Comparison Between One-Point Calibration and Two-Point Calibration Approaches in a Continuous Glucose Monitoring Algorithm

Abstract

The purpose of this study was to investigate the effect of using a 1-point calibration approach instead of a 2-point calibration approach on the accuracy of a continuous glucose monitoring (CGM) algorithm. A previously published real-time CGM algorithm was compared with its updated version, which used a 1-point calibration instead of a 2-point calibration. In addition, the contribution of the corrective intercept (CI) to the calibration performance was assessed. Finally, the sensor background current was estimated real-time and retrospectively. The study was performed on 132 type 1 diabetes patients. Replacing the 2-point calibration with the 1-point calibration improved the CGM accuracy, with the greatest improvement achieved in hypoglycemia (18.4% median absolute relative differences [MARD] in hypoglycemia for the 2-point calibration, and 12.1% MARD in hypoglycemia for the 1-point calibration). Using 1-point calibration increased the percentage of sensor readings in zone A+B of the Clarke error grid analysis (EGA) in the full glycemic range, and also enhanced hypoglycemia sensitivity. Exclusion of CI from calibration reduced hypoglycemia accuracy, while slightly increased euglycemia accuracy. Both real-time and retrospective estimation of the sensor background current suggest that the background current can be considered zero in the calibration of the SCGM1 sensor. The sensor readings calibrated with the 1-point calibration approach indicated to have higher accuracy than those calibrated with the 2-point calibration approach.