WO2005110222A1

WO2005110222A1 - Blood sugar control system and medical treatment method using the same

Info

Publication number: WO2005110222A1
Application number: PCT/KR2005/001244
Authority: WO
Inventors: Hyoung-Soo Jeun
Original assignee: Okto Medical Appliance Co., Ltd.
Priority date: 2004-05-18
Filing date: 2005-04-29
Publication date: 2005-11-24

Abstract

The present invention relates to a blood suger control system and a medical treatment method using the same, wherein the blood suger control system comprises a health status sensing unit which measures various changes in the health status of a diabetic patient occurring in unit time, including changes in the amount of exercise, the amount of food ingested and body temperature, as well as the factors for such changes, respectively; a blood suger measuring unit which measures the blood suger level of the diabetic patient; an insulin supplying unit which supplies insulin in accordance with a control signal applied; a control unit which applies corresponding signals for initiation of measurement respectively to the health status sensing unit and the blood suger measuring unit at scheduled times, receives the respective measured values from the health status sensing unit and the thermometer, thus determines as to whether these respective measured values fall within the established scopes and as to whether blood suger measurement is necessary based on the previous determination, determines as to whether the data of measured value received from the blood suger measuring unit falls within the established scope and as to the amount of insulin to be supplied in accordance therewith, and controls the insulin supplying unit based on each of the above determinations; and a wired/wireless data transmitting and receiving unit which transmits the data including the above-mentioned respective measured values and the amount of insulin supplied through the Internet or mobile telecommunication service.

Description

Description BLOOD SUGAR CONTROL SYSTEM AND MEDICAL TREATMENT METHOD USING THE SAME

Technical Field

[1] The present invention relates to a blood suger control system which helps in maintaining and managing a diabetic patient's health, and to a method of medical care using the same. Background Art

[2] In general, diabetes mellitus is a chronic disease in which glucose absorption is not properly achieved in the body owing to insufficient secretion of insulin or abnormal functioning of secreted insulin, and it can be classified into the insulin-dependent type and the non-insulin-dependent type. Of these, insulin-dependent diabetes mellitus is caused by abnormal secretion of insulin, and it is known that the disease frequently occurs in childhood or before the age of 30's. The other one of them, non- insulin-dependent diabetes mellitus, usually occurs after the age of 40's and occupies 80 to 90% of diabetic patients in total. The latter is deeply related with obesity, and in this case, too, sometimes supply of insulin may be needed.

[3] As the therapeutic method for a diabetic patient, diet therapy of regulating the kind of food taken and the amount of ingestion thereof; exercise therapy of doing aerobic exercise so as to use less insulin in the body and to lower the blood suger level; drug therapy of administering a hypoglycemic agent or controlling the blood suger level forcibly via insulin supply; and the like are widely known.

[4] In these methods, a diabetic patient is instructed to carefully select food and regulate the amount of ingestion thereof, to regulate the amount of activities including aerobic exercise, and to take an oral hypoglycemic agent in response to the change of blood suger level, or to appropriately regulate the amount of insulin to be supplied and the time for supply thereof.

[5] Among the above-described blood suger controlling methods, diet therapy and regulation of the amount of exercise foster the diabetic patient's autonomous ability to control blood suger, and even in the case of an insulin-dependent diabetic patient, the methods help the patient to restrain himself or herself from supply of insulin as much as possible, thus preventing misuse and overuse of insulin and side-effects resulting therefrom, and thereby reducing waste of insulin. Thus, these methods are expected to be the most preferred methods.

[6] However, the pumps for supplying insulin that are well known nowadays are basically intended to supply a constant amount of insulin continuously to a diabetic patient, and when the blood suger level is changed to a hypoglycemic level under the action of a standard amount of insulin supplied (fixed standard amount), the patient is instructed to ingest additional food in accordance with the change in order to maintain the blood suger level.

[7] Now, these problems in the prior art will be more specifically examined with reference to the attached drawing. In Figs. 1 through 4, the vertical axis represents the "blood suger level", and the lateral axis represents "time". Further, the Roman numerals "I", "II" and "III" correspond to the respective meals in a day, that is, breakfast, lunch and supper indicating the times for food ingestion by the diabetic patient.

[8] First, in the case of a normal person, as shown in the graph of Fig. 1, the amount of insulin secretion is spontaneously regulated in accordance with the change in the blood suger level resulting from ingestion of food, and thus the blood suger level can be maintained stably. In contrast, in the case of an insulin-dependent diabetic patient, as shown in Fig. 2, not only the basic amount of insulin secretion is smaller compared with that of a normal person, but also the amount of insulin secretion does not change significantly in spite of the increase of the blood suger level resulting from ingestion of food. Therefore, in an insulin-dependent diabetic patient in the normal state, the blood suger level gradually increases as indicated by the arrow (H) in Fig. 2.

[9] As shown in the above, the insulin-dependent diabetic patient requires a blood suger control system in order to promote glucose absorption in the body. In the insulin supply system of the prior art according to such need, as shown in Fig. 3, the amount of insulin to be supplied which is supplemental to the essentially insufficient secretion of insulin in the diabetic patient is fixed (fixed standard amount), and this amount is continually supplied. Furthermore, the insulin supply system according to the prior art restricts the diet of the diabetic patient such that meals are restricted to be taken in an amount corresponding to a certain amount of calories with a certain frequency according to a restricted time schedule, and the system also supplies additional insulin in accordance with the time of ingestion and the amount of food ingested.

[10] However, the graph illustrated in Fig. 3 shows merely an ideal relation of blood suger control pursued by the prior art. In practice, since the blood suger level of a diabetic patient and the amount of insulin secretion are not maintained constant depending on the diabetic patient's health status and activity status including changes in body temperature and pulse rate, there is difficulty in determining the fixed standard amount of insulin. Further, in a diabetic patient's daily life, the eating habit can be hardly set with an exact time schedule, and also precise control of the amount of insulin to be supplied in response to the amount of food ingested is difficult.

[11] With reference to Fig. 4, the part indicated by Al corresponds to the case where a diabetic patient woke up after the course of sleeping and performed aerobic exercise such as walking. It can be seen from this figure that the blood suger level of a diabetic patient can be maintained at the level of a normal person even during sleep. It can be also seen that when the diabetic patient performs light exercise such as walking, glucose absorption in the body is effectively achieved, thus leading to spontaneous lowering of the blood suger level. In this state, if insulin is supplied in the fixed standard amount, the diabetic patient enters a dangerous state in which the patient rather turns to be in hypoglycemic condition. In this case, even though insulin is not supplied any longer or supplied in an amount less than the fixed standard amount, there is no problem in maintaining the blood suger level within the range of a normal person's level (70 to 140 mg/dl). Thus, in such case as the above, despite the autogenous control of blood suger through the amount of exercise, excessive supply of insulin (XI) to the fixed standard amount leads to waste of insulin and also to the reversion of the diabetic patient to the hypoglycemic condition. Such supply of insulin also makes the control of the blood suger level in a diabetic patient more difficult. In addition, the conditions that are suggested by the insulin supply system with respect to the time and amount of meals require the diabetic patient to check the schedule in detail, which is bothersome to the patient. Also, as indicated by A2 in Fig. 4, when the diabetic patient skips a meal, even though it is not necessary to supply additional insulin, excessive supply of insulin (X2) to the fixed standard amount occurs, rather to cause the problem of hypoglycemia and to make it more difficult to provide a standard for blood suger control. Moreover, in the case where body temperature of the diabetic patient increases, a further supply of insulin becomes meaningless. If insulin is supplied continuously at this point, there occurs the problem of hypoglycemia.

[12] As such, it has been a general practice that a diabetic patient needs to check every time whether the blood suger control by the conventional insulin supply system has been appropriate, and for this checking, the patient has to collect blood by pricking the finger or the like with a needle and measures the blood suger level.

