The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
486
Near-infrared assessment of glycated keratin in middle fingernail
Sant Pau Hospital
Barcelona, Spain
Dichotomised diabetes risk status
YELLOW: HbA1c value \< 48 mmol/mol OR ORANGE: HbA1c value \>= 48 mmol/mol.
Time frame: 10 seconds
Sensitivity and specificity
HbA1c cut-off value of 48 mmol/mol (6.5%) and HbA1c cut-off value of 42 mmol/mol (6.0%)
Time frame: 10 seconds
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