NCT02150109

Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS	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.
DEVICE	Subjects WITH Diabetes Use Karajishi Contour BGMS	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.

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-05-29
• Last updated: 2016-02-29
• Results posted: 2015-07-21

Locations

2 sites across 1 country: United States