IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0639829
(2009-12-16)
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등록번호 |
US-8206297
(2012-06-26)
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발명자
/ 주소 |
- Kamath, Apurv Ullas
- Goode, Jr., Paul V.
- Brauker, James H.
- Thrower, James Patrick
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출원인 / 주소 |
|
대리인 / 주소 |
Knobbe Martens Olson & Bear LLP
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인용정보 |
피인용 횟수 :
15 인용 특허 :
359 |
초록
▼
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 o
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.
대표청구항
▼
1. A method for processing data from an analyte sensor, comprising: receiving, with an electronic device, sensor data from an analyte sensor, wherein the sensor data comprises at least one sensor data point;receiving reference data, wherein the reference data comprises at least one reference data po
1. A method for processing data from an analyte sensor, comprising: receiving, with an electronic device, sensor data from an analyte sensor, wherein the sensor data comprises at least one sensor data point;receiving reference data, wherein the reference data comprises at least one reference data point;matching a first reference data point to a substantially time corresponding first sensor data point to form a calibration set;forming a first conversion function based at least in part on the calibration set, wherein the first conversion function comprises a first baseline and a first analyte sensitivity;forming a second conversion function based at least in part on the calibration set, wherein the second conversion function comprises a second baseline and a second analyte sensitivity, wherein at least one attribute of the first conversion function is different from a corresponding attribute of the second conversion function, wherein the at least one attribute is selected from the group consisting of baseline, analyte sensitivity, and combinations thereof; anddetermining an analyte output value using the electronic device, wherein determining an analyte output value comprises applying the first conversion function to a sensor data point if the sensor data point is within a first predetermined range and applying the second conversion function to the sensor data point if the sensor data point is within a second predetermined range. 2. The method of claim 1, wherein the sensor data are filtered sensor data. 3. The method of claim 2, wherein the filtered sensor data are recursively filtered. 4. The method of claim 1, wherein receiving sensor data comprises receiving sensor data from a continuous analyte sensor. 5. The method of claim 1, wherein receiving reference data comprises receiving reference data from a reference analyte monitor. 6. The method of claim 5, wherein the reference analyte monitor is integral with the electronic device. 7. The method of claim 1, wherein the second conversion function is formed at least in part by modifying or replacing the first conversion function to improve a level of clinical acceptability of the analyte output value based on the first conversion function. 8. The method of claim 7, wherein the level of clinical acceptability is determined by using an evaluation technique selected from the group consisting of a Clarke Error Grid, a mean absolute difference calculation, a rate of change calculation, a consensus grid, a standard clinical acceptance test, and combinations thereof. 9. The method of claim 1, wherein the analyte sensor is a continuous glucose sensor. 10. The method of claim 1, wherein the first predetermined range and the second predetermined range are each independently associated with a range of analyte concentration. 11. The method of claim 1, wherein the first predetermined range and the second predetermined range are each independently associated with a level of clinical acceptability. 12. The method of claim 11, wherein the level of clinical acceptability is determined by using an evaluation technique selected from the group consisting of a Clarke Error Grid, a mean absolute difference calculation, a rate of change calculation, a consensus grid, a standard clinical acceptance test, and combinations thereof. 13. The method of claim 1, wherein a first line associated with the first conversion function is pivoted, at a point, to a second line associated with the second conversion function, and wherein the point corresponds to an intersect between the first line and the second line. 14. A system for processing data from an analyte sensor, comprising: a first receiver module configured to receive sensor data from an analyte sensor, wherein the sensor data comprises at least one sensor data point;a second receiver module configured to receive reference data, wherein the reference data comprises at least one reference data point; anda processor module configured to: match a first reference data point to a substantially time corresponding first sensor data point to form a calibration set;form a first conversion function based at least in part on the calibration set, wherein the first conversion function comprises a first baseline and a first analyte sensitivity;form a second conversion function based at least in part on the calibration set, wherein the second conversion function comprises a second baseline and a second analyte sensitivity, wherein at least one attribute of the first conversion function is different from a corresponding attribute of the second conversion function, wherein the at least one attribute is selected from the group consisting of baseline, analyte sensitivity, and combinations thereof; anddetermine an analyte output value, wherein the analyte output value is determined by applying the first conversion function to a sensor data point if the sensor data point is within a first predetermined range and applying the second conversion function to the sensor data point if the sensor data point is within a second predetermined range. 15. The system of claim 14, wherein the sensor data are filtered sensor data. 16. The system of claim 15, wherein the filtered sensor data are recursively filtered. 17. The system of claim 14, wherein the first receiver module is configured to receive sensor data from a continuous analyte sensor. 18. The system of claim 14, wherein the second receiver module is configured to receive reference data from a reference analyte monitor. 19. The system of claim 18, wherein the reference analyte monitor is integral with a component of a user interface, wherein the user interface comprises the processor module and the reference analyte monitor. 20. The system of claim 14, wherein the second conversion function is formed at least in part by modifying or replacing the first conversion function to improve a level of clinical acceptability of the analyte output value based on the first conversion function. 21. The system of claim 20, wherein the level of clinical acceptability is determined by using an evaluation technique selected from the group consisting of a Clarke Error Grid, a mean absolute difference calculation, a rate of change calculation, a consensus grid, a standard clinical acceptance test, and combinations thereof. 22. The system of claim 14, wherein the analyte sensor is a continuous glucose sensor. 23. The system of claim 14, wherein the first predetermined range and the second predetermined range are each associated with a range of analyte concentration. 24. The system of claim 14, wherein the first predetermined range and the second predetermined range are each associated with a level of clinical acceptability. 25. The system of claim 24, wherein the level of clinical acceptability is determined by using an evaluation technique selected from the group consisting of a Clarke Error Grid, a mean absolute difference calculation, a rate of change calculation, a consensus grid, a standard clinical acceptance test, and combinations thereof. 26. The system of claim 14, wherein a first line associated with the first conversion function is pivoted, at a point, to a second line associated with the second conversion function, and wherein the point corresponds to an intersect between the first line and the second line.
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