System and methods for processing analyte sensor data
First Claim
1. A method for calibrating a substantially continuous analyte sensor, the method comprising:
- receiving a data stream from an analyte sensor, including one or more sensor data points;
receiving reference data from a reference analyte monitor, comprising one or more reference data points;
providing at least one matched data pair by matching reference analyte data to substantially time corresponding sensor data;
creating a conversion function based on said at least one matched data pair;
evaluating said at least one matched data pair, including at least one of
1) ensuring said at least one matched data pair is within a predetermined time range,
2) ensuring said at least one matched data pair is no older than a predetermined value,
3) ensuring said at least one matched data pair is substantially distributed with additional matched data pairs, if present, between high and low matched data pairs over a predetermined time range, and
4) ensuring said at least one matched data pair is within a predetermined range of analyte values, wherein the step of evaluating said at least one matched data pair further comprises at least one of evaluating a rate of change of the analyte concentration, evaluating a congruence of respective sensor and reference data in a matched data pair, and evaluating physiological changes; and
subsequently modifying said conversion function if such modification is required by said evaluation.
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Reexamination
Accused Products
Abstract
Systems and methods for processing sensor analyte data, including initiating calibration, updating calibration, evaluating clinical acceptability of reference and sensor analyte data, and evaluating the quality of sensor calibration. During initial calibration, the analyte sensor data is evaluated over a period of time to determine stability of the sensor. The sensor may be calibrated using a calibration set of one or more matched sensor and reference analyte data pairs. The calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and analyte data and quality of sensor calibration. Algorithms provide for optimized prospective and retrospective analysis of estimated blood analyte data from an analyte sensor.
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Citations
75 Claims
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1. A method for calibrating a substantially continuous analyte sensor, the method comprising:
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receiving a data stream from an analyte sensor, including one or more sensor data points; receiving reference data from a reference analyte monitor, comprising one or more reference data points; providing at least one matched data pair by matching reference analyte data to substantially time corresponding sensor data; creating a conversion function based on said at least one matched data pair; evaluating said at least one matched data pair, including at least one of
1) ensuring said at least one matched data pair is within a predetermined time range,
2) ensuring said at least one matched data pair is no older than a predetermined value,
3) ensuring said at least one matched data pair is substantially distributed with additional matched data pairs, if present, between high and low matched data pairs over a predetermined time range, and
4) ensuring said at least one matched data pair is within a predetermined range of analyte values, wherein the step of evaluating said at least one matched data pair further comprises at least one of evaluating a rate of change of the analyte concentration, evaluating a congruence of respective sensor and reference data in a matched data pair, and evaluating physiological changes; andsubsequently modifying said conversion function if such modification is required by said evaluation. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 18, 19)
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16. A method for calibrating a substantially continuous analyte sensor, the method comprising:
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receiving a data stream from an analyte sensor, including one or more sensor data points; receiving reference data from a reference analyte monitor, comprising one or more reference data points; providing at least one matched data pair by matching reference analyte data to substantially time corresponding sensor data; forming a calibration set including said at least one matching data pair; creating a conversion function based on said calibration set; converting sensor data into calibrated data using said conversion function; subsequently obtaining one or more additional reference data points and creating one or more new matched data pair; evaluating said calibration set when said new matched data pair is created, wherein evaluating said calibration set includes at least one of
1) ensuring matched data pair in said calibration set span a predetermined time range,
2) ensuring matched data pair in said calibration set are no older than a predetermined value,
3) ensuring said calibration set has substantially distributed high and low matched data pair over said predetermined time range, and
4) allowing matched data pair only within a predetermined range of analyte values; andsubsequently modifying said calibration set if such modification is required by said evaluation, wherein the step of forming a calibration set further comprises determining a value for n, where n is greater than one and represents the number of matched data pair in the calibration set, wherein the step of determining a value for n is determined as a function of the frequency of the received reference data points and signal strength over time.
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20. A system for calibrating a substantially continuous analyte sensor, the system comprising:
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means for receiving a data stream from an analyte sensor, a plurality of time-spaced sensor data points; means for receiving reference data from a reference analyte monitor, comprising one or more reference data points; means for providing one or more matched data pairs by matching reference analyte data to substantially time corresponding sensor data; means for creating a conversion function based on said one or more matched data pairs; means for evaluating said one or more matched data pairs including at least one of
1) ensuring one or more matched data pairs is within a predetermined time range,
2) ensuring one or more matched data pairs are no older than a predetermined value,
3) ensuring said one or more matched data pairs have substantially distributed high and low matched data pairs over a predetermined time range, and
4) ensuring said one or more matched data pairs are within a predetermined range of analyte values, wherein said means for evaluating said one or more matched data pairs further comprises at least one means for evaluating a rate of change of the analyte concentration, means for evaluating a congruence of respective sensor and reference data in matched data pairs, and means for evaluating physiological changes; andmeans for modifying said conversion function if such modification is required by said means for evaluating. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 36, 37, 38)
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35. A system for calibrating a substantially continuous analyte sensor, the system comprising:
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means for receiving a data stream from an analyte sensor, a plurality of time-spaced sensor data points; means for receiving reference data from a reference analyte monitor, comprising one or more reference data points; means for providing one or more matched data pair by matching reference analyte data to substantially time corresponding sensor data; means for forming a calibration set comprising at least one matched data pair; means for creating a conversion function based on said calibration set; means for converting sensor data into calibrated data using said conversion function; subsequently obtaining one or more additional reference data points and creating one or more new matched data pair; means for evaluating said calibration set when said new matched data pair is created, wherein evaluating said calibration set includes at least one of
1) ensuring matched data pair in said calibration set span a predetermined time range,
2) ensuring matched data pair in said calibration set are no older than a predetermined value,
3) ensuring said calibration set has substantially distributed high and low matched data pair over said predetermined time range, and
4) allowing matched data pair only within a predetermined range of analyte values; andmeans for modifying said calibration set if such modification is required by said evaluation wherein the means for forming a calibration set further comprises determining a value for n, where n is greater than one and represents the number of matched data pair in the calibration set, and wherein the means for determining a value for n is determined as a function of the frequency of the received reference data points and signal strength over time.
