INSULIN BOLUS CALCULATOR FOR MOBILE COMMUNICATION DEVIE
This invention relates to the fields of diabetes management. It relates in. particular to a mobile phone based application to calculate the type and magnitude of action necessary to control blood glucose levels. It also relates to a method of operation of such a system.
In this specification, the term Equivalent Teaspoon Sugar (ets) means an energy unit used for quantifying energy in food and energy usage in exercise.
Furthermore ets can also be used to quantify energy being expended during exercise by relating the energy to the effective energy available in a teaspoon sugar, ets can also be used to express any quantity of energy e.g. the blood glucose energy in the blood or the amount of glycogen energy stored in the liver. Furthermore, in this specification, the term insulin includes within its scope any blood sugar regulatory substance.
Furthermore, in this specification, the term diabetes or diabetic refers to Type 1 diabetes or Type 1 diabetic respectively unless otherwise stated.
DESCRIPTION OF PRIOR ART
IDDM (Insulin Dependant Diabetes Mellitus) or Type I Diabetes is the condition where the islets of Langerhans can no longer supply the body with the hormone Insulin. Insulin is needed by the human body to help control blood glucose levels. When consuming food containing carbohydrates (CHO) the blood glucose levels will rise. Insulin is then needed to lower the blood glucose level back to an acceptable level again by storing glucose as glycogen. Insulin is also needed by the cells to utilize the energy of the sugar in the blood. It is therefore necessary for patients with IDDM to monitor and control their blood glucose levels by administering insulin. This will help keep their blood glucose levels under a safe range preventing hypoglycemia and hyperglycemia.
Hypoglycemia occurs when the blood glucose level falls too low while hyperglycemia is the result of high blood glucose levels. Hypoglycemia has a more immediate or short-term threat to the diabetic, which can cause comas, seizures or even death. Hyperglycemia's effects become evident after a longer term of elevated blood glucose levels.
A common need therefore exists among diabetics to simplify the control of their disease. Currently many diabetics are following rigid daily schedules concerning their meals, exercises and insulin administrations. This makes it difficult for IDDM diabetics to calculate their insulin requirements when eating different meals or doing irregular extra exercises.
Although several other insulin prediction devices are patented and manufactured, the methods (e.g. carbohydrate counting) used so far have not been very accurate. This invention is unique because the insulin prediction is done using the ets concept discussed in the discussion. Blood glucose prediction for the individual can be done with high accuracy. Using the ets blood glucose prediction model the required insulin dose can be calculated for the individual.
OBJECTS AND ADVANTAGES OF THE INVENTION
The main objective of this invention will be to calculate the type and measure of the corrective action needed at a given time to control the diabetic's blood glucose level within a safe range. The device will take into account the current blood glucose level, immediate food intake, exercise within 6 hours and several parameters measured on the individual patient. The main advantages of this implementation are the very low cost of the device and also the high accuracy of the prediction algorithm discussed in the description. The application for mobile phone will also be a great educational tool to teach diabetics the dynamics involved in their blood glucose control. Further objectives and advantages will be mentioned in the description.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows the block diagram of the mobile phone Insulin bolus calculation device.
FIG. 2 shows the typical blood glucose response of a Type 1 diabetic after consuming a meal containing carbohydrates.
FIG. 3 shows the typical blood glucose response of a Type 1 diabetic after administering short acting insulin.
FIG. 4 shows the increase in blood glucose (for Type 1 diabetics) to ets intake as piecewise linear function with two sections.
DETAILED DESCRIPTION
This present invention is a system using a new method to help patients with IDDM to calculate the type and measure of corrective action needed to control their blood glucose levels within a safe range. Before the functionality of the bolus insulin calculation application can be explained, the ets concept first has to be explained.
The ets concept is the fundamental principal used by the device for calculating the corrective action needed, ets is a new generic energy unit, ets is the abbreviation for Equivalent Teaspoons Sugar. This energy unit can be used to quantify energy in food and energy usage in exercise. Quantifying food in ets, the effect that food intake will have on blood glucose levels for a specific person, can be predicted. The blood sugar response after a meal will be predicted by using the amount of ets in the meal. Exercises can also be quantified in ets for the individual. This is very useful in calculating appropriate insulin doses for Type I diabetics. In general the blood glucose , level rise for a type 1 diabetic is dependent upon the ets intake as shown in Figure 4. The gradient or sensitivity to ets is a person specific factor and can easily be measured.
The characterisation method used by the invention is based on the ets concepts. Characterisation is necessary in order to customize these products for the individual diabetic user. The effect that ets intake has on the increase of blood glucose concentration for the diabetic is approximated by a linear function.
Increase in blood sugar level = EC . Ets consumed (1 )
The ets sensitivity value EC can be calculated performing the simple test procedure to determine the individuals blood glucose increase per unit ets consumed- At high levels of ets inta e, the ets sensitivity (EC) decreases. The blood
glucose response for ets intake can generally be approximated by two piecewise linear continuous functions shown in FIG. 4. Typical patients eating healthy will normally stay within the first part of the approximation function therefore simplifying blood glucose response prediction with a single linear function.
