Fluctuating Blood Glucose Notification Threshold Profiles and Methods of Use

Abstract

Embodiments of the present invention provide a new system and methods for monitoring blood glucose concentration. A user of a continuous glucose monitor may program upper and lower blood glucose notification thresholds to fluctuate over time in order to facilitate management of the short-term effects of food consumption, insulin delivery aberrations, physical activity, emotions, and unforeseen circumstances.

1 . A continuous blood glucose monitoring system comprising:
 a system configured to continuously receive data from blood glucose monitoring sensors;   the system configured to convert sensor data into current blood glucose concentration values;   the system configured to support continuously fluctuating blood glucose notification threshold profiles;
 the continuously fluctuating blood glucose notification threshold profiles comprising:
 an upper blood glucose concentration threshold function; 
 a lower blood glucose concentration threshold function; 
 the threshold functions comprising specific values at specific times; 
 
   the system configured to compare a current blood glucose concentration value with a corresponding upper blood glucose concentration threshold value;   the system configured to compare a current blood glucose concentration value with a corresponding lower blood glucose concentration threshold value;   the system configured to alert a user when a current blood glucose concentration value is greater than a corresponding upper blood glucose concentration threshold value;   and the system configured to alert a user when a current blood glucose concentration value is less than a corresponding lower blood glucose concentration threshold value.   
     
     
         2 . The system of  claim 1  configured to alert a user when one or more events comprising:
 a predetermined period of time passing since threshold profile activation;   a predetermined time of day occurring;   a user maintaining current blood glucose concentration within the threshold profile range for a predetermined period of time;   a current blood glucose concentration crossing a static threshold which is independent of a threshold profile;   a rate of change of current blood glucose concentration exceeding a threshold rate of change;
 a rate of change of current blood glucose concentration falling below a threshold rate of change; 
 a current blood glucose concentration percentage rate of change exceeding a threshold percentage rate of change; 
 a current blood glucose concentration percentage rate of change falling below a threshold percentage rate of change; 
 a second derivative of current blood glucose concentration exceeding a threshold second derivative of blood glucose concentration over time; 
 a second derivative of current blood glucose concentration falling below a threshold second derivative of blood glucose concentration over time; 
   occurs.   
     
     
         3 . The system of  claim 2  wherein the alert comprises one or more of: a visual alert; an auditory alert; a tactile alert. 
     
     
         4 . The system of  claim 1  further comprising a graphic display capable of displaying one or more graphs comprising:
 a graph of an upper blood glucose concentration threshold function;   a graph of a lower blood glucose concentration threshold function;   a graph of an expected blood glucose concentration function;   a graph of measured blood glucose concentration.   
     
     
         5 . The system of  claim 4  wherein
 a graph of an upper blood glucose concentration threshold function is displayed in a first color;   a graph of a lower blood glucose concentration threshold function is displayed in a second color;   a graph of an expected blood glucose concentration function is displayed in a third color;   a graph of measured blood glucose concentration is displayed in a fourth color.   
     
     
         6 . The system of  claim 5  wherein the first color and the second color are the same color. 
     
     
         7 . The system of  claim 1  further comprising a data store configured to support storage and retrieval of blood glucose-related data. 
     
     
         8 . The system of  claim 7  wherein the data are labeled. 
     
     
         9 . The system of  claim 7  configured to allow a user to define a blood glucose threshold profile by using a method comprising one or more steps of:
 the step of retrieving a blood glucose threshold profile from a data store;   the step of retrieving a blood glucose threshold profile from a data store and the further step of modifying the blood glucose threshold profile;   the step of retrieving an expected blood glucose concentration function from a data store;   the step of retrieving an expected blood glucose concentration function from a data store and the further step of modifying the expected blood glucose concentration function;   the step of retrieving an upper blood glucose concentration threshold function from a data store;   the step of retrieving an upper blood glucose concentration threshold function from a data store and the further step of modifying the upper blood glucose concentration threshold function;   the step of retrieving a lower blood glucose concentration threshold function from a data store;   the step of retrieving a lower blood glucose concentration threshold function from a data store and the further step of modifying the lower blood glucose concentration threshold function.   
     
     
         10 . The system of  claim 7  configured to allow a user to define a blood glucose threshold profile by:
 the system analyzing recent measured blood glucose concentration data;   the system retrieving from a data store at least one blood glucose-related data item based upon the analysis of recent measured blood glucose concentration data, wherein the at least one data item comprises one or more of:
 a threshold profile data item; 
 an upper blood glucose concentration threshold function data item; 
 a lower blood glucose concentration threshold function data item; 
 an expected blood glucose concentration function data item; 
   the system optionally modifying the at least one blood glucose-related data item based upon the analysis of recent measured blood glucose concentration data;   the system presenting the at least one blood glucose-related data item to the user;   the system allowing the user to select a blood glucose-related data item;   and the system optionally allowing the user to modify the selected blood glucose-related data item.   
     