[13] As examined in the above, the method of intermittent blood suger measurement faces many problems in coping with the health status of a diabetic patient that changes from moment to moment (for example, mention may be made of drastic changes in the amount of exercise within unit time, drastic changes in body temperature due to an environmental cause, drastic changes in pulse rate due to uncertain reasons, changes in the blood pressure due to complicating diseases, and the like). Disclosure of Invention Technical Problem

[14] It is an object of the present invention to allow selective performing of supply of insulin as well as measurement of the blood suger level including the general method of measuring blood suger, and to allow appropriate control and use of the fixed standard amount of insulin in response to the health status of an insulin-dependent diabetic patient and the environmental factors. Technical Solution

[15] In a constitution to achieve the above-described object, changes in the health status of a diabetic patient, including changes in the amount of exercise, the amount of food ingested, pulse rate and body temperature occurring in each unit time, and the factors for such changes are measured; it is determined therefrom as to whether the blood suger level can be controlled to an appropriate level by the amount of exercise, whether insulin supply should be stopped due to pathogens such as cold virus, and whether blood suger measurement should be carried out in support of the determinations; from the results of the determinations, it is determined as to whether a supply of insulin is needed and as to how the amount of supply should be regulated in response to the need for the supply, and control over these are made; and necessary data including the respective measured values and the amount of insulin supplied as mentioned above are transmitted to the physician in charge, so that the respective measured values and the standard value needed for the supply of insulin can be adjusted. Advantageous Effects

[16] According to the present invention, a medical care service is achieved in which supply of insulin to a diabetic patient as well as blood suger measurement can be carried out properly; waste of insulin is reduced; and the physician in charge can conduct remote medical examination and remote adjustment resulting therefrom on a regular basis by means of bidirectional transmission of data through the Internet or mobile telecommunication service, thereby an autonomous ability being fostered in the diabetic patient and also the diabetic patient's health being maintained stably. Brief Description of the Drawings

[17] Fig. 1 is a graph illustrating the blood suger level and the corresponding amount of insulin secretion in a normal person.

[18] Fig. 2 is a graph illustrating the blood suger level and the corresponding amount of insulin secretion in a diabetic patient.

[19] Fig. 3 is a graph illustrating the amount of insulin to be supplied that is fixed based on regular and quantitative food ingestion and the expected values for the change in the blood suger level in accordance therewith.

[20] Fig. 4 is a graph illustrating inappropriate changes in the blood suger level resulting from a supply of a fixed amount of insulin, in response to the changes in health status of a diabetic patient including the changes in the amount of exercise and the changes in the amount of food ingested.

[21] Fig. 5 is a block diagram schematically representing the constitution of the blood suger control system of the invention.

[22] Fig. 6 is a flowchart illustrating the course of the medical care service using the blood suger control system of the invention. Best Mode for Carrying Out the Invention

[23] The blood suger control system according to the invention comprises, as shown in Fig. 5, a health status sensing unit (100) which measures changes in various health status of a diabetic patient, including the changes in the amount of exercise, the amount of food ingested, pulse rate and body temperature of the diabetic patient occurring in each unit time, as well as the factors for such changes, respectively.

[24] The blood suger control system also comprises with a blood suger measuring unit (200) which measures blood suger of the diabetic patient, an insulin supplying unit (300) which supplies insulin in accordance with the control signal applied, and a control unit (400).

[25] The control unit (400) as described herein applies signals for initiation of measurement correspondingly to the health status sensing unit (100) and the blood suger measuring unit (200) at scheduled times. The control unit (400) also receives from the health status sensing unit (100) the respective values measured in response to the signal for initiation of measurement, such as the measured values for amount of exercise and body temperature, and thus determines as to whether each of these measured values and the degree of change thereof lie in the established scopes. Based on this determination, the control unit (400) determines again as to whether blood suger measurement is necessary. At this stage, the control unit (400) applies a signal for initiation of measurement to the blood suger measuring unit (200) in response to the determination made to carry out blood suger measurement, and as a result, the control unit receives the data of measured values. Subsequently, the control unit (400) determines as to whether the data of the measured values for blood suger lie within the established scope. The control unit then combines the data received from the above- mentioned health status sensing unit (100) with the measured values for blood suger to determine the amount of insulin to be supplied, thus controlling the insulin supplying unit (300). Supply of insulin or additional supply thereof may be determined when the measured value for blood suger lies outside the established scope, such as in the case where the diabetic patient has not carried out exercise to an ordinary level or has not taken enough care in glucose ingestion. Thus, the amount of additional supply of insulin is intended to control blood suger possibly based on the usual amount of exercise and the usual amount of food ingestion, in order to prevent a hypoglycemic condition or overuse of insulin.

