Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples
NCT ID: NCT05467345
Last Updated: 2025-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
120 participants
OBSERVATIONAL
2022-08-24
2023-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Sample blood volume must be sufficient to complete investigational testing in addition to routine prescribed clinical laboratory testing.
Exclusion Criteria
* Samples from subjects who have previously been enrolled into this study.
0 Days
27 Days
ALL
No
Sponsors
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Ascensia Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Dietzen, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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St. Louis Children's Hospital, Washington University
St Louis, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GCA-PRO-2021-003-01
Identifier Type: -
Identifier Source: org_study_id
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