Method and apparatus for providing analyte sensor calibration

Abstract

Methods and apparatus for providing data processing and control for use in verifying the stability of sensor sensitivity of an analyte sensor.

What is claimed is: 
     
         1 . A method, comprising:
 prior to calibrating an in vivo analyte sensor, retrieving one or more parameters to calibrate the analyte sensor data;   analyzing the retrieved one or more parameters to determine whether the analyte sensor data calibration will fail; and   generating a notification based on the analysis of the retrieved one or more parameters.   
     
     
         2 . The method of  claim 1  including determining a calibration time period based on a predetermined calibration schedule. 
     
     
         3 . The method of  claim 2  wherein the predetermined calibration schedule includes a plurality of calibration time periods after the positioning of the analyte sensor in fluid contact with an analyte. 
     
     
         4 . The method of  claim 3  wherein the plurality of calibration time periods includes two or more of 10 minutes, 30 minutes, 45 minutes, one hour, two hours, five hours, 10 hours, 12 hours, 24 hours, 48 hours or 72 hours measured from the positioning of the analyte sensor. 
     
     
         5 . The method of  claim 3  wherein the plurality of calibration time periods is determined based on a valid calibration procedure to calibrate the positioned analyte sensor. 
     
     
         6 . The method of  claim 1  wherein the retrieved one or more parameters to calibrate the analyte sensor includes one or more of a current sensitivity value, a predetermined number of preceding valid analyte sensor data, a valid analyte data verification, a rate of change of analyte sensor data, a predetermined number of valid analyte sensor data for sensitivity determination; a predetermined number of valid analyte sensor data for analyte sensor data rate of change determination, or a temperature data associated with the analyte sensor data. 
     
     
         7 . The method of  claim 6  wherein the predetermined number of preceding valid analyte sensor data includes two valid analyte sensor data from the five most recent analyte sensor data determined from the analyte sensor calibration event. 
     
     
         8 . The method of  claim 1  wherein the notification includes a request for one of a current blood glucose measurement value input, or a delayed blood glucose measurement value input. 
     
     
         9 . The method of  claim 8  wherein the request includes one or more of a text information, a graphical information, an audible information, or a combined one or more of the text, graphical or audible information to alert a user to enter a current blood glucose value. 
     
     
         10 . The method of  claim 1  including storing the generated notification. 
     
     
         11 . The method of  claim 1  wherein the notification includes an output signal to indicate that the one or more retrieved parameters to calibrate the analyte sensor is invalid. 
     
     
         12 . The method of  claim 1  wherein the notification include an output message to prevent entering a current blood glucose value information. 
     
     
         13 . The method of  claim 1  wherein when the retrieved one or more parameters to calibrate the analyte sensor are determined to be out of range for valid calibration, generating one or more notifications associated with correcting the invalid determination. 
     
     
         14 . The method of  claim 13  wherein the one or more notifications associated with correcting the invalid determination includes one or more of a skin temperature adjustment notification, a notification to control the glucose level within a predetermined range, or a notification to delay calibration until the rate of change of the glucose value is within a predetermined threshold range. 
     
     
         15 . The method of  claim 14  wherein each of the one or more notifications includes an icon, an audible and/or vibratory alarm, or a status screen display. 
     
     
         16 . An apparatus, comprising:
 a data storage unit;   a processing unit operatively coupled to the data storage unit, and configured to retrieve one or more sensor calibration parameters to calibrate an analyte sensor data prior to calibrating an in vivo analyte sensor, analyze the retrieved one or more parameters to determine whether the analyte sensor data calibration will fail, and generate a notification based on the analysis of the retrieved one or more parameters.   
     
     
         17 . The apparatus of  claim 16  wherein the processing unit is configured to determine a calibration time period based on a predetermined calibration schedule. 
     
     
         18 . The apparatus of  claim 17  wherein the predetermined calibration schedule includes a plurality of calibration time periods after the positioning of the analyte sensor in fluid contact with an analyte. 
     
     
         19 . The apparatus of  claim 18  wherein the plurality of calibration time periods includes two or more of 10 minutes, 30 minutes, 45 minutes, one hour, two hours, five hours, 10 hours, 12 hours, 24 hours, 48 hours or 72 hours measured from the positioning of the analyte sensor. 
     
     
         20 . The apparatus of  claim 18  wherein the plurality of calibration time periods is determined based on a valid calibration procedure to calibrate the positioned analyte sensor. 
     
     
         21 . The apparatus of  claim 16  wherein the retrieved one or more parameters to calibrate the analyte sensor includes one or more of a current sensitivity value, a predetermined number of preceding valid analyte sensor data, a valid analyte data verification, a rate of change of analyte sensor data, a predetermined number of valid analyte sensor data for sensitivity determination; a predetermined number of valid analyte sensor data for analyte sensor data rate of change determination, or a temperature data associated with the analyte sensor data. 
     
     
         22 . The apparatus of  claim 21  wherein the predetermined number of preceding valid analyte sensor data includes two valid analyte sensor data from the five most recent analyte sensor data determined from the analyte sensor calibration event. 
     
     
         23 . The apparatus of  claim 16  including an output unit operatively coupled to the processing unit, the output unit configured to output the notification to request for one of a current blood glucose measurement value input, or a delayed blood glucose measurement value input. 
     
     
         24 . The apparatus of  claim 23  wherein the request includes one or more of a text information, a graphical information, an audible information, or a combined one or more of the text, graphical or audible information. 
     
     
         25 . The apparatus of  claim 16  wherein the processing unit is configured to store the generated notification in the storage unit. 
     
     
         26 . The apparatus of  claim 16  wherein the notification includes an output signal to indicate that the one or more retrieved parameters to calibrate the analyte sensor is invalid. 
     
     
         27 . The apparatus of  claim 16  wherein the notification include an output message to prevent entering a current blood glucose value information. 
     
     
         28 . The apparatus of  claim 16  wherein when the retrieved one or more parameters to calibrate the analyte sensor are determined to be out of range for valid calibration, the processing unit is configured to generate one or more notifications associated with correcting the invalid determination. 
     
     
         29 . The apparatus of  claim 28  wherein the one or more notifications associated with correcting the invalid determination includes one or more of a skin temperature adjustment notification, a notification to control the glucose level within a predetermined range, or a notification to delay calibration until the rate of change of the glucose value is within a predetermined threshold range. 
     
     
         30 . The apparatus of  claim 29  wherein each of the one or more notifications includes an icon, an audible and/or vibratory alarm, or a status screen display.