CN114099846A - Closed-loop artificial pancreas insulin infusion control system - Google Patents

Closed-loop artificial pancreas insulin infusion control system Download PDF

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Publication number
CN114099846A
CN114099846A CN202010871903.2A CN202010871903A CN114099846A CN 114099846 A CN114099846 A CN 114099846A CN 202010871903 A CN202010871903 A CN 202010871903A CN 114099846 A CN114099846 A CN 114099846A
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Prior art keywords
insulin
module
infusion
amount
program module
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CN202010871903.2A
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Chinese (zh)
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杨翠军
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Medtrum Technologies Inc
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Medtrum Technologies Inc
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    • 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
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • 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
    • A61B5/14503—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 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • 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
    • A61B5/14532—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 for measuring glucose, e.g. by tissue impedance measurement
    • 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
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • 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
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/63—Motion, e.g. physical activity

Abstract

The invention discloses a closed-loop artificial pancreas insulin infusion control system, which comprises: a detection module; a program module coupled to the detection module, the program module for obtaining data including a daily amount of insulin infused by the user, the program module further being imported into a total daily insulin amount algorithm and a current insulin infusion amount algorithm; the infusion module is connected with the program module, and the program module controls the infusion module to infuse insulin according to the current insulin infusion amount data; and a motion sensor for automatically detecting physical activity of the user, the program module may receive physical activity status information. The system can automatically detect the physical condition of the user, accurately calculate the current insulin infusion amount and enhance the user experience.

Description

Closed-loop artificial pancreas insulin infusion control system
Technical Field
The invention mainly relates to the field of medical instruments, in particular to a closed-loop artificial pancreas insulin infusion control system.
Background
The pancreas in a normal human body can automatically monitor the glucose content in the blood of the human body and secrete the required insulin/glucagon automatically. The function of pancreas of diabetics is abnormal, and insulin required by human bodies cannot be normally secreted. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic functions of a human body, and is a lifelong disease. At present, the medical technology can not cure the diabetes radically, and only can control the occurrence and the development of the diabetes and the complications thereof by stabilizing the blood sugar.
Diabetics need to test their blood glucose before injecting insulin into their body. At present, most detection means can continuously detect blood sugar and transmit blood sugar data to remote equipment in real time, so that a user can conveniently check the blood sugar data. The method needs the detection device to be attached to the surface of the skin, and the probe carried by the detection device is penetrated into subcutaneous tissue fluid to finish detection. According to the blood sugar value detected by the CGM, the infusion equipment inputs the currently required insulin subcutaneously so as to form a closed-loop or semi-closed-loop artificial pancreas.
At present, a detection device and an infusion device are connected with each other, the detection device and the infusion device form a closed-loop artificial pancreas through processing of a program module, and the infusion device automatically administers medicine according to data of the detection device. When the program module calculates the insulin infusion amount, Total insulin Dose (TDD) is an important parameter and depends on many factors, such as physical condition, physiological condition, etc. Therefore, it is important to accurately obtain TDD values.
However, the current artificial pancreas needs to manually input physical condition parameters instead of automatically detecting the physical condition of the user, and cannot accurately obtain the TDD value, so that the current insulin infusion amount is inaccurate, and the user experience is poor.
Therefore, there is a need in the art for a closed-loop artificial pancreatic insulin infusion control system that can automatically sense a physical condition and accurately calculate a current insulin infusion amount.
Disclosure of Invention
The embodiment of the invention discloses a closed-loop artificial pancreas insulin infusion control system, which can automatically detect the physical condition of a user, accurately calculate the numerical value of the total daily insulin (TDD) and the current insulin infusion amount and enhance the user experience.
The invention discloses a closed-loop artificial pancreas insulin infusion control system, which comprises: the detection module is used for detecting blood glucose parameters; a program module coupled to the detection module, the program module for obtaining data including a total daily insulin amount infused by the user, the program module further being imported into a total daily insulin amount algorithm and a current insulin infusion amount algorithm, wherein the total daily insulin amount algorithm is for calculating a total daily insulin amount based on the daily insulin amount data infused by the user; a current insulin infusion amount algorithm is used for calculating the current insulin infusion amount according to the blood glucose parameter data, the insulin amount infused by the user per day data or the total insulin amount per day data; the infusion module is connected with the program module, and the program module controls the infusion module to infuse insulin according to the current insulin infusion amount data; and a motion sensor for automatically detecting physical activity of the user, the program module may receive physical activity status information, and the physical activity status is a variable factor of the total daily insulin amount algorithm or the current insulin infusion amount algorithm.
