Diabetes MellitusANODE04NCT07039357
Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes
A study testing Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail in people with Diabetes Mellitus and Healthy, run by Glyconics Ltd at 2 sites in United Kingdom.
Trial summary
A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Healthy
- What is being tested?
- Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 28 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 known (n=50) or unknown T2DM status (n=50) willing to participate in and provide a written consent for the study
- willingness to undertake assisted assessment of glycaemia by both the NIR spectra measurement, and HbA1c by finger prick test
- Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail
Who cannot join
- Individuals with any known medical conditions impacting the PoC device 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 the assay
- 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
- known / diagnosed other diabetes such as T1DM, GDM, MODY, etc.
- For the Glyconics-DS device / targeted nail:
- Mechanical damage or marks on the surface of the nail after removal of nail polish, or
- Use of acrylic or gel nail decoration and polish, which cannot be removed.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Tameside and Glossop Integrated Care NHS Foundation Trust, Tameside General Hospital, Fountain Street
Ashton-under-Lyne, England, OL6 9RW
Barts Liver Centre
London
About this study
Official title: A Single Centre, Open-label Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With or Without Known T2DM: a Confirmatory Performance Evaluation of the Glyconics SW Package Delivering the Dichotomised Screening Test Results in a Known Population.
A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes
- Conditions
- Diabetes Mellitus, Healthy
- Being tested
- Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nailDevice
Also called HbA1c analysis by point-of-care device
both interventions will be applied in both participant groups
| Study group | Role | What they receive |
|---|---|---|
| Apparently healthy volunteers without known diabetes | Experimental | Both methods for assessment of glycaemia will be applied in this group as well Receives: Device: Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail |
| People with known T2DM | Experimental | Both methods for assessment of glycaemia will be applied in this group as well Receives: Device: Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)
Acceptance criteria for specificity is to demonstrate a result being at least or above 75%
Measured: 10 minutes
Sensitivity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)
Acceptance criteria for sensitivity is to demonstrate a result being at least or above 30%
Measured: 10 minutes
Secondary outcomes (1)
Secondary performance measure and accuracy: False positive / negative rates for the screening test result
Assessment of sensitivity and specificity -derived false positive / false negative rates in % for chemometric model outcomes for HbA1c cut-off value of 48 mmol/mol (6.5%) in the study cohort n=100, in individuals with and without known T2DM.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start28 Jan 2026
- Primary completion30 Aug 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glyconics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Queen Mary University of London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039357
- Sponsor's protocol ID
- NIRDM-SXCIP04
- Acronym
- ANODE04
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan will be completed during the incoming weeks
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 Single Centre, Open-label Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With or Without Known T2DM: a Confirmatory Performance Evaluation of the Glyconics SW Package Delivering the Dichotomised Screening Test Results in a Known Population.
- ClinicalTrials.gov ID
- NCT07039357
- Acronym / sponsor ID
- ANODE04 / NIRDM-SXCIP04
- Conditions
- Diabetes Mellitus, Healthy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Glyconics LtdIndustry (pharma, biotech, devices)
- Collaborators
- Queen Mary University of London
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Jun 2025 (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.
A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apparently healthy volunteers without known diabetes | Experimental | Device: Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nailBoth methods for assessment of glycaemia will be applied in this group as well |
| People with known T2DM | Experimental | Device: Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nailBoth methods for assessment of glycaemia will be applied in this group as well |
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 known (n=50) or unknown T2DM status (n=50) willing to participate in and provide a written consent for the study
- willingness to undertake assisted assessment of glycaemia by both the NIR spectra measurement, and HbA1c by finger prick test
- Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail
Key exclusion criteria (12 listed)
- Individuals with any known medical conditions impacting the PoC device assessment methodology for glycaemia, such as
- For the Glyconics-DS device / targeted nail:
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 (spectroscopy) for non-invasive assessment of glycated keratin of nailAlso: HbA1c analysis by point-of-care deviceboth interventions will be applied in both participant groups | Device | Apparently healthy volunteers without known diabetes, People with known T2DM |
Primary outcome
Specificity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)
Time frame: 10 minutes
Acceptance criteria for specificity is to demonstrate a result being at least or above 75%
Sensitivity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)
Time frame: 10 minutes
Acceptance criteria for sensitivity is to demonstrate a result being at least or above 30%
1 secondary outcome
Secondary performance measure and accuracy: False positive / negative rates for the screening test result
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided. The plan will be completed during the incoming weeks
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail in people with Diabetes Mellitus and Healthy, run by Glyconics Ltd at 2 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 12 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: under way, not looking for participants, 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 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Specificity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol) (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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.