A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package.

A clinical trial, NCT06261944, is currently underway to test the accuracy of the Glyconics-DS spectrometer in assessing glycated nail keratin in individuals with unknown diabetes risk. The trial will also evaluate the performance of the associated software in analyzing diabetes risk using algorithms. The study will compare the spectrometer's results with the HbA1c biomarker, which measures glycaemia. The trial is in the recruitment phase and aims to enroll 480 apparently healthy adults. The research study is being conducted by investigators at Sant Pau Hospital, led by Principal Investigator Didac Mauricio. The study utilizes keratins, software, chemometric analysis, and scleroproteins in the field of health and medicine, incorporating emerging technologies like cloud computing and machine learning. This study is part of ongoing efforts to identify biomarkers for diabetes risk and prevention. The information is provided by Glyconics Ltd and was verified in February 2024. [Extracted from the article]