CN117838978A - Multi-sensor artificial pancreas - Google Patents

Multi-sensor artificial pancreas Download PDF

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Publication number
CN117838978A
CN117838978A CN202410120725.8A CN202410120725A CN117838978A CN 117838978 A CN117838978 A CN 117838978A CN 202410120725 A CN202410120725 A CN 202410120725A CN 117838978 A CN117838978 A CN 117838978A
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blood glucose
monitoring device
patient
infusion
monitoring
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CN202410120725.8A
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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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Priority to CN202410120725.8A priority Critical patent/CN117838978A/en
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Abstract

The invention discloses a blood sugar monitoring system, which comprises a main monitoring device and a standby monitoring device, and also comprises a management device which is in communication connection with the main monitoring device and the standby monitoring device, and is at least used for receiving blood sugar concentration information sent by the main monitoring device and the standby monitoring device and displaying blood sugar data.

Description

Multi-sensor artificial pancreas
Technical Field
The invention mainly relates to the field of medical appliances, in particular to a multi-sensor artificial pancreas.
Background
The pancreas of normal people can automatically secrete needed insulin/glucagon according to the blood sugar level in the blood of the human body, so that the reasonable blood sugar fluctuation range is maintained. However, the pancreas function of diabetics is abnormal, and insulin required by human body cannot be normally secreted. Diabetes is a metabolic disease, a life-long disease. The existing medical technology cannot radically cure diabetes, and the occurrence and development of diabetes and complications thereof can be controlled only by stabilizing blood sugar.
Diabetics need to monitor blood glucose before injecting insulin into the body. The majority of monitoring means at present realize the continuous monitoring to blood sugar through the blood sugar monitoring equipment in vivo, and the blood sugar monitoring equipment in vivo uses the disposable percutaneous monitoring equipment that inserts skin to measure the blood sugar concentration in the interstitial fluid to send blood sugar data to external equipment in real time through the transmitter, be convenient for the patient to look over, this kind of monitoring method is called continuous blood sugar monitoring (Continuous Glucose Monitoring, CGM).
The existing artificial pancreas only comprises a blood glucose monitoring device and a drug infusion device, the disposable blood glucose monitoring device has a preset service life, when the service life of the monitoring device is expired or the monitoring device fails, the monitoring device needs to be updated, a period of time is needed for preheating before the monitoring device can always generate normal results, the preheating time can be as long as two hours, during the preheating time, the blood glucose measurement results generated by the newly inserted monitoring device can be inaccurate and unreliable, if hyperglycemia or hypoglycemia occurs during the preheating time, the artificial pancreas can not receive blood glucose data, and the related alarm system is also stopped, so that a patient cannot eat timely or infuse insulin accurately, thereby causing health risks to the patient.
Thus, there is a need in the art for an artificial pancreas that accurately and completely determines blood glucose data and infuses insulin accurately.
Disclosure of Invention
The embodiment of the invention discloses an artificial pancreas, which comprises a first blood glucose monitoring device and at least one second blood glucose monitoring device, wherein the first blood glucose monitoring device and the at least one second blood glucose monitoring device are arranged on the same patient and are used for monitoring and sending the blood glucose value of the patient in real time; an infusion device for infusing a drug into a patient; and the management unit is in communication connection with the first blood sugar monitoring device, the second blood sugar monitoring device and the infusion device and is at least used for receiving the blood sugar values sent by the first blood sugar monitoring device and the second blood sugar monitoring device and sending an instruction of drug infusion to the infusion device. The user installs at least two blood sugar monitoring facilities simultaneously, ensures that artifical pancreas can both receive blood sugar data at any time to calculate and accurate infusion insulin, maintain patient's blood sugar level.
The invention also discloses an artificial pancreas, which comprises a first blood glucose monitoring device and at least one second blood glucose monitoring device, wherein the first blood glucose monitoring device and the at least one second blood glucose monitoring device are arranged on the same patient and are used for monitoring and sending the blood glucose value of the patient in real time; an infusion device for infusing a drug into a patient; and the management unit is in communication connection with the first blood sugar monitoring device, the second blood sugar monitoring device and the infusion device and is at least used for receiving the blood sugar values sent by the first blood sugar monitoring device and the second blood sugar monitoring device and sending an instruction of drug infusion to the infusion device.
According to one aspect of the invention, the first blood glucose monitoring device is integrated with the infusion device.
According to one aspect of the invention, the algorithm A1 is preset in the management unit, the algorithm A2 is preset in the infusion device, the algorithm A3 is preset in the second blood glucose monitoring device, and/or the amount of insulin required by the patient is determined by the management device, the infusion device or the second blood glucose monitoring device.
According to one aspect of the invention, the defined manner includes a single decision or a joint decision.
According to one aspect of the present invention, the independent decision is that the management unit calculates insulin amounts I11 and I12 required by the patient according to the blood glucose values sent by the first blood glucose monitoring device and the second blood glucose monitoring device and a preset algorithm A1, and then selects one as a final insulin infusion amount;
according to one aspect of the invention, the way of independent decision is that the infusion device calculates the insulin amounts I21 and I22 needed by the patient according to the blood sugar values sent by the first blood sugar monitoring device and the second blood sugar monitoring device and a preset algorithm A2, and then selects one as the final insulin infusion amount;
according to one aspect of the invention, the way of the individual decision is that the second blood glucose monitoring device calculates the insulin amounts I31 and I32 required by the patient based on the blood glucose values sent by the first blood glucose monitoring device and the second blood glucose monitoring device and a preset algorithm A3, and then selects one as the final insulin infusion amount.
According to one aspect of the invention, the joint decision is made by the administration device, the infusion device or the second blood glucose monitoring device calculating two insulin amounts required by the patient according to the blood glucose values sent by the first blood glucose monitoring device and the second blood glucose monitoring device and the algorithm A1, A2 or A3 preset by the infusion device, simultaneously receiving the four insulin amounts required by the patient calculated by the other two devices, and further processing at least two of the insulin amounts to determine the final insulin infusion amount.
According to one aspect of the invention, the management unit determines the amount of insulin required by the patient when all devices are in a normal state.
According to one aspect of the invention, the second blood glucose monitoring device determines the amount of insulin required by the patient when the first blood glucose monitoring device is in an abnormal state.
According to one aspect of the invention, one of the first blood glucose monitoring device and the at least one second blood glucose monitoring device is a primary monitoring device and the other is a backup monitoring device.
According to an aspect of the present invention, when both the main monitoring device and the standby monitoring device are in a normal operation state, the management unit displays the blood glucose level C1 monitored by the main monitoring device, the blood glucose level C2 monitored by the standby monitoring device, or the blood glucose level C3 after further processing the blood glucose level C1 and the blood glucose level C2.
According to one aspect of the invention, the further processing mode is to adopt a weighting algorithm, wherein the influence factors of the weights in the weighting algorithm comprise historical faults, calibration errors, historical current values and working time lengths monitored by the main monitoring equipment and the standby monitoring equipment.
According to one aspect of the invention, the impact of dining, sports, personal information of the patient, or the installation location of the primary and back-up monitoring devices is also considered during further processing.
According to one aspect of the invention, the subject who further processes the blood glucose values C1 and C2 is a management unit, one of an infusion device or the second blood glucose monitoring device.
According to one aspect of the present invention, when not both the main monitoring device and the standby monitoring device are in a normal operation state, the management unit displays the blood glucose value C1 monitored by the main monitoring device if the main monitoring device is in a normal state.
According to an aspect of the present invention, when not both the main monitoring device and the standby monitoring device are in a normal operation state, the management unit displays the blood glucose value C2 monitored by the standby monitoring device if the standby monitoring device is in a normal state.
According to one aspect of the invention, the management unit issues an alarm when at least one of the primary or backup monitoring devices is in an abnormal operating state.
According to one aspect of the invention, the management unit periodically calibrates with data monitored by the primary monitoring device and the backup monitoring device, and the reference blood glucose value used in performing the calibration is calculated by a weighting algorithm.
According to one aspect of the invention, the first blood glucose monitoring device is integrated with an infusion needle of an infusion device.
Compared with the prior art, the technical scheme of the invention has the following advantages:
the invention also discloses an artificial pancreas, which comprises a first blood glucose monitoring device and at least one second blood glucose monitoring device, wherein the first blood glucose monitoring device and the at least one second blood glucose monitoring device are arranged on the same patient and are used for monitoring and sending the blood glucose value of the patient in real time; an infusion device for infusing a drug into a patient; and the management unit is in communication connection with the first blood sugar monitoring device, the second blood sugar monitoring device and the infusion device and is at least used for receiving the blood sugar values sent by the first blood sugar monitoring device and the second blood sugar monitoring device and sending an instruction of drug infusion to the infusion device. The user installs at least two blood sugar monitoring facilities simultaneously, ensures that artifical pancreas can both receive blood sugar data at any time to calculate and accurate infusion insulin, maintain patient's blood sugar level.
Further, the first blood glucose monitoring device is integrated with the infusion device, so that the inserted position of the patient is reduced, and the risk of infection of the patient is reduced.
