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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: Completed NA study, sponsored by Abbott Diabetes Care.
NCT02283411 is a NA study that has completed, run by Abbott Diabetes Care. The registered enrollment target is 156 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels \<80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had up to 136 YSI samples colle
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 |
What the finished NCT02283411 record still lists
NCT02283411 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Abbott Sensor Based Glucose Monitoring System is the first listed.
NCT02283411 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02283411's enrollment target sits among peer trials
156 656th of 2000 higher than 1,345 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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