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Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples
Sponsor: Ascensia Diabetes Care
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.
Official title: Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® Blood Glucose Monitoring Systems (BGMS) in Neonates Using Capillary Blood Samples
Key Details
Gender
All
Age Range
0 Days - 27 Days
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2022-08-24
Completion Date
2023-03-14
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
St. Louis Children's Hospital, Washington University
St Louis, Missouri, United States