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Evaluation of Blood Glucose Monitoring Systems With Blood Samples From Neonates

NCT01756274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2017-02-15

Study results available
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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).

Conditions

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).

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Dennis J Dietzen, PhD, DABCC · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01756274 on ClinicalTrials.gov