NCT01474317

Study of an Investigational Glucose Meter System

Performance of the G3 Blood Glucose Monitoring System With TATSU Strip

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (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	G3 Investigational Blood Glucose Monitoring System	Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.

Timeline

• Start date: 2011-11-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-11-18
• Last updated: 2016-02-29
• Results posted: 2013-01-03

Locations

2 sites across 1 country: United States