Clinical trial NCT05476016: Safety and Performance of the Glyconics-SX System (ANODE02)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Glyconics Ltd
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Screening among individuals with or without known diabetes
Primary purpose: SCREENING

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


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

  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.

Primary outcomes:
measure: 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)
timeFrame: 60 seconds
Secondary outcomes:
measure: Assessment of sensitivity and specificity for chemometric model outcomes
timeFrame: 60 seconds
measure: Calculation of negative and positive predictive value for the chemometric model
timeFrame: 60 seconds
measure: Calculation of AUC with axis defined by false positive and negative rates for the model
timeFrame: 60 seconds
measure: Median (IQR) HbA1c values in both groups (with or without DM)
timeFrame: 4 minutes
measure: Analysis of safety outcomes, included suspected de novo DM diagnosis based on HbA1c
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Sant Marti
Study officials:
References: