care. The registered enrollment target is 332 participants, above the 153-participant average among 6 other Diabete Mellitus trials with a reported enrollment target (117% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05251116, a NA study of Diabete Mellitus, has completed, sponsored by Abbott Diabetes Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 332 participants
- Enrollment target
- 5
- Study locations
Study Summary
To characterize the System performance with respect to Yellow Springs Instrument (YSI) reference venous plasma measurements. Safety of the investigational device will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
Primary Outcome
System Performance will be evaluated against the reference system, Yellowstone Instrument (YSI) and against Capillary blood Glucose (BG). During several in clinic visits, plasma samples obtained from the subjects at various time intervals will be analyzed using the YSI. Results will be compared with results obtained from the System, to determine the system accuracy. Similarly, capillary Blood Glucose will be measured and compared with results obtained from the system.
Conditions Studied
Interventions
- DEVICE FreeStyle Libre
Study Locations (5)
California
- Sansum Diabetes Research Institute - Santa Barbara
Georgia
- Atlanta Diabetes Associates - Atlanta
Idaho
- Rocky Mountain Diabetes & Osteoporosis Center - Idaho Falls
Texas
- Diabetes and Glandular Disease Clinic - San Antonio
Washington
- Rainier Clinical Research - Renton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2021-12-11 |
| Est. Completion | 2022-08-15 |
| Phase | NA |
What the finished NCT05251116 record still lists
NCT05251116 is an interventional study that assigns participants to a tested intervention. The registered 332 participants enrollment target is mid-sized for trials with a published cap, above the 153-participant average among 6 other Diabete Mellitus trials with a reported enrollment target (117% higher).
The record links to 1 condition, with Diabete Mellitus appearing as the primary indexed condition, and to 1 intervention - of which FreeStyle Libre is the first listed.
NCT05251116 lists 5 locations in 5 states (California, Georgia, Idaho).
Frequently Asked Questions
What is clinical trial NCT05251116 about?
NCT05251116 is a clinical study titled "Study of an Interstitial Fluid Glucose Sensor". To characterize the System performance with respect to Yellow Springs Instrument (YSI) reference venous plasma measurements. Safety of the investigational device will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
What is the current status of trial NCT05251116?
This trial is currently completed. It is a NA study. The enrollment target is 332 participants. The study started on 2021-12-11. Estimated completion is 2022-08-15.
What conditions does trial NCT05251116 study?
This clinical trial studies the following conditions: Diabete Mellitus.
What interventions are being tested in trial NCT05251116?
The interventions under investigation include: FreeStyle Libre (DEVICE).
Who is sponsoring clinical trial NCT05251116?
This trial is sponsored by Abbott Diabetes Care, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05251116 being conducted?
This trial has 5 study locations across California, Georgia, Idaho, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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