WO2018147483A1

WO2018147483A1 - Insulin administration system using continuous blood glucose detection

Info

Publication number: WO2018147483A1
Application number: PCT/KR2017/001433
Authority: WO
Inventors: 최규동
Original assignee: 최규동
Priority date: 2017-02-09
Filing date: 2017-02-09
Publication date: 2018-08-16

Abstract

The present invention relates to an insulin administration system using continuous blood glucose detection, comprising: a continuous blood glucose measuring sensor unit for continuously measuring the measured value of the blood glucose of a person being measured; a blood glucose analysis/comparison module for receiving the measured value of the blood glucose from the continuous blood glucose measuring sensor unit and calculating, in real time, a dose of insulin to be administered to the person being measured, in according with the patient response characteristic of the person being measured; and a data transmission/reception module for forwarding the dose of insulin, which has been calculated by the blood glucose analysis/comparison module, to an insulin administration apparatus, so that just as much insulin as the dose of insulin can be administered in real time, wherein, if the measured value of the blood glucose is a function determined by the patient response characteristic based on the dose of insulin, the blood glucose analysis/comparison module determines the dose of insulin by using the inverse function of the patient response characteristic so that the measured value of the blood glucose comes within a predetermined blood glucose level target range.

Description

Insulin Dosing System Using Continuous Blood Sugar Detection

The present invention relates to an insulin administration system using continuous blood glucose detection, the continuous blood sugar measurement sensor unit 110 of continuously measuring a blood sugar measurement value of a subject (S1); and the blood sugar measurement value of the continuous blood sugar measurement sensor A blood sugar analysis comparison module 130 that receives the information from the unit 110 and calculates an insulin dose to be administered to the subject in real time according to a patient response characteristic of the subject (S2); and the blood sugar analysis comparison module 130 A data transmission / reception module 150 for delivering the insulin dose calculated in the insulin administration device 200 so that insulin as much as the insulin dose can be administered in real time (S4); Consists of including

The blood sugar analysis comparison module 130 may determine a predetermined blood glucose level target when the blood glucose measurement g (t) is a function determined by R (t) of the patient response characteristic according to the insulin dose i (t). Continuous glucose detection, characterized in that the insulin dose is determined by i (t) and the patient response characteristic is inverse of R (t) so that the blood glucose reading g (t) is within a range. An insulin dosing system 100 relates.

Diabetes is a metabolic disease insisting on chronic hyperglycemia due to lack of insulin action, and the classification according to the cause is (1) type 1 in which the beta cells of the pancreas are autoimmune or suddenly destroyed to produce sufficient insulin. , (2) Insulin secretion lowering is main agent, type 2 with relative lack of insulin as insulin resistance main body, (3) Gene abnormalities or pancreatic secretion disease related to beta cell function of pancreas and delivery mechanism of insulin action Caused by other diseases (4) It is classified into four kinds, such as pregnancy diabetes.

Most of the type 1 diabetics need insulin therapy. Many other diabetics also need insulin therapy.

Insulin was discovered in 1921 by banting and vest, and initially used insulin preparations purified from the pancreas of cattle or pigs. Since the human insulin gene was elucidated in 1979, human insulin preparations and insulin analog preparations by genetic engineering have been widely used now.

Diabetes patients in need of insulin treatment usually inject insulin preparations into the subcutaneous fat layer of the arm, thigh, and abdominal wall using a small pen-shaped syringe. It is due to the inability to take orally because insulin is destroyed in the stomach.

There are three basic types of insulin preparations, which are characterized by different expression times and durations of action. Fast-acting insulins are characterized by the fastest action but short duration. Fast-acting insulin is used when several injections are needed every day and are injected 15-20 minutes before meals or immediately after meals. This action has the highest activity at 2 to 4 hours after administration and has the property of lasting 6 to 8 hours.

Intermediate insulin begins to work at 1 to 3 hours, exerts maximum effect after 6 to 10 hours, and lasts 18 to 26 hours. This type of insulin is commonly used to infuse half the day by injecting it in the morning, or by feeding it at night in the evening.

