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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
106
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).
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).
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, United States
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.
Time frame: 8 hours
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)
Using fresh and glycolyzed samples with Blood Glucose (BG) \<=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.
Time frame: 8 hours
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
Using samples with Blood Glucose \>180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.
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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).
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).
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).
Time frame: 8 hours