According to one aspect of the invention, the program module comprises a manual input interface or an automatic detection sub-module, and the method for acquiring daily insulin infusion data of the user by the program module comprises the following steps: manually inputting daily insulin amount data into the program module by the user through the manual input interface; or the automatic detection submodule automatically detects, stores and calculates the daily insulin infusion amount data of the user.
According to one aspect of the invention, the daily insulin volume data infused by the user includes total volume data infused per day, or bolus and basal volume data infused over different time periods, or temporary basal and corrective bolus data, or infusion data of the infusion module after different events have occurred.
According to one aspect of the present invention, the total daily insulin amount is obtained by calculating total daily insulin amount data infused two or more days before, wherein the total daily insulin amount is an average or median of the total daily insulin amount data infused, and the total daily insulin amount is a variable factor of the current insulin infusion amount algorithm.
According to one aspect of the invention, the average comprises an arithmetic average or a weighted average.
According to one aspect of the invention, the variable factors of the total daily insulin quantity algorithm include one or more of physical activity status, physiological status, psychological status, eating status of the user.
According to one aspect of the invention, the physiological condition includes one or more of weight, sex, age, disease, physiological phase.
According to one aspect of the invention, the physical activity condition includes general body extension, exercise, or sleep.
According to one aspect of the present invention, a user manually inputs meal information, exercise information, sleep information, or physical condition information into a program module through a manual input interface.
According to one aspect of the invention, the motion sensor is provided in a detection module, a program module or an infusion module.
According to one aspect of the invention, the motion sensor comprises a three-axis acceleration sensor or gyroscope.
According to one aspect of the invention, two of the detection module, the program module and the infusion module are connected to each other to form an integral structure and are respectively adhered to different positions of the skin with the third module.
According to one aspect of the invention, the detection module, the program module and the infusion module are connected to form an integral structure and are adhered to the same position of the skin.
Compared with the prior art, the technical scheme of the invention has the following advantages:
in the closed-loop artificial pancreas insulin infusion control system disclosed by the invention, the detection module is used for detecting blood sugar parameters; a program module coupled to the detection module, the program module for obtaining data including a total daily insulin amount infused by the user, the program module further being imported into a total daily insulin amount algorithm and a current insulin infusion amount algorithm, wherein the total daily insulin amount algorithm is for calculating a total daily insulin amount based on the daily insulin amount data infused by the user; the current insulin infusion amount algorithm is used to calculate the current insulin infusion amount based on blood glucose parameter data, user daily insulin infusion amount data, or total daily insulin amount data. The program module is introduced into the total daily insulin amount algorithm and the current insulin infusion amount algorithm, and the calculated current insulin infusion amount will be more accurate using the sensed data, the user daily infused insulin amount data and the total daily insulin amount data, either alone or in combination. Secondly, the control system further comprises a motion sensor for automatically detecting the physical activity of the user, the program module may receive the physical activity status information, and the physical activity status is a variable factor of the total daily insulin amount algorithm or the current insulin infusion amount algorithm. Compared with manual input, the motion sensor can automatically and accurately sense the physical activity state of the user and send the activity state parameters to the program module, so that the calculation result of the daily total insulin quantity or the current insulin infusion quantity is more accurate, and the user experience is enhanced.
Further, the program module comprises a manual input interface or an automatic detection sub-module, and the method for acquiring the daily insulin infusion data of the user by the program module comprises the following steps: manually inputting daily insulin amount data into the program module by the user through the manual input interface; or the automatic detection submodule automatically detects, stores and calculates the daily insulin infusion amount data of the user. The manual input interface or the automatic detection submodule is used independently or the manual input interface and the automatic detection submodule are used in combination, so that the flexibility of using the equipment by a user is enhanced. Moreover, on the premise of combined use of the manual input interface and the automatic detection sub-module, the automatically detected data and the manually input data can be combined and compared, and the program module can adjust the algorithm in real time, so that the calculation result is more accurate.
