Safety and Performance of the Glyconics-SX System

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05198895
• Other study ID #: NIRDM-SXCIP01
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 28, 2022

Study information

• Verified date: October 2023
• Source: Glyconics Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 28, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Device:
• Near-infrared (NIR)
NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c)

Locations

Country	Name	City	State
United Kingdom	Leicester Diabetes Centre	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Glyconics Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of sensitivity and specificity for chemometric model outcomes	False positive and false negative assessments in %	60 seconds
Secondary	Calculation of negative and positive predictive value for the chemometric model	Calculated values in %	60 seconds
Secondary	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
Secondary	Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device	HbA1c value in mmol/mol	4 minutes
Secondary	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