Project VerioVue Enhancements - Arterial Study

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06121856
• Other study ID #: FILE-PROT-005439
• Status: Completed
• Start date: February 7, 2023
• Est. completion date: April 28, 2023

Study information

• Verified date: November 2023
• Source: LifeScan Scotland Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

Age - The potential Subject is at least 16 years old. Language - Subject reads and understands English. Informed Consent - The potential subject must read the Participant Information Sheet and sign the Informed Consent Form. Subject agrees to provide relevant demographic, medical history, and prescription medication information. The subject agrees to allow study staff access to medical records where necessary. The Subject agrees to all aspects of the study process, including arterial blood draws performed by an HCP. Exclusion Criteria: Age - Subject is under 16 years old. Current Covid-19 positive test result.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• VerioVue Enhancements BGMS
Blood glucose monitoring system

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
LifeScan Scotland Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance evaluation: blood glucose monitoring system accuracy: BGMS vs reference instrument using arterial blood	Performance Evaluation to compare the VerioVue BGMS blood glucose results to results obtained using the iSTAT 1 Analyser, a validated comparator method when using arterial blood.	Within 30 minutes of arterial blood sample draw.