A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
100
both interventions will be applied in both participant groups
Tameside and Glossop Integrated Care NHS Foundation Trust, Tameside General Hospital, Fountain Street
Ashton-under-Lyne, England, United Kingdom
Barts Liver Centre
London, United Kingdom
Specificity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)
Acceptance criteria for specificity is to demonstrate a result being at least or above 75%
Time frame: 10 minutes
Sensitivity (%) meeting the acceptability criteria in identification correct dichotomised output / diabetes screening test result (being above or below HbA1c level of 48 mmol/mol)
Acceptance criteria for sensitivity is to demonstrate a result being at least or above 30%
Time frame: 10 minutes
Secondary performance measure and accuracy: False positive / negative rates for the screening test result
Assessment of sensitivity and specificity -derived false positive / false negative rates in % for chemometric model outcomes for HbA1c cut-off value of 48 mmol/mol (6.5%) in the study cohort n=100, in individuals with and without known T2DM.
Time frame: 10 minutes
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