Project VerioVue Enhancements - Arterial Study

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: VerioVue Enhancements BGMS

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.

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, LE4 0ER
    • Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will comprise a minimum of 100 evaluable samples taken from participants who are in the cardiothoracic intensive care unit of an NHS hospital who have an arterial line fitted for other medical purposes.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
In-patients cardiothoracic intensive care; In-patients in the cardiothoracic intensive care department that were at least 16 years old and were fitted with an arterial line. There was no requirement to have diabetes but the study aimed to recruit a minimum of 20% subjects with diabetes.	Device: VerioVue Enhancements BGMS; Blood glucose monitoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: LifeScan Scotland Ltd
• Investigators: Principal Investigator: Nicola Zammitt, MBCHB, Edinburgh Centre for Endocrinology and Diabetes

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FILE-PROT-005439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No