Diabetes Mellitus Clinical Trial
Official title:
VerioVue Enhancements Regulatory Clinical Evaluation - Professional Comparison to Validated Method: Arterial Study
Verified date | November 2023 |
Source | LifeScan Scotland Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
LifeScan Scotland Ltd |
United Kingdom,
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. |
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