Abstract:
The Portable Personal Diabetic Management System (PPDMS) is a portable data processing unit that calculates the carbohydrate and nutritional content of meals, calculates the insulin dosage for the meal based on the carbohydrate information, logs the nutritional data that it collects, logs the insulin dosage a user actually takes, logs blood sugar test results, and performs analysis of the collected data.

Description:
TECHNICAL FIELD OF THE APPLICATION  
         [0001]    This invention relates generally to diabetic management, and more specifically to a system and method of portable diabetic management for calculating the carbohydrate and nutritional content of meals; calculating an insulin dosage based on the carbohydrate information; logging the nutritional data, insulin dosage taken, and sugar test results; and performing analysis of the collected data.  
         BACKGROUND OF THE INVENTION  
         [0002]    The conventional method for determining an insulin dosage for a diabetic requires the completion of several time consuming steps. The insulin/carbohydrate ratio must first be determined. This ratio is unique for each individual and generally requires the individual to measure and record all carbohydrate consumption for several weeks. In addition, the individual must carefully measure and record blood sugar levels several times each day. The blood sugar levels indicate how an individual&#39;s metabolism responds to the consumption of specific quantities of carbohydrates. The individual determines the insulin/carbohydrate ratio by dividing the total short acting insulin injected over this period by the individual&#39;s total carbohydrate intake. If the blood sugar levels are too high or too low after using this newly calculated ratio, the ratio must be adjusted and the entire process repeated.  
           [0003]    Determining the insulin/carbohydrate ratio in some people is further complicated by their inconsistent response to carbohydrate intake. For example, a diabetic may have a different carbohydrate/insulin ratio in the morning than in the afternoon and evening. In this case, the diabetic must calculate separate carbohydrate/insulin ratios for each time period. Once the diabetic determines the ratios, the diabetic calculates insulin dosages by multiplying the appropriate ratio by the total carbohydrates consumed during a meal.  
           [0004]    There are a number of disadvantages in determining the insulin dosage with the conventional method. For example, determining the carbohydrates consumed in a meal requires the diabetic to carefully measure the foods in the meal. This involves use of measuring cups, scales, food labels, reference books to look up carbohydrate values for foods that have no labels (i.e., an apple), and a calculator. Accordingly, determining carbohydrates in a meal is time consuming and difficult. It is nearly impossible to perform this task at a restaurant without significant special effort.  
           [0005]    Another complication in determining the proper insulin dosage is that the diabetic&#39;s insulin/carbohydrate ratio can change as the diabetic&#39;s lifestyle changes and as the diabetic grows older. In order to keep up with these changes, the diabetic must continuously record all carbohydrates consumed as well as blood test results. The diabetic must also constantly analyze and monitor this data.  
           [0006]    Accordingly, there is a need to provide a method that automates the process of successfully managing a diabetic&#39;s blood sugar levels.  
         SUMMARY OF THE INVENTION  
         [0007]    The present invention automates the daily error prone tasks that diabetics must accomplish to control their blood sugar. Using insulin to carbohydrate ratio (hereinafter referred to as counting carbs) is the method that most doctors prescribe to diabetics for assistance in controlling blood sugar. The entire process of controlling blood sugar by counting carbs is extremely difficult. The portable personal diabetic management system (PPDMS) as described herein, through automation of the carb counting process, eliminates most of that burden placed on the diabetic The PPDMS measures and reports nutritional information for a meal as a whole and for each individual item in the meal. The PPDMS minimizes the intrusion in a diabetic&#39;s normal eating routines. Thus, the user should be able to use normal plates, bowls, cups, etc, and the user should not be required to rely on a special tray or bowl to measure values on a scale. The user is not required to measure each food item separately. The diabetic is able to add new food information quickly and easily.  
           [0008]    The invention may be better appreciated from the following figures, taken together with the accompanying Detailed Description of the Invention. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]    The invention will now be described with reference to the accompanying figures, wherein:  
         [0010]    [0010]FIG. 1A is an overview block diagram of the portable personal diabetic management system (PPDMS) of the present invention interfaced via the Internet with a doctor&#39;s office.  
         [0011]    [0011]FIG. 1B is an overview block diagram of the PPDMS interfaced with a computer.  
         [0012]    [0012]FIG. 2A is a block diagram of an embodiment of a PPDMS.  