Further, the physical activity condition includes general body stretching, exercise, or sleep. The control system can distinguish common activities, sports and sleep, so that the control system can control the blood sugar level more finely.
Further, the motion sensor is disposed in the detection module, the program module, or the infusion module. The motion sensor is arranged in a module of the control system, so that the integration level of the control system can be improved as much as possible, the size of the equipment is reduced, and the user experience is enhanced.
Further, the motion sensor includes a three-axis acceleration sensor or a gyroscope. The three-axis acceleration sensor or the gyroscope can sense the activity intensity, the activity mode or the body posture of the body more accurately, and finally the calculation result of the infusion amount is more accurate.
Furthermore, the detection module, the program module and the infusion module are connected to form an integral structure and are stuck to the same position of the skin. The three modules are connected into a whole and are pasted at the same position, so that the number of the skin pasting devices of a user is reduced, and the interference of pasting more devices on the stretching of the user activity is further weakened; meanwhile, the problem of unsmooth wireless communication between the separation devices is effectively solved, and user experience is further enhanced.
Drawings
FIG. 1 is a schematic diagram of the relationship of the modules of a closed-loop artificial pancreas insulin infusion control system according to one embodiment of the present invention.
Detailed Description
As previously mentioned, the prior art artificial pancreas is not capable of accurately sensing the physical condition of the user and obtaining accurate total daily insulin amount data.
The research finds that the reasons causing the problems are as follows: the algorithm of the existing artificial pancreas for calculating the total daily insulin amount is not perfect enough, the calculation mode is single, and the artificial pancreas is not provided with structural components capable of accurately sensing the physical activity condition.
In order to solve the problem, the invention provides a closed-loop artificial pancreas insulin infusion control system, which can automatically detect the physical condition of a user, accurately calculate the value of total daily insulin (TDD) and the current insulin infusion amount, and enhance the user experience.
Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that the relative arrangement of parts and steps, numerical expressions, and numerical values set forth in these embodiments should not be construed as limiting the scope of the present invention unless it is specifically stated otherwise.
Further, it should be understood that the dimensions of the various elements shown in the figures are not necessarily drawn to scale, for example, the thickness, width, length or distance of some elements may be exaggerated relative to other structures for ease of illustration.
The following description of the exemplary embodiment(s) is merely illustrative and is not intended to limit the invention, its application, or uses in any way. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail herein, but are intended to be part of the specification as applicable.
It should be noted that like reference numerals and letters refer to like items in the following figures, and thus, once an item is defined or illustrated in one figure, further discussion thereof will not be required in the subsequent figure description.
FIG. 1 is a schematic diagram of the relationship between modules of a closed-loop artificial pancreas insulin infusion control system according to an embodiment of the present invention.
The closed-loop artificial pancreas insulin infusion control system disclosed by the embodiment of the invention mainly comprises a detection module 100, a program module 101 and an infusion module 102.
The detection module 100 is used to continuously detect a user's real-time blood glucose level parameters. Generally, the detecting module 100 is a Continuous Glucose Monitoring (CGM) capable of detecting a blood Glucose value in real time, Monitoring a blood Glucose change, and sending real-time blood Glucose data to the program module 101.
The program module 101 is used to control the operation of the detection module 100 and the infusion module 102. Thus, the program module 101 is connected to the detection module 100 and the infusion module 102, respectively. Here, the connection includes a conventional electrical connection or a wireless connection.
The infusion module 102 contains the necessary mechanical structure for infusing insulin and is controlled by the program module 101. The infusion module 102 infuses the currently required insulin into the user in accordance with the current insulin infusion amount data issued by the program module 101. At the same time, the infusion status of the infusion module 102 can also be fed back to the program module 101 in real time.
Embodiments of the present invention do not limit the specific locations and connections of the detection module 100, the program module 101, and the infusion module 102, as long as the aforementioned functional conditions are satisfied.
As in one embodiment of the present invention, the three are electrically connected to each other to form an integral structure. Therefore, the three are stuck on the same position of the skin of the user. The three modules are connected into a whole and are pasted at the same position, so that the number of the skin pasting devices of a user is reduced, and the interference of pasting more devices on the stretching of the user activity is further weakened; meanwhile, the problem of unsmooth wireless communication between the separation devices is effectively solved, and user experience is further enhanced.
