At a glance
ClinicalIndex Comparison RecordN/ACompleted· 120 enrolled
Drug / intervention
Contour Next and Contour Plus Elite BGMS testing of neonatal blooddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® Blood Glucose Monitoring Systems (BGMS) in Neonates Using Capillary Blood Samples
In Brief
An observational study evaluating Contour Next and Contour Plus Elite BGMS testing of neonatal blood for Diabetes Mellitus. Completed, enrolled 120 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
First PostedJul 2022
Enrollment StartAug 2022
Primary CompletionNov 2022
Study CompletionMar 2023
TodayJul 2026
First PostedJul 20, 2022
Enrollment StartAug 24, 2022
Primary CompletionNov 30, 2022
Study CompletionMar 14, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.9 years ago
Interventions
Contour Next and Contour Plus Elite BGMS testing of neonatal blooddevice
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.