In addition, the sustained-type insulin had a characteristic of almost no effect for the first about 6 hours, and sustained the effect for 28 to 36 hours. In recent years, in addition, an ultrafast hole type, a mixed type, etc. may be further classified. Thus, although insulin with various characteristics may be used by one type, in many cases, it is used more effectively by combining.

For example, injections of intermediate insulin once a day only provide minimal control of hyperglycemia and rarely provide optimal blood glucose control. However, for example, when a combination of two fast-acting and intermediate-type insulins is used in the morning injection, more precise control is possible. In addition, the second injection is carried out at the time of dinner or at bedtime in one or both kinds.

At present, the most precise control of blood glucose levels is to inject morning and evening fast and mid-sized insulin and several additional fast-acting insulins during the day. It is extremely important for insulin preparations to adjust dosages according to changes in insulin requirement. This high-efficiency regimen requires knowledge of the patient's own diabetes and careful treatment.

The most important thing is the required amount of insulin. The amount of insulin required, in particular, the elderly may inject the same amount of insulin every day, but in general, it is necessary to adjust the amount of insulin for each situation of meal, activity amount and blood glucose level. In a diabetic state, the patient is hyperglycemic and is likely to cause a series of physiological disorders (eg, kidney failure, skin ulcers or vitreous hemorrhages) related to exacerbation of microvascularity.

On the other hand, hypoglycemia occurs due to accidental overdose of insulin, accompanied by excessive exercise or insufficient food intake, or after normal administration of insulin or glucose-lowering agents, and in extreme cases, cerebral energy metabolism cannot be maintained. It may begin to cause mental symptoms, and may even lead to loss of consciousness and, in severe cases, death.

On the other hand, the insulin injection amount is usually determined according to the blood glucose level of the patient and administered by administering insulin at predetermined time intervals. However, since the blood glucose level of each patient and the blood glucose change according to insulin administration vary in real time and are different for each patient, it is difficult to accurately and efficiently determine the insulin dose and administration time / interval.

This problem can be effectively solved by using a continuous glucose monitoring (CGM) system, and the continuous blood glucose monitoring system for the Republic of Korea Patent No. 10-1512566 or Republic of Korea Patent No. 10-1454278 As a sensor for continuously monitoring blood glucose levels in the body, a blood glucose measurement sensor including a needle inserted into a user's skin is based on a nanostructure for improving the sensor's sensitivity, and removes interference by using selective permeability on the surface. Disclosed is a configuration of an electrochemical continuous blood glucose monitoring sensor including a membrane structure and capable of being biocompatible by means for improving biocompatibility.

However, even if the blood glucose can be measured in real time through the continuous blood glucose monitoring system, it is possible to determine the amount of insulin that can be most appropriately applied to each patient according to the weight, age, sex, diet or lifestyle of the patient. The problem was that it was difficult.

The present invention solves the problems of the existing invention described above, while measuring the blood glucose measurement value of the subject in real time, the effect response time according to the dose of insulin, the weight, age, sex, other eating habits or lifestyle of the subject By setting the patient response characteristics of the subject, which reflect various factors in real time, in the form of a numerical analysis function and continuously updating them, the real-time dose of insulin was adjusted according to the updated patient response characteristics of the subject in real time. By determining and administering, it is a subject to make it possible to determine and implement the most appropriate insulin administration pattern specialized for each subject.

