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285d

Spurious Drop-out Detection in Subcutaneously Implanted Continuous Glucose Monitors

Quan Shen, Department of Chemical Engineering, University of Texas at Austin, 1 University Station C0400, Austin, TX 78712 and S. Joe Qin, The Mork Family Department of Chemical Engineering and Materials Science, University of Southern California, 3710 McClintock Ave, RTH 420, Los Angeles, CA 90089.

Continuous glucose monitoring (CGM) is of importance for the management and control of diabetes mellitus, which is a prevalent chronic disease of no cure as yet. CGM can continuously inform diabetic people of the status of their glucose and warn of actual or impending hypo- or hyperglycemia. In the past decades, biosensors have been developed for CGM, among which the implanted wired enzyme biosensor [1] has advantages of consistency and accuracy[4,3] over other subcutaneously implanted sensors.

It is found in the experiments of subcutaneously implanted sensors that there are some spurious drop-outs which do not reflect the true glucose level and will cause problems in subsequent glucose calibration and lag correction. These spurious drop-outs are usually very fast and abrupt. Our objectives are to (1) detect spurious drop-outs online for a single glucose sensor signal, since in practice only one subcutaneously implanted glucose monitor is carried by one person; (2) detect different sizes of spurious drop-outs; and (3) detect drop-outs as quickly as possible.

In this paper, we propose an online spurious drop-out detector based on the discrete wavelet transform (DWT) [2], a signal processing technique which can effectively extract the signal component at a specific frequency range and a specific time region with scaled and shifted wavelets. Because of its multiscale feature, DWT is very useful in detecting singularities of a single sensor signal. In our study, the finest five level details (D1~D5) are found to have the ability to capture the spurious drop-outs in the glucose signal. The online detection scheme is designed in a recursive way. At each new time point, a moving window is reconstructed. Then DWT is applied on the glucose data inside the window to extract the finest five level details and calculate Dc=sum(D1~D5). If Dc exceeds its confidence interval (CI), an abrupt drop-out is warned, which will be confirmed as a spurious drop-out or otherwise by a rule-based evaluator. The rule-based evaluator is a Boolean valued composite measure based on the boundaries, minimum, width of the drop-out, normal signal variations around the drop-out, etc. This evaluator is to exclude normal fast changes such as a real glucose rise after a meal.

The subcutaneously implanted wired enzyme glucose biosensor has been commercially available to diabetic people. In this study, we apply the proposed online spurious drop-out detection method to glucose data from non-diabetic pigs. The results demonstrate effectiveness of the proposed method.

References:

[1]. A. Heller, Implanted electrochemical glucose sensors for the management of diabetes, Annual Reviews of Biomedical Engineering 1 (1999), 153-175.

[2]. R. M Rao and A. S. Bopardikar, Wavelet transforms: Introduction to theory and applications, Addison Wesley Longman Inc, 1998.

[3]. R. L. Weinstein, S. L. Schwartz, R. L. Brazg, J. R. Bugler, T. A. Peyser, and G. V. Mc-Garraugh, Accuracy of the 5-day freestyle navigator continuous glucose monitoring system: comparison with frequent laboratory reference measurements.(emerging treatments and technologies), Diabetes Care 30 (2007), 1125-1130.

[4]. D. M. Wilson, R. W. Reck, W. V. Tamborlane, M. J. Dontchev, C. Kollman, P. Chase, L. A. Fox, K. J. Ruedy, E. Tsalikian, and S. A. Weinzimer, The accuracy of the freestyle navigator continuous glucose monitoring system in children with type 1 diabetes, Diabetes Care 30 (2007), 59-64.