Safety and Performance of the Glyconics-SX System (ANODE02)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open-label, single arm with identical intervention for all participants Glycated keratin assessed by near-infrared and glycated haemoglobin (HbA1c) assessed based on finger prick blood drop sample |
Device: Near-infrared (NIR)
NIR spectral assessment of glycated nail keratin vs HbA1c
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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) [60 seconds]
Overall probability of correct classification by the chemometric model output (yes / no DM)
Secondary Outcome Measures
- Assessment of sensitivity and specificity for chemometric model outcomes [60 seconds]
False positive and false negative assessments in %
- Calculation of negative and positive predictive value for the chemometric model [60 seconds]
Calculated values in %
- Calculation of AUC with axis defined by false positive and negative rates for the model [60 seconds]
Area under curve
- Median (IQR) HbA1c values in both groups (with or without DM) [4 minutes]
HbA1c value in mmol/mol
- Analysis of safety outcomes, included suspected de novo DM diagnosis based on HbA1c [15 minutes]
adverse events
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Glyconics Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NIRDM-SXCIP02