Methods for estimating analyte-related signals, microprocessors comprising programming to control performance of the methods, and analyte monitoring devices employing the methods
First Claim
1. A method of increasing the number of analyte measurement values related to the amount or concentration of an analyte in a subject as measured using an analyte monitoring device, said method comprising providing a series of analyte-related signals obtained from the analyte monitoring device over time, wherein (i) two or more contiguous analyte-related signals are used to obtain a single analyte measurement value (M), (ii) analyte-related signals are not used to calculate more than one analyte measurement value, and (iii) said two or more contiguous analyte-related signals, used to obtain the single analyte measurement value, comprise first and last analyte-related signals of the series;
- mathematically computing rolling analyte measurement values, wherein (i) each rolling analyte measurement value is calculated based on two or more contiguous analyte-related signals from the series of analyte-related signals obtained from the analyte monitoring device, (ii) a subsequent rolling analyte measurement value is mathematically computed by dropping said first analyte-related signal and including an analyte-related signal contiguous and subsequent to the last analyte-related signal, (iii) further rolling analyte measurement values are obtained by repeating the dropping of the first analyte-related signal used to calculate the previous rolling analyte measurement and including an analyte-related signal contiguous and subsequent to the last analyte-related signal used to calculate the previous rolling analyte measurement, and (iv) each rolling analyte measurement value provides a measurement related to the amount or concentration of analyte in the subject; and
increasing the number of analyte measurement values derived from the analyte-related signals in the series of analyte-related signals obtained from the analyte monitoring device by serially calculating rolling analyte measurement values, thereby increasing the number of analyte measurement values.
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Abstract
The present invention relates to methods to increase the number of analyte-related signals used to provide analyte measurement values, e.g., when two or more analyte-related signals are used to obtain a single analyte measurement value a “rolling” value based on the two or more signals can be employed. In another aspect, interpolation and/or extrapolation methods are used to estimate unusable, missing or error-associated analyte-related signals. Further, interpolation and extrapolation of values are employed in another aspect of the invention that reduces the incident of failed calibrations. Further, the invention relates to methods, which employ gradients and/or predictive algorithms, to provide an alert related to analyte values exceeding predetermined thresholds. The invention includes the above-described methods, one or more microprocessors programmed to execute the methods, one or more microprocessors programmed to execute the methods and control at least one sensing and/or sampling device, and monitoring systems employing the methods described herein.
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Citations
90 Claims
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1. A method of increasing the number of analyte measurement values related to the amount or concentration of an analyte in a subject as measured using an analyte monitoring device, said method comprising
providing a series of analyte-related signals obtained from the analyte monitoring device over time, wherein (i) two or more contiguous analyte-related signals are used to obtain a single analyte measurement value (M), (ii) analyte-related signals are not used to calculate more than one analyte measurement value, and (iii) said two or more contiguous analyte-related signals, used to obtain the single analyte measurement value, comprise first and last analyte-related signals of the series; -
mathematically computing rolling analyte measurement values, wherein (i) each rolling analyte measurement value is calculated based on two or more contiguous analyte-related signals from the series of analyte-related signals obtained from the analyte monitoring device, (ii) a subsequent rolling analyte measurement value is mathematically computed by dropping said first analyte-related signal and including an analyte-related signal contiguous and subsequent to the last analyte-related signal, (iii) further rolling analyte measurement values are obtained by repeating the dropping of the first analyte-related signal used to calculate the previous rolling analyte measurement and including an analyte-related signal contiguous and subsequent to the last analyte-related signal used to calculate the previous rolling analyte measurement, and (iv) each rolling analyte measurement value provides a measurement related to the amount or concentration of analyte in the subject; and
increasing the number of analyte measurement values derived from the analyte-related signals in the series of analyte-related signals obtained from the analyte monitoring device by serially calculating rolling analyte measurement values, thereby increasing the number of analyte measurement values. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. One or more microprocessors programmed to control:
