Trial Outcomes & Findings for Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates (NCT NCT01756274)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

162 participants

Primary outcome timeframe

30 minutes

Results posted on

2017-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	162
Overall Study COMPLETED	159
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Protocol Violation	2
Overall Study Laboratory error	1

Baseline Characteristics

Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neonates 'Left-over' Blood Samples n=211 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.
Age, Customized < 24 hours	25 blood samples n=50 blood samples
Age, Customized 1-29 days	186 blood samples n=50 blood samples
Sex/Gender, Customized Female	100 blood samples n=50 blood samples
Sex/Gender, Customized Male	111 blood samples n=50 blood samples
Region of Enrollment United States	211 blood samples n=50 blood samples
Nursery Location Special Care	101 blood samples n=50 blood samples
Nursery Location Well Baby	58 blood samples n=50 blood samples
Nursery Location NICU (Neonatal Intensive Care Unit)	30 blood samples n=50 blood samples
Nursery Location Other	22 blood samples n=50 blood samples

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Neonates 'Left-over' Blood Samples n=211 Blood Samples Blood samples used in this study were '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.
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
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
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

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Neonates 'Left-over' Blood Samples n=211 BLOOD SAMPLES Blood samples used in this study were '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.
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
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
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 outcome

Timeframe: 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.

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.)

Outcome measures

Outcome measures
Measure	Neonates 'Left-over' Blood Samples n=25 BLOOD SAMPLES From Babies <24 hours old Blood samples used in this study were '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.
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
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
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

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

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.)

Outcome measures

Outcome measures
Measure	Neonates 'Left-over' Blood Samples n=30 BLOOD SAMPLES From Babies in the NICU Blood samples used in this study were '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.
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
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
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

Adverse Events

Neonates 'Left-over' Blood Samples

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jane Wallace

Ascensia Diabetes Care

Phone: 574-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60