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39. A computer system for calibrating a substantially continuous analyte sensor, the computer system comprising:
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a sensor data receiving module that receives a data stream comprising a plurality of time spaced sensor data points from a substantially continuous analyte sensor; a reference data receiving module that receives reference data from a reference analyte monitor, including two or more reference data points; a data matching module that forms one or more matched data pair by matching reference data to substantially time corresponding sensor data; a conversion function module that creates a conversion function using said one or more matched data pairs; a calibration evaluation module that evaluates one or more matched data pair, wherein evaluating said one or more matched data pairs includes at least one of
1) ensuring said one or more matched data pairs is within a predetermined time period,
2) ensuring said one or more matched data pairs is no older than a predetermined value,
3) ensuring said one or more matched data pairs have substantially distributed high and low matched data pairs over a predetermined time range, and
4) ensuring said one or more matched data pairs is within a predetermined range of analyte values, wherein said evaluation calibration module further evaluates at least one of a rate of change of the analyte concentration, a congruence of respective sensor and reference data in matched data pairs, and physiological changes, andwherein said conversion function module is programmed to re-create said conversion function if such modification is required by said calibration evaluation module. - View Dependent Claims (40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 55, 56, 57)
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54. A computer system for calibrating a substantially continuous analyte sensor, the computer system comprising:
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a sensor data receiving module that receives a data stream comprising a plurality of time spaced sensor data points from a substantially continuous analyte sensor; a reference data receiving module that receives reference data from a reference analyte monitor, including two or more reference data points; a data matching module that forms one or more matched data pair by matching reference data to substantially time corresponding sensor data; a calibration set module that forms a calibration set comprising at least one matched data pair; a conversion function module that creates a conversion function using said calibration set; a sensor data transformation module that converts sensor data into calibrated data using said conversion function; and a calibration evaluation module that evaluates said calibration set when said new matched data pair is provided, wherein evaluating said calibration set includes at least one of
1) ensuring matched data pair in said calibration set span a predetermined time period,
2) ensuring matched data pair in said calibration set are no older than a predetermined value,
3) ensuring said calibration set has substantially distributed high and low matched data pair over a predetermined time range, and
4) allowing matched data pair only within a predetermined range of analyte values,wherein said conversion function module is programmed to re-create said conversion function of such modification is required by said calibration evaluation module, wherein said programming for determining a value for n determines n as a function of the frequency of the received reference data points and signal strength over time, and wherein the calibration set module further comprises programming for determining a value for n, wherein n is greater than one and represents the number of matched data pairs in the calibration set.
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58. A method for calibrating a glucose sensor, the method comprising:
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receiving a data stream from an analyte sensor, including one or more sensor data points; receiving reference data from a reference analyte monitor, including one or more reference data points; providing at least one matched data pair by matching reference analyte data to substantially time corresponding sensor data; creating a conversion function based on at least one matched data pair; and evaluating at least one of said matched data pairs, wherein evaluating comprises at least one of evaluating a rate of change of the analyte concentration, evaluating a congruence of respective sensor and reference data in a matched data pair, and evaluating physiological changes. - View Dependent Claims (60, 61, 62, 63, 64, 65, 66, 67)
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59. A computer system for calibrating a glucose sensor, the computer system comprising:
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a sensor data module that receives a data stream comprising a plurality of time spaced sensor data points from a substantially continuous analyte sensor; a reference input module that receives reference data from a reference analyte monitor, the reference data comprising one or more reference data points; a processor module that forms one or more matched data pairs by matching reference data to substantially time corresponding sensor data and subsequently forms a calibration set comprising said one or more matched data pairs; and a calibration evaluation module that evaluates one or more matched data pairs, wherein said evaluation calibration module evaluates at least one of a rate of change of the analyte concentration, a congruence of respective sensor and reference data in matched data pairs, and physiological changes. - View Dependent Claims (68, 69, 70, 71, 72, 73, 74, 75)
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Specification