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NCT03730480 · ClinicalTrials.gov registry record · NA
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
A NA study, sponsored by Ascensia Diabetes Care.
- Completed
- Registry status
- NA
- Development phase
- 372
- Enrollment target
NCT03730480 is a NA study that has completed, run by Ascensia Diabetes Care. The registered enrollment target is 372 participants.
The verdict
NCT03730480, a NA study, has completed, sponsored by Ascensia Diabetes Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 372 participants
- Enrollment target
Study Summary
This study will collect lay user ("subjects") and healthcare professional information on the performance of two different blood glucose monitors, the CONTOUR NEXT and the CONTOUR TV3, in people with and without diabetes. Each subject will use both meters, at different times and in different order, using a fingerstick(s) to collect meter samples. Meter results will be compared to standardized test system to assess the accuracy of the meters' results. Additionally, a blood sample will be drawn from the subject's arm by a trained healthcare professional for testing on both BGMS. Subjects will also be asked to complete a questionnaire to rate their experience using the meters and to evaluate the meter's Instructions for Use. After all testing and the first questionnaire have been completed, the study staff will demonstrate only to subjects with diabetes several features of the meters that would not necessarily be experienced during the meter testing. These subjects will then answer questions about the features in a second questionnaire.
Interventions
- DEVICE Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2018-09-06 |
| Est. Completion | 2018-10-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03730480
The ClinicalTrials.gov registry entry for NCT03730480 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 372 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascensia Diabetes Care, which has 42 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes is the first listed.
NCT03730480 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03730480 about?
NCT03730480 is a clinical study titled "User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)". This study will collect lay user ("subjects") and healthcare professional information on the performance of two different blood glucose monitors, the CONTOUR NEXT and the CONTOUR TV3, in people with and without diabetes. Each subject will use both meters, at different times and in different order, u...
What is the current status of trial NCT03730480?
This trial is currently completed. It is a NA study. The enrollment target is 372 participants. The study started on 2018-09-06. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT03730480?
The interventions under investigation include: Contour Next and Contour TV3 BGMS testing by subjects with and without Diabetes (DEVICE).
Who is sponsoring clinical trial NCT03730480?
This trial is sponsored by Ascensia Diabetes Care, which has 42 total clinical trials registered on ClinicalTrials.gov.
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