Toward Calibration-Free Continuous Glucose Monitoring Sensors: Bayesian Calibration Approach Applied to Next-Generation Dexcom Technology

Abstract Background: Continuous glucose monitoring (CGM) sensors need to be calibrated twice/day by using self-monitoring of blood glucose (SMBG) samples. Recently, to reduce the calibration frequency, we developed an online calibration algorithm based on a multiple-day model of sensor time variability and Bayesian parameter estimation. When applied to Dexcom G4 Platinum (DG4P) sensor data, the algorithm allowed the frequency of calibrations to be reduced to one-every-four-days without significant worsening of sensor accuracy. The aim of this study is to assess the same methodology on raw CGM data acquired by a next-generation Dexcom CGM sensor prototype and compare the results with that obtained on DG4P. Methods: The database consists of 55 diabetic subjects monitored for 10 days by a next-generation Dexcom CGM sensor prototype. The new calibration algorithm is assessed, retrospectively, by simulating an online procedure using progressively fewer SMBG samples until zero. Accuracy is evaluated with mean a...

[1]  Buddy D Ratner,et al.  Biomechanics of the Sensor-Tissue Interface—Effects of Motion, Pressure, and Design on Sensor Performance and the Foreign Body Response—Part I: Theoretical Framework , 2011, Journal of diabetes science and technology.

[2]  B Wayne Bequette,et al.  Continuous Glucose Monitoring: Real-Time Algorithms for Calibration, Filtering, and Alarms , 2010, Journal of diabetes science and technology.

[3]  Ben Feldman,et al.  Metabolic Biofouling of Glucose Sensors in Vivo: Role of Tissue Microhemorrhages , 2011, Journal of diabetes science and technology.

[4]  K. Turksoy,et al.  Multivariable adaptive closed-loop control of an artificial pancreas without meal and activity announcement. , 2013, Diabetes technology & therapeutics.

[5]  Joseph P Shivers,et al.  Continuous glucose monitors: current status and future developments , 2013, Current opinion in endocrinology, diabetes, and obesity.

[6]  Christopher G Parkin,et al.  Continuous Glucose Monitoring Use in Type 1 Diabetes: Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization , 2017, Journal of diabetes science and technology.

[7]  Josep Vehí,et al.  Estimating Plasma Glucose from Interstitial Glucose: The Issue of Calibration Algorithms in Commercial Continuous Glucose Monitoring Devices , 2010, Sensors.

[8]  Giovanni Sparacino,et al.  Dexcom G4AP: An Advanced Continuous Glucose Monitor for the Artificial Pancreas , 2013, Journal of diabetes science and technology.

[9]  G. Mcgarraugh The chemistry of commercial continuous glucose monitors. , 2009, Diabetes technology & therapeutics.

[10]  I M E Wentholt,et al.  How to assess and compare the accuracy of continuous glucose monitors? , 2008, Diabetes technology & therapeutics.

[11]  Thomas Peyser,et al.  A new-generation continuous glucose monitoring system: improved accuracy and reliability compared with a previous-generation system. , 2013, Diabetes technology & therapeutics.

[12]  Steven V. Edelman,et al.  Regulation Catches Up to Reality , 2017, Journal of diabetes science and technology.

[13]  Giuseppe De Nicolao,et al.  Nonparametric input estimation in physiological systems: Problems, methods, and case studies , 1997, Autom..

[14]  Andrea Facchinetti,et al.  Continuous Glucose Monitoring Sensors: Past, Present and Future Algorithmic Challenges , 2016, Sensors.

[15]  Giovanni Sparacino,et al.  From Two to One Per Day Calibration of Dexcom G4 Platinum by a Time-Varying Day-Specific Bayesian Prior. , 2016, Diabetes technology & therapeutics.

[16]  John Walsh,et al.  Update on Clinical Utility of Continuous Glucose Monitoring in Type 1 Diabetes , 2016, Current Diabetes Reports.

[17]  Danielle Hessler,et al.  The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial , 2017, Diabetes Care.

[18]  Claudio Cobelli,et al.  Modeling Plasma-to-Interstitium Glucose Kinetics from Multitracer Plasma and Microdialysis Data. , 2015, Diabetes technology & therapeutics.

[19]  T. Bailey,et al.  The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System , 2015, Diabetes technology & therapeutics.

[20]  E. Toschi,et al.  Utility of Continuous Glucose Monitoring in Type 1 and Type 2 Diabetes. , 2016, Endocrinology and metabolism clinics of North America.

[21]  Giovanni Sparacino,et al.  Reduction of Blood Glucose Measurements to Calibrate Subcutaneous Glucose Sensors: A Bayesian Multiday Framework , 2018, IEEE Transactions on Biomedical Engineering.

[22]  W. Clarke The original Clarke Error Grid Analysis (EGA). , 2005, Diabetes technology & therapeutics.