Calibration of analyte measurement system
First Claim
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1. A method, the method comprising:
- positioning a portion of an analyte sensor through a skin surface in fluid contact with biofluid under the skin surface of a subject;
generating a signal from the analyte sensor, the signal corresponding to an analyte concentration level in the biofluid;
storing, using one or more processors, a pre-set calibration schedule and at least one user-defined time period having a beginning time set by the subject and an ending time set by the subject;
prompting, using the one or more processors, the subject to assay a calibration sample of the subject'"'"'s blood to obtain a calibration value only when a first condition is met;
selecting, using the one or more processors, a first time frame and a maximum number of calibrations in the first time frame;
confirming, using the one or more processors, that a time for prompting the subject to assay the calibration sample is outside of the user-defined time period; and
correlating, using the one or more processors, the calibration value to at least one of the signals from the sensor when the first condition is met;
wherein the first condition is met when fewer than the maximum number of calibrations have occurred in the first time frame; and
prior to prompting the subject to assay the calibration sample, performing a data validation routine including a check for sensor electronics hardware error, a check on the data quality, and a check for current and/or voltage saturation.
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Abstract
A method of calibrating an analyte measurement system is provided.
980 Citations
28 Claims
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1. A method, the method comprising:
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positioning a portion of an analyte sensor through a skin surface in fluid contact with biofluid under the skin surface of a subject; generating a signal from the analyte sensor, the signal corresponding to an analyte concentration level in the biofluid; storing, using one or more processors, a pre-set calibration schedule and at least one user-defined time period having a beginning time set by the subject and an ending time set by the subject; prompting, using the one or more processors, the subject to assay a calibration sample of the subject'"'"'s blood to obtain a calibration value only when a first condition is met; selecting, using the one or more processors, a first time frame and a maximum number of calibrations in the first time frame; confirming, using the one or more processors, that a time for prompting the subject to assay the calibration sample is outside of the user-defined time period; and correlating, using the one or more processors, the calibration value to at least one of the signals from the sensor when the first condition is met; wherein the first condition is met when fewer than the maximum number of calibrations have occurred in the first time frame; and prior to prompting the subject to assay the calibration sample, performing a data validation routine including a check for sensor electronics hardware error, a check on the data quality, and a check for current and/or voltage saturation. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. An apparatus, comprising:
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a processing unit; and a memory coupled to the processing unit, the memory storing instructions which, when executed by the processing unit, causes the processing unit to receive a signal from a sensor in fluid contact with biofluid under a skin surface of a subject, the signal corresponding to an analyte concentration level in a biofluid, store a pre-set calibration schedule and at least one user-defined time period having a beginning time set by the subject and an ending time set by the subject, prompt the subject to assay a calibration sample of the subject'"'"'s blood to obtain a calibration value, only when a first condition is met, select a first time frame and a maximum number of calibrations in the first time frame, confirm that a time for prompting the subject to assay the calibration sample is outside of the user-defined time period, and correlate the calibration value to at least one of the signals from the sensor when the first condition is met, wherein the first condition is met when fewer than the maximum number of calibrations have occurred in the first time frame, and further, wherein prior to the processing unit prompting the subject to assay the calibration sample, the memory further includes instructions which, when executed by the processing unit, causes the processing unit to perform a data validation routine including a check for sensor electronics hardware error, a check on the data quality, and a check for current and/or voltage saturation. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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Specification