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mathematical computations of rolling analyte measurement values, wherein (i) each rolling analyte measurement value is calculated based on two or more contiguous analyte-related signals from a series of analyte-related signals obtained from an analyte monitoring device, (ii) said series of analyte-related signals is obtained from the analyte monitoring device over time, wherein (a) two or more contiguous analyte-related signals are used to obtain a single analyte measurement value (M), (b) analyte-related signals are not used to calculate more than one analyte measurement value, and (c) said two or more contiguous analyte-related signals, used to obtain the single analyte measurement value, comprise first and last analyte-related signals of the series, (iii) a subsequent rolling analyte measurement value is mathematically computed by dropping said first analyte-related signal and including an analyte-related signal contiguous and subsequent to the last analyte-related signal, (iv) further rolling analyte measurement values are obtained by repeating the dropping of the first analyte-related signal used to calculate the previous rolling analyte measurement and including an analyte-related signal contiguous and subsequent to the last analyte-related signal used to calculate the previous rolling analyte measurement, and (v) each rolling analyte measurement value provides a measurement related to the amount or concentration of analyte in the subject; and
increases of the number of analyte measurement values derived from the analyte-related signals in the series of analyte-related signals obtained from the analyte monitoring device by serially calculating rolling analyte measurement values. - View Dependent Claims (18, 19)
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20. An analyte monitoring device comprising:
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a sensing device; and
one or more microprocessor programmed to control operation of said sensing device and said one or more microprocessor programmed to control mathematical computations of rolling analyte measurement values, wherein (i) each rolling analyte measurement value is calculated based on two or more contiguous analyte-related signals from a series of analyte-related signals obtained from an analyte monitoring device, (ii) said series of analyte-related signals is obtained from the analyte monitoring device over time, wherein (a) two or more contiguous analyte-related signals are used to obtain a single analyte measurement value (M), (b) analyte-related signals are not used to calculate more than one analyte measurement value, and (c) said two or more contiguous analyte-related signals, used to obtain the single analyte measurement value, comprise first and last analyte-related signals of the series, (iii) a subsequent rolling analyte measurement value is mathematically computed by dropping said first analyte-related signal and including an analyte-related signal contiguous and subsequent to the last analyte-related signal, (iv) further rolling analyte measurement values are obtained by repeating the dropping of the first analyte-related signal used to calculate the previous rolling analyte measurement and including an analyte-related signal contiguous and subsequent to the last analyte-related signal used to calculate the previous rolling analyte measurement, and (v) each rolling analyte measurement value provides a measurement related to the amount or concentration of analyte in the subject; and
increase of the number of analyte measurement values derived from the analyte-related signals in the series of analyte-related signals obtained from the analyte monitoring device by serially calculating rolling analyte measurement values. - View Dependent Claims (21)
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22. A method of replacing unusable analyte-related signals when employing an analyte monitoring device to measure an analyte amount or concentration in a subject, said method comprising
providing a series of analyte-related signals obtained from the analyte monitoring device over time, wherein each analyte-related signal is related to the amount or concentration of analyte in the subject; - and
replacing an unusable analyte-related signal with an estimated signal by either;
(A) if one or more analyte-related signals previous to the unusable analyte-related signal and one or more analyte-related signals subsequent to the unusable analyte related signal are available, then interpolation is used to estimate the unusable, intervening analyte-related signal;
or(B) if two or more analyte-related signals previous to the unusable analyte-related signal are available, then extrapolation is used to estimate the unusable, subsequent analyte-related signal. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40)
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41. One or more microprocessors programmed to control:
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replacement, in a series of analyte-related signals, of an unusable analyte-related signal with an estimated signal by either;
(A) if one or more analyte-related signals previous to the unusable analyte-related signal and one or more analyte-related signals subsequent to the unusable analyte related signal are available, then interpolation is used to estimate the unusable, intervening analyte-related signal;
or(B) if two or more analyte-related signals previous to the unusable analyte-related signal are available, then extrapolation is used to estimate the unusable, subsequent analyte-related signal;
wherein said series of analyte-related signals is obtained from an analyte monitoring device over time, and each analyte-related signal is related to an amount or concentration of analyte in a subject being monitored with the analyte monitoring device. - View Dependent Claims (42, 43)
