Comparison Evaluation of Blood Glucose Meter Systems

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT01548885
• Lead Sponsor: Ascensia Diabetes Care

Brief Summary

The purpose of this study was to evaluate the performance of one investigational Bayer Blood Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring Systems 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 five systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some blood samples were glycolyzed to lower the glucose levels.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-08
• Results First Submitted: 2013-03-27
• Results First Submitted QC: 2013-07-03
• Results First Posted: 2013-08-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Males and females
• 18 years of age or older
• Willing to complete all study procedures

Exclusion Criteria

• Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
• Hemophilia or any other bleeding disorder
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range	10 hours	Using the overall Blood Glucose(BG) range (24 to 386mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all \|(BG meter)-(BG reference)\| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value.

Secondary Outcome Measures

Name	Time	Method
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL)	10 hours	Using fresh and glycolyzed samples with Blood Glucose(BG) below 70 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all \|(BG meter)-(BG reference)\| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value.

Trial Locations

Locations (1)

Bayer HealthCare LLC, Diabetes Care; 🇺🇸 Mishawaka, Indiana, United States