In order to achieve the above object, an insulin administration system using continuous glucose detection according to the present invention includes a continuous glucose measurement sensor unit 110 for continuously measuring a blood sugar measurement value of a subject (S1); and the blood sugar measurement value A blood sugar analysis comparison module 130 which receives the continuous glucose measurement sensor unit 110 and calculates (S2) an insulin dose to be administered to the subject in real time according to a patient response characteristic of the subject;

A data transmission / reception module 150 for delivering the insulin dose calculated by the blood sugar analysis comparison module 130 to the insulin administration device 200 so that insulin as much as the insulin dose may be administered in real time (S4); Consists of including

The blood sugar analysis comparison module 130,

If the blood glucose measurement is g (t), the insulin dose is i (t), and the patient response characteristic is a function of time (t) such as R (t), the patient response characteristic is R (t). Determines that the blood glucose reading g (t) satisfies a relationship such that the patient response characteristic R (t) is the product of the insulin dose i (t),

The insulin dosage is i (t) multiplied by the inverse of the patient response characteristic R (t) and the blood glucose reading g (t) so that the blood glucose reading g (t) is within a predetermined blood glucose target range. It is characterized by using.

The storage module 140 also stores the insulin dose i (t) and the blood glucose measurement g (t) over time.

In addition, the patient response characteristic R (t) is updated in real time in the blood sugar analysis comparison module 130 after receiving a predetermined initial response characteristic stored in the storage module 140 at an initial stage of operation (S0). It is characterized by.

In addition, the display module 160 is connected to the blood sugar analysis comparison module 130 and displays any one or more of the blood sugar measurement value, the insulin dose or the operating state; and the blood sugar analysis comparison module 130 An alarm module 170 that generates an alarm when the blood sugar measurement value is out of a predetermined range; and is connected to the blood sugar analysis comparison module 130, wherein the predetermined blood sugar level target range and the measured object are measured. An input module 180 for receiving an insulin dose determining factor including any one or more of body weight, age, and gender; Characterized in that comprises a.

According to the present invention, the present invention solves the problems of the existing invention described above, while measuring the blood glucose measurement value of the subject in real time, the effect response delay time according to the dose of insulin, the weight of the subject, age, The patient's response characteristics, which reflect various factors such as gender, other eating habits, or lifestyles in real time, are set in the form of a numerical analysis function and continuously updated. Therefore, by determining and administering the real-time dose of insulin, there is an advantage that can be carried out by determining the most appropriate insulin administration pattern, which is specialized for each subject.

1 is a schematic diagram showing the configuration of an insulin administration system using continuous blood sugar detection according to an embodiment of the present invention.

2 is a flow chart showing the operation of the insulin administration system using continuous blood glucose detection in accordance with one embodiment of the present invention.

3 is a graph showing an example of setting a patient response characteristic of an insulin administration system using continuous blood glucose detection according to an embodiment of the present invention in the form of a numerical analytic function.

4 is a graph showing the insulin dose and the blood glucose measurement value using the patient response characteristics of the insulin administration system using continuous blood glucose detection according to an embodiment of the present invention.

Hereinafter, with reference to the accompanying drawings, it will be described in detail the insulin administration system using the continuous blood sugar detection according to an embodiment of the present invention. First, in the drawings, the same components or parts are to be noted that as indicated by the same reference numerals as possible. In describing the present invention, detailed descriptions of related well-known functions or configurations are omitted in order not to obscure the subject matter of the present invention.

Continuous blood glucose measurement system according to an embodiment of the present invention as shown in Figure 1 largely continuous blood glucose measurement sensor unit 110, blood sugar analysis comparison module 130, data transmission and reception module 150 and insulin administration device 200 It is configured to include.

The continuous blood glucose measurement sensor unit 110 is attached to a part of the body of the subject to measure the blood sugar of the subject continuously (S1). The continuous blood glucose measurement sensor unit 110 includes a non-labeled sensor that detects a signal generated from binding of the reversible glucose antibody and glucose molecules in body fluid by fixing a reversible glucose antibody on a surface thereof. Since the structure and operation principle of the continuous blood glucose measurement sensor unit 110 including the non-labeled sensor are described in detail in a number of prior art documents including Patent Document 1 and Patent Document 2, detailed descriptions thereof will be omitted. . On the other hand, since the continuous blood glucose measurement sensor unit 110 is always attached to the body of the subject, it can be made compact so as not to interfere with the daily life of the subject, and waterproof and dustproof so as not to be affected by external attack or impact. It can be manufactured in the form of a case.

