DiabetesPHADENCT05403853
A Performance Evaluation of the Lumiradx Point of Care HbA1c Device
An observational study of Diabetes, run by LumiraDx UK Limited at 4 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Venepuncture and Fingerstick
- How many people
- 177 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 18 Apr 2022to 7 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for assessment or monitoring of diabetes or attending an independent research clinic or present on a diabetes research database.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Ninewells Hospital, Dundee
Dundee
Intelligent Clinical
Glasgow
NHS Lanarkshire
Glasgow
Victoria Hospital
Kirkcaldy
About this study
Official title: A Performance Evaluation of the LumiraDx Point of Care HbA1c Device
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
Read the 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 diabetes.
The LumiraDx POC HbA1c test is a quantitative immunoassay providing results near to the patient in under 10 minutes. The accuracy of the LumiraDx POC HbA1c test will be assessed using capillary whole blood, and venous blood, by comparison to the HbA1c results obtained from the same individuals as analysed by trained laboratory professionals using a CE marked laboratory reference device.
The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the UK, European Union (EU) and other relevant geographies.
Adult males and females attending out-patient, community diabetes and research clinics for HbA1c measurements will be included in the study. Subjects may also be invited to take part via the diabetes research register or by invitation from independent clinical research sites. All subjects recruited will be willing and able to give written informed consent. Approximately 400 subjects will be recruited to ensure that sufficient suitable subjects are enrolled and to allow for a small level of exclusions. The power calculation requires a minimum of 360 valid subjects in total.
After obtaining written informed consent, up to 24mL of venous blood will be obtained from venepuncture into anticoagulated blood tubes. Capillary blood samples should be collected via fingerstick. Finger stick blood should be collected using the transfer loop and placed in the sample tube before addition to the strip for immediate measurement of HbA1c on the LumiraDx POC instrument (one after the other).
Of the drawn blood tubes, one tube is used immediately with the LumiraDx POC HbA1c test. To do this, the clinical staff member lyses a small sample using the lysis kit and then places the sample on the Test Strip which has already been inserted into the LumiraDx POC Instrument. After approx. 8 minutes, the result is displayed on the screen.
The HbA1c results obtained will be used in a set of comparative analyses designed to determine the performance characteristics of the LumiraDx HbA1c test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.
- Conditions
- Diabetes
- Being tested
- Venepuncture, Fingerstick
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenepunctureDiagnostic test
Venous blood draw
FingerstickDiagnostic test
Capillary Blood Draw
| Study group | Role | What they receive |
|---|---|---|
| Monitoring of Diabetes Mellitus | Venous blood draw of up to 24ml and up to 4 fingersticks Receives: Diagnostic Test: Venepuncture; Diagnostic Test: Fingerstick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start18 Apr 2022
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiraDx UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rory McCrimmon, Principal investigator, NHS TaysideIsabel Howat, Principal investigator, NHS LanarkshireCatherine Patterson, Principal investigator, NHS FifeLouise Brown, Principal investigator, Intelligent Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403853
- Sponsor's protocol ID
- S-CLIN-PROT-00009
- Acronym
- PHADE
- Status last verified
- Jun 2026
- First submitted
- 31 May 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Performance Evaluation of the LumiraDx Point of Care HbA1c Device
- ClinicalTrials.gov ID
- NCT05403853
- Acronym / sponsor ID
- PHADE / S-CLIN-PROT-00009
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- LumiraDx UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 diabetes.
The LumiraDx POC HbA1c test is a quantitative immunoassay providing results near to the patient in under 10 minutes. The accuracy of the LumiraDx POC HbA1c test will be assessed using capillary whole blood, and venous blood, by comparison to the HbA1c results obtained from the same individuals as analysed by trained laboratory professionals using a CE marked laboratory reference device.
The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the UK, European Union (EU) and other relevant geographies.
Adult males and females attending out-patient, community diabetes and research clinics for HbA1c measurements will be included in the study. Subjects may also be invited to take part via the diabetes research register or by invitation from independent clinical research sites. All subjects recruited will be willing and able to give written informed consent. Approximately 400 subjects will be recruited to ensure that sufficient suitable subjects are enrolled and to allow for a small level of exclusions. The power calculation requires a minimum of 360 valid subjects in total.
After obtaining written informed consent, up to 24mL of venous blood will be obtained from venepuncture into anticoagulated blood tubes. Capillary blood samples should be collected via fingerstick. Finger stick blood should be collected using the transfer loop and placed in the sample tube before addition to the strip for immediate measurement of HbA1c on the LumiraDx POC instrument (one after the other).
Of the drawn blood tubes, one tube is used immediately with the LumiraDx POC HbA1c test. To do this, the clinical staff member lyses a small sample using the lysis kit and then places the sample on the Test Strip which has already been inserted into the LumiraDx POC Instrument. After approx. 8 minutes, the result is displayed on the screen.
The HbA1c results obtained will be used in a set of comparative analyses designed to determine the performance characteristics of the LumiraDx HbA1c test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring of Diabetes Mellitus | – | Diagnostic Test: Venepuncture, Diagnostic Test: FingerstickVenous blood draw of up to 24ml and up to 4 fingersticks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for assessment or monitoring of diabetes or attending an independent research clinic or present on a diabetes research database.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenepunctureVenous blood draw | Diagnostic test | Monitoring of Diabetes Mellitus |
| FingerstickCapillary Blood Draw | Diagnostic test | Monitoring of Diabetes Mellitus |
Primary outcome
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.
Time frame: 2 months
Measurement of blood samples from participants who have been diagnosed with diabetes mellitus or who are being monitored for symptoms of diabetes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rory McCrimmon principal investigator
NHS Tayside
Isabel Howat principal investigator
NHS Lanarkshire
Catherine Patterson principal investigator
NHS Fife
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by LumiraDx UK Limited at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.