NCT01598610

Performance Evaluation of an Investigational Blood Glucose Monitoring System

Performance of the CONTOUR® PLUS Blood Glucose Monitoring System With CONTOUR® PLUS Strip

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	CONTOUR® PLUS Investigational BG Monitoring System	Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the CONTOUR® PLUS Investigational BG Monitoring System. Study staff test subject venous blood. All Blood Glucose (BG) results are compared to a reference laboratory glucose method.

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-05-15
• Last updated: 2016-02-29
• Results posted: 2013-07-30

Locations

2 sites across 1 country: United States