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 sensor data from a continuous 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
using a processor module to determine in real time during continuous analyte sensing of the analyte sensor the clinical acceptability of at least one of;
(i) said reference data using substantially time corresponding sensor data, wherein said reference data is evaluated for deviation from its substantially time corresponding sensor data in units of blood glucose concentration and clinical risk associated with that deviation based on a user'"'"'s blood glucose concentration as indicated by at least one of said reference data and said sensor data; and
(ii) said sensor data using substantially time corresponding reference data, wherein said sensor data is evaluated for deviation from its substantially time corresponding reference data in units of blood glucose concentration and clinical risk associated with that deviation based on a user'"'"'s blood glucose concentration as indicated by at least one of said sensor data and said time reference data.
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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.
44 Citations
19 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 sensor data from a continuous 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 using a processor module to determine in real time during continuous analyte sensing of the analyte sensor the clinical acceptability of at least one of; (i) said reference data using substantially time corresponding sensor data, wherein said reference data is evaluated for deviation from its substantially time corresponding sensor data in units of blood glucose concentration and clinical risk associated with that deviation based on a user'"'"'s blood glucose concentration as indicated by at least one of said reference data and said sensor data; and (ii) said sensor data using substantially time corresponding reference data, wherein said sensor data is evaluated for deviation from its substantially time corresponding reference data in units of blood glucose concentration and clinical risk associated with that deviation based on a user'"'"'s blood glucose concentration as indicated by at least one of said sensor data and said time reference data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. 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 configured to receive sensor data comprising a plurality of time spaced sensor data points from a substantially continuous analyte sensor; a reference data receiving module configured to receive reference data from a reference analyte monitor, including one or more reference data points; and a clinical acceptability evaluation module configured to determine in real time during continuous analyte sensing of the analyte sensor the clinical acceptability of at least one of; (i) said reference data using substantially time corresponding sensor data, wherein said reference data is evaluated for deviation from its substantially time corresponding sensor data in units of blood glucose concentration and clinical risk associated with that deviation based on a user'"'"'s blood glucose concentration as indicated by at least one of said reference data and said sensor data; and (ii) said sensor data using substantially time corresponding reference data, wherein said sensor data is evaluated for deviation from its substantially time corresponding reference data in units of blood glucose concentration and clinical risk associated with that deviation based on a user'"'"'s blood glucose concentration as indicated by at least one of said sensor data and said reference data. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19)
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Specification