Further, the algorithm A1 is preset in the management unit, the algorithm A2 is preset in the infusion device, and/or the algorithm A3 is preset in the second blood glucose monitoring device, and the insulin amount required by the patient is determined by the management device, the infusion device or the second blood glucose monitoring device. The fixed manner includes a single decision or a combined decision. When the equipment is abnormal, the artificial pancreas can still complete closed-loop control of the blood sugar of the patient, so that the blood sugar level of the patient is maintained at a stable level. In addition, when the sensor of the integrated infusion device fails, but because the infusion function is still normal, the blood glucose monitoring function is replaced by other second blood glucose monitoring devices, so that the service life of the integrated infusion device can be prolonged, and the cost of the patient in the whole diabetes treatment period can be reduced.
Further, the management unit, the infusion device or the second blood glucose monitoring device calculates a more accurate and reliable final blood glucose value by considering not only blood glucose data monitored by at least two blood glucose monitoring devices but also the influence of meal, movement, personal information of a patient or the installation position of the monitoring devices when calculating the insulin amount, so that the infused insulin amount is more accurate and reliable, and the blood glucose level of the patient is better adjusted.
Further, one of the first blood glucose monitoring device and the second blood glucose monitoring device is a main monitoring device, the other is a standby device, and when the main monitoring device and the standby monitoring device are in a normal working state, the management unit displays a blood glucose value C1 monitored by the main monitoring device, a blood glucose value C2 monitored by the standby monitoring device, or a blood glucose value C3 after further processing of the blood glucose value C1 and the blood glucose value C2; when the main monitoring equipment and the standby monitoring equipment are not in the normal working state, if the main monitoring equipment is in the normal state, the management unit displays the blood glucose value C1 monitored by the main monitoring equipment; and if the standby monitoring equipment is in a normal state, the management unit displays the blood glucose value C2 monitored by the standby monitoring equipment. The management unit can display blood sugar data at any time, so that a patient is relieved.
Further, the blood glucose data monitored by the main monitoring device and the standby monitoring device are processed by using a weighting algorithm, and the influence factors of the weights in the weighting algorithm comprise the historical faults, the calibration errors, the historical current values and the working time length monitored by the main monitoring device and the standby monitoring device, so that the weight of each blood glucose monitoring device is more reliable, and further the blood glucose data is more accurate and reliable.
Furthermore, the management unit can also regularly calibrate the blood glucose data monitored by the main monitoring device and the standby monitoring device, the reference blood glucose value used in calibration can be calculated through a weighting algorithm, and the weighted blood glucose data is used for calibrating the main monitoring device and the standby monitoring device, so that the monitored blood glucose value is more reliable and more accurate, and the accuracy and reliability of blood glucose monitoring are improved. Meanwhile, when the main monitoring equipment is abnormal, the standby monitoring equipment can normally monitor blood sugar data of a patient, and the integrity and accuracy of blood sugar data monitoring are guaranteed, so that damage to health of the patient is avoided.
Drawings
FIG. 1a is a schematic diagram of a general blood glucose monitoring system;
FIG. 1b is a schematic diagram of a blood glucose monitoring system according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of an integrated blood glucose monitoring device according to an embodiment of the present invention;
FIG. 3 is a schematic structural view of a split blood glucose monitoring device according to an embodiment of the present invention;
FIG. 4 is a flow chart of a process when an anomaly occurs in a primary monitoring device according to an embodiment of the present invention;
FIG. 5 is a process flow diagram of a primary monitoring device when it is replaced according to an embodiment of the present invention;
FIG. 6 is a schematic layout of a CGM before and after replacement of a primary monitoring device in accordance with an embodiment of the present invention;
FIG. 7 is a flow chart of a process when an anomaly occurs in a primary monitoring device in accordance with another embodiment of the present invention;
FIG. 8 is a schematic diagram of the principle structure of an artificial pancreas according to an embodiment of the invention;
FIG. 9 is a schematic diagram of a decision flow for an artificial pancreas according to an embodiment of the invention;
fig. 10 is a sequence diagram showing blood glucose levels by the artificial pancreas management unit according to an embodiment of the invention.
Detailed Description
As previously mentioned, when the blood glucose monitoring device has expired in its lifetime or the blood glucose monitoring device fails, an updated blood glucose monitoring device is required, which may take up to two hours to warm up before the blood glucose monitoring device can always produce a normal result, and during warm up, blood glucose measurements made by a newly inserted blood glucose monitoring device may be inaccurate and unreliable, and if hyperglycemia or hypoglycemia occurs during warm up, the artificial pancreas is deactivated again because no blood glucose data is received, resulting in a patient failing to eat in time or infusing insulin accurately, thereby creating a health hazard to the patient.
In order to solve the problem, the invention provides an artificial pancreas comprising a first blood glucose monitoring device and at least one second blood glucose monitoring device, which are arranged on the same patient and are used for monitoring and transmitting the blood glucose value of the patient in real time; an infusion device for infusing a drug into a patient; and the management unit is in communication connection with the first blood sugar monitoring device, the second blood sugar monitoring device and the infusion device and is at least used for receiving the blood sugar values sent by the first blood sugar monitoring device and the second blood sugar monitoring device and sending an instruction of drug infusion to the infusion device. The user installs at least two blood sugar monitoring facilities simultaneously, ensures that artifical pancreas can both receive blood sugar data at any time to calculate and accurate infusion insulin, maintain patient's blood sugar level.
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.
Furthermore, it should be understood that the dimensions of the various elements shown in the figures are not necessarily drawn to actual scale, e.g., the thickness, width, length, or distance of some elements may be exaggerated relative to other structures for ease of description.
The following description of the exemplary embodiment(s) is merely illustrative, and is in no way intended to limit the invention, its application, or uses. Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail herein, but where applicable, should be considered part of the present specification.
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, no further discussion thereof will be necessary in the following figure description.
FIG. 1a is a schematic diagram of a general blood glucose monitoring system.
Referring to fig. 1a, the blood glucose monitoring system 10 includes an auxiliary installer 11, a blood glucose monitoring device 12, and a personal diabetes management device (hereinafter referred to as management device) 13. The auxiliary installer 11 is used for installing the blood glucose monitoring device 12 on the skin surface of a patient, generally, only one blood glucose monitoring device 12 is worn by a patient, after the blood glucose monitoring device 12 is installed on the skin surface of the patient, the blood glucose value in the patient is obtained, the blood glucose value and other necessary information are sent to the management device 13, and the management device 13 receives the information such as the blood glucose concentration and the like, analyzes and processes the information, and finally displays the information on a display screen of the management device 13 in an intuitive manner. The management device 13 includes a dedicated handheld device, a smart phone capable of downloading a dedicated APP, a personal computer capable of logging into a dedicated website, a tablet, etc.
The blood glucose monitoring system 10 further includes a diabetes secondary management device (hereinafter referred to as secondary management device) 14. The secondary management device 14 may be a dedicated handheld device, a smart phone capable of downloading a dedicated APP, a personal computer capable of logging into a dedicated website, a tablet, etc., and the user may be the patient itself or another person other than the patient, for example, a patient's guardian or doctor. Typically, the patient himself uses the management device 13, while the guardian or doctor uses the secondary management device 14.
The blood glucose monitoring device 12 is in wireless communication with the management device 13 and/or the secondary management device 14 via NFC, bluetooth, wi-Fi, or the Internet, among others. In one embodiment of the present invention, the blood glucose monitoring device 12 is connected to the management device 13 and/or the secondary management device 14 through bluetooth in a wireless communication manner, so that the power consumption of the blood glucose monitoring device 12 can be saved, and the service life of the blood glucose monitoring device can be prolonged.
The management device 13 may establish a wireless communication connection with the secondary management device 14 through NFC, bluetooth, wi-Fi, or the Internet, or may establish a wired communication connection with the secondary management device 14 through USB, serial port, ethernet, or the like, so as to implement data transmission between the management device 13 and the secondary management device 14.
The blood glucose monitoring system 10 further includes a data relay device 15. The data relay device 15 may be placed within an effective communication distance of the blood glucose monitoring device 12, and establish a wireless bluetooth communication connection with the blood glucose monitoring device 12, and establish a wireless communication connection with the management device 13 (or the secondary management device 14), and since the data relay device 15 may use an additional power source, a wireless communication connection with the management device 13 (or the secondary management device 14) may be established between the data relay device 15 and the management device 13 (or the secondary management device 14) that has a longer signal transmission distance, such as Wi-Fi or the Internet, for example, the effective communication distance between the data relay device 15 and the management device 13 may be 50m,200m, or even 1000m, or more. In the embodiment of the present invention, after receiving the blood glucose information transmitted by the blood glucose monitoring device 12, the data transfer device 15 transfers the blood glucose information to the management device 13, so that ultra-long-distance information transmission can be realized.
FIG. 1b is a schematic diagram of a blood glucose monitoring system according to an embodiment of the present invention.
