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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Staff Test BGMSs | Experimental | All testing and lancing 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): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contour® PLUS BGMS | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Simmons, MD | Ascensia Diabetes Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayer HealthCare LLC, Diabetes Care | Mishawaka | Indiana | 46544 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31789119 | Derived | Pardo S, Dunne N, Simmons DA. A comparison of bolus insulin dose errors based on results of a clinical trial of five blood glucose monitoring systems. Ther Deliv. 2019 Dec;10(12):793-799. doi: 10.4155/tde-2019-0047. Epub 2019 Dec 2. | |
| 26169192 | Derived | Dunne N, Viggiani MT, Pardo S, Robinson C, Parkes JL. Accuracy Evaluation of CONTOUR((R))PLUS Compared With Four Blood Glucose Monitoring Systems. Diabetes Ther. 2015 Sep;6(3):377-88. doi: 10.1007/s13300-015-0121-3. Epub 2015 Jul 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Staff Test BGMSs | All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Staff Test BGMSs | All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 (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. | 314 BG results possible for each BGMS (318-4=314). Staff collected 3 capillary samples from each subject-total 318 samples. One subject hematocrit(56%) was above the study evaluable limit 55%, so that subject's 3 samples were not analyzed. One sample from another subject was below meter operating limit (12.3mg/dL) so it was not analyzed. | Posted | Mean | Standard Error | Percent Difference | 8 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Staff Test BGMSs | All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment | Adverse events were mild, anticipated, non-device related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace | Ascensia Diabetes Care | 574-257-3063 | jane.wallace@ascensia.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| OneTouch® SelectSimple™ BGMS | Device | 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). |
|
| Accu-Chek® Performa BGMS | Device | 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). |
|
| Accu-Chek® Active BGMS | Device | 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). |
|
| Freestyle Freedom® BGMS | Device | 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). |
|
| 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. | 8 hours |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Study Staff Test BGMSs | All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS. |
|
|
| Secondary | 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. | Same number (93) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 314), of which 93 samples were less than or equal to 80 mg/dL. | Posted | Mean | Standard Error | Percent Difference | 8 hours | BG Test Results | Participants |
|
|
|
| Secondary | 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. | Same number (113) of BG results was possible for each BGMS. Staff collected capillary samples from each subject as described in primary objective population description, of which 113 samples were greater than 180 mg/dL. | Posted | Mean | Standard Error | Percent Difference | 8 hours | BG Test Results | Participants |
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| 0 |
| 106 |
| 3 |
| 106 |
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| Title | Measurements |
|---|---|
|
| OneTouch® SelectSimple™ BGMS |
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| Freestyle Freedom® BGMS |
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| Title | Measurements |
|---|---|
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| OneTouch® SelectSimple™ BGMS |
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| Freestyle Freedom® BGMS |
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