WO2018147483A1 - Système d'administration d'insuline utilisant une détection continue de la glycémie - Google Patents

Système d'administration d'insuline utilisant une détection continue de la glycémie Download PDF

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Publication number
WO2018147483A1
WO2018147483A1 PCT/KR2017/001433 KR2017001433W WO2018147483A1 WO 2018147483 A1 WO2018147483 A1 WO 2018147483A1 KR 2017001433 W KR2017001433 W KR 2017001433W WO 2018147483 A1 WO2018147483 A1 WO 2018147483A1
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WO
WIPO (PCT)
Prior art keywords
insulin
blood glucose
blood sugar
response characteristic
comparison module
Prior art date
Application number
PCT/KR2017/001433
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English (en)
Korean (ko)
Inventor
최규동
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최규동
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Publication date
Application filed by 최규동 filed Critical 최규동
Priority to PCT/KR2017/001433 priority Critical patent/WO2018147483A1/fr
Publication of WO2018147483A1 publication Critical patent/WO2018147483A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • an ultrafast hole type, a mixed type, etc. may be further classified.
  • insulin with various characteristics may be used by one type, in many cases, it is used more effectively by combining.
  • injections of intermediate insulin once a day only provide minimal control of hyperglycemia and rarely provide optimal blood glucose control.
  • the second injection is carried out at the time of dinner or at bedtime in one or both kinds.
  • 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.
  • the patient 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • an electrochemical continuous blood glucose monitoring sensor including a membrane structure and capable of being biocompatible by means for improving biocompatibility.
  • 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
  • the real-time dose of insulin was adjusted according to the updated patient response characteristics of the subject in real time.
  • an insulin administration system using continuous glucose detection 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;
  • the blood sugar analysis comparison module 130 The blood sugar analysis comparison module 130,
  • the blood glucose measurement is g (t)
  • the insulin dose is i (t)
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 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.
  • FIG. 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.
  • FIG. 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.
  • FIG. 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.
  • Continuous blood glucose measurement system 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. .
  • the continuous blood glucose measurement sensor unit 110 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.
  • 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.
  • the blood glucose measurement value is g (t)
  • the insulin dose is i (t)
  • 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).
  • 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.
  • 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
  • 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)).
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • an alarm module 170 for generating an alarm when the blood sugar measurement value is out of a predetermined range.
  • the module further includes an input module 180 for receiving an insulin dosage determining factor.
  • the data transmission and 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.

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Abstract

La présente invention concerne un système d'administration d'insuline utilisant une détection continue de la glycémie, qui comprend : un ensemble capteur de mesure de glycémie en continu pour mesurer en continu la valeur mesurée pour la glycémie d'une personne faisant l'objet de la mesure ; un module d'analyse/comparaison de la glycémie pour recevoir la valeur mesurée pour la glycémie en provenance de l'ensemble capteur de mesure de la glycémie en continu et calculer, en temps réel, la dose d'insuline à administrer à la personne faisant l'objet de la mesure, en fonction de la caractéristique de réponse patient de la personne faisant l'objet de la mesure ; et un module d'émission/réception de données pour transmettre la dose d'insuline, calculée par le module d'analyse/comparaison de la glycémie, à un appareil d'administration d'insuline, de telle sorte que seule une quantité d'insuline égale à ladite dose d'insuline puisse être administrée en temps réel, le module d'analyse/comparaison de la glycémie déterminant la dose d'insuline, si la valeur mesurée pour la glycémie est une fonction déterminée par la caractéristique de réponse patient sur la base de la dose d'insuline, en utilisant la fonction inverse de la caractéristique de réponse patient de sorte que la valeur mesurée pour la glycémie se situe dans une plage cible de glycémie prédéterminée.
PCT/KR2017/001433 2017-02-09 2017-02-09 Système d'administration d'insuline utilisant une détection continue de la glycémie WO2018147483A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112515628A (zh) * 2019-09-17 2021-03-19 小甑科技有限公司 一种血糖管控系统

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20120047841A (ko) * 2009-02-26 2012-05-14 몰 리서치 어플리케이션스 엘티디 당뇨병 관련 치료의 자동 감시를 위한 방법 및 시스템
JP2014524294A (ja) * 2011-08-12 2014-09-22 ジーン オニキス リミテッド インスリンポンプ
KR20150043534A (ko) * 2012-08-30 2015-04-22 메드트로닉 미니메드 인코포레이티드 폐쇄-루프 인슐린 주입 시스템을 위한 보호 기술
JP2016047388A (ja) * 2010-10-31 2016-04-07 トラスティーズ オブ ボストン ユニバーシティ 血糖制御システム
KR20170056904A (ko) * 2015-11-16 2017-05-24 최규동 연속 혈당 감지를 이용한 인슐린 투여 시스템

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20120047841A (ko) * 2009-02-26 2012-05-14 몰 리서치 어플리케이션스 엘티디 당뇨병 관련 치료의 자동 감시를 위한 방법 및 시스템
JP2016047388A (ja) * 2010-10-31 2016-04-07 トラスティーズ オブ ボストン ユニバーシティ 血糖制御システム
JP2014524294A (ja) * 2011-08-12 2014-09-22 ジーン オニキス リミテッド インスリンポンプ
KR20150043534A (ko) * 2012-08-30 2015-04-22 메드트로닉 미니메드 인코포레이티드 폐쇄-루프 인슐린 주입 시스템을 위한 보호 기술
KR20170056904A (ko) * 2015-11-16 2017-05-24 최규동 연속 혈당 감지를 이용한 인슐린 투여 시스템

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112515628A (zh) * 2019-09-17 2021-03-19 小甑科技有限公司 一种血糖管控系统

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