NCT06121856

Project VerioVue Enhancements - Arterial Study

VerioVue Enhancements Regulatory Clinical Evaluation - Professional Comparison to Validated Method: Arterial Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: LifeScan Scotland Ltd · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Up to two UK NHS hospital sites will be used to collect a minimum of 100 evaluable samples from participants fitted with an arterial line that meet the acceptance criteria. Consent will be obtained from the participants prior to taking part in the study. If the participant meets the enrolment criteria then demographics and medical history information will be collected. A small volume of blood (max 150µl) will be collected from an existing arterial line. The blood will then be applied to six investigational OneTouch VerioVue meters (with expanded haematocrit range 20-65%) fitted with OneTouch Verio test strips and the blood glucose meter readings recorded. Three different lots of test strips will be used in rotation across the study. Within 5 minutes of the last meter test, trained staff will use blood from the same sample and perform a test on the iSTAT Analyser to obtain the blood glucose, haematocrit and oxygen levels of the sample. No treatment decisions will be made based on the blood glucose results obtained for this study. The study documentation will be reviewed by LifeScan monitors for completeness and accuracy and the results entered into a validated database. The data will be extracted and statistically analysed to determine the accuracy of the arterial blood glucose results obtained using the OneTouch VerioVue BGMS when compared to the arterial blood glucose results obtained on the iSTAT 1 Analyser.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	VerioVue Enhancements BGMS	Blood glucose monitoring system

Timeline

• Start date: 2023-02-07
• Primary completion: 2023-04-28
• Completion: 2023-04-28
• First posted: 2023-11-08
• Last updated: 2023-11-08

Locations

1 site across 1 country: United Kingdom