Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

Performance of Three Bayer Blood Glucose Monitoring Systems With Blood Samples From Neonates

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).

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Contour® NEXT BGMS; Device: Contour® PLUS BGMS; Device: Contour® Next EZ BGMS

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neonates 'Left-over' Blood Samples; 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.

Device: Contour® 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).; Device: Contour® 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).; Device: Contour® 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	30 minutes

Other Outcome Measures

Outcome Measure	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.)	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

Collaborators and Investigators

• Sponsor: Ascensia Diabetes Care
• Investigators: Principal Investigator: Dennis J Dietzen, PhD, DABCC, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: December 20, 2012
• First Posted (Estimate): December 25, 2012

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: December 30, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CTD-2010-009-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO