UnknownNot Applicable

A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package

Spain486 participantsStarted 2024-03-13

Plain-language summary

The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (onycho…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dichotomised diabetes risk status

Timeframe: 10 seconds

Trial details

NCT IDNCT06261944

SponsorGlyconics Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-21

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