[26] In addition to the above constitution, the control unit (400) further comprises a timer (500), a memory unit (600) for saving the above-mentioned measured values, a processing unit (700) which has the functions of inputting and processing the established standards for the blood suger measurement and insulin supply with respect to the above-mentioned measured values that can be done directly by the diabetic patient himself/herself so that the patient can adjust the standards, and a wired/wireless data transmitting and receiving unit (800) which has the function of transmitting and receiving various data including the amount of insulin supplied, which are saved in the above-mentioned memory unit (600), with the terminal of the physician in charge through the Internet or mobile telecommunication service. Here, the memory unit (600) has the function of sequentially saving the measured values taken in each unit time and the measured values for body temperature change in the diabetic patient which are received from the health status sensing unit (100) under the control of the control unit (400), the measured values received from the blood suger measuring unit (200), and the data of the amount of insulin supplied via the insulin supplying unit (300). Also, the wired/wireless data transmitting and receiving unit (800) has the functions of regularly transmitting to the terminal of the physician in charge the information on the amount of insulin supplied at the times corresponding to the data of measured values taken in each unit time, which have been saved in the memory unit (600) by the user's manipulation through the processing unit (700), and of receiving from the physician's terminal the instructions for medical examination and the examination results including the adjusted values for the established standards prepared by the physician in charge. In this connection, the control unit (400) applies the measures instructed by the physician in charge that have been received through the wired/wireless data transmitting and receiving unit (800), to the adjustment of the above-mentioned established scopes. The processing unit (700) is preferably constituted so as to have the function of inputting the above-mentioned established scopes and the parameters needed in calculation of the amount of insulin to be supplied, after adjusting them by manipulation of the user, and the function of resetting the data in each unit time that are saved in the memory unit (600) in order to initialize them as needed.

[27] Now, the constitution of the health status sensing unit (100) and the information on the data of measured values obtained from that constitution will be examined more specifically. First, the constitution of the health status sensing unit (100) may consist of a combination of at least one of a step meter (120) which counts the number of impact exerted on the body, a pulse meter (130) which senses changes in pulse rate of the body, a thermometer (110) which senses changes in body temperature of the diabetic patient, and a blood pressure monitor (140) which senses changes in the blood pressure in the body. Each of the components constituting the health status sensing unit (100) has a distinctive code value, and the data of various measured values obtained from the components, correspondingly accompanied with the respective code values for the components, are saved in the memory unit (600) by the above-mentioned control unit (400) sequentially in each unit time. Furthermore, in the health status sensing unit (100), each piece of information is measured separately in order to enable comparison at the control unit (400) of the data of the measured values taken in each unit time so that it may be determined whether the factors for changes in health status correspond to the amount of exercise of the diabetic patient, or the temperature condition of the environment or a factor attributable to a cold or the like which has been input through the processing unit (700).

[28] Meanwhile, the above-mentioned processing unit (700) further comprises an output device for indicating the information on the level of change in health status obtained from the health status sensing unit (100), the information on the measured values for blood suger obtained from the blood suger measuring unit (200), and data including the amount of insulin to be supplied. The control unit (400) has the function of accumulating the information on the amount of insulin supplied and calculating the residual amount of insulin in the insulin supplying unit (300), and of indicating the calculated values by means of the output device. The foregoing output device has the function of providing output signals including alarm, lamplight and vibration so that the time for measuring blood suger, the time for supplying insulin and the time for replacing insulin can be checked separately according to the control signals from the control unit (400). Mode for the Invention

[29] Based on such constitution of a blood suger control system, the course of the medical care service using the same will be examined with reference to attached Fig. 6.

[30] First, the step (a) is carried out in which the elements indicating the health status of a diabetic patient such as the kind of food taken by the diabetic patient and the amount of food ingested, change in body temperature, change in pulse rate, change in the blood pressure and change in the amount of exercise are determined (ST 102), and each of the data combining at least one of these measured values taken in each unit time is saved sequentially (ST104). The step (b) is carried out in which the control unit (400) determines based on these data as to whether the above-mentioned data of measured values fall in the established scopes (ST106). Then, the step (c) is carried out in which the control unit (400) applies a signal for initiating blood suger measurement to the blood suger measuring unit (200) in response to the deviation of the results as determined in the step (b) from the established scopes, so that the blood suger measuring unit (200) measures the blood suger level (ST 108). Then, the step (d) is carried out, in which the control unit (400) calculates the amount of insulin to be supplied, as described above, with reference to the respective data of measured values from the step (a) and the step (b), including the measured values for blood suger from the step (c) that is optionally carried out (ST110).