In the embodiment of the invention, N (N is more than or equal to 2) blood sugar monitoring devices 12 are arranged on the same patient, and are sequentially numbered 12 (1), 12 (2) … (N), 12 (1) are used as main monitoring devices, and the other are used as standby monitoring devices. The same management device 13 and/or secondary management device 14 can manage all the blood glucose monitoring devices 12 at the same time, i.e. the N blood glucose monitoring devices 12 send the monitored blood glucose information to the management device 13 and/or secondary management device 14 directly or indirectly through the transit device 15, and the management device 13 and/or secondary management device 14 analyze and process after receiving the blood glucose values monitored by the N blood glucose monitoring devices 12 at the same time, and finally display the blood glucose values on the display screen of the management device 13 and/or secondary management device 14 in an intuitive and selectable manner. The communication manner among the blood glucose monitoring device 12, the management device 13, the secondary management device 14 and the data relay device 15 is as described above, and will not be described herein.
The N blood glucose monitoring devices 12 may be of the same configuration or of different configurations, so long as normal communication can be established with the management device 13, the secondary management device 14 and the data relay device 15, and data transfer is achieved. Preferably, the configuration of the N blood glucose monitoring devices 12 is identical, facilitating unified management and data processing by the management device 13 and/or the secondary management device 14.
In the embodiment of the present invention, the N blood glucose monitoring devices 12 are wearable continuous blood glucose monitors (CGM for short hereinafter), the CGM includes a sensor for collecting blood glucose content in a human body and transmitting collected blood glucose content information, and a transmitter connected to the sensor for receiving blood glucose content information transmitted by the subcutaneously implanted sensor and converting the blood glucose content information into a wireless signal for output. Each CGM has a unique identifier including, but not limited to, a device identifier, a hardware identifier, a universal unique identifier, a serial number, a communication protocol-based identifier (e.g., BLE ID), a manufacturer's identifier, etc., preferably, the identifier is a serial number of the CGM, which is formed by combining digits and letters randomly combined in multiple bits, and may be disposed on a housing or package of the CGM, or may be disposed differently depending on the type of CGM.
Specifically, in one embodiment of the present invention, the CGM is in an integral structure, i.e. the sensor and the emitter are integrated before use and are disposable after use, as shown in fig. 2, and fig. 2 is a schematic structural diagram of the integral continuous blood glucose monitor. The integrated blood glucose monitor comprises a sensor 201, a housing 202 and a transmitter (not shown) disposed within the housing 202, wherein the sensor 301 is configured to monitor blood glucose information of a body fluid of a patient, and the blood glucose information is transmitted to the transmitter through an internal circuit and then transmitted to the receiver by the transmitter. The identifier may be provided on the outer housing or on the outer envelope of the CGM or within the CGM.
In another embodiment of the present invention, the CGM is in a split structure, that is, the sensor and the emitter are two different components, respectively packaged before use, and are integrated together when in use, as shown in fig. 3, and fig. 3 is a schematic structural diagram of the split continuous blood glucose monitor. The split type continuous blood glucose monitor comprises a bottom shell 301 and a transmitter 302, wherein a sensor 3011 is arranged on the bottom shell, the transmitter 302 is provided with an independent shell, clamping structures 3012 and 3022 are respectively arranged on the shells of the bottom shell 301 and the transmitter 302, the bottom shell 301 and the transmitter 302 are clamped into a whole through the clamping structures when the split type continuous blood glucose monitor is used, the sensor 3011 is electrically connected with the transmitter 302 through an electric connector 3013, the sensor 301 is used for monitoring blood glucose information of body fluid of a patient, the blood glucose information is transmitted to the transmitter 302 through the electric connector 3013, and then the blood glucose information is transmitted to the receiver through the transmitter 302.
In one embodiment of the invention, the sensor and transmitter of the split continuous glucose monitor are both single use products, which are discarded after use, so that the identifier can be provided on the housing or on the outer envelope of the sensor or transmitter. In yet another embodiment of the present invention, only the sensor of the split continuous blood glucose monitor is a disposable product and the transmitter is a reusable product, so preferably, in this embodiment, the identifier is provided on the housing or outer package of the transmitter, and since the transmitter is reusable, the binding frequency of patient information and the identifier can be reduced, improving the patient experience.
When on the housing or outer package of the identifier device CGM or transmitter, it may be provided in a form including but not limited to a QR code, a bar code, or an NFC tag. In the embodiment of the present invention, when the patient wears N (N is greater than or equal to 2) CGMs simultaneously, one is used as a main monitoring device, the number is CGM (1), the other N-1 is used as a standby monitoring device, the serial numbers are CGM (2) … CGM (N), the monitored blood glucose data are all sent to the management device 13, it should be noted that, the monitored blood glucose data of the N CGMs can be all sent to the management device 13, the secondary management device 14, or the transfer device 15, and herein, for the sake of brevity, only the data are sent to the management device 13 for illustration, where the management device 13 is a smart phone, and the same special APP for managing the N CGMs is installed.
FIG. 4 is a flow chart of a process when an anomaly occurs in a primary monitoring device according to an embodiment of the present invention.
In one embodiment of the present invention, the management device 13 receives the information sent by the N CGMs at the same time, and defaults to display the blood glucose value monitored by the first CGM (1), that is, the blood glucose value monitored by the main monitoring device, when the management device 13 detects that the first CGM (1) is abnormal, the management device 13 first determines whether a standby monitoring device is still connected, if not, an alarm is sent to remind the patient that the standby monitoring device does not exist on the current body, and a new monitoring device needs to be replaced; if so, detecting whether the standby monitoring equipment is abnormal or not in sequence, and if not, giving an alarm to remind a patient that the available standby monitoring equipment does not exist on the body at present, and replacing the standby monitoring equipment; if there is a standby monitoring device without abnormality, the blood glucose value monitored by the first CGM without abnormality is displayed, where it is assumed that the first standby monitoring device without abnormality is CGM (2).
It should be noted that, in the embodiment of the present invention, the abnormality may cause the CGM to be replaced, but the CGM may not be replaced, which will be described in detail below. If the final main monitoring equipment is replaced, when the CGM (1) is abnormal, the stand horse displays the blood glucose value monitored by the CGM (2), so that the replacement of a new CGM and the waiting time required by the new CGM during preheating can be avoided, thereby causing the loss of blood glucose data and further causing health risks to patients. If the final main monitoring equipment is not replaced, when the CGM (1) is abnormal, the stand-by horse displays the blood glucose value monitored by the CGM (2), and the waiting time required by the main monitoring equipment from the abnormal condition to the abnormal recovery can be avoided, so that the blood glucose data is lost, and the health risk is further caused for the patient. Therefore, no matter whether the final main monitoring equipment is replaced or not, when the CGM (1) is abnormal, the stand horse displays the blood glucose value monitored by the CGM (2), so that the defect of blood glucose data can be avoided, and health risks are further caused to patients.
Fig. 5 is a flowchart of a process when a primary monitoring device is replaced according to an embodiment of the present invention. Fig. 6 is a schematic layout diagram of CGM before and after replacement of the main monitoring device according to an embodiment of the present invention.
With reference to fig. 5 and 6, when the main monitoring device is finally replaced, the management device continues to display the blood glucose value monitored by the CGM (2), the CGM (2) is used as a new main monitoring device, and the newly replaced monitoring device is used as an n+1th standby monitoring device CGM (n+1), and since the CGM (2) is used as the main monitoring device, the number of the standby monitoring devices in the blood glucose monitoring system of the invention is still N-1 (N is more than or equal to 2). Similarly, when the M-1 th main monitoring device is abnormal and needs to be replaced, the standby monitoring device with the number of CGM (M) is used as a new main monitoring device, and the (N+M-1) th new monitoring device is added as a new standby monitoring device, so that the number of the standby monitoring devices in the blood glucose monitoring system is always N-1 (N is more than or equal to 2). When the main monitoring equipment is abnormal, the standby monitoring equipment is guaranteed to be used for monitoring real-time blood glucose data all the time, the integrity of blood glucose monitoring is guaranteed, and meanwhile health risks to patients are avoided. After installing a new monitoring device, generally, the new monitoring device can be normally used only after the calibration-free code or the measured fingertip blood glucose value is required to be input to calibrate the new monitoring device, but in the embodiment of the invention, since the standby monitoring device such as the CGM (2) displays the blood glucose data in real time, the new monitoring device CGM (n+1) can calibrate the blood glucose value monitored by the CGM (2), the calibration-free code or the fingertip blood glucose value is not required to be input, the operation steps are reduced, and the experience of a patient is improved.
When the first main monitoring device CGM (1) is recovered to be normal after a period of abnormality, the CGM (1) is continuously used as the main monitoring device without replacing the CGM (1), and new standby monitoring devices are not needed to be newly added. The CGM (1) is continuously used to prolong the CGM replacement time, so that the cost of the patient in the whole diabetes treatment period is saved.
FIG. 7 is a flow chart of a process when an anomaly occurs in a primary monitoring device in accordance with another embodiment of the present invention.