     
         11 . The system of  claim 1  configured to allow a user to define a blood glucose threshold profile by a method comprising one or more steps of:
 the step of drawing the graph of an upper blood glucose concentration threshold function using a device capable of accepting graphic input;   the step of drawing the graph of a lower blood glucose concentration threshold function using a device capable of accepting graphic input;   the step of spotting points defining an upper blood glucose concentration threshold function using a device capable of accepting graphic input;   the step of spotting points defining a lower blood glucose concentration threshold function using a device capable of accepting graphic input;   the step of entering numeric data defining an upper blood glucose concentration threshold function using a device capable of accepting numeric input;   the step of entering numeric data defining a lower blood glucose concentration threshold function using a device capable of accepting numeric input;   the step of drawing a graph of an expected blood glucose concentration function using a device capable of accepting graphic input;   the step of spotting points defining an expected blood glucose concentration function using a device capable of accepting graphic input;   the step of entering numeric data defining an expected blood glucose concentration function using a device capable of accepting numeric input.   
     
     
         12 . The system of  claim 1  wherein the duration of the threshold profile is from about one hour to about twelve hours. 
     
     
         13 . A method of using a continuous blood glucose monitoring system comprising the steps of:
 defining a continuously fluctuating blood glucose notification threshold profile comprising:
 an upper blood glucose concentration threshold function; 
 a lower blood glucose concentration threshold function; 
   the upper and lower blood glucose concentration threshold functions forming the bounds of an expected blood glucose concentration range for the duration of the threshold profile;   the threshold functions comprising specific values at specific times;   activating the threshold profile;   continuously receiving data from blood glucose monitoring sensors;   converting the sensor data to current blood glucose concentration values;   comparing a current blood glucose concentration value to a corresponding upper blood glucose concentration threshold value;   comparing a current blood glucose concentration value to a corresponding lower blood glucose concentration threshold value;   alerting a user if the current blood glucose concentration value is greater than the corresponding upper blood glucose concentration threshold value;   and alerting a user if the current blood glucose concentration value is less than the corresponding lower blood glucose concentration threshold value.   
     
     
         14 . The method of  claim 13  further comprising the step of alerting a user when one or more events comprising:
 a predetermined amount of time passing since threshold profile activation;   a predetermined time of day occurring;   a user maintaining current blood glucose concentration within the threshold profile range for a predetermined period of time;   a current blood glucose concentration crossing a static threshold which is independent of a threshold profile;   a rate of change of current blood glucose concentration exceeding a threshold rate of change;   a rate of change of current blood glucose concentration falling below a threshold rate of change;   a current blood glucose concentration percentage rate of change exceeding a threshold percentage rate of change;   a current blood glucose concentration percentage rate of change falling below a threshold percentage rate of change;   a second derivative of current blood glucose concentration exceeding a threshold second derivative of blood glucose concentration over time;   a second derivative of current blood glucose concentration falling below a threshold second derivative of blood glucose concentration over time;   occurs.   
     
     
         15 . The method of  claim 13  wherein the alert comprises one or more of: a visual alert; an auditory alert; a tactile alert. 
     
     
         16 . The method of  claim 13  further comprising the step of displaying, on a graphic display, one or more graphs comprising:
 a graph of an upper blood glucose concentration threshold function;   a graph of a lower blood glucose concentration threshold function;   a graph of an expected blood glucose concentration function;   a graph of measured blood glucose concentration.   
     
     
         17 . The method of  claim 16  wherein
 a graph of an upper blood glucose concentration threshold function is displayed in a first color;   a graph of a lower blood glucose concentration threshold function is displayed in a second color;   a graph of an expected blood glucose concentration function is displayed in a third color;   a graph of measured blood glucose concentration is displayed in a fourth color.   
     
     
         18 . The method of  claim 17  wherein the first color and the second color are the same color. 
     
     
         19 . The method of  claim 13  further comprising the steps of storing blood glucose-related data in a data store and retrieving blood glucose-related data from a data store. 
     
     
         20 . A computer readable medium comprising executable processor code configured to support a continuous blood glucose monitoring system;
 the code comprising:
 code for receiving data from continuous blood glucose monitoring sensors; 
 code for converting blood glucose sensor data into current blood glucose concentration values; 
 code supporting continuously fluctuating blood glucose notification threshold profiles; 
 the threshold profiles comprising:
 an upper blood glucose concentration threshold function; 
 a lower blood glucose concentration threshold function; 
 
 the threshold functions comprising specific values at specific times; 
 code for comparing a current blood glucose concentration value with a corresponding upper blood glucose concentration threshold value; 
 code for comparing a current blood glucose concentration value with a corresponding lower blood glucose concentration threshold value; 
 code for alerting a user when a current blood glucose concentration is greater than a corresponding upper blood glucose concentration threshold value; 
 and code for alerting a user when a current blood glucose concentration is less than a corresponding lower blood glucose concentration threshold value.