[31] At this stage, when the amount of insulin to be supplied that is obtained by calculation at the step (d) is considered to have little effect onto the control of the blood suger of the diabetic patient, the patient is induced to stop the insulin supply, while when it is decided that blood suger control is necessary, a calculated amount of supply of insulin is supplied in response to the control (ST112) (ST114).

[32] That is, the blood suger control system of the invention determines as to whether to supply insulin to a diabetic patient or not at each predetermined unit time and induces the patient to possibly restrain himself or herself from insulin supply.

[33] It is confirmed that the course of the steps (a) through (f) as described above is repeated within a predetermined time period or for a certain number of times (X) (ST116), and the data of various measured values corresponding to the health status of a diabetic patient including the amount of insulin supplied and the amount of exercise done up to the point of time, and the data such as the amount of insulin to be supplied are output (ST118). Outputting of data here includes transmission of data to the terminal of the physician in charge by means of the wired/wireless data transmitting and receiving unit (800) as described above.

[34] The output obtained from the above-mentioned course is checked by the physician in charge or by the diabetic patient under the consult of the physician, and it is used as the supporting material for the determination on whether the established scopes and the calculation parameters in the repeated course of the steps (a) through (f) are suitable in blood suger control of the diabetic patient (ST 120). When it is considered therefrom that adjustment is needed for the established scopes and the calculation parameters, the control unit (400), which has received the measures instructed by the physician from the user or from the wire/wireless data transmitting and receiving unit (800), carries out adjustment of the established scopes and calculation parameters in accordance with the measures instructed by the physicians, through the control unit (700) (ST 122).

[35] Here, the above-described step of outputting (ST118) has been explained as the process of transmission and reception of the above-described data through the network with the terminal of the physician in charge who can judge based on the data. But, the definition is not limited thereto. The step can be also explained as the process of transmission and reception of the data with a terminal in which a program for converting the data to a form that makes checking easy and displaying them is installed.

[36] In addition to the above constitution, it is preferable that the control unit (400) of the above-described blood suger control system further includes a conventional input device, including a voice input device or a manual input device, so that the information on the kind and the amount of food ingested as well as the time of food ingestion can be easily input in the step (a) through such voice input device or manual input device. Industrial Applicability

[37] On behalf of a diabetic patient, the present invention reduces the frequency of blood suger measurement and any problems associated with the measurement based on the standard values for the respective measurements; economically benefits by suppressing insulin supply and thereby reducing the amount supplied; allows remote medical examination by the physician in charge and remote adjustment in accordance with the medical examination on a regular basis by means of bidirectional transmission of data through the Internet or mobile telecommunication service, thus fostering an autonomous ability of the diabetic patient; and maintains the diabetic patient's health stably.

Claims

[1] A blood suger control system comprising (i) a health status sensing unit which measures changes in the health status of a diabetic patient, including changes in the amount of exercise, the amount of food ingested, pulse rate and body temperature of the diabetic patient occurring in each unit time, as well as factors for the changes; (ii) a blood suger measuring unit which measures the blood suger level of the diabetic patient in response to a control signal applied; (iii) an insulin supplying unit which supplies insulin in accordance with a control signal applied; and (iv) a control unit which applies corresponding signals for initiation of measurement respectively to the health status sensing unit and the blood suger measuring unit at scheduled times, receives the measured values from the health status sensing unit, including the value for change in body temperature, thus determines as to whether these respective measured values fall within the established scopes, determines as to whether blood suger measurement is necessary based on the previous determination, determines as to whether the data of measured value received from the blood suger measuring unit falls within the established scope and as to the amount of insulin to be supplied in accordance therewith, and controls the insulin supplying unit based on each of the above determinations.

[2] The blood suger control system according to claim 1, wherein the control unit further comprises a processing unit for inputting data such as the amount of food taken or the health status of the user, a memory unit for saving data including the input items and a timer; and the memory unit sequentially saves the reference for the determinations made at the control unit, the respective measured values taken in each unit time that are received from the health status sensing unit and the blood suger measuring unit, the amount of insulin to be supplied determined by the control unit, and the data input at the processing unit, in accordance with the control of the control unit.

