Background: Diabetes mellitus (DM) screening is currently complex, inefficient and requires resource-intensive, invasive sampling. Development of affordable, rapid, and precise mass-screening tools is valuable in identifying the millions with undiagnosed DM, especially in lower income countries.
Materials and Methods: Accuracy and safety of a novel miniaturized full-spectrum near-infrared (NIR) spectroscopy device intended for DM screening was assessed in a multi-ethnic population with (n=50) or without (n=50) DM. Thirty NIR spectra scans per each middle fingernail and hand were tested for detection of dichotomised DM status based on cut-off values (< HbA1c 6.5% or 6.0 ≥) and specificity (%) of chemometrics outcomes, in assessment of glycated nail keratin versus an HbA1c point-of-care assay as control.
Results: The cohort had mean age of 43.6 vs 64.4 years, 42 vs 76% females and 54 vs 68% Caucasians for non-DM and DM participants. Median (IQR) HbA1c % was 5.45 (5.2 - 5.6) and 6.8 (6.3-7.6), respectively. Clinical feasibility for NIR use was confirmed with no adverse device -related events reports for the over 6000 spectral measurements. The NIR-device demonstrated a specificity of 95.2% and 94.1% at HbA1c 6.5 and 6.0% cut-off levels, respectively (Table).
Conclusions: Our preliminary results indicate high specificity and potential for clinical implementation of non-invasive NIR technology in detection of those without immediate DM risk.
P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. D.Lazaro-pacheco: Consultant; Glyconics Ltd. J.E.Salter: None. P.M.Paldanius: Consultant; Glyconics Ltd, Speaker's Bureau; Novartis.
Glyconics
