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252    CHAPTER 12 Modeling the CGM measurement error




                         sensor engineering. The generic deviations can be approximatedreasonablywell
                         by a diffusion model. The sensor-specific errors appear to be generally limited
                         to the order of the ARMA model and the shape of the sensor error distribution.
                         Thus, both types of errors can be described by a few model parameters and
                         included in a simulation. A specific type of error is omitted by this methodology:
                         high-frequency errors (period of 1e15 min) cannot be modeled with our tech-
                         niques. At this time, no data are available to extract the characteristic of the error
                         at that fine a sample frequency (we would need reference values every minute in a
                         large dataset). Nonetheless, the development of a simulated sensor becomes
                         feasible and became a component of the larger metabolic system simulator devel-
                         oped at the University of Virginia and the University of Padova. This simulator was
                         accepted by the Food and Drug Administration for preclinical testing of closed-
                         loop glucose control strategies. Such in silico testing is now employed by the
                         Juvenile Diabetes Research Foundation Artificial Pancreas Consortium, provides
                         insights on the effectiveness of control algorithms during realistic conditions,
                         and allows the direct transition from in silico testing to clinical trials.




                         References
                          [1] Klonoff DC. Continuous glucose monitoring: roadmap for 21st century diabetes
                             therapy. Diabetes Care 2005;28(5):1231e9.
                          [2] Garg K, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. Improvement in
                             glycemic excursions with a transcutaneous, real-time continuous glucose sensor.
                             Diabetes Care 2006;29(1):44e50.
                          [3] Deiss D, Bolinder J, Riveline J, Battelino T, Bosi E, Tubiana-Rufi N, Kerr D, Phillip M.
                             Improved glycemic control in poorly controlled patients with type 1 diabetes using real-
                             time continuous glucose monitoring. Diabetes Care 2006;29(12):2730e2.
                          [4] Kovatchev B, Clarke W. Continuous glucose monitoring (CGM) reduces risks for hypo-
                             and hyperglycemia and glucose variability in diabetes. Diabetes 2007;56(Suppl. 1):A23.
                          [5] Gerritsen M, Jansen JA, Lutterman JA. Performance of subcutaneously implanted
                             glucose sensors for continuous monitoring. The Netherlands Journal of Medicine
                             1999;54(4):167e79.
                          [6] Gross TM, Bode BW, Einhorn D, Kayne DM, Reed JH, White NH, Mastrototaro JJ.
                             Performance evaluation of the MiniMed continuous glucose monitoring system during
                             patient home use. Diabetes Technology and Therapeutics 2000;2(1):49e56.
                          [7] Cheyne EH, Cavan DA, Kerr D. Performance of a continuous glucose monitoring
                             system during controlled hypoglycaemia in healthy volunteers. Diabetes Technology
                             and Therapeutics 2002;4(5):607e13.
                          [8] Kovatchev BP, Gonder-Frederick LA, Cox DJ, Clarke WL. Evaluating the accuracy of
                             continuous glucose-monitoring sensors: continuous glucose error-grid analysis illus-
                             trated by TheraSense FreeStyle Navigator data. Diabetes Care 2004;27(8):1922e8.
                          [9] Clarke WL, Anderson S, Farhy L, Breton M, Gonder-Frederick L, Cox D, Kovatchev B.
                             Evaluating the clinical accuracy of two continuous glucose sensors using continuous
                             glucose-error grid analysis. Diabetes Care 2005;28(10):2412e7.
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