[3] The blood suger control system according to claim 1, wherein the health status sensing unit comprises a combination of at least one of a step meter which counts the number of impact exerted on the body, a thermometer which measures changes in body temperature, a pulse meter which senses changes in pulse rate in the body, and a blood pressure monitor which senses changes in blood pressure in the body.

[4] The blood suger control system according to claim 1, wherein the control unit further comprises an output device for indication of data including the information on the level of changes in the health status, the information on the blood suger level measurement obtained from the blood suger measuring unit, and the amount of insulin to be supplied.

[5] The blood suger control system according to claim 4, wherein the control unit is to accumulate the information on the amount of insulin supplied, thus to calculate the residual amount of insulin in the insulin supplying unit, and to control the output device in order to display the calculated value.

[6] The blood suger control system according to claim 4, wherein the output device controls the output signals including alarm, lamplight and vibration so that the time for blood suger measurement, the time for insulin supply and the time for insulin replacement can be checked separately in accordance with the control signals from the control unit.

[7] The blood suger control system according to claim 2, which further includes a wire/wireless data transmitting and receiving unit which has the function of transmitting and receiving the data saved in the memory unit, including the respective measured values and the amount of insulin supplied, with the terminal of the physician in charge through the Internet or mobile telecommunication service in accordance with the control signals from the control unit.

[8] The blood suger control system according to claim 7, wherein the wired/wireless data transmitting and receiving unit has the function of transmitting the data that have been saved in the memory unit by means of manipulation at the processing unit, to the terminal of the physician in charge on a regular basis, and the function of receiving the results of medical examination including the adjusted values for the established standards from the physician's terminal; and the control unit further has the function of adjusting the established scopes in accordance with the measures instructed by the physician in charge that are received from the physician's terminal.

[9] The blood suger control system according to claim 2, wherein the processing unit has the function of inputting after adjusting the established scopes and parameters for the calculation of the amount of insulin to be supplied by means of the user's manipulation, and the function of resetting the data of the measured values taken in each unit time that have been saved in the memory unit in order to selectively initialize the data.

[10] A medical treatment method using a blood suger control system, which uses the constitution of the blood suger control system according to any one of claims 1 to 9 and comprises the following steps: (a) sequentially saving the data of the measured values taken in each unit time by combining at least one of the kind of food taken and the amount of food ingested, changes in body temperature, changes in pulse rate, changes in blood pressure and changes in the amount of exercise of a diabetic patient; (b) determining as to whether the respective data from step (a) fall within the established scopes; (c) measuring the blood suger level in response to any deviation of the results obtained in the step (b) from the established scopes; (d) calculating the amount of insulin to be supplied in accordance with the results obtained in the steps (a) to (c); (e) determining as to whether insulin should be supplied in response to the results obtained in the steps (a), (b) and (d); (f) supplying insulin according to the above calculation in response to any deviation of the result obtained in the step (e) from the established scope; and (g) saving the data of the measured values for blood suger and the amount of insulin supplied that are obtained from steps (c) to (f).

[11] The medical treatment method using a blood suger control system according to claim 10, which further comprises a step of determining as to whether the saved data should be output in response to the repetition of the above steps (a) through (f) for one or more times within a predetermined time period; and a step of determining as to whether it is necessary to adjust the calculation parameters relating to the established scopes and the amount of insulin to be supplied, in response to the change in the output data.

[12] The medical treatment method using a blood suger control system according to claim 10, which further comprises a step of transmitting the data obtained in the above steps (a) through (g) to the terminal of the physician in charge through the wired/wireless data transmitting and receiving unit on a regular basis; a step of receiving the results of medical examination including the adjustment values for the established standards from the terminal of the physician in charge; and a step of adjusting at the control unit the established scopes in accordance with the measures arranged by the physician in charge that are received from the physician's terminal .

[13] The medical treatment method using a blood suger control system according to claim 10, wherein the processing unit further comprises a voice input device or a manual input device, and the above step (a) further includes a step of inputting the information on the kind of food taken and the amount of food ingested as well as the information on the time schedule for food ingestion, using the voice input device or the manual input device.