Method of Calibrating an Analyte-Measurement Device, and Associated Methods, Devices and Systems

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.

1 . (canceled) 
     
     
         2 . A machine-executed method of continuous analyte monitoring for a host to facilitate management of the host's blood glucose level, the method comprising:
 receiving a first input from a continuous analyte monitor (CAM) device including analyte concentration data of the host;
 receiving or determining an expected maximum value and an expected minimum reference value; 
 receiving a first reference value from a reference analyte monitor; 
 processing the first reference value by comparing it to the expected maximum value and the expected minimum value; and 
 producing an output of an alert to obtain a second reference value if the first reference value does not meet the range defined by the expected maximum value and the expected minimum value. 
   
     
     
         3 . The method of  claim 2 , wherein the method of  claim 1  is performed by a hand-held computing device in wireless communication with the CAM, and wherein the CAM comprises a continuous analyte sensor coupled to CAM electronics, the CAM electronics configured to calibrate the continuous analyte sensor output. 
     
     
         4 . The method of  claim 3 , wherein the CAM electronics determines the expected maximum reference value and the expected minimum reference value and transmits each of the expected maximum reference value, the expected minimum reference value and the calibrated continuous analyte sensor output to the hand-held computing device. 
     
     
         5 . The method of  claim 4 , further comprising periodically and regularly establishing a wireless communication channel between the CAM electronics and the hand-held computing device, and wherein the transmitting occurs within an established communication channel. 
     
     
         6 . The method of  claim 4 , wherein the CAM electronics periodically generates a calibrated continuous sensor data value. 
     
     
         7 . The method of  claim 6 , wherein both the period for establishing the communication channel and the period for generating the calibrated continuous sensor data value are substantially the same. 
     
     
         8 . The method of  claim 7 , wherein both of the establishing period and the generating period are 1, 5 or 10 minutes. 
     
     
         9 . The method of  claim 3 , wherein the reference analyte monitor is a single-point blood glucose monitor, and wherein the receiving the first reference analyte value comprises receiving a user input on a user interface of the hand-held computing device. 
     
     
         10 . The method of  claim 3 , further comprising displaying the first reference analyte value on the display of the hand-held computing device if the first reference analyte value meets the range defined by the expected maximum value and the expected minimum value, wherein the first reference value is displayed on the hand-held computing device until a calibrated continuous analyte sensor value based on the first reference value is received from the CAM and displayed on the hand-held computing device display. 
     
     
         11 . A system for continuous analyte monitoring for a host to facilitate management of the host's blood glucose level, the method comprising:
 a hand-held computing device configured to receive a first input from a continuous analyte monitor (CAM) device including analyte concentration data of the host;   receive or determine an expected maximum value and an expected minimum reference value;   receive a first reference value from a reference analyte monitor;   process the first reference value by comparing it to the expected maximum value and the expected minimum value; and   produce an output of an alert to obtain a second reference value if the first reference value does not meet the range defined by the expected maximum value and the expected minimum value.   
     
     
         12 . The system of  claim 11 , wherein the CAM comprises a continuous analyte sensor coupled to CAM electronics, the CAM electronics configured to calibrate the continuous analyte sensor output. 
     
     
         13 . The system of  claim 12 , wherein the CAM electronics are configured to determine the expected maximum reference value and the expected minimum reference value and transmits each of the expected maximum reference value, the expected minimum reference value and the calibrated continuous analyte sensor output to the hand-held computing device. 
     
     
         14 . The system of  claim 13 , wherein the hand-held computing device is configured to regularly establish a wireless communication channel with the CAM electronics, and wherein the CAM electronics transmits each of the expected maximum reference value, the expected minimum reference value and the calibrated continuous analyte sensor output to the hand-held computing device within the established communication channel. 
     
     
         15 . The system of  claim 13 , wherein the CAM electronics are configured to periodically generate a calibrated continuous sensor data value. 
     
     
         16 . The system of  claim 15 , wherein both the period for establishing the communication channel and the period for generating the calibrated continuous sensor data value are substantially the same. 
     
     
         17 . The system of  claim 16 , wherein both of the establishing period and the generating period are 1, 5 or 10 minutes. 
     
     
         18 . The system of  claim 12 , wherein the reference analyte monitor is a single-point blood glucose monitor, and wherein the receiving the first reference analyte value comprises receiving a user input on a user interface of the hand-held computing device. 
     
     
         19 . The system of  claim 12 , wherein the hand-held computing device is further configured to display the first reference analyte value on the display of the hand-held computing device if the first reference analyte value meets the range defined by the expected maximum value and the expected minimum value, and wherein the hand-held computing device is configured to display the first reference value until a calibrated continuous analyte sensor value based on the first reference value is received from the CAM.