At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
User Performance of the Karajishi Contour TS Blood Glucose Monitoring System
In Brief
A clinical study evaluating Karajishi TS 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 subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) with no training and obtain valid glucose results.
Study Details
Timeline
Interventions
Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.