         [0013]    [0013]FIG. 2B is a bock diagram of another embodiment of a PPDMS.  
         [0014]    [0014]FIG. 2C is a block diagram of still another embodiment of a PPDMS.  
         [0015]    [0015]FIG. 2D is a bock diagram of still another additional embodiment of a PPDMS.  
         [0016]    [0016]FIG. 3 shows a flow chart of a nutrition measurement method of the PPDMS of the present invention.  
         [0017]    [0017]FIG. 4 shows a flow chart of a carbohydrate/insulin logging method of the PPDMS of the present invention.  
         [0018]    [0018]FIG. 5 shows a flow chart of a blood sugar logging method of the PPDMS of the present invention.  
         [0019]    [0019]FIG. 6 shows a flowchart of a method to calculate an insulin/carbohydrate ratio.  
         [0020]    [0020]FIG. 7A shows an exemplary insulin/carbohydrate ratio database of the present invention.  
         [0021]    [0021]FIG. 7B shows a nutrition/insulin database of the present invention.  
         [0022]    [0022]FIG. 7C shows exemplary data fields of the nutrition information of the nutrition/insulin database of FIG. 7B.  
         [0023]    [0023]FIG. 7D shows an exemplary blood sugar database of the present invention.  
         [0024]    [0024]FIG. 8A is an exemplary PPDMS start screen.  
         [0025]    [0025]FIG. 8B is an exemplary PPDMS data entry screen for input of a food name.  
         [0026]    [0026]FIG. 8C is an exemplary PPDMS update display of nutritional information.  
         [0027]    [0027]FIG. 8D is an exemplary PPDMS display result of nutritional information and an insulin dosage for a specific user.  
         [0028]    [0028]FIG. 8E is an exemplary PPDMS data entry screen for input of another food name.  
         [0029]    [0029]FIG. 9 shows exemplary data structures of the weight measurement module  229  of FIGS.  2 A- 2 D.  
         [0030]    [0030]FIG. 10 shows an exemplary nutrition fact record. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0031]    The following description is provided to enable any person skilled in the art to make and use the invention, and is provided in the context of a particular application and its requirements. Various modifications to the embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles, features and teachings disclosed herein.  
         [0032]    I. General Discussion  
         [0033]    Before discussing details of the present invention, an example of a data processing system implementing an embodiment of the present invention is discussed in the following section. Referring first to FIG. 1, an example of a data processing system in accordance with a first embodiment of the present invention may be appreciated. In particular, communication links between the PPDMS  104 , the Internet  106 , a doctor&#39;s office  108  and a database update provider  110  are shown. Also shown is a user  102  of the PPDMS, typically an individual with a sugar problem such as a diabetic. It will be appreciated that the systems communicating with the PPDMS were arbitrarily chosen, and that alternative embodiments may include other systems. One of ordinary skill in the art will understand the PPDMS may also communicate to an Intranet, or any other type of network instead of Internet  106 .  
         [0034]    It will also be appreciated that the PPDMS is a stand alone portable system and is typically connected to other systems for minimal time periods. For example, PPDMS  104  enables the user  102  to communicate the information stored in its databases via the Internet  106  or any other available network to a doctor&#39;s office  108  or healthcare provider. PPDMS  104  also enables updates of its programs and data from database update provider  110 . It will be appreciated that there are a number of different methods for enabling the PPDMS  104  to receive and send data to clients and servers of other computer sites.  
         [0035]    For example, referring now to FIG. 1B, the PPDMS  104  is connected directly to a computer  118 . Without a network, the PPDMS  104  sends data directly to the computer  118 , and receives database and program updates directly from the computer  118 .  
         [0036]    Referring now to FIG. 2A, a block diagram illustrating details of an embodiment of the PPDMS  104  may be better appreciated. PPDMS  104  includes a processor  200  coupled to a communications channel  206 . PPDMS further includes input devices such as a blood sugar measurement sensor  202  for measuring a user&#39;s blood sugar and a weight measurement sensor  204  for measuring the weight of food to be consumed by the user. PPDMS also includes an output device  208  such as a liquid crystal display (LCD) display, a communications interface  210 , permanent memory  212  such as a magnetic disk, and working memory such as Random-Access Memory (RAM), each coupled to the communications channel  206 . One skilled in the art will recognize that, although permanent memory  21  and working memory  220  are illustrated as separate units, permanent memory  21  and working memory  220  can be distributed units, integral units or portions of the same unit.  
