NCT06121856

Project VerioVue Enhancements - Arterial Study

VerioVue Enhancements Regulatory Clinical Evaluation - Professional Comparison to Validated Method: Arterial Study
LifeScan Scotland Ltd·ClinicalTrials.gov·device·Device trialCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Diabetes Mellitus
Drug/Device/Intervention
VerioVue Enhancements BGMS
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
LifeScan Scotland Ltd
Location
Edinburgh, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
Feb 07, 2023
End date
Apr 28, 2023
Enrollment
116 participants
Primary outcome

Performance evaluation: blood glucose monitoring system accuracy: BGMS vs reference instrument using arterial blood

Summary

The aim 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 arterial blood. The main question the study 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 arterial blood on these two types of
 instrument? Participants will have a small amount of blood taken 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
NCT06121856
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06121856 through Pure Global AI's free database. This phase not specified trial is sponsored by LifeScan Scotland Ltd and is currently Completed. The study focuses on Diabetes Mellitus. Target enrollment is 116 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.