Next, the blood sugar analysis comparison module 130 will be described. As shown in FIG. 1, the blood sugar analysis comparison module 130 receives the blood sugar measurement value from the continuous blood sugar measurement sensor unit 110, and as shown in FIG. It performs the function of calculating in real time (S2) the insulin dose to be administered to the measurer.

In this case, the process of calculating the insulin dose in real time (S2) in the blood sugar analysis comparison module 130 will be described in detail as follows.

First, when the blood glucose measurement value is g (t), the insulin dose is i (t), and the patient response characteristic is a function of time (t) such as R (t), the patient response characteristic is R ( t) is determined to satisfy a relationship such that the blood glucose measurement g (t) is the product of the patient response characteristic R (t) and the insulin dose i (t).

That is, when the blood glucose measurement value over time is called g (t), the blood glucose measurement value g (t) is the patient response characteristic R (t) as the input value of the insulin dose i (t) over time. ) Can be interpreted as an output value (function value).

In this case, the patient response characteristics R (t) may vary in principle, such as the type of insulin to be administered, the mixed ratio and mixing ratio of each mixed component in the case of mixed insulin, and the lifestyle, such as the weight, age, sex, medical history, and eating habits of the patient. This is the type of function affected by the variable. The most basic form of this patient response characteristic R (t) is a predetermined time delay until the effect of insulin administration is established after setting a predetermined dose for a standard body weight, which is generally widely used in the current medical community. It is possible to have the form of a linear function with

On the other hand, when approaching in terms of pure numerical analysis, it is assumed that the insulin dose i (t) having a δ input having a predetermined value is administered to the subject (patient), as shown in FIG. After calculating the blood glucose measurement value g (t) according to the time shown in Figure 3 (in Figure 3 divided the blood glucose measurement value g (t) that can be different for each subject (patient) divided by α, β, and γ, respectively) It is also possible to numerically overlap this to obtain the function of the patient response characteristic R (t).

Thus, using this in reverse, the insulin dose i (t) can be calculated. That is, the blood sugar measurement value is within a predetermined blood sugar level target range (for example, a value within a predetermined upper / lower range (for example, ± 10%) from a reference value indicated as “R” in FIG. 4)). After setting g (t) to be located (the simplest constant, the reference value, which is a constant), the insulin dose is i (t) using the inverse of the patient response characteristic R (t). The insulin dosage is i (t) so that the blood glucose reading g (t) is within a predetermined blood glucose target range, and the inverse function of the patient response characteristic R (t) and the blood glucose reading g (t) It can be determined using the product of.

This process is typically implemented through a numerical analysis program in the blood sugar analysis comparison module 130 composed of a microprocessor and the like. As described above, setting a function using a numerical analysis, obtaining an inverse function, and performing an operation using the same are well known and practiced in the field of numerical analysis, and thus, detailed descriptions thereof will be omitted.

On the other hand, for the patient response characteristic R (t), which is in principle influenced by a wide variety of factors, as described above, a constant blood sugar level through a kind of closed loop control without considering these various factors. In order to enable maintenance, the blood glucose analysis comparison module 130 is configured to further comprise a storage module 140, wherein the patient response characteristic R (t) is shown in FIG. It is preferable to continue to update to be stored in the storage module 140 (S3). Due to this characteristic, when a sudden fluctuation of the blood glucose measurement value g (t) occurs due to a meal or the like as shown in "a" in FIG. 4, the insulin dose i (t) is increased accordingly. In addition, when the blood glucose measurement value decreases according to the increased insulin dose, the patient response characteristic R (t) is also continuously updated in real time. Therefore, the fluctuation of the blood glucose measurement value g (t) can be operated to converge to the predetermined blood glucose target R at all times as a result as shown in FIG. 4 as a result of time.

In this case, the patient response characteristic R (t) is a linear function having a predetermined initial response characteristic (for example, the predetermined time delay described above) stored in the storage module 140 at the beginning of operation as shown in FIG. 2. After receiving the form (S0) and the like can be updated in real time in the blood sugar analysis comparison module 130.