In the embodiment of the present invention, the abnormality may include abnormal blood glucose data monitored by CGM, for example, the abnormal blood glucose data exceeds the normal range that can be detected by CGM, for example, the normal range is 2.2-22.2mmol/L, the management device displays the blood glucose value as NA, that is, when the blood glucose value monitored by CGM (1) cannot be displayed normally or the data is distorted, the management device 13 immediately confirms whether the CGM (2) is connected, if the management device confirms that the CGM (2) is not connected, an alarm is sent to remind the patient that no standby monitoring device exists, and a new monitoring device needs to be replaced; if so, it is further confirmed whether the CGM (2) monitoring is that the blood glucose value is within the normal range. If the monitoring of the CGM (2) is that the blood sugar value is in the normal range, displaying the blood sugar value in the normal range monitored by the CGM (2); after a period of time, such as 30 minutes, 1 hour, 2 hours, or 3 hours, if the monitored blood glucose level of the CGM (1) still exceeds the normal range that can be displayed by the management device 13, the management device 13 issues a warning to alert the patient that the CGM may malfunction, a new monitoring device needs to be replaced, and the management device 13 continues to display the monitored blood glucose level of the CGM (2) during the replacement of the monitoring device and the preheating of the new monitoring device. Correspondingly, if the blood glucose value monitored by the CGM (1) is recovered to be normal after a period of time, the data processing module in the management equipment 13 compares the blood glucose values monitored by the two monitoring equipment, if the difference value of the two monitoring equipment is not in an acceptable range, namely the absolute value of the difference value of the two monitoring equipment is larger than a preset threshold value, such as 3mmol/L, the management equipment 13 continuously displays the blood glucose value monitored by the CGM (2); if the difference between the two is within the acceptable range, that is, the absolute value of the difference between the two is less than or equal to the preset threshold, for example, 3mmol/L, the management device 13 redisplays the first CGM, that is, the blood glucose value monitored by the main monitoring device. If the monitoring of the CGM (2) is that the blood glucose level is not within the normal range, the management device 13 sequentially checks whether other monitoring devices are connected and confirms whether the blood glucose level monitored by the other monitoring devices is within the normal range, and when the monitoring devices with the blood glucose level within the normal range are confirmed, the blood glucose level of the monitoring devices is displayed, and if the blood glucose level monitored by all the monitoring devices is not within the normal range, an alarm is sent to remind the patient to replace the new monitoring device.
In another embodiment of the present invention, the management device stores a data processing module therein, and when the blood glucose level monitored by the CGM (1) is recovered to be normal after a period of time, the data processing module recalculates the blood glucose level in the patient using the blood glucose data monitored by the main monitoring device and the standby monitoring device, and the calculation method includes, but is not limited to, a weighting algorithm, and when calculating the blood glucose data, different weights may be given according to the accuracy and reliability of each monitoring device. For example, the standby monitoring device always shows stability, high accuracy, and no malfunction or blood glucose level out of the normal range, then the weight is given higher when calculating the final blood glucose level. Conversely, if the primary monitoring device often fails or has low accuracy, then its weight is given lower when calculating the final blood glucose value. Specifically, the weight of each monitoring device is determined through the historical fault, the calibration error, the historical current value and the working time of each monitoring device in a weighting algorithm.
Assuming that the initial weights of the working time length in the weights of each monitoring device are A, B, C, D respectively and a certain proportional relationship exists, assuming that the actual weights of the working time length in the weights of each monitoring device are A ', B', C ', D', the calibration error and the historical current value are assumed
A' = [ 1/(1+n) ], a, n being the number of times the monitoring device failed in the past period of time; if the monitoring device does not fail within the past period of time, the actual weight A' occupied by the historical failure of the monitoring device is equal to the initial weight A.
B' = [ 1/(1+s) ], and s is the error between the measured value and the standard value of the monitoring device after calibration; if the error between the measured value and the standard value of the monitoring device is 0 after calibration, the actual weight B' occupied by the calibration error of the monitoring device is equal to the initial weight B.
C' =e×c, e is a ratio of the historical current value of the monitoring device in the past period of time in a set normal range; if the historical current values of the monitoring device in the past time period are all in the set normal range, the actual weight C' occupied by the historical current values of the monitoring device is equal to the initial weight C.
D' =d when the number of days of sensor use is equal to or less than T; when the number of days of use of the monitoring device is greater than T, D' = [ 1/(1+m (T-T)) ] D, T is the number of days of current use of the monitoring device, m is a constant smaller than 1, T is the number of days of use when the accuracy or sensitivity of the monitoring device starts to decrease, such as for a monitoring device with a service life of 14 days, T may be equal to 10; if the accuracy or sensitivity of the monitoring device does not start to decrease when the number of days of use of the monitoring device is less than or equal to T, the actual weight D' occupied by the working time of the sensor is equal to the initial weight D.
For the Nth monitoring device, the total actual weight is W N ＝A N ’+B N ’+C N ’+D N ' the sum of all weights of all monitoring devices is 1, i.e. W 1 +W 2 +…+W N =1, and thus the actual weight of each monitoring device.
In other embodiments of the present invention, in processing blood glucose data, the factors considered, in addition to the data of the primary and backup monitoring devices, the management device may recalculate the blood glucose level in the patient based on other information including, but not limited to, the amount of carbohydrates consumed, the type and intensity of exercise, the time and quality of sleep, and the patient's personal condition such as gender, age, eating habits, medical history, etc. The meal may also affect the weight that the primary or back-up monitoring device is given, and in particular, depending on the carbohydrate sensitivity of the patient device and the amount of carbohydrate input, the management device predicts the blood glucose level of the patient at different times, and the primary and back-up monitoring devices will be given a higher weight when they monitor blood glucose levels closer to the predicted blood glucose levels. In another embodiment of the present invention, the blood glucose values monitored by the main and backup monitoring devices after meals may also be compared with the historical blood glucose values at meals, with blood glucose values closer to the historical blood glucose values being given a higher weight. The exercise may also affect the weight that is assigned to the primary or backup monitoring devices, and specifically, the blood glucose values monitored by the primary and backup monitoring devices are compared to the historical blood glucose values during exercise, and higher weights are assigned when the blood glucose values are closer to the historical blood glucose values. The final blood glucose value which is more accurate and reliable can be obtained through weighted calculation, and the accuracy and the reliability of blood glucose monitoring are improved.
In another embodiment of the present invention, the management device may also perform calibration by periodically using the blood glucose data monitored by the primary monitoring device and the backup monitoring device, where the reference blood glucose value used in calibration may be calculated by using the weighting algorithm as described above, and the weighted blood glucose data is used to calibrate the primary monitoring device and the backup monitoring device, so that the monitored blood glucose value is more reliable and more accurate, and the accuracy and reliability of blood glucose monitoring are improved. The time for performing the calibration periodically may be set according to practical requirements, for example, 3-10 times during the whole life cycle of the sensor, or once every 2-5 days, or more frequently during the early or later period of the life cycle of the sensor than during the middle period of the life cycle, etc., and is not particularly limited herein.
In another embodiment of the invention, the reference blood glucose value used in the regular calibration is the fingertip blood glucose value input by the patient, so that the main monitoring device and the standby monitoring device can be calibrated more reliably and accurately, and the accuracy and the reliability of blood glucose monitoring are improved.
In another embodiment of the present invention, the reference blood glucose level used in the periodic calibration may be related to the blood glucose level monitored by the main monitoring device, the blood glucose level monitored by the standby monitoring device, and the fingertip blood glucose level at the same time.
In the embodiment of the invention, the management equipment can check whether the standby monitoring equipment is abnormal while regularly calibrating the main monitoring equipment and the standby monitoring equipment, if the standby monitoring equipment is abnormal, the abnormality is processed as soon as possible to enable the standby monitoring equipment to recover to be normal, and if the standby monitoring equipment cannot recover, the new standby monitoring equipment is replaced as soon as possible to ensure that the standby monitoring equipment which can be normally used at any time is available, so that the standby monitoring equipment can normally monitor blood sugar data of a patient when the main monitoring equipment is abnormal, the integrity and the accuracy of blood sugar data monitoring are ensured, and the damage to the health of the patient is avoided.
In the embodiment of the invention, N monitoring devices cannot be inserted into the same position in the patient at the same time, even in a symmetrical position, and because repeated puncture at the same position can leave scars and even be infected, rotation puncture at different positions is required when a new monitoring device is replaced. Because of the differences in the composition of various parts of the patient's body, such as fat thickness, skin thickness, capillaries, muscle tissue, etc., and whether the exposure causes the difference from the temperature of other parts, etc., the blood glucose values monitored at different parts will have certain differences, the data processing module in the management device recalculates the blood glucose values in the patient's body by using the blood glucose data monitored by the main monitoring device and the standby monitoring device, the calculation method includes, but is not limited to, the weighting algorithm described above, the data monitored by the monitoring devices at different positions are given different weights, and the blood glucose values after the treatment can more represent the actual blood glucose levels in the patient's body, thereby improving the accuracy and reliability of blood glucose monitoring.
