Diabetes
Conditions
Brief summary
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).
Interventions
DEVICEContour® NEXT BGMS
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).
DEVICEContour® PLUS BGMS
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).
DEVICEContour® Next EZ BGMS
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).
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
Yes
Inclusion criteria
* Routine blood samples (heelstick) collected from neonates (less than 30 days of age). * A portion of the samples (approximately 10%) will be from subjects \<24 hours old. * A portion of the samples (at least 10%) will be from subjects in the NICU. * Sample blood volume must be sufficient to complete investigational testing in addition to prescribed testing.
Exclusion criteria
* Samples from babies \>=30 days of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value | 30 minutes | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30 minutes | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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) | 30 minutes | 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.) |
| 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) | 30 minutes | 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.) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 162 |
| 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. | 211 |
| Total | 373 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Laboratory error | 1 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Neonates 'Left-over' Blood Samples |
|---|---|
| Age, Customized 1-29 days | 186 blood samples |
| Age, Customized < 24 hours | 25 blood samples |
| Nursery Location NICU (Neonatal Intensive Care Unit) | 30 blood samples |
| Nursery Location Other | 22 blood samples |
| Nursery Location Special Care | 101 blood samples |
| Nursery Location Well Baby | 58 blood samples |
| Region of Enrollment United States | 211 blood samples |
| Sex/Gender, Customized Female | 100 blood samples |
| Sex/Gender, Customized Male | 111 blood samples |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 162 |
| serious Total, serious adverse events | 0 / 162 |
Outcome results
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).
Time frame: 30 minutes
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neonates 'Left-over' Blood Samples | Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value | Contour® NEXT BGMS | 100.0 percentage of Blood Glucose Results |
| Neonates 'Left-over' Blood Samples | Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value | Contour® PLUS BGMS | 99.5 percentage of Blood Glucose Results |
| Neonates 'Left-over' Blood Samples | Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value | Contour® Next EZ BGMS | 99.5 percentage of Blood Glucose Results |
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).
Time frame: 30 minutes
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neonates 'Left-over' Blood Samples | 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 | Contour® NEXT BGMS | 99.5 percentage of BLOOD GLUCOSE RESULTS |
| Neonates 'Left-over' Blood Samples | 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 | Contour® PLUS BGMS | 99.1 percentage of BLOOD GLUCOSE RESULTS |
| Neonates 'Left-over' Blood Samples | 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 | Contour® Next EZ BGMS | 99.1 percentage of BLOOD GLUCOSE RESULTS |
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.)
Time frame: 30 minutes
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neonates 'Left-over' Blood Samples | 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) | Contour® NEXT | 4 BLOOD SAMPLES |
| Neonates 'Left-over' Blood Samples | 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) | Contour® PLUS | 2 BLOOD SAMPLES |
| Neonates 'Left-over' Blood Samples | 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) | Contour® Next EZ | 3 BLOOD SAMPLES |
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.)
Time frame: 30 minutes
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neonates 'Left-over' Blood Samples | 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) | Contour® NEXT | 1 BLOOD SAMPLES |
| Neonates 'Left-over' Blood Samples | 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) | Contour® PLUS | 2 BLOOD SAMPLES |
| Neonates 'Left-over' Blood Samples | 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) | Contour® Next EZ | 1 BLOOD SAMPLES |