NCT01268488

Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting

Clinical Trial Protocol for NINJA 2 System With CONTOUR Sensor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Ninja 2 Investigational Blood Glucose Meter	Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.

Timeline

• Start date: 2010-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-12-31
• Last updated: 2016-11-03
• Results posted: 2012-10-16

Locations

1 site across 1 country: United States