Diabetes
Conditions
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.
Interventions
DEVICECONTOUR® NEXT EZ BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of CONTOUR® NEXT EZ BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICEFreeStyle Freedom Lite® BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of FreeStyle Freedom Lite® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICEACCU-CHEK® Aviva BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of ACCU-CHEK® Aviva BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICETRUEtrack® BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of TRUEtrack® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICEOneTouch® Ultra®2 BGMS
Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® Ultra®2 BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Staff Test BGMSs All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS. | 146 |
| Total | 146 |
Baseline characteristics
| Characteristic | Study Staff Test BGMSs |
|---|---|
| Age, Continuous | 62 years |
| Region of Enrollment United States | 146 participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 146 |
| serious Total, serious adverse events | 0 / 146 |
Outcome results
Primary
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 (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.
Time frame: 10 hours
Population: Same number 388(393-3-2)BG results possible for each BGMS.Subjects provided 1,2,or 3 capillary samples-total 393 samples. 3 glycolyzed samples were not analyzed - glycolysis exceeded the protocol-defined time. All meter data for 2 glycolyzed samples were not evaluable (not analyzed)- their YSI results were less than the meter operating ranges.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range | CONTOUR® NEXT EZ BGMS | 4.7 percentage |
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range | ACCU-CHEK® Aviva BGMS | 6.3 percentage |
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range | FreeStyle Freedom Lite® BGMS | 18.3 percentage |
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range | OneTouch® Ultra®2 BGMS | 23.4 percentage |
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range | TRUEtrack® BGMS | 26.2 percentage |
Secondary
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL)
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.
Time frame: 10 hours
Population: Same number (190) of BG results was possible for each BGMS. Subjects provided 1,2,or 3 capillary samples, of which 190 samples were less than 70 mg/dL.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) | CONTOUR® NEXT EZ BGMS | 0.7 percentage |
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) | ACCU-CHEK® Aviva BGMS | 2.5 percentage |
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) | FreeStyle Freedom Lite® BGMS | 18.3 percentage |
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) | OneTouch® Ultra®2 BGMS | 22.4 percentage |
| Study Staff Test BGMSs | MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) | TRUEtrack® BGMS | 33.2 percentage |