A Performance Evaluation of the Lumiradx Point of Care HbA1c Device
PHADE
1 other identifier
interventional
334
1 country
4
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, as an aid in the monitoring of diabetes Mellitus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Apr 2022
Shorter than P25 for not_applicable diabetes
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2022
CompletedFirst Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2022
CompletedJanuary 12, 2024
January 1, 2024
6 months
May 31, 2022
January 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Performance of the LumiraDx POC HbA1c assay when compared to a current CE marked reference method in patients being assessed for diagnosis or monitored for diabetes.
Measurement of blood samples from participants who have been diagnosed with diabetes mellitus or who are being monitored for symptoms of diabetes
2 months
Study Arms (1)
Monitoring of Diabetes Mellitus
EXPERIMENTALVenous blood draw of up to 24ml and up to 4 fingersticks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Ninewells Hospital, Dundee
Dundee, United Kingdom
Intelligent Clinical
Glasgow, United Kingdom
NHS Lanarkshire
Glasgow, United Kingdom
Victoria Hospital
Kirkcaldy, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rory McCrimmon
NHS Tayside
- PRINCIPAL INVESTIGATOR
Isabel Howat
NHS Lanarkshire
- PRINCIPAL INVESTIGATOR
Catherine Patterson
NHS Fife
- PRINCIPAL INVESTIGATOR
Louise Brown
Intelligent Clinical
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 3, 2022
Study Start
April 19, 2022
Primary Completion
October 7, 2022
Study Completion
October 7, 2022
Last Updated
January 12, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share