In another embodiment of the invention, the anomaly may be an expiration of life reminder for the primary monitoring device, the current life being typically 7-14 days due to the predetermined life of the disposable monitoring device, and the future life of the monitoring device may extend to 21 days, even 30 days, with further innovations in technology. In the embodiment of the invention, when the monitoring device is inserted into the body, the management device starts to record the service time of the monitoring device, when the service time of the monitoring device is close to the preset service life of the monitoring device, such as 2 days, 1 day, half a day, 3h,1h and the like from the service life of the monitoring device, the management device gives an alarm to remind a patient to replace the monitoring device, according to the reminding of the management device, the patient replaces the monitoring device in advance before the service life of the monitoring device expires, and meanwhile, the monitoring data of the standby monitoring device is used during the replacement and the preheating of the new monitoring device, so that the defect of blood sugar data can be avoided, health risks are further caused to the patient, the first standby monitoring device is used as a new main monitoring device, the replaced new monitoring device is used as a standby monitoring device, and the N-1 standby monitoring devices are always kept as shown in fig. 6. Preferably, the interval between the time of replacement of the first primary monitoring device and the expiration time of the life span of the monitoring device is slightly longer than the time of preheating the monitoring device, for example, the manufacturer declares that the time required for preheating the monitoring device is 30 minutes, then it is preferable to replace the monitoring device within 35min-60min before expiration of the monitoring device because, in general, the first primary monitoring device such as CGM (1) and the first backup monitoring device such as CGM (2) are inserted into the patient at the same time, and have the same service life because they are configured in the same way, and if the first primary monitoring device CGM (1) is replaced after expiration of the life span, the first backup monitoring device CGM (2) cannot normally monitor the blood glucose value of the patient because of expiration of the service life span, so the interval between the time of replacement of the first primary monitoring device and the expiration time of the life span of the monitoring device is slightly longer than the time of preheating the monitoring device, not only ensuring the integrity of blood glucose monitoring data during replacement and new monitoring device preheating, but also maximally using the monitoring device, and saving the cost of the whole diabetes patient during the whole treatment period because diabetes is a life span disease. When starting from a second main monitoring device, such as CGM (2), the replacement time can be postponed until the lifetime of the monitoring device expires, even for a period of time, because the insertion of a new back-up monitoring device, such as CGM (3), into the patient is always later than the previous main monitoring device, CGM (2), i.e. the previous main monitoring device, CGM (3), is still within the normal lifetime, so that the back-up monitoring device, CGM (3), can be used as a new main monitoring device and display the blood glucose value it monitors both when replacing the new monitoring device, CGM (4) and when warming up. However, in this case, the replacement time of the first primary monitoring device may be after its lifetime has expired, since the lifetime expiration time of the first backup monitoring device is longer than the warm-up time of the new monitoring device, considering that the patient may also be after the primary monitoring device has been inserted into the body for a period of time, such as two hours, for a period of time longer than the warm-up time of the new monitoring device. In summary, the replacement time of the first primary monitoring device may be determined based on the insertion times of the primary and backup monitoring devices.
It should be noted that, in the embodiment of the present invention, the primary monitoring device and the backup monitoring device, that is, the CGM (1) and the CGM (2), may be inserted into the patient at the same time, or the primary monitoring device may be inserted into the patient after being inserted into the patient for a period of time, so long as it is ensured that the backup monitoring device exists at the same time during the service life of the earliest primary monitoring device. Preferably, the primary monitoring device and the standby monitoring device at the beginning are inserted into the patient at the same time, so that the standby monitoring device can be ensured to provide complete and accurate blood sugar detection data whenever the primary monitoring device is abnormal, and damage to the health of the patient is avoided.
In another embodiment of the present invention, the abnormality may be an interruption or a failure of the communication connection, and when the communication between the main monitoring device and the management device is abnormal, the management device gives an alarm to remind the patient to check the communication connection between the main monitoring device and the management device, and at the same time check whether the communication connection of the standby monitoring device is normal, and check whether the blood glucose data monitored by the standby monitoring device is normal, if both are normal, the monitoring data of the standby monitoring device is used before the communication between the main monitoring device and the management device is restored to be normal, so that the loss of the blood glucose data can be avoided, and further health risks are caused to the patient. When the communication between the main monitoring equipment and the management equipment is recovered to be normal, comparing the blood glucose values monitored by the two monitoring equipment, if the difference value of the two monitoring equipment is not in an acceptable range, namely the absolute value of the difference value of the two monitoring equipment is larger than a preset threshold value, such as 3mmol/L, the management equipment continuously displays the blood glucose value monitored in standby mode; if the difference value is within the acceptable range, that is, the absolute value of the difference value is smaller than or equal to a preset threshold value, such as 3mmol/L, the management equipment redisplays the blood glucose value monitored by the main monitoring equipment. If the communication between the main monitoring device and the management device is still not recovered after a period of time, such as 1h or 3h, the standby monitoring device is used as a new main monitoring device, and the management device simultaneously sends an alarm to remind the patient to replace the new monitoring device as a new standby monitoring device. If the standby monitoring equipment is not detected by the management equipment, or the connection of the standby monitoring equipment is abnormal, or the blood sugar data monitored by all the standby monitoring equipment is not in the normal blood sugar range monitored by the monitoring equipment, the management equipment can give an alarm to remind a patient to replace the new monitoring equipment.
In one embodiment of the present invention, the primary monitoring device and the standby monitoring device may have multiple communication modes, such as NFC, bluetooth, etc., one is used as a primary communication mode, the other is used as a standby communication mode, and when the primary communication mode of the primary monitoring device is abnormal, the primary communication mode may be switched to the standby communication mode, and when the primary communication mode resumes normal connection, the primary communication mode may be switched to the primary communication mode again. When the main communication mode and the standby communication mode of the main monitoring equipment are abnormal, detecting the communication connection of the standby monitoring equipment, if the main communication connection of the standby monitoring equipment is normal, connecting the main communication connection mode, otherwise, connecting the standby monitoring equipment in the standby communication connection mode, so as to prevent the connection in only one communication mode, and the abnormal situation cannot be recovered in time, thereby causing blood sugar data loss and further causing risks to patients.
In another embodiment of the invention, the primary and backup monitoring devices may each provide a monitoring signal at different frequencies, as is typically the case, the primary monitoring device at a first frequency f 1 Providing a main monitoring signal, and a standby monitoring device at a second frequency f 2 Providing a standby signal. Preferably, the first frequency is not lower than the second frequency, the main monitoring device provides a first main monitoring signal at a higher first frequency to meet the daily monitoring requirement of the patient, and the standby monitoring device provides a standby monitoring signal at a lower second frequency, so that the sensitivity decay is slow to maintain the high-confidence standby monitoring. In a preferred embodiment of the invention, the first frequency f 1 At a second frequency f of 6-3600 times/h 2 Is 0.01 to 60 times/h. Preferably, the first frequency f 1 Is the second frequency f 2 The main monitoring device can simultaneously provide the first detection signal while the standby monitoring device provides the standby signal, so that the occurrence time difference of the detection signals is avoided, and the detection environments are inconsistent. Still further preferably, the first frequency f 1 =30 times/h, second frequency f 2 =10 times/h. When the main monitoring equipment is abnormal and needs to be replaced, the standby monitoring equipment is used as new main monitoring equipment, and the monitoring frequency is also lowerThe second frequency is switched to the higher first frequency and the newly replaced monitoring device monitors as a new backup monitoring device at the second frequency.
In another embodiment of the present invention, an exception may also be the patient actively terminating or removing the primary monitoring device and actively selecting any one of the backup monitoring devices as a new primary monitoring device.
In another embodiment of the present invention, the patient is provided with a drug infusion device while the N blood glucose monitoring devices are installed, the management device simultaneously controls the N blood glucose monitoring devices and the drug infusion device to form an artificial pancreas, and the management device calculates the insulin amount required by the patient at least according to the blood glucose value monitored by one of the N blood glucose monitoring devices and controls the drug infusion device to infuse.
In another embodiment of the invention at least one of the N blood glucose monitoring devices is integrated with an infusion device, e.g. the sensor is integrated with an infusion needle or tube of the infusion device, at least one of which is a continuous blood glucose monitor CGM. Compared with the traditional artificial pancreas, the patient does not need two mounting devices, and infusion equipment and blood glucose monitoring equipment are respectively mounted at two different parts of the body, so that the risk of infection of the patient is reduced.
Fig. 8 is a schematic structural view of an artificial pancreas according to an embodiment of the invention.
The artificial pancreas comprises: blood glucose monitoring and insulin administration management unit 81, integrated infusion device 82, and blood glucose monitoring device (2) through blood glucose monitoring device (N), integrated infusion device 82 includes control unit 822 and infusion unit 821, and infusion unit 821 includes drive unit 8211, stores up medicine unit 8212, infusion needle 8213 and sensor 8214, and sensor 8214 can be equivalently blood glucose monitoring device (1), and sensor 8214 is integrated on infusion needle 8213, implants simultaneously in patient same subcutaneous tissue department, simple installation like this and reduced the probability that diabetes patient was infected. The blood glucose monitoring device (2) to the blood glucose monitoring device (N) may be the aforementioned integrated or split blood glucose monitoring device CGM.
In another embodiment of the present invention, the sensor 8214 is not integrated on the infusion needle 8213, but is separately provided in the infusion unit 821, and the infusion needle 8213 and the sensor 8214 are penetrated into the skin of the patient by a guide needle or a installer, i.e., in the embodiment of the present invention, the infusion needle 8213 and the sensor 8214 are respectively penetrated into the skin at different positions of the patient, and two penetration points are provided, and the separate arrangement of the infusion needle 8213 and the sensor 8214 can reduce the design and production difficulty of the infusion needle 8213 and the sensor 8214, thereby reducing the production cost of the integrated infusion device 82.
