NCT01268267

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

Clinical Trial Protocol for Ninja 2 System With TATSU Sensor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (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 and acceptability of an investigational blood glucose monitoring system, which includes meter and sensor strip.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Ninja 2 Investigational Blood Glucose Monitoring System	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 and an investigational sensor. 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: 2010-12-30
• Last updated: 2016-02-29
• Results posted: 2012-05-31

Locations

1 site across 1 country: United States