Status:
COMPLETED
Project VerioVue Enhancements - Arterial Study
Lead Sponsor:
LifeScan Scotland Ltd
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
16+ years
Brief Summary
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...
Detailed Description
Up to two UK NHS hospital sites will be used to collect a minimum of 100 evaluable samples from participants fitted with an arterial line that meet the acceptance criteria. Consent will be obtained fr...
Eligibility Criteria
Inclusion
- 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
- Age - Subject is under 16 years old. Current Covid-19 positive test result.
Key Trial Info
Start Date :
February 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06121856
Start Date
February 7 2023
End Date
April 28 2023
Last Update
November 8 2023
Active Locations (1)
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1
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, LE4 0ER