The blood glucose monitoring devices (1) to (N) are all used for monitoring the blood glucose value in the patient, the blood glucose value monitored by the blood glucose monitoring device (1) is sent to the blood glucose monitoring and insulin administration management unit 81 through the control unit 822, the blood glucose value monitored by the blood glucose monitoring device (2) to (N) is directly sent to the blood glucose monitoring and insulin administration management unit 81, the blood glucose monitoring and insulin administration management unit 81 sends an instruction for whether to perform drug infusion or not to the integrated infusion device 82 at least by using the blood glucose value monitored by the blood glucose monitoring device (1) to (N), and the control unit 822 receives the instruction of the blood glucose monitoring and insulin administration management unit 81 and controls the infusion unit 821 to infuse the drug stored in the drug storage unit 8212 into the skin along the infusion needle 8213 by using the driving unit 8211, so that the blood glucose level of the patient is adjusted.
The communication system between the blood glucose monitoring and insulin administration management unit 81 and the integrated infusion device 82, and the blood glucose monitoring devices (2) to (N) is identical to the communication system between the management device 13 and the blood glucose monitoring device 12.
In the embodiment of the present invention, the blood glucose monitoring and insulin administration management unit 81 may be integrated with the integrated type infusion device 82, or may be a separate device from the integrated type infusion device 82, such as the aforementioned management device 13.
In the embodiment of the present invention, the sensor 8214 in the integrated infusion device 82 is a main monitoring device, and the blood glucose monitoring devices (2) to (N) are standby monitoring devices. The blood glucose values monitored by the main monitoring device and the standby monitoring device are sent to the blood glucose monitoring and insulin administration management unit 81, when the monitoring by the main monitoring device and the standby monitoring device are in a normal state, the blood glucose monitoring and insulin administration management unit 81 displays the blood glucose values monitored by the main monitoring device, calculates the insulin amount required by a patient by utilizing the blood glucose values monitored by the main monitoring device, and sends an indication to the integrated drug infusion device 82, and the integrated drug infusion device 82 controls the infusion unit 821 to infuse drugs according to the indication. When the sensor 8214 of the integrated infusion device 82 is abnormal, but the infusion function is still normal, the blood glucose monitoring and insulin administration management unit 81 first determines whether a standby monitoring device is connected, and if not, an alarm is sent to remind the patient that the standby monitoring device does not exist on the body at present and that a new monitoring device needs to be replaced; if so, sequentially detecting whether the standby monitoring equipment is abnormal, if not, giving an alarm to remind a patient that no available standby monitoring equipment exists on the body at present, and replacing the standby monitoring equipment, wherein the replaced novel monitoring equipment can be integrated infusion equipment or CGM; if there is a standby monitoring device without abnormality, displaying a first CGM-monitored blood glucose value without abnormality, wherein it is assumed that the first standby monitoring device without abnormality is a blood glucose monitoring device (2) 83, and simultaneously calculating an amount of insulin required for a patient using the blood glucose value monitored by the blood glucose monitoring device (2) 83 and transmitting an instruction to an integrated drug infusion device 82, and the integrated drug infusion device 82 controls the infusion unit 821 to perform drug infusion in accordance with the instruction. The sensor 8214 in the integrated infusion device 82 displays the blood glucose value monitored by other CGM and calculates the insulin required by the patient when the sensor is abnormal, so that on one hand, the defect of blood glucose data can be avoided, the calculation and the infusion of the required insulin are influenced, and further, the risk is caused to the health of the patient, and on the other hand, although the sensor of the integrated infusion device is faulty, the blood glucose monitoring function is replaced by other standby monitoring devices due to the fact that the infusion function is still normal, and therefore the service life of the integrated infusion device can be prolonged, and the cost of the patient in the whole diabetes treatment period is reduced.
In another embodiment of the present invention, the main monitoring device is a CGM, such as a blood glucose monitoring device (2) 83, the standby monitoring device is an integrated type infusion device 82, and when both the main monitoring device and the standby monitoring device monitor a normal state, the blood glucose monitoring and insulin administration management unit 81 displays a blood glucose value monitored by the main monitoring device, calculates an amount of insulin required by a patient using the blood glucose value monitored by the main monitoring device, and sends an indication to the integrated type drug infusion device 82, and the integrated type drug infusion device 82 controls the infusion unit 821 to perform drug infusion according to the indication. When the main monitoring device is abnormal, the blood glucose monitoring and insulin administration management unit 81 confirms whether the sensor 8214 of the integrated infusion device 82 is abnormal, if so, reminds the patient of the abnormal sensor of the standby monitoring device, and needs to replace the new monitoring device, wherein the replaced new monitoring device can be the integrated infusion device or CGM; if there is no abnormality, the blood glucose value monitored by the sensor 8214 of the integrated type drug infusion device 82 is displayed and used to calculate the amount of insulin required for the patient, and an instruction is sent to the integrated type drug infusion device 82, and the integrated type drug infusion device 82 controls the infusion unit 821 to perform drug infusion in accordance with the instruction.
In this embodiment, when one of the sensor 8214 and the blood glucose monitoring device (2) to the blood glucose monitoring device (N) is a main monitoring device and the other is a standby monitoring device, the management device periodically calibrates blood glucose data monitored by the main monitoring device and the standby monitoring device, and checks whether the standby monitoring device is abnormal, which is consistent with the foregoing manner. The mode that the management equipment processes the data in different positions by using the main monitoring equipment and the standby monitoring equipment is consistent with the mode; the abnormality is the expiration reminding of the service life of the main monitoring equipment, the abnormality is communication interruption or failure, various communication modes between the main monitoring equipment, the standby monitoring equipment and the management equipment are consistent with the communication frequency conversion modes.
In another embodiment of the present invention, at least one of the blood glucose monitoring and insulin administration management unit 81, the integrated infusion device 82, the blood glucose monitoring device (2) to the blood glucose monitoring device (N) is preset with an algorithm, preferably, the blood glucose monitoring and insulin administration management unit 81 has a processor, the processor is preset with an algorithm A1, the control unit 822 of the integrated infusion device 82 has a processor, the processor is preset with an algorithm A2, the transmitter of the blood glucose monitoring device (2) to the blood glucose monitoring device (N) has a processor, and the processor is preset with an algorithm A3, which in the embodiment of the present invention is only described by the blood glucose monitoring device (2), wherein the algorithm A1, the algorithm A2 and the algorithm A3 may be one or more of an MPC algorithm, a PID algorithm and an autoregressive algorithm. The blood glucose monitoring and insulin administration management unit 81 may receive the blood glucose values monitored by the sensor 8214 and the blood glucose monitoring device (2), respectively, and calculate insulin amounts I11 and I12 required by the patient; the integrated infusion device 82 can calculate the required insulin amount I21 of the patient according to the blood glucose value monitored by the sensor 8214 and the preset algorithm A2, and can receive the blood glucose value monitored by the blood glucose monitoring device (2) and calculate the required insulin amount I22 of the patient according to the preset algorithm A2; the blood glucose monitoring device (2) can calculate the insulin amount I31 required by the patient according to the blood glucose value monitored by the blood glucose monitoring device and the preset algorithm A3, and can receive the blood glucose value monitored by the sensor 8214 and calculate the insulin amount I32 required by the patient according to the preset algorithm A3.
Thus, in embodiments of the present invention, the amount of insulin required by the patient may be determined by the integrated infusion device 82, the monitoring and insulin administration management unit 81, or the blood glucose monitoring device (2) to the blood glucose monitoring device (N), in a manner that includes both individual decisions and joint decisions. When one or both of the management unit, the infusion device, or the blood glucose monitoring device (2) is abnormal, the artificial pancreas can still complete closed loop control of the patient's blood glucose, so that the patient's blood glucose level is maintained at a stable level.
Referring to the following table, the individual decision is to select one of the two insulin amounts calculated by itself as the final insulin infusion amount, the joint decision is to receive the 4 insulin amounts calculated from the other two devices in addition to the two insulin amounts calculated by itself, and further process at least two of the insulin amounts, including average optimization, weighted average optimization, comparison optimization with statistical analysis results of historical data, and the like.
Table 1: individual or joint decision table
Specifically:
when the amount of insulin required by the patient is determined by the blood glucose monitoring and insulin administration management unit 81 alone, it includes:
The blood glucose monitoring and insulin administration management unit 81 receives the blood glucose value monitored by the sensor 8214, calculates the insulin amount I11 required by the patient according to a preset algorithm A1, and sends an instruction to the integrated infusion device 82 for drug infusion; or the blood glucose monitoring and insulin administration management unit 81 receives the blood glucose value monitored by the blood glucose monitoring device (2) 83, calculates the insulin amount I12 required by the patient according to a preset algorithm A1, and sends an instruction to the integrated infusion device 82 for drug infusion.
