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NCT06052371

Project VerioVue Enhancements - Neonate Study

VerioVue Enhancements Regulatory Clinical Evaluation - Professional Comparison to Validated Method: Neonate Study
LifeScan Scotland Ltd·ClinicalTrials.gov·device·Device trialRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Diabetes Mellitus
Drug/Device/Intervention
VerioVue (Enhancements) blood glucose monitoring system
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
LifeScan Scotland Ltd
Location
London,London,Manchester, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
Oct 16, 2023
End date
Feb 15, 2024
Enrollment
200 participants
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
Diabetes mellitusUnspecified diabetes mellitusOther specified diabetes mellitusUnspecified diabetes mellitus without complicationsUnspecified diabetes mellitus with unspecified complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06052371
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.