Methods for improving performance and reliability of biosensors
First Claim
1. One or more microprocessors, comprising programming to control(i) operating a sensing device for obtaining a measured signal over time, comprising a measured signal response curve, from a sample comprising glucose collected from a biological system, wherein said measured signal is specifically related to the amount or concentration of glucose present in the biological system, and said measured signal response curve comprises kinetic and equilibrium regions;
- and (ii) a computation method using (a) a mathematical model comprising selected parameters, wherein said model describes the measured signal response curve, and said mathematical model is selected from the group consisting of a first order process, combined first order and zero order process, a parallel multiple first order process, a flux process, and an nth order process, and (b) an error minimization method to iteratively estimate values of the parameters using said model to fit a predicted response curve to said measured signal response curve, wherein (a′
) the error minimization method provides a calculated error based on differences between said predicted and measured signal response curves, and (b′
) said estimating is iteratively performed until the calculated error between the predicted and measured signal response curves falls within an acceptable range or until no further statistically significant change is seen in the calculated error, at which time iterative estimation of the parameters is stopped, said iterative estimation and error minimization results in a predicted response curve corresponding to said measured signal response curve, said predicted response curve yields a predicted end-point value and a measurement correlated to the amount or concentration of the glucose.
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Abstract
The present invention relates to a predictive-kinetic method for use with data processing of a sensor-generated signal, as well as, microprocessors and monitoring systems employing such a predictive-kinetic method. Data from a transient region of a signal is used with suitable models and curve-fitting methods to predict the signal that would be measured for the system at the completion of the reaction. The values resulting from data processing of sensor response using the methods of the present invention are less sensitive to measurement variables.
462 Citations
66 Claims
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1. One or more microprocessors, comprising programming to control
(i) operating a sensing device for obtaining a measured signal over time, comprising a measured signal response curve, from a sample comprising glucose collected from a biological system, wherein said measured signal is specifically related to the amount or concentration of glucose present in the biological system, and said measured signal response curve comprises kinetic and equilibrium regions; - and
(ii) a computation method using (a) a mathematical model comprising selected parameters, wherein said model describes the measured signal response curve, and said mathematical model is selected from the group consisting of a first order process, combined first order and zero order process, a parallel multiple first order process, a flux process, and an nth order process, and (b) an error minimization method to iteratively estimate values of the parameters using said model to fit a predicted response curve to said measured signal response curve, wherein (a′
) the error minimization method provides a calculated error based on differences between said predicted and measured signal response curves, and (b′
) said estimating is iteratively performed until the calculated error between the predicted and measured signal response curves falls within an acceptable range or until no further statistically significant change is seen in the calculated error, at which time iterative estimation of the parameters is stopped, said iterative estimation and error minimization results in a predicted response curve corresponding to said measured signal response curve, said predicted response curve yields a predicted end-point value and a measurement correlated to the amount or concentration of the glucose. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52)
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53. A monitoring system for frequent measurement of glucose amount or concentration present in a subject, said system comprising, in operative combination:
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(A) a sensing device for obtaining a measured signal over time, comprising a measured signal response curve, from a sample comprising glucose collected from the subject, wherein said measured signal is specifically related to the amount or concentration of glucose present in the subject, and said measured signal response curve comprises kinetic and equilibrium regions;
(B) one or more microprocessor(s) in operative communication with the sensing device, wherein said microprocessor is capable of (i) controlling the sensing device to obtain a series of measured signals, in the form of measured signal response curves, at selected time intervals, (ii) predicting measurement values for each measured signal in the series by employing (a) a mathematical model comprising selected parameters, wherein said model describes the measured signal response curve, and said mathematical model is selected from the group consisting of a first order process, combined first order and zero order process, a parallel multiple first order process, a flux process, and an nth order process, and (b) an error minimization method to iteratively estimate values of the parameters using said model to fit a predicted response curve to said measured signal response curve, wherein (a′
) the error minimization method provides a calculated error based on differences between said predicted and measured signal response curves, and (b′
) said estimating is iteratively performed until the calculated error between the predicted and measured signal response curves falls within an acceptable range or until no further statistically significant change is seen in the calculated error, at which time iterative estimation of the parameters is stopped, said iterative estimation and error minimization results in a predicted response curve corresponding to said measured signal response curve, said predicted response curve yields a predicted end-point value and a measurement correlated to the amount or concentration of the glucose, and (iii) converting each measurement correlated to the amount or concentration of the glucose in the series to a measurement value indicative of the amount or concentration of glucose present in the subject. - View Dependent Claims (54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66)
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Specification