When the amount of insulin required by the patient is determined by the blood glucose monitoring and insulin administration management unit 81 in combination, it includes:
the control unit 822 of the integrated infusion device 82 calculates the amount of insulin I21 required by the patient according to the blood glucose level monitored by the sensor 8214 and the preset algorithm A2, and sends it to the monitoring and insulin administration management unit 81; the control unit 822 of the integrated infusion device 82 receives the blood glucose value monitored by the blood glucose monitoring device (2) 83, calculates the insulin amount I22 required by the patient according to a preset algorithm A2, and sends the insulin amount I22 to the blood glucose monitoring and insulin administration management unit 81; the blood glucose monitoring device (2) 83 calculates the insulin amount I31 required by the patient according to the monitored blood glucose value and a preset algorithm A3, and sends the insulin amount I31 to the blood glucose monitoring and insulin administration management unit 81; the blood glucose monitoring device (2) 83 receives the blood glucose value monitored by the sensor 8214, calculates the insulin amount I32 required by the patient according to a preset algorithm A3, and sends the insulin amount I32 to the blood glucose monitoring and insulin administration management unit 81; the blood glucose monitoring and insulin administration management unit 81 receives the blood glucose value monitored by the sensor 8214, calculates the insulin amount I11 required by the patient according to the preset algorithm A1, receives the blood glucose value monitored by the blood glucose monitoring device (2) 83, calculates the insulin amount I12 required by the patient according to the preset algorithm A1, and further processes at least 2 of the insulin amounts I11, I12, I21, I22, I31 and I32 to determine the final insulin amount, and sends an indication to the integrated infusion device 82 for drug infusion; the further processing mode comprises average value optimization, weighted average value optimization, comparison optimization with the statistical analysis result of the historical data and the like.
When the amount of insulin required by the patient is determined solely by the integrated infusion device 82, this includes:
the control unit 822 of the integrated infusion device 82 calculates the insulin amount I21 required by the patient according to the blood glucose value monitored by the sensor 8214 and the preset algorithm A2 and infuses the insulin, and when the blood glucose monitoring and insulin administration management unit 81 has a fault, the integrated infusion device 82 can also complete the closed-loop control on the diabetic patient, so that the blood glucose level of the patient is maintained at a stable level; or the control unit 822 receives the blood glucose value monitored by the blood glucose monitoring device (2) 83, calculates the required insulin amount I22 according to the preset algorithm A2 and infuses, and when the blood glucose monitoring and insulin administration management unit 81 and the sensor 8214 have faults, the integrated infusion device 82 and the blood glucose monitoring device (2) 83 can complete closed-loop control on the diabetic patient, so that the blood glucose level of the patient is maintained at a stable level.
When the amount of insulin required by the patient is determined jointly by the integrated infusion device 82, this includes:
the control unit 822 of the integrated infusion device 82 calculates the required insulin amount I21 of the patient according to the blood glucose value monitored by the sensor 8214 and the preset algorithm A2, and simultaneously receives the blood glucose value monitored by the blood glucose monitoring device (2) 83 and calculates the required insulin amount I22 of the patient according to the preset algorithm A2; the blood glucose monitoring device (2) 83 calculates the insulin amount I31 required by the patient according to the monitored blood glucose value and a preset algorithm A3, can accept the blood glucose value monitored by the sensor 8214 and calculate the insulin amount I32 required by the patient according to the preset algorithm A3, and sends the insulin amount I31 and the insulin amount I32 to the integrated infusion device 82; the blood glucose monitoring and insulin administration management unit 81 receives the blood glucose values monitored by the sensor 8214 and the blood glucose monitoring device (2) 83, calculates an insulin amount I11 and an insulin amount I12 required by a patient according to a preset algorithm A1, and sends the insulin amounts I11 and I12 to the integrated infusion device 82; the integrated infusion device 82 further processes at least 2 of the insulin amounts I11, I12, I21, I31 to determine a final insulin amount and sends an indication to the integrated infusion device 82 for drug infusion; the further processing mode comprises average value optimization, weighted average value optimization, comparison optimization with the statistical analysis result of the historical data and the like.
When the amount of insulin required by the patient is determined solely by the blood glucose monitoring device (2) 83, it includes:
the blood sugar monitoring device (2) 83 calculates the insulin quantity I31 required by the patient according to the blood sugar value monitored by the blood sugar monitoring device and a preset algorithm A3, and sends an instruction to the integrated infusion device 82 for drug infusion; or the blood glucose monitoring device (2) 83 receives the blood glucose value monitored by the sensor 8214 and calculates the patient's required insulin amount I32 according to the set algorithm A3 and sends an indication to the integrated infusion device 82 for drug infusion. Closed loop control of the diabetic patient can be accomplished by the integrated infusion device 82 and blood glucose monitoring device (2) 83 to maintain the patient's blood glucose level at a stable level when both the blood glucose monitoring and insulin administration management unit 81 and the sensor 8214 fail.
When the amount of insulin required by the patient is jointly determined by the blood glucose monitoring device (2) 83, it comprises:
the control unit 822 of the integrated infusion device 82 calculates the amount of insulin I21 required by the patient from the blood glucose value monitored by the sensor 8214 and the preset algorithm A2 and sends it to the blood glucose monitoring device (2) 83; the control unit 822 of the integrated infusion device 82 receives the blood glucose value monitored by the blood glucose monitoring device (2) 83, calculates the insulin amount I22 required by the patient according to a preset algorithm A2, and sends the insulin amount I22 to the blood glucose monitoring device (2) 83; the blood glucose monitoring device (2) 83 calculates the insulin amount I31 required by the patient according to the monitored blood glucose value and a preset algorithm A3, and meanwhile, the blood glucose monitoring device (2) 83 receives the blood glucose value monitored by the sensor 8214 and calculates the insulin amount I32 required by the patient according to the preset algorithm A3; the blood glucose monitoring and insulin administration management unit 81 receives the blood glucose value monitored by the sensor 8214, calculates the insulin amount I11 required by the patient according to the preset algorithm A1, receives the blood glucose value monitored by the blood glucose monitoring device (2) 83, calculates the insulin amount I12 required by the patient according to the preset algorithm A1, and sends the insulin amount I11 and the insulin amount I12 to the blood glucose monitoring device (2) 83, and the blood glucose monitoring device (2) 83 further processes at least 2 of the insulin amount I11, the insulin amount I12, the insulin amount I21, the insulin amount I22, the insulin amount I31 and the insulin amount I32 to determine the final insulin amount and sends an indication to the integrated infusion device 82 for drug infusion; the further processing mode comprises average value optimization, weighted average value optimization, comparison optimization with the statistical analysis result of the historical data and the like.
Therefore, in the embodiment of the present invention, when the blood glucose monitoring and insulin administration management unit 81 cannot work normally or one of the sensor 8214 and the blood glucose monitoring device (2) 83 cannot work normally, the artificial pancreas can still realize the closed-loop control of the blood glucose of the patient according to the blood glucose data monitored by the other blood glucose monitoring device and the algorithm preset in the other control unit. Preferably, as shown in fig. 9, when all devices of the artificial pancreas of the embodiment of the invention are operating normally, the amount of insulin required for the patient is determined by the monitoring and insulin administration management unit 81, the determination means including the individual determination and the joint determination as described above; when the blood glucose monitoring and insulin administration management unit 81 is not working properly, determining whether the sensor 8214 is working properly, if the sensor 8214 is working properly, determining the amount of insulin required by the patient by the integrated infusion device 82 in a manner comprising a single decision and a combined decision as described above, but only further processing of at least two of the amounts of insulin I21, I22, I31, I32 is possible when the combined decision is made; if the sensor 8214 is not functioning properly, the amount of insulin required by the patient is determined by the blood glucose monitoring device (2) 83 in a manner that includes both individual and combined decisions as described above, but the combined decisions still allow for further processing of the insulin amounts I22 and I31. In another embodiment of the invention, if the sensor 8214 is operating properly, the amount of insulin required by the patient may also be determined by the blood glucose monitoring device (2) 83, including the single and combined decisions as described above, but only at least two of the insulin amounts I21, I22, I31, I32 may be further processed in the combined decision.
In the embodiment of the invention, at least one main monitoring device and one standby monitoring device are used in the artificial pancreas, and the blood glucose monitoring and insulin administration management unit 81, the integrated infusion device 82 and the blood glucose monitoring device (2) are respectively provided with a processor, so that the blood glucose value monitored by the main monitoring device and the blood glucose value monitored by the standby monitoring device can be processed at the same time, the processing mode comprises, but is not limited to, the weighting algorithm, the weight of each monitoring device can be determined through the historical fault, the calibration error and the historical current value and the working time of each monitoring device in the weighting algorithm, and meanwhile, the influence of the meal, the movement, the personal information of a patient or the installation position of the monitoring device is considered, so that the monitored blood glucose value is more accurate and more reliable, and the infused insulin amount is more accurate and reliable, and the blood glucose level of the patient is better regulated.
Therefore, the blood glucose level may be displayed in a different manner when the blood glucose monitoring and insulin administration management unit 81 displays the blood glucose level. Fig. 10 is a sequence diagram of a management unit displaying blood glucose levels according to an embodiment of the present invention.
As shown in fig. 10, when both the main monitoring device and the standby monitoring device are in a normal operation state, the blood glucose monitoring and insulin administration management unit 81 displays the processed blood glucose value, and here, the main monitoring device is assumed to be the sensor 8214 of the integrated infusion device 82, and the standby monitoring device is assumed to be the blood glucose monitoring device (2) 83. It should be noted that, the main body for processing the blood glucose values monitored by the main monitoring device and the standby monitoring device may be any one of the blood glucose monitoring and insulin administration management unit 81, the integrated infusion device 82 and the blood glucose monitoring device (2) 83, for example, in one embodiment of the present invention, the integrated infusion device 82 sends the blood glucose value C1 monitored by the sensor 8214 to the blood glucose monitoring and insulin administration management unit 81, the blood glucose monitoring device (2) 83 sends the monitored blood glucose value C2 to the blood glucose monitoring and insulin administration management unit 81, and the blood glucose monitoring and insulin administration management unit 81 receives the blood glucose values C1 and C2 and further processes the blood glucose values C1 and C2 to display as C3; in another embodiment of the present invention, the integrated infusion device 82 receives the blood glucose value C2 monitored by the blood glucose monitoring device (2) 83, further processes the blood glucose values C1 and C2, and sends the processed blood glucose values to the blood glucose monitoring and insulin administration management unit 81 for display; in another embodiment of the present invention, the blood glucose monitoring device (2) 83 receives the blood glucose value C2 monitored by the sensor 8214 of the integrated infusion device 82, further processes the blood glucose values C1 and C2, and sends the processed blood glucose values to the blood glucose monitoring and insulin administration management unit 81 for display; the manner of processing is as previously described, including but not limited to weighting algorithms.
It should be further noted that, when the main monitoring device and the standby monitoring device are both in the normal working state, the user may set the blood glucose monitoring and insulin administration management unit 81 to directly display the blood glucose value C1 monitored by the sensor 8214 or the blood glucose value C2 monitored by the blood glucose monitoring device (2) 83 according to the actual requirement, without further processing.
When the main monitoring device and the standby monitoring device are not in the normal working state, if the main monitoring device is in the normal working state, the integrated infusion device 82 directly sends the blood glucose value C1 monitored by the sensor 8214 to the blood glucose monitoring and insulin administration management unit 81 for display; when the main monitoring equipment is in an abnormal working state, the artificial pancreas gives an alarm to remind a user to replace the new blood glucose monitoring equipment; if the standby monitoring equipment is in a normal working state, the blood glucose monitoring equipment (2) 83 directly sends the monitored blood glucose value C2 to the blood glucose monitoring and insulin administration management unit 81 for display; when the standby monitoring equipment is in an abnormal working state, the artificial pancreas gives an alarm to remind a user to replace the new blood glucose monitoring equipment.
In summary, the invention discloses an artificial pancreas comprising a first blood glucose monitoring device and at least one second blood glucose monitoring device, which are arranged on the same patient and are used for monitoring and transmitting the blood glucose value of the patient in real time; an infusion device for infusing a drug into a patient; and the management unit is in communication connection with the first blood sugar monitoring device, the second blood sugar monitoring device and the infusion device and is at least used for receiving the blood sugar values sent by the first blood sugar monitoring device and the second blood sugar monitoring device and sending an instruction of drug infusion to the infusion device. The user installs at least two blood sugar monitoring facilities simultaneously, ensures that artifical pancreas can both receive blood sugar data at any time to calculate and accurate infusion insulin, maintain patient's blood sugar level.
While certain specific embodiments of the invention have been described in detail by way of example, it will be appreciated by those skilled in the art that the above examples are for illustration only and are 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 (20)

1. An artificial pancreas comprising:
a first blood glucose monitoring device and at least a second blood glucose monitoring device, which are installed on the same patient, and are used for monitoring and transmitting the blood glucose value of the patient in real time;
an infusion device for infusing a drug into the patient;
and the management unit is in communication connection with the first blood glucose monitoring device, the second blood glucose monitoring device and the infusion device and is at least used for receiving the blood glucose values sent by the first blood glucose monitoring device and the second blood glucose monitoring device and sending an instruction of drug infusion to the infusion device.
2. The artificial pancreas of claim 1, wherein the first blood glucose monitoring device is integral with the infusion device.
3. The artificial pancreas according to claim 2, wherein the management unit is pre-programmed with an algorithm A1, the infusion device is pre-programmed with an algorithm A2, and/or the second blood glucose monitoring device is pre-programmed with an algorithm A3, the amount of insulin required by the patient being determined by the management unit, the infusion device or the second blood glucose monitoring device.
4. The artificial pancreas according to claim 3, wherein the manner of determination comprises a single determination or a combined determination.
5. The artificial pancreas according to claim 4, wherein the individual decision is that the management unit calculates the insulin amounts I11 and I12 required for the patient based on the blood glucose values transmitted from the first blood glucose monitoring device and the second blood glucose monitoring device and a preset algorithm A1, and then selects one as the final insulin infusion amount.
6. The artificial pancreas according to claim 4, wherein the individual decision is that the infusion device calculates the required insulin amounts I21 and I22 of the patient based on the blood glucose values sent by the first blood glucose monitoring device and the second blood glucose monitoring device and a preset algorithm A2, and then selects one as the final insulin infusion amount.
7. The artificial pancreas according to claim 4, wherein the individual decision is that the second blood glucose monitoring device calculates the required insulin amounts I31 and I32 of the patient based on the blood glucose values transmitted from the first blood glucose monitoring device and the second blood glucose monitoring device and a preset algorithm A3, and then selects one as the final insulin infusion amount.
8. The artificial pancreas according to claim 4, wherein the joint decision is the management unit, wherein the infusion device or the second blood glucose monitoring device calculates two insulin amounts required by the patient based on the blood glucose values sent by the first blood glucose monitoring device and the second blood glucose monitoring device and a preset algorithm A1, A2 or A3, and simultaneously receives four insulin amounts required by the patient calculated by the other two devices, and further processes at least two insulin amounts thereof to decide a final insulin infusion amount.
9. The artificial pancreas according to claim 3, wherein the management unit determines the amount of insulin required by the patient when all devices are in a normal state.
10. The artificial pancreas of claim 9, wherein the second blood glucose monitoring device determines the amount of insulin required by the patient when the first blood glucose monitoring device is in an abnormal state.
11. The artificial pancreas according to claim 2, wherein one of the first blood glucose monitoring device and the at least one second blood glucose monitoring device is a primary monitoring device and the other is a backup monitoring device.
12. The artificial pancreas according to claim 11, wherein the management unit displays the blood glucose level C1 monitored by the main monitoring device, the blood glucose level C2 monitored by the standby monitoring device, or the blood glucose level C3 after further processing of the blood glucose level C1 and the blood glucose level C2, when both the main monitoring device and the standby monitoring device are in a normal operation state.
13. The artificial pancreas according to claim 12, wherein the further processing is performed by using a weighting algorithm, wherein the weighting factors include historical faults, calibration errors, historical current values, and operating time periods monitored by the primary monitoring device and the backup monitoring device.
14. The artificial pancreas according to claim 13, wherein effects of meal, movement, personal information of the patient, or installation positions of the primary and backup monitoring devices are also taken into account during the further processing.
15. The artificial pancreas according to claim 14, wherein the body further processing the blood glucose level C1 and the blood glucose level C2 is one of the administration unit, the infusion device or the second blood glucose monitoring device.
16. The artificial pancreas according to claim 12, wherein the management unit displays the blood glucose value C1 monitored by the primary monitoring device if the primary monitoring device is in a normal state when not both the primary monitoring device and the backup monitoring device are in a normal operation state.
17. The artificial pancreas according to claim 12, wherein the management unit displays the blood glucose level C2 monitored by the backup monitoring device if the backup monitoring device is in a normal state when not both the primary monitoring device and the backup monitoring device are in a normal operation state.
18. The artificial pancreas according to claim 12, wherein the management unit issues an alarm when at least one of the primary monitoring device or the backup monitoring device is in an abnormal operating state.
19. The blood glucose monitoring system of claim 11, wherein the management unit periodically calibrates with data monitored by the primary monitoring device and the backup monitoring device, and wherein a reference blood glucose value used in performing the calibration is calculated by a weighting algorithm.
20. The blood glucose monitoring system of claim 2, wherein the first blood glucose monitoring device is integrated with an infusion needle of the infusion device.
CN202410120725.8A 2024-01-29 2024-01-29 Multi-sensor artificial pancreas Pending CN117838978A (en)

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Application Number Priority Date Filing Date Title
CN202410120725.8A CN117838978A (en) 2024-01-29 2024-01-29 Multi-sensor artificial pancreas

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202410120725.8A CN117838978A (en) 2024-01-29 2024-01-29 Multi-sensor artificial pancreas

Publications (1)

Publication Number Publication Date
CN117838978A true CN117838978A (en) 2024-04-09

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Application Number Title Priority Date Filing Date
CN202410120725.8A Pending CN117838978A (en) 2024-01-29 2024-01-29 Multi-sensor artificial pancreas

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Country Link
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