Clinical validation of electrochemical biosensor for the detection of methylglyoxal in subjects with type-2 diabetes mellitus.

Methylglyoxal (MG), a highly reactive by-product of glycolysis, is involved in the formation of advanced glycation end-products (AGEs). Elevated levels of MG have been correlated with micro-and macro-angiopathic complications in diabetes, including neuropathy, kidney disease, retinopathy, and cardiovascular disease. Therefore, point-of-care devices for detecting MG may be of great use in the screening of diabetes complications. This study was designed to determine the utility of the developed electrochemical biosensor to measure the level of MG in human plasma from type-2 diabetes mellitus patients. Electrochemical studies were carried out with optimized experimental parameters using the modified Platinum-electrode. Subsequently, clinical studies using 350 blood plasma samples were conducted and the results were validated against the ELISA kit, Normal Glucose Tolerance (NGT), and glycosylated haemoglobin (HbA1c). The MG sensor exhibited a linear range of 1.0-7.5 μM concentration with a sensitivity of 1.02 mA µM-1, a limit of detection of 0.21 µM, a limit of quantification of 0.70 µM and a response time less than 10 s. The sensor showed 90% correlation with ELISA data. The developed biosensor showed a significant correlation with HbA1c and fasting plasma glucose suggesting that it can be used as a point-of-care device to screen for diabetes.