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Reduction of Blood Glucose Measurements to Calibrate Subcutaneous Glucose Sensors: A Bayesian Multiday Framework

Objective: In most continuous glucose monitoring (CGM) devices used for diabetes management, the electrical signal measured by the sensor is transformed to glucose concentration by a calibration function whose parameters are estimated using self-monitoring of blood glucose (SMBG) samples. The calibration function is usually a linear model approximating the nonlinear relationship between electrical signal and glucose concentration in certain time intervals. Thus, CGM devices require frequent calibrations, usually twice a day. The aim here is to develop a new method able to reduce the frequency of calibrations. Methods: The algorithm is based on a multiple-day model of sensor time-variability with second-order statistical priors on its unknown parameters. In an online setting, these parameters are numerically determined by the Bayesian estimation exploiting SMBG sparsely collected by the patient. The method is assessed retrospectively on 108 CGM signals acquired for 7 days by the Dexcom G4 Platinum sensor, testing progressively less-calibration scenarios. Results: Despite the reduction of calibration frequency (on average from 2/day to 0.25/day), the method shows a statistically significant accuracy improvement compared to manufacturer calibration, e.g., mean absolute relative difference when compared to a laboratory reference decreases from 12.83% to 11.62% (p-value of 0.006).  Conclusion: The methodology maintains (sometimes improves) CGM sensor accuracy compared to that of the original manufacturer, while reducing the frequency of calibrations. Significance: Reducing the need of calibrations facilitates the adoption of CGM technology both in terms of ease of use and cost, an obvious prerequisite for its use as replacement of traditional SMBG devices.