System and methods for processing analyte sensor data
First Claim
1. A method for evaluating clinical acceptability of at least one of reference and sensor analyte data, 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 one or more reference data points; and
evaluating the clinical acceptability at least one of said reference and sensor analyte data using substantially time corresponding reference or sensor data, wherein said at least one of said reference and sensor analyte data is evaluated for deviation from its substantially time corresponding reference or sensor data and clinical risk associated with that deviation based on the glucose value indicated by at least one of said sensor and reference data, further comprising a step of matching reference data to substantially time corresponding sensor data to form a matched pair after the clinical acceptability evaluation step.
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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.
1356 Citations
24 Claims
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1. A method for evaluating clinical acceptability of at least one of reference and sensor analyte data, 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; and
evaluating the clinical acceptability at least one of said reference and sensor analyte data using substantially time corresponding reference or sensor data, wherein said at least one of said reference and sensor analyte data is evaluated for deviation from its substantially time corresponding reference or sensor data and clinical risk associated with that deviation based on the glucose value indicated by at least one of said sensor and reference data, further comprising a step of matching reference data to substantially time corresponding sensor data to form a matched pair after the clinical acceptability evaluation step. - View Dependent Claims (2, 3, 4, 8)
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- 5. The method of claim 5, further comprising providing an output through a user interface responsive to said clinical acceptability evaluation.
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9. A method for evaluating clinical acceptability of at least one of reference and sensor analyte data, the method 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 one or more reference data points; and
means for evaluating the clinical acceptability of at least one of said reference and sensor analyte data using substantially time corresponding reference and sensor data, wherein said at least one of said reference and sensor analyte data is evaluated for deviation from its substantially time corresponding reference or sensor data and clinical risk associated with that deviation based on the glucose value indicated by at least one of said sensor and reference data, further comprising means for matching reference data to substantially time corresponding sensor data to form a matched data pair after the clinical acceptability evaluation. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
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17. A computer system for evaluating clinical acceptability of at least one of reference and sensor analyte data, 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 one or more reference data points; and
a clinical acceptability evaluation module that evaluates at least one of said reference and sensor analyte data using substantially time corresponding reference and sensor data, wherein said at least one of said reference and sensor analyte data is evaluated for deviation from its substantially time corresponding reference or sensor data and clinical risk associated with that deviation based on the glucose value indicated by at least one of said sensor and reference data, further comprising a data matching module that matches clinically acceptable reference data to substantially time corresponding clinically acceptable sensor data to form a matched pair. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24)
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Specification