Diabetes Mellitus, Type 2
Conditions
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 of the participants and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.
Interventions
DEVICENear-infrared (NIR)
NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c)
Sponsors
Glyconics Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Screening among individuals with or without known diabetes
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model | 60 seconds | Area under the curve value |
| Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device | 4 minutes | HbA1c value in mmol/mol |
| 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 | 15 minutes | Adverse events |
Countries
United Kingdom
Outcome results
None listed