NCT02041377

Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System

User Performance of the Karajishi Contour TS Blood Glucose Monitoring System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Karajishi TS Investigational Blood Glucose Monitoring System	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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2014-01-22
• Last updated: 2016-02-29
• Results posted: 2015-02-16

Locations

2 sites across 1 country: United States