SYSTEM AND METHODS FOR PROCESSING ANALYTE SENSOR DATA
First Claim
1. A method for matching continuous glucose sensor data with reference data, the method comprising:
- receiving sensor data from a continuous glucose sensor, the sensor data comprising one or more sensor data points;
receiving reference data from a reference glucose monitor, the reference data comprising one or more reference data points;
forming a matched pair by pairing a sensor value with a reference value, wherein the sensor value comprises a sensor data point or an averaged sensor data point, and wherein the reference value comprises a reference data point or an averaged reference data point; and
calibrating the sensor data in real-time, wherein the sensor data is calibrated using at least the matched pair.
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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.
1276 Citations
132 Claims
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1. A method for matching continuous glucose sensor data with reference data, the method comprising:
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receiving sensor data from a continuous glucose sensor, the sensor data comprising one or more sensor data points;
receiving reference data from a reference glucose monitor, the reference data comprising one or more reference data points;
forming a matched pair by pairing a sensor value with a reference value, wherein the sensor value comprises a sensor data point or an averaged sensor data point, and wherein the reference value comprises a reference data point or an averaged reference data point; and
calibrating the sensor data in real-time, wherein the sensor data is calibrated using at least the matched pair. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A system for matching continuous glucose sensor data with reference data, the system comprising:
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a sensor data module configured to receive a data stream from a continuous glucose sensor, the sensor data comprising one or more sensor data points;
a reference data module configured to receive reference data from a reference glucose monitor, the reference data comprising one or more reference data points; and
a processor module configured to form a matched pair by pairing a sensor data point with a reference data point, wherein the processor module is further configured to calibrate sensor data in real-time, wherein the sensor data is calibrated using at least said matched data pair. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method for calibrating a continuous glucose sensor data, the method comprising:
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receiving a data stream from a continuous glucose sensor, the data stream comprising one or more sensor data points;
receiving reference data from a reference glucose monitor, the reference data comprising one or more reference data points;
forming at least one matched pair by pairing one or more sensor data points with one or more reference data points;
forming a first calibration line and a second calibration line that have different slopes; and
calibrating the one or more sensor data points in real-time, wherein the first calibration line is applied when a blood glucose concentration is at or below a predetermined threshold, and wherein the second calibration line is applied when a blood glucose concentration is at or above the predetermined threshold - View Dependent Claims (22, 23, 24, 25, 26, 31, 32)
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27. A system for calibrating continuous glucose sensor data, the system comprising:
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a sensor data module configured to receive a data stream from a continuous glucose sensor, the data stream comprising one or more sensor data points;
a reference input module configured to receive reference data from a reference glucose monitor, the reference data comprising one or more reference data points;
a processor module configured to form at least one matched pair by pairing one or more sensor data points with one or more reference data points;
wherein the processor module is further configured to form a first calibration line and a second calibration line that have different slopes, and wherein at least one of the two calibration lines is based at least in part on the at least one matched pair; and
calibrating the one or more sensor data points in real-time, wherein the first calibration line is applied when a blood glucose concentration is at or below a predetermined threshold, and wherein the second calibration line is applied when a blood glucose concentration is at or above the predetermined threshold - View Dependent Claims (28, 29, 30)
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33. An integrated system, comprising:
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a continuous glucose sensor configured to measure a glucose concentration in a host and to provide sensor data associated therewith; and
an insulin delivery device configured to administer insulin, wherein the insulin delivery device comprises a processor module configured to receive and store, at least temporarily, sensor data obtained from the continuous glucose sensor, and wherein the processor module is further configured to analyze sensor data to predict a future glucose concentration in the host, whereby insulin is administered at least in part responsive to the predicted future glucose concentration. - View Dependent Claims (34, 35, 36, 38, 39, 40, 42, 43)
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37. An integrated system, comprising:
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a continuous glucose sensor configured to measure a glucose concentration in a host and to provide sensor data associated therewith; and
an insulin delivery device configured to administer insulin, wherein the insulin delivery device comprises a processor module configured to receive and store, at least temporarily, sensor data obtained from the continuous glucose sensor, wherein the processor module is further configured to analyze sensor data to determine a rate of change of glucose concentration in the host, whereby insulin is administered at least in part responsive to the rate of change.
