Glycemic risk determination based on variability of glucose levels

Abstract

A system and method for determining glycemic risks based on an analysis of glucose data includes visualization of hypoglycemia, variability, and hyperglycemia with a control grid, increasing the accuracy of glucose estimates using a combination of CGM and HbA1c, calculating glycemic risk by applying a probability distribution, and tailoring SMBG test schedules based on CGM use/wear.

1 . A system for determining glycemic risk based on analysis of glucose data, the system comprising:
 a non-volatile memory in which is stored a glucose data processing program configured to program a processor to analyze received glucose data and from the analysis, produce a display;   an input at which glucose data is received;   a display on which glucose data and analytics thereof may be visually presented;   a processor connected with the nonvolatile memory, the input, and the display, the processor being configured to access the memory to load and run in the processor the program to analyze glucose data, wherein the processor is programmed to:
 analyze the received glucose data to determine a glucose median, a low range variability of glucose, and a hypoglycemia risk; and 
 control the display to visually present glycemic risks of hypoglycemia and glucose variability for different times of the day, and thereby allow investigation and illustration of how changes in glucose levels could affect those risks; 
   whereby periods of the day needing a reduction in hypoglycemia and/or a reduction in glycemic variability can be seen.   
     
     
         2 . The system of  claim 1  wherein the glucose processing program further programs the processor to control the display to visually present a control grid on which is shown a hypoglycemia risk curve and a glucose variability curve and also showing risk reduction distances for hypoglycemia and glucose variability. 
     
     
         3 . The system of  claim 2  wherein the glucose processing program further programs the processor to control the display to visually present on the control grid a treatment recommendation point. 
     
     
         4 . The system of  claim 2  wherein the glucose processing program further programs the processor to control the display to visually present on the control grid an uncertainty boundary. 
     
     
         5 . The system of  claim 2  wherein the glucose processing program further programs the processor to control the display to visually present on the control grid a hyperglycemia curve and a risk reduction distance for hyperglycemia. 
     
     
         6 . The system of  claim 1  wherein the glucose processing program further programs the processor to control the display to visually present a graphical representation of risk reduction showing hyperglycemia and glucose variability separately. 
     
     
         7 . The system of  claim 1  wherein the glucose processing program further programs the processor to control the display to visually present graphs representing risk reduction showing hyper and hypo combined with glucose variability. 
     
     
         8 . The system of  claim 1  wherein the system further comprises a touch screen associated with the display;
 wherein the glucose processing program further programs the processor to receive input from the touch screen and control the display to visually present changes in hypoglycemia risk resulting from input from the touch screen showing alteration in glucose median and/or glucose variability. 
 
     
     
         9 . The system of  claim 1  wherein the glucose processing program further programs the processor to:
 receive HbA1c data; 
 analyze the HbA1c data with the glucose data; 
 determine an estimate of average glucose; and 
 control the display to visually present the estimate of average glucose. 
 
     
     
         10 . The system of  claim 1  wherein the glucose processing program further programs the processor to subject the glucose data to an analysis of probability distribution in determining glycemic risk. 
     
     
         11 . The system of  claim 1  wherein the glucose processing program further programs the processor to control the display to visually present a hypoglycemic risk curve and blood glucose variability on a time period scale;
 whereby the visual presentation on a time period scale indicates how an SMBG test schedule may be tailored to obtain further desired glucose data. 
 
     
     
         12 . A method for determining glycemic risk based on analysis of glucose data, the method comprising:
 storing in a non-volatile memory a glucose data processing program configured to program a processor to analyze received glucose data and from the analysis, produce a display;   receiving glucose data;   accessing the non-volatile memory and loading and running the glucose data processing program;   analyzing the received glucose data to determine a glucose median, a low range variability of glucose, and a hypoglycemia risk;   controlling a display to visually present glycemic risks of hypoglycemia and glucose variability for different times of the day, thereby allowing investigation and illustration of how changes in glucose levels could affect those risks;   whereby periods of the day needing a reduction in hypoglycemia and/or a reduction in glycemic variability can be seen.   
     
     
         13 . The method of  claim 12  wherein the glucose processing program further programs the processor for:
 controlling the display to visually present a control grid on which is shown a hypoglycemia risk curve and a glucose variability curve and also showing risk reduction distances for hypoglycemia and glucose variability. 
 
     
     
         14 . The method of  claim 13  wherein the glucose processing program further programs the processor for:
 controlling the display to visually present on the control grid a treatment recommendation point. 
 
     
     
         15 . The method of  claim 13  wherein the glucose processing program further programs the processor for:
 controlling the display to visually present on the control grid an uncertainty boundary. 
 
     
     
         16 . The method of  claim 13  wherein the glucose processing program further programs the processor for:
 controlling the display to visually present on the control grid a hyperglycemia curve and a risk reduction distance for hyperglycemia. 
 
     
     
         17 . The method of  claim 12  wherein the glucose processing program further programs the processor for:
 controlling the display to visually present a graphical representation of risk reduction showing hyperglycemia and glucose variability separately. 
 
     
     
         18 . The method of  claim 12  wherein the glucose processing program further programs the processor for:
 controlling the display to visually present graphs representing risk reduction showing hyper and hypo combined with glucose variability. 
 
     
     
         19 . The method of  claim 12  wherein the glucose processing program further programs the processor for:
 receiving input from a touch screen and controlling the display to visually present changes in hypoglycemia risk resulting from input from the touch screen showing alteration in glucose median and/or glucose variability. 
 
     
     
         20 . The method of  claim 12  wherein the glucose processing program further programs the processor for:
 receiving HbA1c data; 
 analyzing the HbA1c data with the glucose data; 
 determining an estimate of average glucose; and 
 controlling the display to visually present the estimate of average glucose. 
 
     
     
         21 - 22 . (canceled)