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NCT02283411 · ClinicalTrials.gov registry record · NA
Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems
A NA study, sponsored by Abbott Diabetes Care.
- Completed
- Registry status
- NA
- Development phase
- 156
- Enrollment target
NCT02283411 is a NA study that has completed, run by Abbott Diabetes Care. The registered enrollment target is 156 participants.
The verdict
NCT02283411, a NA study, has completed, sponsored by Abbott Diabetes Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 156 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring System - Professional Sensors will be worn by adult subjects over a 14-day wear period. The primary objective is to characterize the Systems performance with respect to Yellow Spring Instrument (YSI) reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the Abbott Sensor Based Glucose Monitoring Systems in reference to YSI. Safety of the Abbott Sensor Based Glucose Monitoring Systems will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants. 240 subjects will be enrolled and additional healthy subjects may also be enrolled in the study as training subjects.
Interventions
- DEVICE Abbott Sensor Based Glucose Monitoring System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2014-11 |
| Est. Completion | 2015-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02283411
The ClinicalTrials.gov registry entry for NCT02283411 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Diabetes Care, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Abbott Sensor Based Glucose Monitoring System is the first listed.
NCT02283411 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02283411 about?
NCT02283411 is a clinical study titled "Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems". The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing over a 14-day wear period in adul...
What is the current status of trial NCT02283411?
This trial is currently completed. It is a NA study. The enrollment target is 156 participants. The study started on 2014-11. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02283411?
The interventions under investigation include: Abbott Sensor Based Glucose Monitoring System (DEVICE).
Who is sponsoring clinical trial NCT02283411?
This trial is sponsored by Abbott Diabetes Care, which has 26 total clinical trials registered on ClinicalTrials.gov.
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