Method of calibrating of an analyte-measurement device, and associated methods, devices and systems
First Claim
1. An in vivo analyte sensor calibration system, comprising:
- an in vivo analyte sensor, at least a portion of the sensor subcutaneously positioned to generate one or more signals;
a calibration sensor configured to be placed in contact with a blood sample from an off-finger calibration site to provide a calibration measurement; and
a calibration device in signal communication with one or more of the in vivo analyte sensor or the calibration sensor to calibrate the in vivo analyte sensor by determining whether a quality of the calibration measurement is suitable for calibration, and converting the one or more signals from the in vivo analyte sensor into a corresponding one or more analyte concentration values using the calibration measurement if the quality of the calibration measurement is determined to be suitable;
wherein the calibration device is configured to determine a temperature compensated analyte concentration value based at least in part on the one or more analyte concentration values and a temperature compensation factor;
wherein the calibration device is further configured to determine a lag compensated analyte concentration value by applying a lag factor to a change in the temperature compensated analyte value over a time period between two acceptable calibration points divided by the time period between the two acceptable calibration points added to the temperature compensated analyte value; and
wherein the two acceptable calibration points is deemed acceptable based on at least one evaluation standard being met.
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Abstract
The invention relates to a method for calibrating an analyte-measurement device that is used to evaluate a concentration of analyte in bodily fluid at or from a measurement site in a body. The method involves measuring a concentration, or calibration concentration, of an analyte in blood from an “off-finger” calibration site, and calibrating the analyte-measurement device based on that calibration concentration. The invention also relates to a device, system, or kit for measuring a concentration of an analyte in a body, which employs a calibration device for adjusting analyte concentration measured in bodily fluid based on an analyte concentration measured in blood from an “off-finger” calibration site.
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Citations
26 Claims
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1. An in vivo analyte sensor calibration system, comprising:
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an in vivo analyte sensor, at least a portion of the sensor subcutaneously positioned to generate one or more signals; a calibration sensor configured to be placed in contact with a blood sample from an off-finger calibration site to provide a calibration measurement; and a calibration device in signal communication with one or more of the in vivo analyte sensor or the calibration sensor to calibrate the in vivo analyte sensor by determining whether a quality of the calibration measurement is suitable for calibration, and converting the one or more signals from the in vivo analyte sensor into a corresponding one or more analyte concentration values using the calibration measurement if the quality of the calibration measurement is determined to be suitable; wherein the calibration device is configured to determine a temperature compensated analyte concentration value based at least in part on the one or more analyte concentration values and a temperature compensation factor; wherein the calibration device is further configured to determine a lag compensated analyte concentration value by applying a lag factor to a change in the temperature compensated analyte value over a time period between two acceptable calibration points divided by the time period between the two acceptable calibration points added to the temperature compensated analyte value; and wherein the two acceptable calibration points is deemed acceptable based on at least one evaluation standard being met. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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Specification