Near-Infrared Device for Screening of Diabetes-ANODE02 Study

Background: Currently, screening for diabetes mellitus (DM) can be complex, inefficient and often resource-intensive with invasive sampling. Affordable screening tools with high specificity will be essential for smart allocation of limited healthcare resources for those in need of further diagnostics. Materials and methods: We explored the accuracy and safety of a novel compact miniaturized near-infrared (NIR) full-spectrum spectroscopy device intended for DM screening. Assessments of up to 30 NIR spectra per each middle fingernail and hand, in a cohort of people living with (n=50) or without (n=50) DM focused on detection of dichotomised DM status (< HbA1c 48 mmol/mol or 6.5% ≥) and specificity (%) based chemometrics outcomes, in assessment of glycated nail keratin versus an HbA1c point-of-care assay as control. Results: Demographics of a community primary care centre-based cohort (n=100) are presented in Table. Overall, no adverse NIR-device-related events were being reported for any of the over 6000 spectral measurements. Based on the best chemometrics model, the NIR-device demonstrated a specificity of 98.5% (95%CI 95.5 - 100.0) and 88.9% (80.5 - 97.3) at 48 and 42 mmol/mol cut-off levels, respectively, in detection of those without DM. Conclusions: Our preliminary results are indicative of high specificity and safe implementation of non-invasive NIR technology with potential for early detection and management of increasing DM risk. Disclosure F.Cos: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Abbott Diagnostics, Lilly, Novo Nordisk, Consultant; Glyconics Ltd, Menarini Group, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly. D.Lazaro-pacheco: Consultant; Glyconics Ltd. J.E.Salter: None. P.M.Paldanius: Consultant; Glyconics Ltd, Speaker's Bureau; Novartis. Funding Glyconics