As in another embodiment of the present invention, the program module 101 and the infusion module 102 are interconnected to form a unitary structure, while the detection module 100 is provided separately in another structure. At this time, the detection module 100 and the program module 101 transmit wireless signals to each other to achieve connection with each other. Thus, the program module 101 and the infusion module 102 are affixed to a certain location of the user's skin, while the detection module 100 is affixed to another location of the user's skin.
As in yet another embodiment of the present invention, program module 101 and detection module 100 are interconnected to form the same device, while infusion module 102 is provided separately in another configuration. Infusion module 102 and program module 101 transmit wireless signals to each other to enable connectivity. Thus, the program module 101 and the detection module 100 may be affixed to a certain location of the skin of the user, while the infusion module 102 may be affixed to other locations of the skin of the user.
In another embodiment of the present invention, the three components are disposed in different structures. Therefore, the three are respectively stuck on different positions of the skin of the user. At this time, the program module 101 and the detection module 100 and the infusion module 102 respectively transmit wireless signals to each other to realize connection with each other.
It should be noted that the program module 101 according to the embodiment of the present invention also has functions of storing, recording, and accessing a database, and therefore, the program module 101 can be reused. Therefore, the physical condition data of the user can be stored, and the production cost and the consumption cost of the user are saved. As described above, when the detection module 100 or the infusion module 102 expires, the program module 101 may be separate from the detection module 100, the infusion module 102, or both the detection module 100 and the infusion module 102.
Generally, the detection module 100, the program module 101, and the infusion module 102 have different lifetimes. Therefore, when the three are electrically connected with each other to form the same device, the three can be separated from each other two by two. If a module is first terminated, the user can only replace the module and keep the other two modules for continuous use.
Here, it should be noted that the program module 101 of the embodiment of the present invention may further include a plurality of sub-modules. The different sub-modules may be respectively arranged in different configurations according to the functions of the sub-modules, and are not particularly limited as long as the control conditions of the program module 101 can be satisfied.
In an embodiment of the invention, the program module 101 is further adapted to obtain data comprising an amount of insulin infused by the user on a daily basis. Generally, for an artificial pancreas, the amount of insulin currently required by the user is closely related to the historical daily insulin infusion. Specifically, in the embodiment of the present invention, the daily insulin amount data infused by the user includes total insulin amount infused per day (d) data, or insulin bolus and bolus data infused at different time periods, or temporary bolus and corrective bolus data, or infusion amount data of the infusion module 102 after a specific event occurs.
Program module 101 includes a manual input interface (not shown) or an automatic detection sub-module (not shown). The user's physical condition data may be obtained by the program module 101 using a manual input interface alone, or an automatic detection sub-module alone, or a combination of both. The manual input interface is used alone or the automatic detection submodule is used, or the manual input interface and the automatic detection submodule are used in combination, so that the flexibility of using the equipment by a user is enhanced.
As in one embodiment of the present invention, the user may manually input previous daily infused insulin volume data to program module 101 according to the physician's instructions and by means of a manual input interface. In another embodiment of the present invention, program module 101 has stored infusion data that records the user's previous insulin. With the automatic detection sub-module, the program module 101 can automatically acquire and calculate daily insulin amount data infused by the user. Preferably, in the embodiment of the present invention, the manual input interface and the automatic detection sub-module are used in combination by the user. At this point, the automatically detected data and the manually entered data may be combined and compared, allowing program module 101 to adjust the algorithm in real time to obtain more accurate calculation results.
In other embodiments of the present invention, the user may also input other information through the manual input interface, such as meal information, exercise information, sleep information, and physical condition information, which are manually input into the program module 101, and are not limited herein.
Generally, the purpose of using an artificial pancreas is to stabilize blood glucose levels, i.e., to infuse a suitable amount of insulin into the body of a user. The current insulin infusion is closely related to Total insulin Dose (TDD), which is an important factor in the current insulin infusion. Thus, the program module 101 is imported into a total daily insulin quantity TDD algorithm and a current insulin infusion quantity algorithm for calculating the TDD and the current insulin infusion quantity, respectively.
