Clinical trial NCT06121856: Project VerioVue Enhancements - Arterial Study
Official title: VerioVue Enhancements Regulatory Clinical Evaluation - Professional Comparison to Validated Method: Arterial Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: LifeScan Scotland Ltd
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 116
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Performance evaluation: blood glucose monitoring system accuracy: BGMS vs reference instrument using arterial blood
timeFrame: Within 30 minutes of arterial blood sample draw.
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: Edinburgh Centre for Endocrinology and Diabetes
name: Nicola Zammitt, MBChB
role: PRINCIPAL_INVESTIGATOR
References: