WO2023124316A1

WO2023124316A1 - Glucose monitoring system

Info

Publication number: WO2023124316A1
Application number: PCT/CN2022/121793
Authority: WO
Inventors: 洛佩; 何宇星; 彭璨; 陈中钊; 雷启洲; 明瑞彬; 吴家怀; 李健; 谭良; 龚明利; 黄修良; 黄腾姣; 陈慧静; 熊望; 熊晓辉; 孔书毅; 王如彬; 李建云; 詹仕欣; 孙俊杰
Original assignee: 深圳硅基仿生科技股份有限公司
Priority date: 2021-12-31
Filing date: 2022-09-27
Publication date: 2023-07-06

Abstract

The present invention provides a glucose monitoring system, comprising a sensing module, an interaction module, a communication module and a processing module. The sensing module is configured to continuously monitor the glucose concentration of a wearer. The communication module is configured to receive the glucose concentration and send the glucose concentration to the processing module. The interaction module is configured to interact with the wearer to obtain an interaction result, the interaction comprising: acquiring a preset time interval, and on the basis of the glucose concentration, querying a pre-sleep behavior, a post-lunch behavior or a post-supper behavior of the wearer. The processing module is configured to determine, on the basis of the glucose concentration and the interaction result in a time interval, whether the wearer has a glucose fluctuation type of a dawn phenomenon, a Somogyi phenomenon, a dusk phenomenon, or a late dusk phenomenon, and to generate guidance information. Therefore, the glucose fluctuation type such as the Somogyi phenomenon may be recognized, a corresponding interpretation of the fluctuation phenomenon may be intelligently output, the wearer can be better helped to monitor blood glucose and conduct blood glucose management, and then the life quality of the wearer is improved.

Description

Glucose Monitoring System

technical field

The invention specifically relates to a glucose monitoring system.

Background technique

Diabetes and its chronic complications have become one of the diseases that seriously affect human health today. In order to delay and reduce the chronic complications of diabetes, blood sugar needs to be strictly controlled. Therefore, the continuous glucose monitoring system (CGMS) for dynamically reflecting blood sugar fluctuations is widely used. At present, there are a variety of continuous blood glucose monitoring systems that have been approved by the US FDA or CE to be used in Europe and the United States. Most of them are minimally invasive, using subcutaneous probes to monitor interstitial fluid glucose, and a few monitor on the skin surface. The interstitial fluid glucose concentration measured by CGMS has a good correlation with venous blood glucose concentration and finger blood glucose concentration, and can be used as an auxiliary blood glucose monitoring method.

The fluctuation of blood sugar in diabetic patients varies from person to person, and is also related to the individual state. There are not only simple high and low blood sugar phenomena, but also a variety of complex physiological or pathological phenomena, such as dawn phenomenon, somogyi phenomenon, dusk phenomenon, and late dusk phenomenon. Usually, it is difficult for diabetic patients to distinguish other complex phenomena except hyperglycemia and hypoglycemia in non-professional situations.

In the existing technology, if the blood sugar monitoring system only obtains high and low blood sugar data to show the high and low levels of blood sugar to diabetic patients, it is not enough. Glucose fluctuation types such as twilight phenomenon and late twilight phenomenon can better help diabetic patients manage blood sugar. Therefore, in view of the deficiencies in the prior art, it is particularly important to provide a monitoring system for identifying the type of glucose fluctuation and intelligently outputting to explain the fluctuation phenomenon.

Contents of the invention

The present invention has been accomplished in view of the state of the prior art described above, and its object is to provide a glucose monitoring system for identifying blood sugar fluctuations, capable of recognizing glucose fluctuation types such as Somogyi phenomenon, dawn phenomenon, dusk phenomenon or late dusk phenomenon and intelligently The output explains the corresponding glucose fluctuation type, which can better help diabetic patients monitor blood sugar and manage blood sugar, thereby improving the quality of life of diabetic patients.

To this end, the present invention provides a glucose monitoring system comprising a sensing module, an interaction module, a communication module and a processing module, the sensing module configured to continuously monitor the wearer's glucose concentration; the communication module configured to receive glucose The concentration is sent to the processing module; the interaction module is configured to interact with the wearer to obtain an interaction result, and the interaction includes: obtaining the first time interval, the second time interval, the third time interval, or the fourth time interval At least one of the preset time intervals in the interval, and based on the glucose concentration, query the wearer's behavior before going to bed, after lunch or after dinner; the processing module is configured to be based on the glucose concentration in the preset time interval and the Based on the above interaction results, it is judged whether the wearer has a glucose fluctuation type in the dawn phenomenon, the Somogyi phenomenon, the twilight phenomenon or the late twilight phenomenon, and guidance information is generated.

In this case, the blood sugar data of the wearer (that is, diabetic patients) can be obtained through the sensing module, the glucose monitoring system can be exchanged with the wearer through the interaction module to obtain the interaction result, and the glucose concentration can be sent through the communication module To the processing module and then the processing module can judge the wearer's glucose fluctuation type based on the glucose concentration and the interaction result, and generate guidance information. Therefore, when the wearer has glucose fluctuation types such as Somogyi phenomenon, dawn phenomenon, dusk phenomenon or late dusk phenomenon, it can explain to the wearer the reason for the corresponding glucose fluctuation type and provide guidance to better help the wearer monitor Blood sugar and blood sugar management to improve the wearer's quality of life.

