Status:
TERMINATED
Project VerioVue Enhancements - Neonate Study
Lead Sponsor:
LifeScan Scotland Ltd
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
Up to 28 years
Brief 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 metho...
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 par...
Eligibility Criteria
Inclusion
- Age - Newborn babies, 28 days old or less with a corrected gestational age of at least 34 weeks and a weight of at least 1700g or more at the time of participation.
- Informed Consent - Study participants parents must read the Parental Participant Information Sheet and sign the Parental Informed Consent Form
- Study participants parent agrees to provide information related to demographics, prescription medication, dietary supplements, and results from other physician ordered testing e.g., Bilirubin (total, conjugated, and unconjugated) where available.
- Study participants parent agrees to allow study staff access to medical records where necessary.
- Study participants parents agree to all aspects of the study process, including where applicable arterial blood draw from an existing arterial line or a heel prick performed by an HCP for medical purposes.
Exclusion
- Age- Newborn more than 28 days old.
- Study participants with a gestational age of less than 34 weeks at the time of participation.
- Study participants with a gestational weight of less than 1700g
- Current positive test result for Covid-19.
Key Trial Info
Start Date :
October 16 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06052371
Start Date
October 16 2023
End Date
December 1 2023
Last Update
December 27 2023
Active Locations (3)
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1
Whipps Cross University Hospital (Barts Health NHS Trust)
London, United Kingdom, E1 1FR,
2
Queens Hospital Romford (BHRUT)
London, United Kingdom, RM7 0AG
3
The Royal Oldham Hospital (Northern Care Alliance NHS Foundation Trust)
Manchester, United Kingdom, OL1 2JH