NCT01699763

Evaluation of Blood Glucose Monitoring Systems

Evaluation of Blood Glucose Meter Systems - Contour® NEXT LINK Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (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 two additional Blood Glucose Monitoring Systems (BGMS) from other companies. 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 two additional Blood Glucose Monitoring Systems (BGMS) from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the three systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing was 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® NEXT LINK BGMS	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Contour® NEXT LINK BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	OneTouch® UltraLink® BGMS	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® UltraLink® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICE	Nova Max Link® BGMS	Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Nova Max Link® BGMS was evaluated across the glucose range of the BGMSs. 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: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-10-04
• Last updated: 2016-02-29
• Results posted: 2013-11-28

Locations

1 site across 1 country: United States