         [0037]    Permanent memory  212  includes an insulin/carb ratio database  214 , nutrition information database  216 , user nutrition/insulin database  218  and blood sugar database  219 . The insulin/car ratio database  214  preferably includes the user&#39;s last ratio entry calculated for each time period. The nutrition information database  216  includes all the nutrition information, such as carbohydrates and fats, for each specific type and brand of food. The user nutrition/insulin database  218  includes an historical record of a user&#39;s specific nutritional intake and insulin dosage as determined by PPDMS  104 . The blood sugar database  220  includes an historical record of the user&#39;s blood sugar as measured by blood sugar measurement sensor  202 .  
         [0038]    Working memory  224  includes a communication interface module  222 , a blood sugar module  278 , a data management module  226 , a display module  228 , a weight measurement module  229  and an insulin determination module  230 . More specifically, the blood sugar module  278  drives the measurement of the blood sugar, the weight measurement module  229  drives the measurement of the food to be consumed, and the insulin determination module  230  performs the analysis and calculations to determine a user&#39;s insulin dosage. One of ordinary skill in the art will recognize that the modules are previously stored in permanent memory  212  and when executed are loaded into working memory  220 .  
         [0039]    Referring now to FIGS. 2B to  2 D, alternative embodiments of the PPDMS  104  may be better appreciated. In the embodiment shown in FIG. 2B, the PPDMS  104  includes an external scale that includes a weight measurement sensor  204  that interfaces with the other components of this hand held unit. In the embodiment shown in FIG. 2C, the PPDMS  104  includes a device inclusive of a blood sugar measurement sensor  202  and the weight measurement sensor that interfaces with the other components of this hand held unit. In the embodiment shown in FIG. 2D, the PPDMS  104  includes two separate devices, one a weight measurement sensor  204 , and the other a blood sugar measurement sensor that independently interfaces with the other components of this hand held unit. It will be appreciated that these embodiment are only exemplary of the numerous alternative hardware and software configurations that may be employed to implement PPDMS  104  of the present invention.  
         [0040]    PPDMS  104  provides the user maximum portability and reliability. In an embodiment of the invention, PPDMS  104  may be implemented with a PALM IIIXE PDA, manufactured by the PALM CORPORATION with a principle place of business in Santa Clara, Calif., and is attached to an OHAUS SCOUT II electronic balance, manufactured by OHAUS with a principal place of business in Pine Brook, N.J., through the serial cradle of the PALM IIIXE. One of ordinary skill in the art will recognize that the PALM IIIEX PDA and OHAUS SCOUT II electronic balance are provided only as examples and that the present invention may be implemented with alternative components.  
         [0041]    Referring now to FIG. 3, a flow chart  300  of the nutrition measurement process of the present invention may be better appreciated. The process begins in step  302  when a user clicks measure shown on an input screen of the hand held device of the PPDMS  104 . In step  304 , weight measurement module  229  determines whether this is the first food item. If so, in step  306 , weight measurement sensor  204  determines the weight of the food container, and weight measurement module  229  records that weight. If not, data management module  226  looks up the food item in the nutritional information database  218  (See FIGS. 7B &amp; 7C). In step  312 , if the food item is not found in the database, the user may enter the nutritional information about this food directly into the PPDMS  104 . It will be appreciated that although not shown, a user may request and obtain the nutrition information from a database update system  110  via the Internet, Intranet or stand-alone computer.  
         [0042]    In step  312 , if the food item is found in the nutrition information database  216 , insulin determination module  230  determines the nutritional values of the food item and updates the user nutrition/insulin database  218  and the running totals. In step  318 , display module  228  queries the user whether the meal is done. If not, steps  302  to  318  are performed for each additional food item. If the meal is done, in step  320  insulin determination module  230  determines the insulin dosage based upon the insulin/carb ratio retrieved from the insulin/carb ratio database  214  (See FIG. 7A). The retrieved ratio will correlate with the specific time period of the user&#39;s meal. It will be appreciated that the insulin/carb ratio will vary depending upon the time period of the day. Since this ratio directly effects the determined insulin dosage, it is necessary to retrieve the ratio from the appropriate time period. In step  322 , display module  228  displays the users nutritional values and insulin dosage for the meal. In step  324 , the PPDMS process continues to the flowchart shown in FIG. 4.  
