Project VerioVue Enhancements - Neonate Study - Trial NCT06052371
Access comprehensive clinical trial information for NCT06052371 through Pure Global AI's free database. This phase not specified trial is sponsored by LifeScan Scotland Ltd and is currently Recruiting. The study focuses on Diabetes Mellitus. Target enrollment is 200 participants.
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Study Focus
Sponsor & Location
LifeScan Scotland Ltd
Timeline & Enrollment
N/A
Oct 16, 2023
Feb 15, 2024
Primary Outcome
Performance evaluation: blood glucose monitoring system accuracy: BGMS vs reference instrument
Summary
The goal of this performance evaluation is to compare the blood glucose results obtained
 using the VerioVue Blood Glucose Monitoring system (BGMS) with those obtained from a
 validated comparator method (iSTAT 1 Analyser) using blood obtained from neonates. The main
 question it aims to answer is:
 
 •How accurate is the VerioVue BGMS when compared to a product that has already been confirmed
 as accurate (iSTAT 1 Analyser) when hospital staff test blood taken from neonates on these
 instruments? Participants (neonates) will have a small amount of blood taken from a heel
 prick (performed by a HCP for medical purposes) or from an existing arterial line.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06052371
Device Trial