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, comprising: determining by an analyte monitoring system a change in analyte value since a prior calibration;
 providing a change in analyte value threshold as a function of time elapsed since the prior calibration;   determining by the analyte monitoring system whether the change in analyte value as a function of time exceeds the threshold; and   if the change in analyte value as a function of time exceeds the threshold, providing by the analyte monitoring system an indication of that determination.   
     
     
         3 . The method of  claim 2 , wherein providing an indication comprises providing by the analyte monitoring system a recommendation to perform an additional calibration of the analyte monitoring system. 
     
     
         4 . The method of  claim 2 , wherein the analyte monitoring system is a glucose monitoring system. 
     
     
         5 . The method of  claim 2 , wherein the threshold defines a maximum allowable change in analyte value since the prior calibration. 
     
     
         6 . The method of  claim 2 , wherein the threshold defines a maximum allowable elapsed time since the prior calibration. 
     
     
         7 . The method of  claim 2 , wherein the threshold defines a line between a maximum allowable change in analyte value since the prior calibration and a maximum allowable elapsed time since the prior calibration. 
     
     
         8 . The method of  claim 2 , wherein the threshold defines a parameterized curve or function between a maximum allowable change in analyte value since the prior calibration and a maximum allowable elapsed time since the prior calibration. 
     
     
         9 . The method of  claim 2 , wherein, if the change in analyte value as a function of time does not exceed the threshold, waiting a period of time before re-determining a change in analyte value since the prior calibration and re-determining whether the change in analyte value as a function of time exceeds the threshold. 
     
     
         10 . An electronic monitoring unit comprising, a telemetry component configured to receive signals transmitted from an on-skin unit of an analyte monitoring system;
 and a processor configured to determine a change in analyte value since a prior calibration;   provide a change in analyte value threshold as a function of time elapsed since the prior calibration;   determine whether the change in analyte value as a function of time exceeds the threshold; and   if the change in analyte value as a function of time exceeds the threshold, provide an indication of that determination.   
     
     
         11 . The electronic monitoring unit of  claim 10 , wherein the telemetry component is further configured to transmit signals to the on-skin unit of the analyte monitoring system. 
     
     
         12 . The electronic monitoring unit of  claim 10 , further comprising a display. 
     
     
         13 . The electronic monitoring unit of  claim 12 , wherein the processor configured to provide an indication comprises a processor configured to provide a recommendation to perform an additional calibration of the analyte monitoring system. 
     
     
         14 . The electronic monitoring unit of  claim 13 , wherein the display includes one or more indicators configured to indicate the additional recommended calibration. 
     
     
         15 . The electronic monitoring unit of  claim 14 , wherein the one or more indicators are at least one of a textual, graphical, numerical, and pictorial indicator. 
     
     
         16 . An analyte monitoring system comprising:
 an on-skin unit coupled to at least one analyte sensor;   an electronic monitoring unit comprising, a telemetry component configured to receive signals measured by the analyte sensor and transmitted from the on-skin unit; and   a processor configured to determine a change in analyte value since a prior calibration;   provide a change in analyte value threshold as a function of time elapsed since the prior calibration;   determine whether the change in analyte value as a function of time exceeds the threshold; and   if the change in analyte value as a function of time exceeds the threshold, provide an indication of that determination.   
     
     
         17 . The analyte monitoring system of  claim 16 , wherein the analyte sensor is a glucose sensor. 
     
     
         18 . The analyte monitoring system of  claim 16 , wherein the telemetry component is further configured to transmit signals to the on-skin unit. 
     
     
         19 . The analyte monitoring system of  claim 16 , further comprising a display. 
     
     
         20 . The analyte monitoring system of  claim 19 , wherein the processor configured to provide an indication comprises a processor configured to provide a recommendation to perform an additional calibration of the analyte monitoring system. 
     
     
         21 . The analyte monitoring system of  claim 20 , wherein the display includes one or more indicators configured to indicate the additional recommended calibration. 
     
     
         22 . The analyte monitoring system of  claim 21 , wherein the one or more indicators are at least one of a textual, graphical, numerical, and pictorial indicator.