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Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples

NCT05467345 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-02-24

Study results available
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Summary

The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.

Conditions

Interventions

DEVICE

Contour Next and Contour Plus Elite BGMS testing of neonatal blood

The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.

Sponsors & Collaborators

  • Ascensia Diabetes Care

    lead INDUSTRY

Principal Investigators

  • Dennis Dietzen, PhD · Washington University School of Medicine

Eligibility

Min Age
0 Days
Max Age
27 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2022-11-30
Completion
2023-03-14
FDA Device
Yes

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 NCT05467345 on ClinicalTrials.gov