On the other hand, the storage module 140 preferably stores the insulin dose i (t) and the blood glucose measurement value g (t) over time, so that it can be used as a later medical data.

Also, for convenience of operation, as shown in FIG. 1, the display module 160 connected to the blood sugar analysis comparison module 130 for displaying any one or more of the blood sugar measurement value, the insulin dose, and the operation state is provided. It is preferable to comprise more.

In addition, as shown in Figure 1 is connected to the blood sugar analysis comparison module 130, it is preferable to further comprise an alarm module 170 for generating an alarm when the blood sugar measurement value is out of a predetermined range. .

On the other hand, in order to receive the information necessary for the operation, as shown in Figure 1 is connected to the blood sugar analysis comparison module 130, the predetermined blood sugar level target range and any one or more of the weight, age, gender of the subject Preferably, the module further includes an input module 180 for receiving an insulin dosage determining factor.

Next, the data transmission and reception module 150 will be described. As shown in FIG. 1, the data transmission / reception module 150 delivers the insulin dose calculated by the blood sugar analysis comparison module 130 to the insulin administering device 200, and the insulin dose as shown in FIG. 2. As much as insulin can be administered in real time (S4) to perform a function.

In the foregoing description, optimal embodiments have been disclosed in the drawings and the specification. Although specific terms have been used herein, they are used only for the purpose of describing the present invention and are not used to limit the scope of the present invention as defined in the meaning or claims. Therefore, those skilled in the art will understand that various modifications and equivalent other embodiments are possible. Therefore, the true technical protection scope of the present invention will be defined by the technical spirit of the appended claims.

Claims

A continuous blood glucose measurement sensor unit 110 for continuously measuring a blood sugar measurement value of the subject (S1);

A blood sugar analysis comparison module 130 which receives the blood sugar measurement value from the continuous blood glucose measurement sensor unit 110 and calculates an insulin dose to be administered to the subject in real time according to a patient response characteristic of the subject (S2);

A data transmission / reception module 150 for delivering the insulin dose calculated by the blood sugar analysis comparison module 130 to the insulin administration device 200 so that insulin as much as the insulin dose may be administered in real time (S4); Consists of including

The blood sugar analysis comparison module 130,

If the blood glucose measurement is g (t), the insulin dose is i (t), and the patient response characteristic is a function of time (t) such as R (t), the patient response characteristic is R (t). Determines that the blood glucose reading g (t) satisfies a relationship such that the patient response characteristic R (t) is the product of the insulin dose i (t),

The insulin dosage is i (t) multiplied by the inverse of the patient response characteristic R (t) and the blood glucose reading g (t) so that the blood glucose reading g (t) is within a predetermined blood glucose target range. Insulin administration system using continuous blood sugar detection, characterized in that determined using.
The method according to claim 1,

A storage module (140) connected to the blood sugar analysis comparison module (130); Characterized in that further comprises;

The patient response characteristic R (t) is continuously updated in real time and stored in the storage module (140). Insulin administration system (100) using continuous blood sugar detection, characterized in that.
The method according to claim 2,

The storage module 140 stores the insulin dose i (t) and the blood glucose measurement g (t) over time.
The method of claim 3, wherein

The patient response characteristic R (t) is updated in real time in the blood sugar analysis comparison module 130 after receiving a predetermined initial response characteristic stored in the storage module 140 at an initial stage of operation (S0). Insulin administration system 100 using a continuous blood sugar detection.
The method according to claim 1,

A display module (160) connected to the blood sugar analysis comparison module (130) for displaying at least one of the blood sugar measurement value, the insulin dose, and the operation state;

An alarm module (170) connected to the blood sugar analysis comparison module (130) for generating an alarm when the blood sugar measurement value is out of a predetermined range;

An input module 180 connected to the blood sugar analysis comparison module 130 and receiving an insulin dose determining factor including at least one of the predetermined blood sugar target range and the weight, age, and gender of the subject; Insulin administration system using continuous blood sugar detection, characterized in that it comprises a.