Method of Calibrating an Analyte-Measurement Device, and Associated Methods, Devices and Systems
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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
121 Claims
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1-22. -22. (canceled)
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23. A method for calibrating a signal from a subcutaneous sensor, comprising:
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obtaining a calibration measurement from a calibration sensor placed in contact with capillary blood from an off-finger calibration site within a body; evaluating whether the calibration measurement is within a predetermined range of analyte concentration; and determining that the calibration measurement is suitable for use in converting an analyte signal from the subcutaneous sensor into an analyte concentration if the calibration measurement is within the predetermined range, wherein the subcutaneous sensor comprises a working electrode, the working electrode comprising an analyte responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with a polymer disposed on the working electrode. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78)
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79. 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, wherein the analyte sensor comprises a working electrode, the working electrode comprising an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with a polymer disposed on the working electrode; 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. - View Dependent Claims (80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121)
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Specification