A fingernail scan could reveal hidden diabetes risk
NCT ID NCT06261944
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing a device called Glyconics-DS that shines near-infrared light on a fingernail to measure glycated keratin, a marker linked to blood sugar. The trial enrolls about 486 adults who do not know their diabetes status and compares the scan result with a standard HbA1c blood test. The goal is to see whether the fingernail scan can correctly sort people into lower or higher diabetes risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- near-infrared scan of glycated keratin in a fingernail
- What this could lead to
- If it works, people could learn their diabetes risk from a quick fingernail scan instead of a blood draw, which may make screening easier to offer in more places.
- What could go wrong
- The scan may not match the blood test closely enough to be trusted, especially for people with nail damage or other conditions. This is a device accuracy study, so it cannot show whether screening this way improves health.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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486 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Aug 2024
- 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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Apparently healthy adults (≥18 years of age) with unknown diabetes status willing to participate in and provide a written consent for the study * Willingness to undertake assisted assessment of glycaemia: by both the NIR spectral measurements in a chosen middle fingernail, and HbA1c (blood sample) * Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail. Exclusion Criteria: * Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as: * Severe forms of anaemia (diagnosed iron deficiency, sickle cell anaemia or similar). * Haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular (local) laboratory assays for HbA1c. * Severe renal impairment (CKD stage III-IV) or decompensated hepatic disease. * Severe Vitamin D deficiency (diagnosed or measured 25(OH)D3 \< 25 nmol/ml). * Known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia. * Eating disorders (as per clinical assessment) * Recent (within 28 days) blood donation * Any other type of known diabetes than T2DM, if diagnosed (T1DM, GDM, MODY, etc.) * Any structural, deviating and visually detectable deviations in the appearance of the (only/ to be assessed) middle fingernail potentially impacting the spectra measurement, including: * nail dystrophy or deformity * severe nail infections (onychomycosis causing visual changes in the appearance of the nail). * rare hereditable conditions impacting the structure of keratin. * mechanical damage or marks on the surface of the nail after removal of nail polish. * use of acrylic or gel nail decoration and polish, which cannot be removed with acetone (use of acetone necessitates a 15 min post-removal wash-out time) * Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
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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
-
Sant Pau Hospital
Barcelona, Spain
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