Diabetes Mellitus, Type 2ANODE01NCT05198895
Safety and Performance of the Glyconics-SX System
A study testing Near-infrared (NIR) in people with Diabetes Mellitus, Type 2, run by Glyconics Ltd at 1 site in United Kingdom.
Trial summary
The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status of the participants and as controlled by values of an internal… 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, Type 2
- 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
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2022to 28 Oct 2022
- 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 known or unknown T2DM status 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 two visually assessed apparently healthy, undamaged, and intact fingernails, one in both right- and left-hand middle fingers
Who cannot join
- Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as
- anaemia (iron deficiency sickle cell anaemia or similar)
- haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular assays,
- severe renal impairment (CKD stage III-IV) or decompensated hepatic disease
- severe Vitamin D deficiency
- known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia
Show all 15Show fewer
- eating disorders (as per clinical assessment)
- Recent (within 28 days) blood donation
- Any structural, deviating and visually detectable deviations in the appearance of the nails 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
- 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 Single-centre, Open-label Study Testing the Safety and Performance of the Glyconics-SX System in Individuals With or Without Type 2 Diabetes
The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status of the participants and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Near-infrared (NIR)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared (NIR)Device
Also called point-of-care device (HbA1c analyser)
NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c)
| Study group | Role | What they receive |
|---|---|---|
| Open-label, single arm with identical assessment of both biomarkers for all participants | Experimental | All participants will have their glycated nail keratin assessed by infrared and blood HbA1c levels measured via an assay (based on finger prick blood drop sample) Receives: Device: Near-infrared (NIR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Glyconics-SX System in detection of DM status based on dichotomised outcomes as per the chemometric model (HbA1c measurements as internal control)
Overall probability of correct classification by the chemometric model output (yes / no DM)
Measured: 60 seconds
Secondary outcomes (5)
Assessment of sensitivity and specificity for chemometric model outcomes
False positive and false negative assessments in %
Measured: 60 seconds
Calculation of negative and positive predictive value for the chemometric model
Calculated values in %
Measured: 60 seconds
Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model
Area under the curve value
Measured: 60 seconds
Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device
HbA1c value in mmol/mol
Measured: 4 minutes
Analysis of safety outcomes (AEs, SAEs), including any safety outcomes listed in the comments, such as potential, suspected de novo diabetes diagnosis cases based on HbA1c readings
Adverse events
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Aug 2022
- Primary completion19 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Screening among individuals with or without known diabetes
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glyconics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paivi M Paldanius, MMed PhD, Study director, Glyconics Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198895
- Sponsor's protocol ID
- NIRDM-SXCIP01
- Acronym
- ANODE01
- Status last verified
- Oct 2023
- First submitted
- 16 Dec 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choudhary P, Paldanius PM, Salter JE, Lazaro-Pacheco D, Cos Claramunt FX. Use of a Miniaturized Near-Infrared Spectroscopy Device for Type 2 Diabetes Mellitus Screening: Pooled Analysis of the Pilot ANODE01 and ANODE02 Studies. J Diabetes Sci Technol. 2026 Jul;20(4):1313-1321. doi: 10.1177/19322968251331069. Epub 2025 Apr 12.
PubMed 40219802
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open-label Study Testing the Safety and Performance of the Glyconics-SX System in Individuals With or Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05198895
- Acronym / sponsor ID
- ANODE01 / NIRDM-SXCIP01
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Glyconics LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 20 Jan 2022 (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 retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status of the participants and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Screening among individuals with or without known diabetes
| Arm | Type | Receives |
|---|---|---|
| Open-label, single arm with identical assessment of both biomarkers for all participants | Experimental | Device: Near-infrared (NIR)All participants will have their glycated nail keratin assessed by infrared and blood HbA1c levels measured via an assay (based on finger prick blood drop sample) |
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 or unknown T2DM status 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 two visually assessed apparently healthy, undamaged, and intact fingernails, one in both right- and left-hand middle fingers
Key exclusion criteria (15 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 nails 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)Also: point-of-care device (HbA1c analyser)NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c) | Device | Open-label, single arm with identical assessment of both biomarkers for all participants |
Primary outcome
Accuracy of the Glyconics-SX System in detection of DM status based on dichotomised outcomes as per the chemometric model (HbA1c measurements as internal control)
Time frame: 60 seconds
Overall probability of correct classification by the chemometric model output (yes / no DM)
5 secondary outcomes
Assessment of sensitivity and specificity for chemometric model outcomes
Time frame: 60 seconds
Calculation of negative and positive predictive value for the chemometric model
Time frame: 60 seconds
Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model
Time frame: 60 seconds
Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device
Time frame: 4 minutes
Analysis of safety outcomes (AEs, SAEs), including any safety outcomes listed in the comments, such as potential, suspected de novo diabetes diagnosis cases based on HbA1c readings
Time frame: 15 minutes
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 23 Oct 2023.
- Derived from this study: PubMed 40219802Choudhary P, Paldanius PM, Salter JE, Lazaro-Pacheco D, Cos Claramunt FX. Use of a Miniaturized Near-Infrared Spectroscopy Device for Type 2 Diabetes Mellitus Screening: Pooled Analysis of the Pilot ANODE01 and ANODE02 Studies. J Diabetes Sci Technol. 2026 Jul;20(4):1313-1321. doi: 10.1177/19322968251331069. Epub 2025 Apr 12.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Paivi M Paldanius, MMed PhD study director
Glyconics Ltd
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 Diabetes Mellitus, Type 2, run by Glyconics Ltd at 1 site 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 15 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 23 Oct 2023. 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 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?
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?
Accuracy of the Glyconics-SX System in detection of DM status based on dichotomised outcomes as per the chemometric model (HbA1c measurements as internal control) (time frame: 60 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05198895, which also lists 1 linked publication.
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 23 Oct 2023.