Safety and Performance of the Glyconics-SX System

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Device: Near-infrared (NIR)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Screening among individuals with or without known diabetes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label, single arm with identical assessment of both biomarkers for all participants<br>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)<br>* NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c)<br>* 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 |