Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

Overview

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).

Full Title of Study: “Performance of Three Bayer Blood Glucose Monitoring Systems With Blood Samples From Neonates”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2013

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value
    • Time Frame: 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 Measures

  • 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
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 30 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ascensia Diabetes Care
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dennis J Dietzen, PhD, DABCC, Principal Investigator, Washington University School of Medicine

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