Status:
COMPLETED
A Performance Evaluation of the Lumiradx Point of Care HbA1c Device
Lead Sponsor:
LumiraDx UK Limited
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In patients who have diabetes, symptoms of diabetes or attending a diabetic clinic the study will evaluate agreement between the HbA1c measurements from the LumiraDx POC HbA1c assay and the Tosoh G8, ...
Detailed Description
This is a performance evaluation study designed to assess the precision and accuracy of the LumiraDx Point of Care (POC) HbA1c test when used in patients presenting for assessment or monitoring of dia...
Eligibility Criteria
Inclusion
- Subject greater that 18 years of age
- Willing and able to provide written informed consent and comply with study procedures
- Presenting at clinic for assessment of diabetes, diagnosis of diabetes or HbA1c monitoring of diabetes therapy, or attending an independent research clinic or present on a diabetes research database.
Exclusion
- Patient has previously participated in this study
- Investigator opinion of short life expectancy of \< 1 month
- Patients who have received an Investigational Medicinal Product within the last 30 days
- Haemodynamically unstable (e.g. cardiogenic shock)
- Conditions where HbA1c cannot be used for diagnosis (see John et al., 2011 (4). Pregnancy or two months postpartum, patients with symptoms of diabetes for less than two months, patients at high diabetes risk who are acutely ill, patients taking medication that can cause a rapid glucose rise such as corticosteroids, antipsychotic drugs (2 months or less); acute pancreatic damage including pancreatic surgery, renal failure, HIV infection or patients who have received a blood transfusion or cancer chemotherapy within 3 weeks.
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2022
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT05403853
Start Date
April 19 2022
End Date
October 7 2022
Last Update
January 12 2024
Active Locations (4)
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1
Ninewells Hospital, Dundee
Dundee, United Kingdom
2
Intelligent Clinical
Glasgow, United Kingdom
3
NHS Lanarkshire
Glasgow, United Kingdom
4
Victoria Hospital
Kirkcaldy, United Kingdom