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44. An analyte monitoring device comprising:
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a sensing device; and
one or more microprocessor programmed to control operation of said sensing device and said one or more microprocessor programmed to control replacement, in a series of analyte-related signals, of an unusable analyte-related signal with an estimated signal by either;
(A) if one or more analyte-related signals previous to the unusable analyte-related signal and one or more analyte-related signals subsequent to the unusable analyte related signal are available, then interpolation is used to estimate the unusable, intervening analyte-related signal;
or(B) if two or more analyte-related signals previous to the unusable analyte-related signal are available, then extrapolation is used to estimate the unusable, subsequent analyte-related signal;
wherein said series of analyte-related signals is obtained from an analyte monitoring device over time, and each analyte-related signal is related to an amount or concentration of analyte in a subject being monitored with the analyte monitoring device. - View Dependent Claims (45)
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46. A method for reducing the incidence of failed calibration for an analyte monitoring system that is used to monitor an amount or concentration of analyte present in a subject, wherein the analyte monitoring system provides a series of signals or measurement values, said method comprising:
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sensing the analyte in each of a series of samples to obtain an analyte-related signal from each sample that is related to the analyte amount or concentration in the subject, thus providing a series of analyte-related signals, said sensing device comprising a first sensor (A) and second sensor (B), wherein (1) said first sensor (A) is in operative contact with a first collection reservoir and said second sensor (B) is in operative contact with a second collection reservoir, and (2) two consecutive analyte-related signals comprise a measurement cycle, and each of the two consecutive analyte-related signals is half-cycle analyte-related signal; and
performing a calibration method to relate analyte amount or concentration in the subject to analyte-related signals obtained from the sensors, said calibration method comprising;
(i) obtaining a first half-cycle analyte-related signal Sj, wherein a second half-cycle analyte-related signal Sj+1, or an estimate thereof, and a third half-cycle analyte-related signal Sj+2, or an estimate thereof, are both used in the calibration method so that the sensor analyte-related signals correlate to the analyte amount or concentration in the subject, wherein the calibration method also employs an analyte calibration value that is independently determined;
(ii) providing the analyte calibration value;
(iii) selecting a conditional statement selected from the group consisting of;
(a) if neither the second half-cycle signal Sj+1 nor the third half-cycle signal Sj+2 comprise errors, then Sj+1 and Sj+2 are used in the calibration method;
(b) if only the second half-cycle signal Sj+1 comprises an error, then an estimated signal SEj+1 is obtained by determining an interpolated value using signal Sj and Sj+2, wherein said interpolated value is SEj+1, and SEj+1 and Sj+2, are used in the calibration method;
(c) if only the third half-cycle signal Sj+2 comprises an error, then an estimated signal SEj+2 is obtained by determining an extrapolated value using signal Sj and Sj+1, wherein said extrapolated value is SEj+2, and Sj+1 and SEj+2 are used in the calibration method; and
(d) if both the second half-cycle signal Sj+1 and the third half-cycle signal Sj+2 comprise errors, then return to (i) to obtain a new half-cycle signal Sj from a later measurement half-cycle than the first half-cycle signal, wherein said calibration method reduces the incidence of failed calibration for the analyte monitoring system. - View Dependent Claims (47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62)
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63. One or more microprocessors programmed to control:
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operation of a sensing device for sensing an analyte in each of a series of samples to obtain an analyte-related signal from each sample that is related to analyte amount or concentration in a subject, thus providing a series of analyte-related signals, said sensing device comprising a first sensor (A) and second sensor (B), wherein (1) said first sensor (A) is in operative contact with a first collection reservoir and said second sensor (B) is in operative contact with a second collection reservoir, and (2) two consecutive analyte-related signals comprise a measurement cycle, and each of the two consecutive analyte-related signals is half-cycle analyte-related signal; and
performance of a calibration method to relate analyte amount or concentration in the subject to analyte-related signals obtained from the sensors, said calibration method comprising;
(i) obtaining a first half-cycle analyte-related signal Sj, wherein a second half-cycle analyte-related signal Sj+1, or an estimate thereof, and a third half-cycle analyte-related signal Sj+2, or an estimate thereof, are both used in the calibration method so that the sensor analyte-related signals correlate to the analyte amount or concentration in the subject, wherein the calibration method also employs an analyte calibration value that is independently determined;
