NCT01714232

Evaluation of Blood Glucose Meter Systems

Evaluation of Blood Glucose Meter Systems - Contour® PLUS Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Ascensia Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Detailed description

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems were evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some samples were tested from subject fingertips. Additionally, some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Contour® PLUS BGMS	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	OneTouch® SelectSimple™ BGMS	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	Accu-Chek® Performa BGMS	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	Accu-Chek® Active BGMS	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	Freestyle Freedom® BGMS	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-10-25
• Last updated: 2016-02-29
• Results posted: 2013-12-27

Locations

1 site across 1 country: United States