Verio Vue Regulatory Clinical Evaluation - Arterial Study
Research type
Research Study
Full title
Project Verio Vue Enhancements Regulatory Clinical Evaluation – Professional Comparison to Validated Method - Arterial Study
IRAS ID
311569
Contact name
Nicola Zammitt
Contact email
Sponsor organisation
LifeScan
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Diabetes is a condition that affects blood sugar levels in the body. LifeScan designs and manufactures products to help people with diabetes and Health Care Professionals monitor and manage the condition. We conduct extensive testing of our products in laboratories at LifeScan and also conduct studies to determine how well our products perform and contribute to an understanding of the benefits and positive health outcomes for people with diabetes.
The existing LifeScan One Touch Verio Vue Point Of Care (POC) Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose in venous whole blood and fresh capillary whole blood samples as an aid in monitoring the effectiveness of blood glucose management. The system is intended for testing outside the body (in vitro diagnostic use) and for multiple-patient use in professional healthcare settings.
The Verio Vue BGMS, launched in the Asia Pacific region, uses the existing OneTouch Verio Control Solutions and marketed LifeScan Lancing Systems (lancing device and lancets) and is cleared for use with capillary and venous blood indications in the EU and China, submissions are pending in other Asia Pacific countries.
Competitor products similar to the LifeScan Verio Vue POC BGMS can be applied to multiple indications including arterial and neonate.
In order for LifeScan to remain competitive in the tendering environment, additional blood indications (arterial and neonate) will be added to the system which will enable enhanced capability for testing sample types during clinical assessments.
To validate these additional indications, clinical studies are required in both the EU and China to satisfy regulatory requirements.
REC name
West of Scotland REC 3
REC reference
22/WS/0035
Date of REC Opinion
20 Apr 2022
REC opinion
Further Information Favourable Opinion