The current insulin infusion amount algorithm is used to calculate the amount of insulin currently required by the body. In the embodiment of the present invention, there are many factors that influence the current insulin infusion amount, such as physical activity status, TDD, etc., which are variable factors. Specifically, in the embodiment of the present invention, TDD is a variable factor of the current insulin infusion amount algorithm. Thus, the more accurate the TDD, or artificial pancreas, is able to sense the physical activity of the user, the more accurate the current insulin infusion will be. Whereas TDD can be calculated by the total daily insulin amount TDD algorithm by the total amount of insulin infused per day (d). At the same time, the program module 101 uses the sensed data, the user's daily insulin amount data and the total daily insulin amount data, alone or in combination, to calculate the current insulin infusion amount.
The factors affecting TDD are many and mostly related to the user's physical condition. Thus, in an embodiment of the present invention, the variable factors of the total daily insulin amount (TDD) algorithm comprise one or more of physical activity status, physiological status, psychological status, eating status of the user.
Here, the physiological condition of the user includes one or more of weight, sex, age, disease condition, physiological period, and the like.
The psychological condition of the user includes emotional conditions such as anger, fear, drooping, hyperactivity, excitement, and the like.
The physical activity condition of the user includes general body extension, exercise or sleep. The control system can distinguish common activities, sports and sleep, so that the control system can control the blood sugar level more finely.
TDD is the total daily insulin algorithm obtained by calculating the total insulin infused daily (d) data for the first two or more days. Specifically, in the present embodiment, TDD is a daily insulin total algorithm obtained by calculating total insulin infused daily (d) data for the first 7 days. Preferably, TDD is the average of the data of total insulin infused by the user per day (d).
In one embodiment of the present invention, if d7、d6、...、d2、d1Data representing total insulin (d) infused daily by the user on the previous 7 th day, the previous 6 th day,. the previous day, and yesterday, respectively, then:
TDD＝(d7+d6+...+d2+d1)/7
that is, TDD is the arithmetic mean of the total amount of insulin (d) infused by a user per day.
The closer to the current time, the closer the data of total amount of insulin infused per day (d) is to the actual TDD. Thus, in another embodiment of the invention, the TDD algorithm also assigns dnDifferent weight gammanIf the corresponding weight is γ7、γ6、...、γ2、γ1And then:
TDD＝γ7d7+γ6d6+...+γ2d2+γ1d1
that is, TDD is a weighted average of the total amount of insulin infused per day (d).
It should be noted that the embodiment of the present invention does not limit dnStatistical method of data. In yet another embodiment of the present invention, the TDD value may be determined by a method of determining the median of the total amount of insulin (d) infused daily for the first 7 days. In yet another embodiment of the present invention, d can be eliminated firstnAnd then averaging the maximum and minimum values of (2). In yet another embodiment of the present invention, variance or standard deviation is introduced, and points with larger errors are discarded and averaged. Other embodiments of the present invention may also adopt a method of combining weighted average with sliding data frame, so that the TDD calculation result is more accurate.
Here, the sliding data frame means that data statistics is performed by selecting, for example, data for 5 consecutive days as one data frame, and the entire data frame is shifted backward for several days according to the passage of time, but data including 5 consecutive days is maintained. For a specific statistical method of the sliding data frame, please refer to the foregoing description, and will not be described herein again.
As previously mentioned, physical activity conditions affect both TDD and the current amount of insulin infusion. Accordingly, the closed loop artificial pancreas insulin infusion control system further comprises a motion sensor (not shown). The motion sensor is used to automatically detect physical activity of the user and the program module 101 may receive physical activity status information. The motion sensor can automatically and accurately sense the physical activity state of the user and send the activity state parameters to the program module 101, so that the calculation result of the total daily insulin amount or the current insulin infusion amount is more accurate, and the user experience is enhanced. Meanwhile, the motion sensor is arranged in a module of the control system, so that the integration level of the control system can be improved as much as possible, the size of the equipment is reduced, and the user experience is enhanced.
The motion sensor is provided in the detection module 100, the program module 101 or the infusion module 102. Preferably, in the embodiment of the present invention, the motion sensor is disposed in the program module 101.
It should be noted that, in the embodiment of the present invention, the number of the motion sensors and the arrangement positions of the plurality of motion sensors are not limited, as long as the condition that the motion sensors sense the activity condition of the user can be satisfied.
The motion sensor includes a three-axis acceleration sensor or a gyroscope. The three-axis acceleration sensor or the gyroscope can sense the activity intensity, the activity mode or the body posture of the body more accurately, and finally the calculation result of the infusion amount is more accurate. Preferably, in the embodiment of the present invention, the motion sensor is a combination of a three-axis acceleration sensor and a gyroscope.
