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Project VerioVue Enhancements - Arterial Study - Trial NCT06121856

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.

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Trial Details
ClinicalTrials.gov โ€ข NCT06121856
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Project VerioVue Enhancements - Arterial Study
VerioVue Enhancements Regulatory Clinical Evaluation - Professional Comparison to Validated Method: Arterial Study

Study Focus

Diabetes Mellitus

VerioVue Enhancements BGMS

Observational

device

Sponsor & Location

LifeScan Scotland Ltd

Edinburgh, United Kingdom

Timeline & Enrollment

N/A

Feb 07, 2023

Apr 28, 2023

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 mellitus
Unspecified diabetes mellitus
Other specified diabetes mellitus
Unspecified diabetes mellitus without complications
Unspecified diabetes mellitus with unspecified complications

Data Source

ClinicalTrials.gov

NCT06121856

Device Trial