NCT06052371

Project VerioVue Enhancements - Neonate Study

VerioVue Enhancements Regulatory Clinical Evaluation - Professional Comparison to Validated Method: Neonate Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: LifeScan Scotland Ltd · Industry
• Sex: All
• Age: 0 Days – 28 Days
• Healthy volunteers: Accepted

Summary

The goal 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 blood obtained from neonates. The main question it 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 blood taken from neonates on these instruments? Participants (neonates) will have a small amount of blood taken from a heel prick (performed by a HCP for medical purposes) or from an existing arterial line.

Detailed description

UK NHS Hospital sites (between 1 and 3 sites) will be used to collect a minimum of 200 evaluable blood samples from neonates meeting the inclusion criteria. Consent will be taken from the neonates parent prior to participation in the study. They will consent to one or two blood samples to be taken from their child. If the participant meets the enrolment criteria then demographics and prescription medication (including dietary supplements) information will be collected. A small volume of blood (max 150µl) will be collected from an existing arterial line or from a heel prick that is being performed for medical purposes. This blood will then be applied to six investigational One Touch VerioVue meters (with expanded haematocrit range of 20-65%) fitted with OneTouch Verio test strips and the blood glucose meter readings recorded. Three different lots of test strips will used in rotation across the study. Within 5 minutes of the last meter test, NHS study staff will use blood from the same sample and perform a test on the iSTAT 1 Analyser to obtain 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 blood glucose results obtained using the OneTouch VerioVue BGMS when compared to the blood glucose results obtained on the iSTAT 1 Analyser.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	VerioVue (Enhancements) blood glucose monitoring system	VerioVue meter with expanded haematocrit range

Timeline

• Start date: 2023-10-16
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-09-25
• Last updated: 2023-12-27

Locations

3 sites across 1 country: United Kingdom