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The purpose of this study was to evaluate the performance of three Bayer Blood Glucose Monitoring Systems (BGMS) with neonatal blood. Blood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. All meter Blood Glucose (BG) results were compared with capillary plasma results obtained with a reference laboratory glucose method (Cobas® 6000 instrument).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates 'Left-over' Blood Samples | Experimental | Blood samples used in this study were 'left-over samples'. The blood samples were from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Two left-over samples could be obtained from a single neonate. Laboratory professionals tested the BG concentration using three Bayer Blood Glucose Monitoring Systems (BGMS): Contour® NEXT BGMS, Contour® PLUS BGMS, and Contour® Next EZ BGMS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contour® NEXT BGMS | Device | Lab professionals tested the BG concentration using Contour® NEXT BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value | Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of BG Results (Per Population) Within +/-15 mg/dL (<100 mg/dL)and Within +/-15% (>=100 mg/dL) of the Reference Instrument BG Value | Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Blood Samples From Babies Less Than 24 Hours Old That Produced Meter Results Beyond What Random Chance Would Predict (i.e. Outside 95% Limits for Studentized Residuals) | To evaluate the effect of neonatal age on the meter systems' performances, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies less than 24 hours old was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis J Dietzen, PhD, DABCC | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neonates 'Left-over' Blood Samples | Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Of 217 blood samples from 162 neonates 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors.
| ID | Title | Description |
|---|---|---|
| BG000 | Neonates 'Left-over' Blood Samples | Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples. Baseline Characteristics for Participant Flow based on number of blood samples, not number of subjects. |
| 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 | Number |
| 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 | Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value | Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). | Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors. | Posted | Number | percentage of Blood Glucose Results | 30 minutes | Blood Samples | Blood Samples |
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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 | Neonates 'Left-over' Blood Samples | Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. |
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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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| Contour® PLUS BGMS | Device | Lab professionals tested the BG concentration using Contour® PLUS BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). |
|
| Contour® Next EZ BGMS | Device | Lab professionals tested the BG concentration using Contour® Next EZ BGMS (Blood Glucose Monitoring System). All meter BG results were compared with plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). |
|
| 30 minutes |
| 30 minutes |
| Number of Blood Samples From Babies in the Neonatal Intensive Care Unit (NICU) That Produced Meter Results Beyond What Random Chance Would Predict (i.e., Outside 95% Limits for Studentized Residuals) | To evaluate how the meter systems perform with blood samples drawn in the Neonatal Intensive Care Unit, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies in Neonatal Intensive Care was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.) | 30 minutes |
| blood samples |
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| blood samples |
| blood samples |
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| Sex/Gender, Customized | Number | blood samples | blood samples |
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| Region of Enrollment | Number | blood samples | blood samples |
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| Nursery Location | Number | blood samples | blood samples |
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| Secondary | Percent of BG Results (Per Population) Within +/-15 mg/dL (<100 mg/dL)and Within +/-15% (>=100 mg/dL) of the Reference Instrument BG Value | Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN). | Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors. | Posted | Number | percentage of BLOOD GLUCOSE RESULTS | 30 minutes | BLOOD SAMPLES | BLOOD SAMPLES |
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| Other Pre-specified | Number of Blood Samples From Babies Less Than 24 Hours Old That Produced Meter Results Beyond What Random Chance Would Predict (i.e. Outside 95% Limits for Studentized Residuals) | To evaluate the effect of neonatal age on the meter systems' performances, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies less than 24 hours old was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.) | Of 217 'left-over' blood samples, 211(217-6) were included in data analysis. Of these, twenty five (25) blood samples were obtained from babies that were less than 24 hours old. | Posted | Number | BLOOD SAMPLES | 30 minutes | BLOOD SAMPLES From Babies <24 hours old | BLOOD SAMPLES From Babies <24 hours old |
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| Other Pre-specified | Number of Blood Samples From Babies in the Neonatal Intensive Care Unit (NICU) That Produced Meter Results Beyond What Random Chance Would Predict (i.e., Outside 95% Limits for Studentized Residuals) | To evaluate how the meter systems perform with blood samples drawn in the Neonatal Intensive Care Unit, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies in Neonatal Intensive Care was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.) | Of 217 'left-over' blood samples, 211(217-6) were included in data analysis and, of these, thirty (30) blood samples were obtained from babies in the Neonatal Intensive Care Unit (NICU). | Posted | Number | BLOOD SAMPLES | 30 minutes | BLOOD SAMPLES From Babies in the NICU | BLOOD SAMPLES From Babies in the NICU |
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| 162 |
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| 162 |
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