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Safety and Performance of the Glyconics-SX System (ANODE01)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Near-infrared (NIR)
Sponsored by
Glyconics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
    • 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.

Sites / Locations

  • Leicester Diabetes Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label, single arm with identical assessment of both biomarkers for all participants

Arm Description

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)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Assessment of sensitivity and specificity for chemometric model outcomes
False positive and false negative assessments in %
Calculation of negative and positive predictive value for the chemometric model
Calculated values in %
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
Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device
HbA1c value in mmol/mol
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

Full Information

First Posted
December 16, 2021
Last Updated
October 19, 2023
Sponsor
Glyconics Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05198895
Brief Title
Safety and Performance of the Glyconics-SX System
Acronym
ANODE01
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glyconics Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Screening among individuals with or without known diabetes
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label, single arm with identical assessment of both biomarkers for all participants
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Near-infrared (NIR)
Other Intervention Name(s)
point-of-care device (HbA1c analyser)
Intervention Description
NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c)
Primary Outcome Measure Information:
Title
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)
Description
Overall probability of correct classification by the chemometric model output (yes / no DM)
Time Frame
60 seconds
Secondary Outcome Measure Information:
Title
Assessment of sensitivity and specificity for chemometric model outcomes
Description
False positive and false negative assessments in %
Time Frame
60 seconds
Title
Calculation of negative and positive predictive value for the chemometric model
Description
Calculated values in %
Time Frame
60 seconds
Title
Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model
Description
Area under the curve value
Time Frame
60 seconds
Title
Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device
Description
HbA1c value in mmol/mol
Time Frame
4 minutes
Title
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
Description
Adverse events
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paivi M Paldanius, MMed PhD
Organizational Affiliation
Glyconics Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Leicester Diabetes Centre
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Performance of the Glyconics-SX System

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