Development of an error model for a factory-calibrated continuous glucose monitoring sensor with 10-day lifetime

Factory-calibrated continuous glucose monitoring (FC-CGM) sensors are new devices used in type 1 diabetes (T1D) therapy to measure the glucose concentration almost continuously for 10–14 days without requiring any in vivo calibration. Understanding and modelling CGM errors is important when designing new tools for T1D therapy. Available literature CGM error models are not suitable to describe the FC-CGM sensor error, since their domain of validity is limited to 12-h time windows, i.e., the time between two consecutive in vivo calibrations. The aim of this paper is to develop a model of the error of FC-CGM sensors. The dataset used contains 79 FC-CGM traces collected by the Dexcom G6 sensor. The model is designed to dissect the error into its three main components: effect of plasma-interstitium kinetics, calibration error, and random measurement noise. The main novelties are the model extension to cover the entire sensor lifetime and the use of a new single-step identification procedure. The final error model, which combines a first-order linear dynamic model to describe plasma-interstitium kinetics, a second-order polynomial model to describe calibration error, and an autoregressive model to describe measurement noise, proved to be suitable to describe FC-CGM sensor errors, in particular improving the estimation of the physiological time-delay.