Clinical Performance Evaluation and Comparative Study of the ConfiGlu G1 Portable Blood Glucose Monitoring System

with international standards, particularly ISO 15197:2013.ISO 15197 provides standardized criteria for evaluating the performance and reliability of blood glucose monitors and is also adopted and applied in Europe.A clinical performance evaluation of the device was conducted at the Department of Laboratory Medicine, Dankook University Hospital, using a trial product that had already undergone analytical performance evaluation.The product was assessed for accuracy, repeatability, linearity, interference resistance, and stability across hematocrit (Hct) levels, as well as for comparative performance with blood glucose monitors from major international and domestic manufacturers.