         [0043]    It will be appreciated that there are two methods a user may employ to measure food. In the first method, the user starts with an empty container and then adds food to it. In the second method, the user starts with a full container and then removes food from it. The overall method for determining food weight is:  
           W   n   =|W   T   −W   P | 
         [0044]    where  
         [0045]    W n =actual weight of food n  
         [0046]    W c =weight of the container object  
         [0047]    W T =W c +W 1 +W 2 +W 3 + . . . +W n    
         [0048]    W P =W c +W 1 +W 2 +W 3 + . . . +W n-1    
         [0049]    When a user is finished with a container, W P  and W T  are initialized to zero and the process starts over. This method allows the scale to be completely analog except for the ADC. The end user does not need to separately measure each food item in the meal. This allows food to be served in a normal manner.  
         [0050]    Referring now to FIG. 4, a flow chart  400  for logging the users insulin and carbohydrate information may be better appreciated. The process begins in step  402  when display module  228  queries the user whether the user will save or cancel the carb and insulin information. If the user clicks “cancel” the process jumps to step  414  and ends. If the user clicks to “save” the results, in step  404  the user may change the time/date that will be associated with the insulin and carb information. In step  406 , the insulin determination module  230  determines whether the user changed the time value. If the user did change the time value, in step  408  the insulin determination module  230  determines the insulin dosage using the new time value. If the user did not change the time value, in step  406  the process continues to step  410 . In step  410 , the user may change short and/or long term insulin dosage values. In step  412 , data management module  226  stores nutrition, insulin and time information in the user nutrition/insulin database  228 . In step  414  this process ends.  
         [0051]    Referring now to FIG. 5, a flow chart  500  for logging the user&#39;s blood sugar may be better appreciated. The process begins in step  501  when the user provides a sample of blood sugar to blood sugar measurement sensor  202 .  
         [0052]    Blood sugar module  202  determines the blood sugar information. In step  502 , display module  228  queries the user whether the user will save or cancel the blood sugar information. If the user clicks “cancel” the process jumps to step  510  and ends. If the user clicks to “save” the results, in step  504  the user may change the time/date stamp that will be associated with the blood sugar information. In step  506 , data management module  226  stores blood sugar and time information in the blood sugar database  219  (See FIG. 7D). In step  508 , insulin determination module  230  determines the insulin/car ratio for this time period, and data management module  226  saves the results in the user nutrition/insulin database  218 . In step  510  this process ends.  
         [0053]    Referring now to FIG. 6, a flow chart  600  of the process to determine the insulin/carb ratio may be better appreciated. The process begins in step  602  with the insulin determination module  230  determining whether there are “X” samples in the blood sugar database  219  during daily time period “Y” for the last “Z” weeks. If not, the process jumps to step  616  and display module  228  displays an insufficient data warning to the user.  
         [0054]    If there is sufficient blood sugar data, in step  604  insulin determination module  230  calculates a statistical average on the “X” samples. In step  606 , insulin determination module  230  sums all of the carb information during the time period “Y” for the last “Z” weeks. In step  608 , insulin determination module  230  sums all of the short term insulin data during timer period “Y” for the last “Z” weeks. In step  610 , insulin determination module  230  calculates the insulin carb ratio by dividing total short term insulin by the total number of carbs. It will be appreciated that data management module  230  retrieves the carbohydrate and short term insulin information from user nutrition/insulin database  218  for insulin determination module  230 .  
         [0055]    In step  612 , insulin determination module  230  adjusts the nutrition/insulin ratio to account for deviation of average blood sugar “X” from the targeted blood sugar level. In step  614 , data management module  226  saves the ratio to insulin/carb ratio database  214 . It will be appreciated that each ratio is associated with a specific time period since a user&#39;s reaction to carb intake may vary during a given day. In step  614  the process ends.  
         [0056]    Referring now to FIG. 7A, an exemplary insulin/carb ratio database  214  may be better appreciated. As shown, database  214  for each time period  702  includes a start time  704 , an end time  706  and an insulin/carb ratio  708 . It is preferable that only the prior day&#39;s values are included in database  700 . However, one of ordinary skill in the art will recognize that historical insulin/carb data could be stored for the purpose of tracking the ratio.  