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41. An integrated system, comprising:
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a continuous glucose sensor configured to measure a glucose concentration in a host and provide sensor data associated therewith; and
an insulin delivery device configured to administer insulin, wherein the insulin delivery device comprises a processor module configured to receive and store, at least temporarily, sensor data obtained from the continuous glucose sensor, wherein the processor module is further configured to analyze sensor data to determine a glucose trend in the host, whereby insulin is administered at least in part responsive to the glucose trend.
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44. A method for determining at least one of an amount of insulin to be administered or a duration of time of insulin administration, the method comprising:
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receiving continuous glucose sensor data, the sensor data comprising one or more sensor data points;
processing said glucose sensor data to determine at least one of an amount of insulin to be administered or a duration of time of insulin administration by analyzing a glucose trend in the sensor data; and
instructing an insulin delivery device to deliver insulin, the instruction comprising at least one of the amount of insulin to be administered or the duration of time of insulin administration, responsive to the glucose trend. - View Dependent Claims (45, 46)
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47. A glucose sensor system, comprising:
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a glucose sensor; and
sensor electronics configured to receive and retain glucose data from the glucose sensor;
wherein the sensor electronics are configured to process the glucose data to predict a glucose-related trend. - View Dependent Claims (48, 49, 50, 51)
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52. A glucose monitoring device, comprising:
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a sensor data module configured to receive glucose data from a continuous glucose sensor;
a data storage module coupled to the sensor data module and configured to store glucose data; and
a processor configured to process the stored glucose data to predict a glucose-related trend. - View Dependent Claims (53, 54, 55, 56, 57, 58, 59, 60)
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61. A method of processing glucose data, comprising:
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positioning at least a portion of a glucose sensor in contact with a bodily fluid of a host;
obtaining glucose-related information using the sensor;
storing the glucose-related information; and
processing the stored glucose-related information and predicting glucose-related trend. - View Dependent Claims (62)
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63. A method for calibrating a continuous glucose sensor, comprising:
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positioning at least a portion of an electrochemical sensor in a body of a host;
obtaining one or more sensor data points from the electrochemical sensor;
determining a rate of change from the one or more sensor data points; and
determining whether calibration is appropriate based on the determined rate of change. - View Dependent Claims (64, 65, 66, 67, 68)
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69. A method of glucose determination, comprising:
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positioning at least a portion of an electrochemical sensor in a body of a host;
obtaining one or more sensor data points from the electrochemical sensor; and
performing a rate of change analysis based on the one or more sensor data points. - View Dependent Claims (70)
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71. A glucose sensor system, comprising:
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an electrochemical glucose sensor; and
a receiver configured to receive one or more sensor data points from an electrochemical sensor, the receiver further configured to determine a rate of change of the one or more sensor data points and to determine whether calibration is appropriate based on the determined rate of change. - View Dependent Claims (72)
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73. A method for processing sensor data from a continuous glucose sensor, the method comprising:
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receiving sensor data from a continuous glucose sensor;
filtering or data smoothing the received sensor data to form first filtered sensor data; and
filtering or data smoothing the first filtered sensor data to obtained second filtered sensor data. - View Dependent Claims (74, 75, 76)
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77. A system for processing sensor data from a continuous glucose sensor, the system comprising:
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a sensor data module configured to receive sensor data from a continuous glucose sensor; and
a processor module configured to filter or smooth the received sensor data to form first filtered sensor data, wherein the processor module is further configured to filter or smooth the first filtered sensor data to obtain second filtered sensor data. - View Dependent Claims (78, 79, 80)
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81. A method for predicting future data from real-time continuous glucose sensor data, the method comprising:
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receiving sensor data from a continuous glucose sensor, the sensor data comprising one or more sensor data points; and
