CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 372 enrolled
Drug / intervention
Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS +1 moredevice
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.

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NCT02150109N/ACompleted
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User Performance of the Karajishi Contour Blood Glucose Monitoring System (ISO/FDA Study)

Ascensia Diabetes Care·interventional·Posted May 29, 2014·Updated Feb 29, 2016

In Brief

A clinical study evaluating Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS and Subjects WITH Diabetes Use Karajishi Contour BGMS for Diabetes. Completed, enrolled 372 participants across 2 sites.

Detailed Summary

The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.

Study Details

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

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 29, 2014
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 12.1 years ago

Interventions

Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMSdevice

Untrained subjects WITH and WITHOUT diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.

Subjects WITH Diabetes Use Karajishi Contour BGMSdevice

Untrained subjects WITH diabetes use the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.