CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 376 enrolled
Drug / intervention
ONYX NEXT BGMSdevice
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/NCT02390167
NCT02390167N/ACompleted
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User Performance of the ONYX NEXT Blood Glucose Monitoring System

Ascensia Diabetes Care·interventional·Posted Mar 17, 2015·Updated Jul 17, 2019

In Brief

A clinical study evaluating ONYX NEXT BGMS for Diabetes. Completed, enrolled 376 participants across 2 sites.

Detailed Summary

The purpose of this study was to determine if untrained subjects with diabetes and without diabetes could operate the Investigational 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 PostedMar 17, 2015
Enrollment StartMar 1, 2015
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.3 years ago

Interventions

ONYX NEXT BGMSdevice

Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested venous blood from subjects WITH Diabetes and BG results were compared to reference method results obtained from the subjects' venous plasma.