predicting one or more glucose values for a future time, based at least in part on the sensor data. - View Dependent Claims (82, 83, 84, 85, 86, 87)
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88. A system for predicting future data from real-time continuous glucose sensor data, the system comprising:
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a sensor data module configured to receive sensor data from a continuous glucose sensor, the sensor data comprising one or more sensor data points; and
a processor module configured to predict one or more glucose values for a future time, based at least in part on the sensor data. - View Dependent Claims (89, 90, 91, 92, 93, 94)
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95. A continuous glucose sensing system, the system comprising:
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a continuous glucose sensor device comprising a first sensor configured to continuously measuring a glucose concentration in a host, wherein at least a portion of the first sensor is positioned in or under a host'"'"'s tissue;
a glucose monitor comprising a second sensor configured to determine a glucose concentration of the host at a point in time; and
a processor module configured to calibrate data from said first sensor using data from said second sensor, and wherein the second sensor is integral with at least a portion of the continuous glucose sensor device. - View Dependent Claims (96, 97)
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98. A method of calibrating, the method comprising:
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inserting at least a portion of a first sensor in a host'"'"'s tissue; and
calibrating the first sensor unit after a predetermined time period has lapsed from the inserting step. - View Dependent Claims (99)
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100. An analyte monitoring system, comprising:
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a sensor device including a sensor, the sensor device configured to receive a data stream corresponding to a glucose concentration in a host, the data stream comprising one or more sensor data points; and
a display unit operatively coupled to the sensor, the display unit configured to output data based on signals received from the sensor device. - View Dependent Claims (101)
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102. An analyte monitoring device, comprising:
a receiver unit for receiving one or more signals related to an analyte level in a host detected by an electrochemical sensor, the receiver unit comprising a display to display an indication of the analyte level wherein the receiver unit comprises a calibrator. - View Dependent Claims (103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119)
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120. A system for calibrating a glucose sensor, the system comprising:
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a continuous glucose sensor configured to substantially continuously measure a glucose concentration in a host and to provide sensor data associated therewith;
a reference glucose monitor configured to measure the host'"'"'s blood glucose concentration at a time point and provide reference data associated therewith; and
a processor module, configured to form at least one matched data pair by matching reference analyte data to substantially time corresponding sensor data, wherein the processor module is further configured determine a rate of change of the glucose concentration at time substantially corresponding to the at least one matched data pair and to determine whether to calibrate the continuous glucose sensor responsive thereto. - View Dependent Claims (121, 122, 123, 124, 127, 128, 129, 131, 132)
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125. A system for calibrating a glucose sensor, the system comprising:
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a continuous glucose sensor configured to substantially continuously measure a glucose concentration in a host and to provide sensor data associated therewith;
a reference glucose monitor configured to measure a host'"'"'s blood glucose concentration at a time point and provide reference data associated therewith; and
a processor module configured to form at least one matched data pair by matching reference analyte data to substantially time corresponding sensor data, wherein the processor module is further configured evaluate a congruence of at least one matched data pair and to determine whether to calibrate the sensor responsive thereto. - View Dependent Claims (126)
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130. A system for calibrating a glucose sensor, the system comprising:
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a continuous glucose sensor configured to substantially continuously measure a glucose concentration in a host and to provide sensor data associated therewith;
a reference glucose monitor configured to measure the host'"'"'s blood glucose concentration at a time point and to provide reference data associated therewith; and
a processor module, configured to form at least one matched data pair by matching reference analyte data to substantially time corresponding sensor data, wherein the processor module is further configured evaluate physiological changes of the host at time substantially corresponding to the at least one matched data pair and to determine whether to calibrate the continuous glucose sensor responsive thereto.
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Specification