Pre-diabetesANODE03NCT06261944
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
A study testing Near-infrared (NIR) in people with Pre-diabetes and Undiagnosed Diseases, run by Glyconics Ltd at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes, Undiagnosed Diseases
- What is being tested?
- Near-infrared (NIR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2024to 8 Aug 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal Multi-centre, Open-label, Two-part 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 Delivering the Dichotomised Results
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.
- Conditions
- Pre-diabetes, Undiagnosed Diseases
- Being tested
- Near-infrared (NIR)
- Medical subject headings
- Glucose Intolerance, Undiagnosed Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared (NIR)Device
Near-infrared assessment of glycated keratin in middle fingernail
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | All individuals will be screened for their diabetes risk / status (if previously undiagnosed) Receives: Device: Near-infrared (NIR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dichotomised diabetes risk status
YELLOW: HbA1c value < 48 mmol/mol OR ORANGE: HbA1c value >= 48 mmol/mol.
Measured: 10 seconds
Secondary outcomes (1)
Sensitivity and specificity
HbA1c cut-off value of 48 mmol/mol (6.5%) and HbA1c cut-off value of 42 mmol/mol (6.0%)
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start13 Mar 2024
- Primary completion21 May 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mass-screening
- Masking
- None (open label)
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glyconics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didac Mauricio, MD, PhD, Principal investigator, Sant Pau Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261944
- Sponsor's protocol ID
- NIRDM-SXCIP03
- Acronym
- ANODE03
- Status last verified
- Sep 2026
- First submitted
- 8 Feb 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Multi-centre, Open-label, Two-part 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 Delivering the Dichotomised Results
- ClinicalTrials.gov ID
- NCT06261944
- Acronym / sponsor ID
- ANODE03 / NIRDM-SXCIP03
- Conditions
- Pre-diabetes, Undiagnosed Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Glyconics LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 15 Feb 2024 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mass-screening
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Device: Near-infrared (NIR)All individuals will be screened for their diabetes risk / status (if previously undiagnosed) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as:
- Any structural, deviating and visually detectable deviations in the appearance of the (only/ to be assessed) middle fingernail potentially impacting the spectra measurement, including:
- Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
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 |
|---|---|---|
| Near-infrared (NIR)Near-infrared assessment of glycated keratin in middle fingernail | Device | All participants |
Primary outcome
Dichotomised diabetes risk status
Time frame: 10 seconds
YELLOW: HbA1c value < 48 mmol/mol OR ORANGE: HbA1c value >= 48 mmol/mol.
1 secondary outcome
Sensitivity and specificity
Time frame: 10 seconds
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 15 Sep 2026.
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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.
Didac Mauricio, MD, PhD principal investigator
Sant Pau Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-infrared (NIR) in people with Pre-diabetes and Undiagnosed Diseases, run by Glyconics Ltd at 1 site in Spain.
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 16 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Dichotomised diabetes risk status (time frame: 10 seconds). 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 15 Sep 2026.