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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Near-infrared (NIR)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom
    • Leicester Diabetes Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open-label, single arm with identical assessment of both biomarkers for all participants; 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)	Device: Near-infrared (NIR); NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c); Other Names: point-of-care device (HbA1c analyser)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	60 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of sensitivity and specificity for chemometric model outcomes	False positive and false negative assessments in %	60 seconds
Calculation of negative and positive predictive value for the chemometric model	Calculated values in %	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	60 seconds
Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device	HbA1c value in mmol/mol	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	15 minutes

Collaborators and Investigators

• Sponsor: Glyconics Ltd
• Investigators: Study Director: Paivi M Paldanius, MMed PhD, Glyconics Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NIRDM-SXCIP01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No