Project VerioVue Enhancements - Arterial Study

NCT06121856 | Completed

• 1 other identifier: FILE-PROT-005439
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

VerioVue Enhancements BGMS DEVICE

Blood glucose monitoring system

In-patients cardiothoracic intensive care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Age - Subject is under 16 years old. Current Covid-19 positive test result.

Sponsors & Collaborators

• LifeScan Scotland Ltd: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, LE4 0ER, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nicola Zammitt, MBChB

  Edinburgh Centre for Endocrinology and Diabetes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 8, 2023
• Study Start: February 7, 2023
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)