Safety and Performance of the Glyconics-SX System

NCT05198895 | Completed

• 1 other identifier: NIRDM-SXCIP01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of sensitivity and specificity for chemometric model outcomes

  60 seconds

• Calculation of negative and positive predictive value for the chemometric model

  60 seconds

• Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model

  60 seconds

• Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device

  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

  15 minutes

Study Arms (1)

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)

Device: Near-infrared (NIR)

Interventions

Near-infrared (NIR) DEVICE

NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c)

Also known as: point-of-care device (HbA1c analyser)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glyconics Ltd: lead

Study Sites (1)

Leicester Diabetes Centre

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Paivi M Paldanius, MMed PhD

  Glyconics Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Screening among individuals with or without known diabetes

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 20, 2022
• Study Start: August 1, 2022
• Primary Completion: October 19, 2022
• Study Completion: October 28, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)