Safety and Performance of the Glyconics-SX System (ANODE02)

Glyconics

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Near-infrared (NIR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05476016

NIRDM-SXCIP02

Details and patient eligibility

About

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 and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with a validated comparator device.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

  o 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 o Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Open-label, single arm with identical intervention for all participants

Experimental group

Description:

Glycated keratin assessed by near-infrared and glycated haemoglobin (HbA1c) assessed based on finger prick blood drop sample

Treatment:

Device: Near-infrared (NIR)