(ii) providing the analyte calibration value;
(iii) selecting a conditional statement selected from the group consisting of;
(a) if neither the second half-cycle signal Sj+1 nor the third half-cycle signal Sj+2 comprise errors, then Sj+1 and Sj+2 are used in the calibration method;
(b) if only the second half-cycle signal Sj+1 comprises an error, then an estimated signal SEj+1 is obtained by determining an interpolated value using signal Sj and Sj+2 wherein said interpolated value is SE+1, and SEj+1, and Sj+2 are used in the calibration method;
(c) if only the third half-cycle signal Sj+2 comprises an error, then an estimated signal SEj+2 is obtained by determining an extrapolated value using signal Sj and Sj+1, wherein said extrapolated value is SEj+2, and Sj+1 and SEj+2 are used in the calibration method; and
(d) if both the second half-cycle signal Sj+1 and the third half-cycle signal Sj+2 comprise errors, then return to (i) to obtain a new half-cycle signal Sj from a later measurement half-cycle than the first half-cycle signal. - View Dependent Claims (64, 65)
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66. An analyte monitoring device comprising:
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a sensing device; and
one or more microprocessor programmed to control operation of said sensing device and said one or more microprocessor programmed to control performance of a calibration method to relate analyte amount or concentration in the subject to analyte-related signals obtained from the sensors, said calibration method comprising;
(i) obtaining a first half-cycle analyte-related signal Sj, wherein a second half-cycle analyte-related signal. Sj+1, or an estimate thereof, and a third half-cycle analyte-related signal Sj+2 or an estimate thereof, are both used in the calibration method so that the sensor analyte-related signals correlate to the analyte amount or concentration in the subject, wherein the calibration method also employs an analyte calibration value that is independently determined;
(ii) providing the analyte calibration value;
(iii) selecting a conditional statement selected from the group consisting of;
(a) if neither the second half-cycle signal Sj+1 nor the third half-cycle signal Sj+2 comprise errors, then Sj+1 and Sj+2 are used in the calibration method;
(b) if only the second half-cycle signal Sj+1 comprises an error, then an estimated signal SE+1 is obtained by determining an interpolated value using signal Sj and Sj+2 wherein said interpolated value is SEj+1, and SEj+1 and Sj+2 are used in the calibration method;
(c) if only the third half-cycle signal Sj+2 comprises an error, then an estimated signal SEj+2 is obtained by determining an extrapolated value using signal Sj and Sj+1, wherein said extrapolated value is SEj+2, and Sj+1 and SEj+2 are used in the calibration method; and
(d) if both the second half-cycle signal Sj+1 and the third half-cycle signal Sj+2 comprise errors, then return to (i) to obtain a new half-cycle signal Sj from a later measurement half-cycle than the first half-cycle signal. - View Dependent Claims (67)
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68. A method for predicting an analyte concentration-related event in a subject being monitored for levels of a selected analyte using an analyte monitoring device, said method comprising
providing (A) a series of analyte-related signals obtained from the analyte monitoring device over time, wherein each analyte-related signal is related to the amount or concentration of analyte in the subject, (B) a predetermined threshold value indicative of an analyte concentration-related event in the subject, and (C) a predetermined threshold rate of change of analyte concentration indicative of an analyte concentration-related event in the subject; -
calculating (A) a predicted analyte-related signal at a future time interval, which occurs after the series of analyte-related signals is obtained, using one or more predictive algorithms, and (B) a rate of change of analyte concentration in the subject;
comparing (A) the predicted analyte-related signal to the threshold value, then (i) if the predicted value is within the threshold value, then the analyte monitoring device continues to provide a series of analyte-related signals and repeats said calculating and comparing of a predicted analyte-related signal based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal, or (ii) if the predicted value is beyond the threshold value, then an analyte concentration-related event is indicated, and the analyte monitoring device continues to provide a series of analyte-related signals and repeats said calculating and comparing of a predicted analyte-related signal based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal;
(B) the rate of change of analyte concentration in the subject to the predetermined threshold rate of change, then (i) if the rate of change is beyond the predetermined threshold rate of change then an analyte concentration-related event is indicated and the analyte monitoring system continues to provide a series of analyte-related signals and repeats said calculating of a rate of change based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal, or (ii) if the rate of change is within the predetermined threshold rate of change, then the analyte monitoring system continues to provide a series of analyte-related signals and repeats said calculating of a rate of change based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal; and
