System and methods for processing analyte sensor data
First Claim
1. A method for evaluating the quality of a calibration of an 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;
receiving additional sensor data from the analyte sensor;
converting sensor data into calibrated data using said conversion function; and
evaluating the quality of said calibration set using a data association function.
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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.
1228 Citations
62 Claims
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1. A method for evaluating the quality of a calibration of an 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;
receiving additional sensor data from the analyte sensor;
converting sensor data into calibrated data using said conversion function; and
evaluating the quality of said calibration set using a data association function. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A system for evaluating the quality of a calibration of an 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;
means for evaluating the quality of said calibration set based on a data association function. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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39. A computer system for evaluating the quality of a calibration of an 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 quality evaluation module that evaluates the quality of said calibration set based on a data association function. - View Dependent Claims (40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57)
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58. A method for evaluating the quality of a calibration of an 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;
receiving additional sensor data from the analyte sensor;
converting sensor data into calibrated data using said conversion function; and
evaluating the quality of said calibration set based on a data association function selected from the group consisting of linear regression, non-linear regression, rank correlation, least mean square fit, mean absolute deviation, and mean absolute relative difference.
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59. A method for evaluating the quality of a calibration of an 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;
receiving additional sensor data from the analyte sensor;
converting sensor data into calibrated data using said conversion function;
evaluating the quality of said calibration set using a data association function; and
providing an output to a user interface responsive to the quality of said calibration set.
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60. A computer system for evaluating the quality of a calibration of an analyte 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 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;
a quality evaluation module that evaluates the quality of said calibration set based on a data association selected from the group consisting of linear regression, non-linear regression, rank correlation, least mean square fit, mean absolute deviation, and mean absolute relative difference.
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61. A computer system for evaluating the quality of a calibration of an analyte 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 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;
a quality evaluation module that evaluates the quality of said calibration set based on data association; and
a fail-safe module that controls the user interface based on the quality of said calibration set.
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62. A method for evaluating the quality of a calibration of a glucose sensor, the method comprising:
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receiving sensor data from a glucose sensor, including one or more sensor data points;
receiving reference data from a reference glucose monitor, including one or more reference data points;
providing one or more matched data pairs by matched reference glucose data to substantially time corresponding sensor data;
forming a calibration set including at least one matched data pair; and
evaluating the quality of said calibration set based on data association.
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Specification