N/A
N=120
Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT05467345 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values — 240 blood samples
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Contour Next and Contour Plus Elite BGMS testing of neonatal blood (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Ascensia Diabetes Care
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values |
240 | — |
| PRIMARY Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values |
240 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Residual capillary (heel-stick) blood samples from neonates (less than 28 days of age) after birth as part of prescribed testing.
- Sample blood volume must be sufficient to complete investigational testing in addition to routine prescribed clinical laboratory testing.
Exclusion Criteria
- Samples from subjects who are ≥ 28 days of age.
- Samples from subjects who have previously been enrolled into this study.
Data sourced from ClinicalTrials.gov (NCT05467345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.