NCT01575080

Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design

Performance Evaluation of the Contour TS BGMS Using ISO/DIS 15197:2011 Section 8 Study Design and Performance Criteria

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (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 untrained subjects who have diabetes can operate the Blood Glucose Monitoring System (BGMS) and obtain acceptable glucose results.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Contour TS Blood Glucose Monitoring System	Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method.

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-04-11
• Last updated: 2016-02-29
• Results posted: 2013-07-08

Locations

1 site across 1 country: United States