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 method for processing data from an analyte sensor, the method comprising:
 receiving, with an electronic system, sensor data from an analyte sensor, wherein the sensor data comprises at least one sensor data point;   receiving, with the electronic system, reference data, wherein the reference data comprises at least one reference data point;   matching, with the electronic system, a first reference data point to a substantially time corresponding first sensor data point to form a calibration set;   forming, with the electronic system, a conversion function based at least in part on the calibration set, wherein the conversion function comprises a first non-zero baseline and a first analyte sensitivity;   adjusting, with the electronic system, the conversion function using a second baseline determined at least in part by prior information; and   determining, with the electronic system, an analyte output value in substantially real-time by applying the adjusted conversion function to a sensor data point.   
     
     
         3 . The method of  claim 2 , wherein adjusting the conversion function comprises modifying the first analyte sensitivity. 
     
     
         4 . The method of  claim 2 , further comprising:
 adjusting, with the electronic system, the adjusted conversion function using a third baseline determined at least in part by prior information; and   determining, with the electronic system, an analyte output value in substantially real-time by applying the twice-adjusted conversion function to a sensor data point.   
     
     
         5 . The method of  claim 4 , wherein adjusting the adjusted conversion function comprises modifying a second analyte sensitivity. 
     
     
         6 . The method of  claim 2 , wherein the first non-zero baseline is predetermined. 
     
     
         7 . The method of  claim 2 , further comprising:
 determining, with the electronic system, whether at least one attribute of the conversion function is outside at least one predetermined range, wherein the at least one attribute of the conversion function is selected from the group consisting of a baseline, an analyte sensitivity, and combinations thereof; and   determining, with the electronic system, whether at least one attribute of the adjusted conversion function is outside the at least one predetermined range, wherein the at least one attribute of the adjusted conversion function is selected from the group consisting of a baseline, an analyte sensitivity, and combinations thereof;
 wherein adjusting the conversion function is performed in response to a determination that the at least one attribute of the conversion function is outside the at least one predetermined range; and 
 wherein determining an analyte output value is performed in response to a determination that the at least one attribute of the adjusted conversion function is within the at least one predetermined range. 
   
     
     
         8 . The method of  claim 7 , wherein the at least one predetermined range is based on at least one of a baseline, an analyte sensitivity, or combinations thereof. 
     
     
         9 . The method of  claim 7 , wherein the at least one predetermined range is associated with a clinical acceptability, wherein the clinical acceptability is determined by an evaluation technique selected from the group consisting of a Clarke Error Grid, a mean absolute difference calculation, a consensus grid, and combinations thereof. 
     
     
         10 . The method of  claim 2 , wherein receiving sensor data comprises receiving sensor data from a continuous analyte sensor. 
     
     
         11 . The method of  claim 2 , wherein the analyte sensor is a continuous glucose sensor. 
     
     
         12 . The method of  claim 2 , wherein prior information is obtained from in vivo tests or in vitro tests. 
     
     
         13 . A system for processing data from an analyte sensor, the system comprising:
 a first receiver module configured to receive sensor data from an analyte sensor, wherein the sensor data comprises at least one sensor data point;   a second receiver module configured to receive reference data, wherein the reference data comprises at least one reference data point; and   a processor module configured to:
 match a first reference data point to a substantially time corresponding first sensor data point to form a calibration set; 
 form a conversion function based at least in part on the calibration set, wherein the conversion function comprises a first non-zero baseline and a first analyte sensitivity; 
 adjust the conversion function using a second baseline determined at least in part by prior information; and 
 determine an analyte output value in substantially real-time by applying the adjusted conversion function to a sensor data point. 
   
     
     
         14 . The system of  claim 13 , wherein the processor module is further configured to adjust the conversion function by modifying the first analyte sensitivity. 
     
     
         15 . The system of  claim 13 , wherein the processor module is further configured to:
 adjust the adjusted conversion function by using a third baseline determined at least in part by prior information; and   determine an analyte output value in substantially real-time by applying the twice-adjusted conversion function to a sensor data point.   
     
     
         16 . The system of  claim 15 , wherein the processor module is further configured to adjust the adjusted conversion function by modifying a second analyte sensitivity. 
     
     
         17 . The system of  claim 13 , wherein the first non-zero baseline is predetermined. 
     
     
         18 . The system of  claim 13 , wherein the processor module is further configured to:
 determine whether at least one attribute of the conversion function is outside at least one predetermined range, wherein the at least one attribute of the conversion function is selected from the group consisting of a baseline, an analyte sensitivity, and combinations thereof; and   determine whether at least one attribute of the adjusted conversion function is outside the at least one predetermined range, wherein the at least one attribute of the adjusted conversion function is selected from the group consisting of a baseline, an analyte sensitivity, and combinations thereof;
 wherein adjustment of the conversion function is performed in response to a determination that the at least one attribute of the conversion function is outside the at least one predetermined range; and 
 wherein determination of an analyte output value is performed in response to a determination that the at least one attribute of the adjusted conversion function is within the at least one predetermined range. 
   
     
     
         19 . The system of  claim 18 , wherein the at least one predetermined range is based on at least one of a baseline, an analyte sensitivity, or combinations thereof. 
     
     
         20 . The system of  claim 13 , wherein the analyte sensor is a continuous glucose sensor. 
     
     
         21 . A system for processing data from an analyte sensor, the system comprising:
 means for receiving sensor data from an analyte sensor, wherein the sensor data comprises at least one sensor data point;   means for receiving reference data, wherein the reference data comprises at least one reference data point;   means for matching a first reference data point to a substantially time corresponding first sensor data point to form a calibration set;   means for forming a conversion function based at least in part on the calibration set, wherein the conversion function comprises a first non-zero baseline and a first analyte sensitivity;   means for adjusting the conversion function using a second baseline determined at least in part by prior information; and   means for determining an analyte output value in substantially real-time by applying the adjusted conversion function to a sensor data point.