NCT01614613

Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting

Clinical Evaluation of Bayer G3 / Tatsu System and BGMs From Other Companies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to test the performance of an investigational Bayer Blood Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal was to obtain glucose samples from subjects with diabetes across the meter operating ranges. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). All lancings and testing were performed by study staff.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Bayer G3 / Tatsu System	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	Freestyle Lite® Meter and Test Strips with ZipwikTM tabs	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips	Study staff performed Blood Glucose (BG) tested with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	One Touch® VerioTM Pro/One Touch® VerioTM Test Strips	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	Truetrack® Meter/Truetrack® Test Strips	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2012-06-08
• Last updated: 2016-02-29
• Results posted: 2013-09-09

Locations

1 site across 1 country: United States