         [0057]    Referring now to FIG. 7B, an exemplary user nutrition/insulin database  218  may be better appreciated. As shown, each time period of database  218  includes nutrition information  702 , short term insulin  714 , long term insulin  716  and a time/date stamp  718 .  
         [0058]    Referring now to FIG. 7C, the nutrition information  702  of FIG. 7B may be better appreciated. As shown, nutrition information  702  includes a food name  722 , calories  724 , fat  726 , saturated fat  728 , cholesterol  730 , sodium  732 , total carbs  734 , dietary fiber  736 , sugars  738 , protein  740  and serving size  742 . It will be appreciated that this list is only exemplary and additional nutritional information could also be included.  
         [0059]    Referring now to FIG. 7D, an exemplary blood sugar database  219  may be better appreciated. As shown, for each time period  744 , database  219  includes a time stamp  748  and blood sugar  750   
         [0060]    Referring now to FIGS.  8 A- 8 E, the use of PPDMS may be better appreciated. The example begins with a user that wants to measure a meal that starts with sliced applies. First, the user turns the hand held PPDMS on. FIG. 8A shows a screen provided by display module  228  that a user may view. In response the user places an empty container on the scale and clicks (M) measure. Weight measurement sensor  204  obtains and temporarily stores the weight in working memory  220 .  
         [0061]    In FIG. 8B, the user then enters the food name on the food-input line and then clicks (M) measure. In response, the nutrition analysis as described in FIG. 3 occurs. Insulin determination module  230  calculates the nutritional amounts based on the values in nutrition information database  216  and the measured weight of the food. As shown in FIG. 8C, display module  228  displays the nutritional results for the entered food.  
         [0062]    The user may continue to enter additional food items to the container and click measure after each entry. It will be appreciated that the user may also use additional containers. When the user completely accounts for all of the food in the meal, the user may click the “Done With Meal” button. In response, as shown in FIG. 8D, display module  228  displays the meal total nutritional results. Display module  228  also displays the time/date stamp  718 ,short-term insulin dosage  714  and long term insulin dosage  716 . It will be appreciated that the long-term insulin dosage is not shown in FIG. 8D.  
         [0063]    If data management module  226  had not located sliced apples in nutrition information database  226 , the user has the opportunity to enter the nutritional data. In FIG. 8E, display module  228  displays an input screen for entry of nutritional information for a specific food. It will be appreciated that the user may alternatively retrieve the nutritional information from a database update provider  110  via the Internet, Intranet or stand-alone computer.  
         [0064]    Referring now to FIG. 9, an embodiment of the data structures for weighing the food and calculating nutritional information for a given meal may be better appreciated. As shown, an instant of tMeal  902  consists of multiple container instances (tcontainer  904 ) and a running total of nutritional information (of type tNutr_FactsRecord) for the meal. The functions of tMeal  902  manipulate the included data structures.  
         [0065]    An instance of tContainer  904  consists of multiple food instances of type tFood_Weight  906  and the associated function listed for manipulating the included data structures. An instance of tFood_Weight  906  consists of a single food record instance of type tNutr_FactsRecord and the weight of the food. The information stored in tNutr_FactsRecord object is shown in FIG. 10. It will be appreciated that tNutr_FactsRecord object provides the data structure for user nutrition/insulin database  218 .  
         [0066]    It will also be appreciated that the data structures in FIG. 9 allow a user to measure the nutritional value of the user&#39;s meal without the use of special containers. A user simply places a typical container on the scale and adds to or removes food from the container. These data structures also allow a meal to be reviewed. For example, if a user want to view detailed information for a particular food item, the information can be easily retrieved from these data structures.  
         [0067]    One of ordinary skill in the art will recognized that FIG. 9 shows an embodiment of data structures and modules, and that other embodiments may implement PPDMS with alternative data structures and modules.  
         [0068]    It can therefore be appreciated that a new and novel system and method for portable personal diabetic management has been described. It will be appreciated by those skilled in the art that, given the teaching herein, numerous alternatives and equivalent will be seen to exist which incorporate the disclosed invention. Further, this teaching can be applied to other fields. For example, if the insulin calculations are not included, the device could assist people who are trying to maintain a diet, such as athletes, people with heart problems, and those who are trying to lose weight. As a result, the invention is not to be limited by the foregoing exemplary embodiments, but only by the following claims.