NCT02041286

Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System

User Performance of the Karajishi Contour Blood Glucose Monitoring System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Karajishi Contour Investigational BG Monitoring System	Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are 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: 2015-06-19

Locations

2 sites across 1 country: United States