A METHOD OF CALIBRATING AN ANALYTE-MEASUREMENT DEVICE, AND ASSOCIATED METHODS, DEVICES AND SYSTEMS
First Claim
1. A method of calibration, comprising:
- providing a device at a measurement site within a body, the device sufficient for providing an analyte signal indicative of an analyte concentration in a bodily fluid at the measurement site;
determining a calibration concentration of the analyte in blood from an off-finger calibration site within the body; and
calibrating the device or the analyte signal therefrom using the calibration concentration.
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Accused Products
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
82 Claims
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1. A method of calibration, comprising:
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providing a device at a measurement site within a body, the device sufficient for providing an analyte signal indicative of an analyte concentration in a bodily fluid at the measurement site;
determining a calibration concentration of the analyte in blood from an off-finger calibration site within the body; and
calibrating the device or the analyte signal therefrom using the calibration concentration. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A method of calibration, comprising:
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inserting a sensor at a measurement site within the body, the sensor sufficient for providing at least one analyte signal indicative of analyte concentration in a bodily fluid at the measurement site;
obtaining at least two analyte signals via the sensor;
determining a calibration concentration of the analyte in blood from an off-finger calibration site within the body; and
adjusting the at least two analyte signals based on the calibration concentration. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46)
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47. A method for use in calibrating a signal from a subcutaneous sensor, comprising:
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obtaining one analyte signal from the subcutaneous sensor placed in contact with a subcutaneous fluid of a body;
obtaining a calibration measurement from a calibration sensor placed in contact with capillary blood from an off-finger calibration site within the body;
associating a sensitivity with said one analyte signal, said sensitivity being within a predetermined range; and
converting an analyte signal from the subcutaneous sensor into an analyte concentration based on the sensitivity. - View Dependent Claims (48, 49, 50, 51, 52)
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53. A method for use in calibrating a signal from a subcutaneous sensor, comprising:
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obtaining one analyte signal from the subcutaneous sensor placed in contact with a subcutaneous fluid of a body at one time;
obtaining another analyte signal from the subcutaneous sensor placed in contact with the subcutaneous fluid of the body at another time;
determining a rate of change in analyte concentration over a period from said one time to said another time; and
evaluating whether the rate of change falls within a predetermined range such that at least one of said one analyte signal and said another analyte signal is suitable for being converted into an analyte concentration. - View Dependent Claims (54)
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55. A method for use in 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 such that the calibration measurement is suitable for use in converting an analyte signal from the subcutaneous sensor into an analyte concentration. - View Dependent Claims (56)
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57. A method for use in connection with a subcutaneous sensor, comprising:
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obtaining an analyte signal from the subcutaneous sensor placed in contact with a subcutaneous fluid of a body;
obtaining a calibration measurement from a calibration sensor placed in contact with capillary blood of the body;
said obtaining the analyte signal and said obtaining a calibration measurement occurring within a period of about 10 minutes of each other;
evaluating at least one of the analyte signal and the calibration measurement for suitability for use in converting an analyte signal from the subcutaneous sensor into an analyte concentration. - View Dependent Claims (58, 59, 60, 61, 62, 63, 64, 65, 66)
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67. A system for calibrating a signal from a sensor, comprising:
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a measurement sensor sufficient for providing an analyte signal indicative of a concentration of an analyte in a bodily fluid at a measurement site within a body;
a calibration sensor sufficient for determining a calibration concentration of the analyte in blood from a calibration site within the body; and
a calibration device in operative communication with the measurement sensor and the calibration sensor for receipt of data therefrom, the device comprising;
a receiving element for receiving at least one analyte signal from the measurement sensor;
a receiving element for receiving at least one calibration value for the calibration concentration from the calibration sensor; and
a calibration element for calibrating the at least one analyte signal based on the at least one calibration value, said calibration element being other than manual. - View Dependent Claims (68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82)
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Specification