FIG. 2 shows a typical blood glucose response of a Type I diabetic after eating a meal containing carbohydrates. The meal is ingested after fasting for six hours or longer. The time of the meal is taken as 0 minutes (15). The ets sensitivity test is performed after a six hour fast to eliminate the effects of the previous meal and previous short acting insulin injection. By this time the blood glucose level is stable. The test should not be performed if the patient is stressed or has an illness that can have an effect on the blood glucose levels. The meal that the patient eats during the test should be carefully quantified in ets. This can be done using ets tables published in literature, databases available on the Internet or other products available. The patient's blood glucose level is measured every 30 minutes (or continuosly) after the meal for the next 3 hours using a blood glucose monitor. The maximum value of these blood glucose level measurements will be used to calculate the rise in blood glucose level 13 caused by the meal. The level rise 13 is the difference between the maximum level 12 and the blood glucose level prior to the meal 14. ets sensitivity (EC) can then be calculated. Increase in bloodsugar level ets in meal
ets sensitivity (EC) for higher values of ets intake can also be calculated by eating more ets after the blood sugar stabilized after the meal. Equation (2) can then be used to calculate ets sensitivity (EC) at higher levels of ets intake.
The effect that insulin has on the decrease of blood glucose concentration for the diabetic can also be approximated by a linear function.
Decrease in blood sugar level = IC . Umsuym inj-ected (3)
The sensitivity of insulin value IC can be calculated performing the second part of the test procedure. The insulin sensitivity value (IC) gives a good indication of how resistant the patient is to. insulin. Better insulin sensitivity values imply low insulin resistance and vice versa.
FIG. 3 shows a typical blood glucose response of a Type I diabetic after administering short acting insulin. This response illustrates an initial high blood glucose level being lowered by the administering short acting insulin. For purpose of the test insulin is only injected after the blood glucose level has stabilized after the meal. The time of the short acting insulin injection is taken at 0 minutes (19). The insulin dosage or units to be injected should be sufficient to lower blood glucose level back to an acceptable value. The patient's blood glucose level is measured right before the injection and every 30 minutes (or continuosly) thereafter. The minimum value where the blood glucose level stabilizes is used to calculate the decrease in blood glucose level. This is merely the difference 17 between the stabilized blood glucose level after the meal 16 and the stabilized blood glucose level after the insulin injection 18. The insulin sensitivity can then be calculated. _ Decrease in bloodsugar level resulting from insulin injection number of units insulin injected
To calculate the corrective action needed to control blood glucose level becomes a simple task. The predicted blood sugar level can be calculated using Equation 5.
DOpredicted = DOcurrent "'" E . θfS consumed- IC.L jnsulin injected (5)
If we want to control the blood sugar level in a safe range, we specify the SSpredicted value as the desire blood glucose level BSdesired and calculate the Uinsuiin needed.
D wanted = D current "*" EC etS consumed ~" 'C. L/jnsulin needed (6)
Therefore the (Λιsuiin needed can be calculated by manipulating equation 6.
(-'insulin needed = ( oScurrent ~ oS anted + EU. etS consumed) / IC (7)
The effect of exercise can also be introduced in a similar way by quantifying exercise in terms of ets exercised. This will result in a reduction in blood glucose level per unit exercise performed. Different exercises can be quantified in terms of ets exercised. The sensitivity EXC will be determined by the decrease in blood glucose level per unit ETSeXercised. If exercise is to be considered Equation 7 can be altered.
(-'insulin needed = ( β^current " D wanted + EL>. etS consumed ~EχL>. etS exercised) ' IC. (o)
If (Jinsuiiπ needed provides a positive value, the value indicates the number of short acting insulin units to inject. If l/jnSuiin needed provides a negative value, this means that the blood glucose level will already be too low without injecting any insulin. This means that some food containing a certain amount of ets should be eaten. To calculate the amount of eteto be eaten to restore normal blood glucose levels equation 9 can be used.
StS fo be eaten ~ (EχO. ΘifS exercised " S^current + SSwanted ) ' E (9)
In short if the diabetic knows what the effect of a certain amount of food and exercise will be on his/her blood sugar, and the diabetic knows what effect one unit of insulin will have on his/her blood glucose level, it becomes an easy task to calculate the required insulin dosage. Therefore it is important to calculate the ets and insulin sensitivity values accurately using the device.
Fig. 1 shows the block diagram for the mobile communication device based insulin bolus calculation application. Said application consists of an input means , processing means, storage means and output means. Input means receives from the user current blood glucose values, selections of food and beverages to be consumed, user specific parameters such as sensitivities to ets and isulin and othe body characteristics, selections of exercises to be performed as well as the duration and time of activities.
Said storage means stores exercise, food and medication databases as well as user specific parameters and a log of all activities including food intake, exercises, medication and time thereof. Equations 7, 8 and 9 is executed by the processing means by taking the inputs and stored information into account. More complex versions of these equations are executed by the processing means to take into account the time lapsed since events, medication release and absorbtion rates as well as effects on meals altering the gucose absorbtion of these meals.
Said output means is responsible for displaying suggestions such as an insulin bolus dosage, amount of carbohydrates to be consumed and other recommendations regarding blood glucose control. The output means is also responsible for the general display of information such as the content of the databases and other information or instructions deemed necessary.