In summary, the present invention discloses a closed-loop artificial pancreas insulin infusion control system, which can automatically detect the physical condition of a user, accurately calculate the value of total daily insulin (TDD) and the current insulin infusion amount, and enhance the user experience.
Although some specific embodiments of the present invention have been described in detail by way of illustration, it should be understood by those skilled in the art that the above illustration is only for the purpose of illustration and is not intended to limit the scope of the invention. It will be appreciated by those skilled in the art that modifications may be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims (13)

1. A closed-loop artificial pancreas insulin infusion control system, comprising:
a detection module for continuously detecting a real-time blood glucose level parameter;
a program module coupled to the detection module, the program module for obtaining data including a total daily insulin amount infused by the user, the program module further being adapted to introduce a total daily insulin amount algorithm for calculating a total daily insulin amount based on the total daily insulin amount infused by the user and a current insulin infusion amount algorithm; (ii) the current insulin infusion amount algorithm is configured to calculate a current insulin infusion amount based on the blood glucose parameter data, the user daily infused insulin amount data, or the total daily insulin amount data;
an infusion module coupled to the program module, the program module controlling the infusion module to infuse insulin based on the current insulin infusion volume data; and
a motion sensor for automatically detecting physical activity of a user, the program module may receive the physical activity status information, and the physical activity status is a variable factor of the total daily insulin amount algorithm or the current insulin infusion amount algorithm.
2. The closed-loop artificial pancreas insulin infusion control system according to claim 1, wherein the program module includes a manual input interface or an automatic detection sub-module, the method of the program module acquiring daily insulin volume data infused by the user includes:
manually inputting, by the user, daily infused insulin amount data into the program module via the manual input interface; or
The automatic detection sub-module automatically detects, stores and calculates daily insulin volume data infused by the user.
3. The closed-loop artificial pancreas insulin infusion control system according to claim 2, characterized in that the insulin amount data infused by the user per day comprises total insulin amount data infused per day, or bolus and basal amount data infused over different time periods, or temporary basal and corrective bolus data, or infusion data of the infusion module after different events have occurred.
4. The closed-loop artificial pancreas insulin infusion control system according to claim 3, wherein the total daily insulin amount is the total daily insulin amount algorithm obtained by calculating total insulin amount data infused each day two or more days before, the total daily insulin amount is an average or median of the total insulin amount data infused each day, and the total daily insulin amount is a variable factor of the current insulin infusion amount algorithm.
5. The closed-loop artificial pancreas insulin infusion control system according to claim 4, characterized in that the average value comprises an arithmetic average or a weighted average.
6. The closed-loop artificial pancreas insulin infusion control system according to claim 3, wherein the variable factors of the total daily insulin quantity algorithm include one or more of physical activity conditions, physiological conditions, psychological conditions, eating conditions.
7. The closed loop artificial pancreas insulin infusion control system according to claim 6, wherein the physiological condition includes one or more of weight, gender, age, disease, physiological phase.
8. The closed loop artificial pancreas insulin infusion control system according to claim 6, characterized in that the physical activity condition comprises normal body stretching, exercise or sleep.
9. The closed-loop artificial pancreas insulin infusion control system of claim 6,
through the manual input interface, a user manually inputs meal information, exercise information, sleep information and physical condition information into the program module.
10. The closed-loop artificial pancreas insulin infusion control system of claim 1, wherein the motion sensor is disposed in the detection module, the program module or the infusion module.
11. The closed-loop artificial pancreas insulin infusion control system according to claim 10, characterized in that the motion sensor comprises a three-axis acceleration sensor or a gyroscope.
12. The single-sided driven closed-loop artificial pancreas as claimed in claim 1, wherein two of the detection module, the program module and the infusion module are connected to each other to form a unitary structure and are attached to a third module at different positions on the skin.
13. The single-sided drive closed loop artificial pancreas as claimed in claim 1, wherein the detection module, the program module and the infusion module are connected to form an integral structure and are adhered to the same position of the skin.
CN202010871903.2A 2020-08-26 2020-08-26 Closed-loop artificial pancreas insulin infusion control system Pending CN114099846A (en)

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