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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
100
NIR spectral assessment of glycated nail keratin vs glycated haemoglobin (HbA1c)
Leicester Diabetes Centre
Leicester, United Kingdom
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)
Time frame: 60 seconds
Assessment of sensitivity and specificity for chemometric model outcomes
False positive and false negative assessments in %
Time frame: 60 seconds
Calculation of negative and positive predictive value for the chemometric model
Calculated values in %
Time frame: 60 seconds
Calculation of area under the curve (AUC) with axis defined by false positive and negative rates (FPR, FNR) for the chemometric model
Area under the curve value
Time frame: 60 seconds
Median (IQR) HbA1c values in both groups (with or without diabetes) as measured by the comparative device
HbA1c value in mmol/mol
Time frame: 4 minutes
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
Adverse events
Time frame: 15 minutes
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