Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label, single arm with identical intervention for all participants | Experimental | Glycated keratin assessed by near-infrared and glycated haemoglobin (HbA1c) assessed based on finger prick blood drop sample |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-infrared (NIR) | Device | NIR spectral assessment of glycated nail keratin vs HbA1c |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of sensitivity and specificity for chemometric model outcomes | False positive and false negative assessments in % | 60 seconds |
| Calculation of negative and positive predictive value for the chemometric model |
Not provided
Inclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sant Marti | Barcelona | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 19, 2023 | |
| Reset | Apr 12, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 19, 2023 | Apr 12, 2024 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
Not provided
Not provided
Screening among individuals with or without known diabetes
Not provided
Not provided
Not provided
Not provided
Calculated values in %
| 60 seconds |
| Calculation of AUC with axis defined by false positive and negative rates for the model | Area under curve | 60 seconds |
| Median (IQR) HbA1c values in both groups (with or without DM) | HbA1c value in mmol/mol | 4 minutes |
| Analysis of safety outcomes, included suspected de novo DM diagnosis based on HbA1c | adverse events | 15 minutes |
| D004700 | Endocrine System Diseases |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |