An interventional study of CONTOUR® NEXT EZ BGMS and FreeStyle Freedom Lite® BGMS in Diabetes, sponsored by Ascensia Diabetes Care. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-29.
Sponsored by Ascensia Diabetes Care · Not applicable, Interventional, and Diagnostic
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.
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This study's enrollment of 146 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
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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; ACCU-CHEK® Aviva BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; CONTOUR® NEXT EZ BGMS.
Device: CONTOUR® NEXT EZ BGMS · Device: FreeStyle Freedom Lite® BGMS · Device: ACCU-CHEK® Aviva BGMS · Device: TRUEtrack® BGMS · Device: OneTouch® 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 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).
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).
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).
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).
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).
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
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
| Milestone | Study Staff Test BGMSs |
|---|---|
| Started | 146 |
| Completed | 146 |
| Not completed | 0 |
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.
| percentage | Study Staff Test BGMSs |
|---|---|
| CONTOUR® NEXT EZ BGMS | 4.7 (0 to 11.4) |
| ACCU-CHEK® Aviva BGMS | 6.3 (0 to 13.0) |
| FreeStyle Freedom Lite® BGMS | 18.3 (11.6 to 25.0) |
| OneTouch® Ultra®2 BGMS | 23.4 (16.7 to 30.1) |
| TRUEtrack® BGMS | 26.2 (19.5 to 32.9) |
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.
| percentage | Study Staff Test BGMSs |
|---|---|
| CONTOUR® NEXT EZ BGMS | 0.7 (0 to 6.8) |
| ACCU-CHEK® Aviva BGMS | 2.5 (0 to 8.7) |
| FreeStyle Freedom Lite® BGMS | 18.3 (12.1 to 28.6) |
| OneTouch® Ultra®2 BGMS | 22.4 (16.2 to 28.6) |
| TRUEtrack® BGMS | 33.2 (27.1 to 39.4) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Staff Test BGMSs | — | 0/146 (0%) | 4/146 (2.7%) |
| Event | Study Staff Test BGMSs |
|---|---|
| hypoglycemiaEndocrine disorders | 4/146 |
Per protocol
| Age, Continuous(years) | Study Staff Test BGMSs |
|---|---|
| Median | 62 (19 to 87) |
| Sex: Female, Male(Participants) | Study Staff Test BGMSs |
|---|---|
| Female | 85 |
| Male | 61 |
| Region of Enrollment(participants) | Study Staff Test BGMSs |
|---|---|
| United States | 146 |
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