predicting an analyte concentration-related event in a subject if both the predicted value indicates an analyte concentration-related event and the rate of change indicates an analyte concentration-related event. - View Dependent Claims (69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85)
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86. One or more microprocessors programmed to control:
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provision of (A) a series of analyte-related signals obtained from the analyte monitoring device over time, wherein each analyte-related signal is related to the amount or concentration of analyte in the subject, (B) a predetermined threshold value indicative of an analyte concentration-related event in the subject, and (C) a predetermined threshold rate of change of analyte concentration indicative of an analyte concentration-related event in the subject;
calculation of (A) a predicted analyte-related signal at a future time interval, which occurs after the series of analyte-related signals is obtained, using one or more predictive algorithms, wherein and (B) a rate of change of analyte concentration in a subject;
comparison of (A) the predicted analyte-related signal to the threshold value, then (i) if the predicted value is within the threshold value, then the analyte monitoring device continues to provide a series of analyte-related signals and repeats said calculating and comparing of a predicted analyte-related signal based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal, or (ii) if the predicted value is beyond the threshold value, then an analyte concentration-related event is indicated, and the analyte monitoring device continues to provide a series of analyte-related signals and repeats said calculating and comparing of a predicted analyte-related signal based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal;
(B) the rate of change of analyte concentration in the subject to the predetermined threshold rate of change, then (i) if the rate of change is beyond the predetermined threshold rate of change then an analyte concentration-related event is indicated and the analyte monitoring system continues to provide a series of analyte-related signals and repeats said calculating of a rate of change based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal, or (ii) if the rate of change is within the predetermined threshold rate of change, then the analyte monitoring system continues to provide a series of analyte-related signals and repeats said calculating of a rate of change based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal; and
prediction of an analyte concentration-related event in a subject if both the predicted value indicates an analyte concentration-related event and the rate of change indicates an analyte concentration-related event. - View Dependent Claims (87, 88)
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89. An analyte monitoring device comprising:
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a sensing device; and
one or more microprocessor programmed to control operation of said sensing device and said one or more microprocessor programmed to control provision of (A) a series of analyte-related signals obtained from the analyte monitoring device over time, wherein each analyte-related signal is related to the amount or concentration of analyte in the subject, (B) a predetermined threshold value indicative of an analyte concentration-related event in the subject, and (C) a predetermined threshold rate of change of analyte concentration indicative of an analyte concentration-related event in the subject;
calculation of (A) a predicted analyte-related signal at a future time interval, which occurs after the series of analyte-related signals is obtained, using one or more predictive algorithms, wherein and (B) a rate of change of analyte concentration in a subject;
comparison of (A) the predicted analyte-related signal to the threshold value, then (i) if the predicted value is within the threshold value, then the analyte monitoring device continues to provide a series of analyte-related signals and repeats said calculating and comparing of a predicted analyte-related signal based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal, or (ii) if the predicted value is beyond the threshold value, then an analyte concentration-related event is indicated, and the analyte monitoring device continues to provide a series of analyte-related signals and repeats said calculating and comparing of a predicted analyte-related signal based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal;
(B) the rate of change of analyte concentration in the subject to the predetermined threshold rate of change, then (i) if the rate of change is beyond the predetermined threshold rate of change then an analyte concentration-related event is indicated and the analyte monitoring system continues to provide a series of analyte-related signals and repeats said calculating of a rate of change based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal, or (ii) if the rate of change is within the predetermined threshold rate of change, then the analyte monitoring system continues to provide a series of analyte-related signals and repeats said calculating of a rate of change based on the series of analyte-related signals comprising new analyte-related signal obtained subsequent to the previous predicted analyte-related signal; and
prediction of an analyte concentration-related event in a subject if both the predicted value indicates an analyte concentration-related event and the rate of change indicates an analyte concentration-related event. - View Dependent Claims (90)
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Specification