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 evaluating a congruence of respective sensor and reference data in a matched data pair; and
subsequently modifying said conversion function if such modification is required by said evaluation.
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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.
1182 Citations
69 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 evaluating a congruence of respective sensor and reference data in a matched data pair; 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)
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16. 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 means for evaluating a congruence of respective sensor and reference data in matched data pairs;and means for modifying said conversion function if such modification is required by said means for evaluating. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. 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 a congruence of respective sensor and reference data in matched data pairs, and wherein 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 (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
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46. 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 evaluating a congruence of respective sensor and reference data in a matched data pair. - View Dependent Claims (47, 48, 49, 50, 51, 52, 53, 54)
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55. 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 a congruence of respective sensor and reference data in matched data pairs. - View Dependent Claims (56, 57, 58, 59, 60, 61, 62, 63)
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64. A method for processing continuous glucose sensor data, the method comprising:
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receiving a data stream from a continuous glucose sensor, the data stream comprising at least one sensor data point; receiving reference data from a reference glucose monitor, the reference data comprising at least one reference data point; and evaluating a congruence of at least one sensor data point with at least one reference data point. - View Dependent Claims (65, 66, 67, 68, 69)
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Specification