System and methods for processing analyte sensor data
First Claim
1. A method for maintaining calibration of 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, including two or more reference data points;
providing at least two matched data pairs by matching reference analyte data to substantially time corresponding sensor data;
forming a calibration set including said at least two matching data pairs;
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 pairs;
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 pairs in said calibration set span a predetermined time range,
2) ensuring matched data pairs in said calibration set are no older than a predetermined value,
3) ensuring said calibration set has substantially distributed high and low matched data pairs over said predetermined time range, and
4) allowing matched data pairs only within a predetermined range of analyte values; and
subsequently modifying said calibration set if such modification is required by said evaluation.
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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.
1172 Citations
65 Claims
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1. A method for maintaining calibration of 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, including two or more reference data points;
providing at least two matched data pairs by matching reference analyte data to substantially time corresponding sensor data;
forming a calibration set including said at least two matching data pairs;
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 pairs;
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 pairs in said calibration set span a predetermined time range,
2) ensuring matched data pairs in said calibration set are no older than a predetermined value,
3) ensuring said calibration set has substantially distributed high and low matched data pairs over said predetermined time range, and
4) allowing matched data pairs only within a predetermined range of analyte values; and
subsequently modifying said calibration set 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, 16, 17, 18, 19, 20, 21)
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22. A system for maintaining calibration of 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, including two or more reference data points;
means for providing two or more matched data pairs by matching reference analyte data to substantially time corresponding sensor data;
means for forming a calibration set including at least two 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 pairs;
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 pairs in said calibration set span a predetermined time range,
2) ensuring matched data pairs in said calibration set are no older than a predetermined value,
3) ensuring said calibration set has substantially distributed high and low matched data pairs over said predetermined time range, and
4) allowing matched data pairs only within a predetermined range of analyte values; and
means for modifying said calibration set if such modification is required by said evaluation. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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43. A computer system for maintaining calibration of 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 two or more matched data pairs by matching reference data to substantially time corresponding sensor data;
a calibration set module that forms a calibration set including at least two matched data pairs;
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 pairs in said calibration set span a predetermined time period,
2) ensuring matched data pairs in said calibration set are no older than a predetermined value,
3) ensuring said calibration set has substantially distributed high and low matched data pairs over a predetermined time range, and
4) allowing matched data pairs 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. - View Dependent Claims (44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63)
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64. A method for maintaining calibration of 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 two or more reference data points;
providing at least two matched data pairs by matching reference analyte data to substantially time corresponding sensor data;
forming a calibration set including said at least two matching data pairs;
creating a conversion function based on said calibration set;
subsequently obtaining one or more additional reference data points and creating one or more new matched data pairs; and
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 pairs in said calibration set span a predetermined time range,
2) ensuring matched data pairs in said calibration set are no older than a predetermined value,
3) ensuring said calibration set has substantially distributed high and low matched data pairs over said predetermined time range, and
4) allowing matched data pairs only within a predetermined range of analyte values.
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65. A computer system for maintaining calibration of 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, including two or more reference data points;
a processor module that forms two or more matched data pairs by matching reference data to substantially time corresponding sensor data and subsequently forms a calibration set including said two or more matched data pairs; 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 pairs in said calibration set span a predetermined time period,
2) ensuring matched data pairs in said calibration set are no older than a predetermined value,
3) ensuring said calibration set has substantially distributed high and low matched data pairs over a predetermined time range, and
4) allowing matched data pairs 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.
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Specification