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NCT05467345 · ClinicalTrials.gov registry record
Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples
A clinical trial, sponsored by Ascensia Diabetes Care.
- Completed
- Registry status
- 120
- Enrollment target
NCT05467345: Completed study, sponsored by Ascensia Diabetes Care.
NCT05467345 is a clinical trial that has completed, run by Ascensia Diabetes Care. The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05467345 has completed, sponsored by Ascensia Diabetes Care.
- COMPLETED
- Registry status
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \<100 mg/dL(5.55 mmol/L).
Interventions
- DEVICE Contour Next and Contour Plus Elite BGMS testing of neonatal blood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-08-24 |
| Est. Completion | 2023-03-14 |
What the finished NCT05467345 record still lists
NCT05467345 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Contour Next and Contour Plus Elite BGMS testing of neonatal blood is the first listed.
NCT05467345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05467345 about?
NCT05467345 is a clinical study titled "Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples". 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.
What is the current status of trial NCT05467345?
This trial is currently completed. The enrollment target is 120 participants. The study started on 2022-08-24. Estimated completion is 2023-03-14.
What interventions are being tested in trial NCT05467345?
The interventions under investigation include: Contour Next and Contour Plus Elite BGMS testing of neonatal blood (DEVICE).
Who is sponsoring clinical trial NCT05467345?
This trial is sponsored by Ascensia Diabetes Care, which has 42 total clinical trials registered on ClinicalTrials.gov.
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