VerioVue Regulatory Clinical Evaluation - Neonate
Research type
Research Study
Full title
Project VerioVue Enhancements Regulatory Clinical Evaluation – Professional Comparison to a Validated Method - Neonate Study
IRAS ID
311465
Contact name
Nicola Zammitt
Contact email
Sponsor organisation
LifeScan
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Summary of Research
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 VerioVue 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 VerioVue 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.
The aim of the project is to offer a BGMS POC device with increased flexibility in terms of testing within the hospital environment with a solution that requires a low volume of blood from the patient. HCPs are familiar with the existing VerioVue BGMS, the addition of arterial and neonate indications will provide HCPs with a POC device that allows 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.
Summary of Results
: As a result of an in depth review and change in business strategy for the VerioVue Enhancements Project, the Neonate study was terminated early, before the recruitment phase was completed.For the samples that were collected, the analysis showed that the VerioVue Enhancements Blood Glucose Monitoring System met the accuracy acceptance criteria defined within the study protocol with 100% of all results falling within ±15 milligrams per decilitre or ±15% of the reference reading obtained on the Abbott i-STAT Blood Analyser.
REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0109
Date of REC Opinion
28 Aug 2022
REC opinion
Favourable Opinion