CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 134 enrolled
Drug / intervention
ONYX PLUS Investigational Blood Glucose Monitoring Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02371876
NCT02371876N/ACompleted
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User Performance of the ONYX PLUS Blood Glucose Monitoring System

Ascensia Diabetes Care·interventional·Posted Feb 26, 2015·Updated Oct 30, 2019

In Brief

A clinical study evaluating ONYX PLUS Investigational Blood Glucose Monitoring System for Diabetes. Completed, enrolled 134 participants across 2 sites.

Detailed Summary

The purpose of this study was to determine if untrained subjects with diabetes can operate the Investigational ONYX PLUS Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 26, 2015
Enrollment StartFeb 1, 2015
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.3 years ago

Interventions

ONYX PLUS Investigational Blood Glucose Monitoring Systemdevice

Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.