New rapid test could simplify diabetes monitoring
NCT ID NCT05403853
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new rapid blood test (LumiraDx HbA1c) to see how well it measures blood sugar control in people with diabetes. Researchers compared it to a standard lab method in 177 adults. The goal was to see if the quick test is accurate enough for routine diabetes monitoring.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If the test works well, it could provide faster, easier diabetes monitoring at the point of care.
- What could go wrong
- This is a small, completed device comparison study, not a treatment trial. The test may not be as accurate in real-world settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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177 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Oct 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients presenting for assessment or monitoring of diabetes or attending an independent research clinic or present on a diabetes research database.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Intelligent Clinical
Glasgow, United Kingdom
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NHS Lanarkshire
Glasgow, United Kingdom
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Ninewells Hospital, Dundee
Dundee, United Kingdom
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Victoria Hospital
Kirkcaldy, United Kingdom
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