System and methods for processing analyte sensor data
First Claim
1. A method for evaluating a quality of a calibration of an analyte sensor, the method comprising:
- receiving sensor data from an analyte sensor during a time period of continuous analyte sensing of a host, including one or more sensor data points;
receiving reference data during the time period of continuous analyte sensing of the host, including one or more reference data points;
providing one or more matched data pairs by matching a reference data point to a substantially time corresponding sensor data point;
forming a calibration set including a plurality of matched data pairs;
evaluating a quality of the calibration set, during the time period of continuous analyte sensing of the host, based on a statistical association of the calibration set and a clinical association of the one or more matched data pairs, wherein the statistical association comprises a statistical analysis of the plurality of matched data pairs'"'"' correlation to or deviation from a curve;
modifying the calibration set in response to the statistical association not meeting a criterion or the clinical association not meeting a criterion; and
processing the sensor data in response to the statistical association meeting a criterion and the clinical association meeting a criterion.
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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.
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Citations
34 Claims
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1. A method for evaluating a quality of a calibration of an analyte sensor, the method comprising:
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receiving sensor data from an analyte sensor during a time period of continuous analyte sensing of a host, including one or more sensor data points; receiving reference data during the time period of continuous analyte sensing of the host, including one or more reference data points; providing one or more matched data pairs by matching a reference data point to a substantially time corresponding sensor data point; forming a calibration set including a plurality of matched data pairs; evaluating a quality of the calibration set, during the time period of continuous analyte sensing of the host, based on a statistical association of the calibration set and a clinical association of the one or more matched data pairs, wherein the statistical association comprises a statistical analysis of the plurality of matched data pairs'"'"' correlation to or deviation from a curve; modifying the calibration set in response to the statistical association not meeting a criterion or the clinical association not meeting a criterion; and processing the sensor data in response to the statistical association meeting a criterion and the clinical association meeting a criterion. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A computer system for evaluating a quality of a calibration of an analyte sensor, the system comprising:
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a sensor data receiving module configured to receive, during a time period of continuous analyte sensing of a host, a data stream comprising one or more sensor data points; a reference data receiving module configured to receive, during the time period of continuous analyte sensing of the host, reference data, including one or more reference data points; a data matching module configured to form one or more matched data pairs by matching one or more reference data points to one or more substantially time corresponding sensor data points; a calibration set module configured to form a calibration set including a plurality of matched data pairs; an evaluation module configured to evaluate, during the time period of continuous analyte sensing of the host, a quality of the calibration set based on a statistical association of the calibration set and a clinical association of the one or more matched data pairs, wherein the calibration set is modified in response to the statistical association not meeting a criterion or the clinical association not meeting a criterion, wherein the statistical association comprises a statistical analysis of the plurality of matched data pairs'"'"' correlation to or deviation from a curve; and a processor module configured to process the sensor data in response to the statistical association meeting a criterion and the clinical association meeting a criterion. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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Specification