Method of calibrating an analyte-measurement device, and associated methods, devices and systems
First Claim
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1. A method, comprising:
- subcutaneously positioning at least a portion of an in vivo glucose sensor;
obtaining a signal from the in vivo glucose sensor;
determining if the obtained signal is acceptable for use in determining a sensitivity factor based on a first predetermined criteria;
obtaining a calibration measurement;
determining if the obtained calibration measurement is acceptable for use in determining the sensitivity factor based on a second predetermined criteria;
determining the sensitivity factor using the obtained signal and the obtained calibration measurement when it is determined that the obtained signal and the obtained calibration measurement are acceptable for use in determining the sensitivity factor; and
determining a suitability of the sensitivity factor for calibration of the in vivo glucose sensor by evaluating whether the sensitivity factor is within a predetermined range assigned to a production lot of the in vivo glucose sensor.
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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.
782 Citations
15 Claims
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1. A method, comprising:
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subcutaneously positioning at least a portion of an in vivo glucose sensor; obtaining a signal from the in vivo glucose sensor; determining if the obtained signal is acceptable for use in determining a sensitivity factor based on a first predetermined criteria; obtaining a calibration measurement; determining if the obtained calibration measurement is acceptable for use in determining the sensitivity factor based on a second predetermined criteria; determining the sensitivity factor using the obtained signal and the obtained calibration measurement when it is determined that the obtained signal and the obtained calibration measurement are acceptable for use in determining the sensitivity factor; and determining a suitability of the sensitivity factor for calibration of the in vivo glucose sensor by evaluating whether the sensitivity factor is within a predetermined range assigned to a production lot of the in vivo glucose sensor. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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Specification