Are our self-care devices accurate and on the mark? Validation of a diabetes point-of-care device

Abstract

A point-of-care device (POCD) is a medical diagnostic tool designed for use at or near the patient, providing rapid results outside traditional laboratory settings. The term “Gold Standard” refers to a diagnostic tool that is considered the accurate benchmark for diagnosis. A glucometer is a popularly used point-of-care device for the diagnosis of diabetes, which, when validated against the gold standard, saves time, money, and manpower resources invested into the diagnosis of diabetes. To validate a POCD, i.e., glucometer, against the gold standard method (hexokinase method). A diagnostic accuracy cross-sectional study was conducted from September 2025 to December 2025 among patients with diabetes mellitus type 2 in the urban field practice area of a medical college, among 240 patients. Blood glucose levels were measured using the POCD glucometer and the gold standard method, i.e. the hexokinase method, simultaneously. Data entry and analysis were done. Validity testing of the POCD was performed. Sensitivity and specificity were found to be 84.4% and 71.1%, respectively. Positive predictive value (80.2%), negative predictive value (76.6%), and accuracy (78.8%), all confirmed the validity of POCD. Area under the curve (AUC) =0.932 showed the good performance of the POCD. The Bland–Altman plot showed the good concordance of the POCD with the gold standard. Intraclass correlation coefficient = 0.985, which showed that POCD has excellent reliability. The glucometer used in the study is an efficient tool to use in mass screening programs.