According to the glucose monitoring system involved in the present invention, optionally, the interaction result includes the wearer's sleep time, behavior before going to bed, sleep status, lunch time, post-lunch behavior, post-lunch status, dinner time, post-dinner behavior or At least one of the after-dinner states. In this case, at least one of the wearer's sleep time, bedtime behavior, sleep state, lunch time, post-lunch behavior, post-lunch state, dinner time, post-dinner behavior or post-dinner state is obtained through the interaction module , it can be more beneficial for the glucose monitoring system to analyze the type of glucose fluctuation of the wearer, thus, it can better help the wearer to monitor blood sugar and manage blood sugar so as to improve the quality of life of the wearer.

According to the glucose monitoring system involved in the present invention, optionally, the first time interval is from the time when the wearer falls asleep at night to the time when he wakes up in the morning, and the second time interval is from the time when the wearer wakes up in the morning to the time when he eats in the morning, The third time interval is from 2 hours after lunch to dinner time of the wearer, and the fourth time interval is from 2 hours after dinner to sleep time of the wearer. In this case, by analyzing the wearer's glucose concentration in the first time interval and the second time interval, it can be judged whether the wearer's glucose fluctuation type conforms to the fluctuation type of Somogyi phenomenon and dawn phenomenon. The wearer's glucose concentration in the time interval and the fourth time interval, so that it can be judged whether the wearer's glucose fluctuation type conforms to the fluctuation type of dusk phenomenon and late dusk phenomenon, and can provide corresponding guidance information to the wearer according to the judgment result Help them better manage blood sugar.

According to the glucose monitoring system involved in the present invention, optionally, the glucose concentration includes the fasting glucose concentration in the first time interval, the lowest glucose concentration in the second time interval, and the lowest glucose concentration in the third time interval. The evening maximum glucose concentration and evening minimum glucose concentration of , and the evening evening maximum glucose concentration and evening evening minimum glucose concentration in the fourth time interval. In this case, it can provide a data basis for the glucose monitoring system to subsequently judge whether the wearer has a glucose fluctuation type in the dawn phenomenon, the somogyi phenomenon, the twilight phenomenon or the late twilight phenomenon.

According to the glucose monitoring system involved in the present invention, optionally, if the fasting glucose concentration is not less than a first preset value, the minimum glucose concentration is greater than a second preset value, and the fasting glucose concentration and the minimum If the difference in glucose concentration is not less than the third preset value, it is determined that the wearer has the dawn phenomenon. In this case, it is possible to obtain the glucose fluctuation type whether the wearer has the dawn phenomenon based on the wearer's glucose concentration.

According to the glucose monitoring system involved in the present invention, optionally, if the fasting glucose concentration is not less than the first preset value and the minimum glucose concentration is not greater than the second preset value, it is determined that the wearer has the somogyi phenomenon ; If the fasting glucose concentration is less than the first preset value and the minimum glucose concentration is greater than the second preset value, it is determined that the wearer does not have the somogyi phenomenon. In this case, it is possible to determine whether the wearer is experiencing the glucose fluctuation type of Somogyi phenomenon.

According to the glucose monitoring system involved in the present invention, optionally, if the difference between the evening maximum glucose concentration and the evening minimum glucose concentration is not less than the fourth preset value, and the preset time interval is not greater than the fifth preset value, and the time period between the time corresponding to the highest glucose concentration at dusk and the time corresponding to the lowest glucose concentration at dusk is not less than the sixth preset value, it is determined that the wearer has dusk phenomenon; or, if the The difference between the highest glucose concentration at dusk and the lowest glucose concentration at dusk is not less than the fourth preset value, and the preset time interval is not greater than the fifth preset value, and the time corresponding to the highest glucose concentration at dusk to the If the rate of change of glucose concentration between the times corresponding to the lowest glucose concentration at dusk is greater than the seventh preset value, it is determined that the wearer has dusk phenomenon. In this case, it is possible to determine whether the wearer is experiencing the type of glucose fluctuation of the twilight phenomenon.

According to the glucose monitoring system involved in the present invention, optionally, if the difference between the evening maximum glucose concentration and the evening evening minimum glucose concentration is not less than the eighth preset value, and the preset time interval is not greater than The ninth preset value, and the time period between the time corresponding to the highest glucose concentration in late dusk and the time corresponding to the lowest glucose concentration in late dusk is not less than the tenth preset value, then it is determined that the wearer has late dusk phenomenon; Or, if the difference between the highest late evening glucose concentration and the late evening lowest glucose concentration is not less than the eighth preset value, and the preset time interval is not greater than the ninth preset value, and the late evening highest glucose concentration If the rate of change of glucose concentration between the time corresponding to the glucose concentration and the time corresponding to the lowest glucose concentration in late evening is greater than the eleventh preset value, it is determined that the wearer has late evening phenomenon. In this case, it is possible to determine whether the wearer is experiencing the type of glucose fluctuation of the late twilight phenomenon.

According to the glucose monitoring system of the present invention, optionally, the interaction module includes a display unit configured to display at least one of guidance information, interactive questions, glucose concentration curves, and glucose fluctuation types. In this case, the display unit of the interactive module can intuitively display guidance information, interactive questions, glucose concentration curves, glucose fluctuation types and other information to the wearer, so that the wearer can better manage blood sugar according to the guidance information.

According to the glucose monitoring system involved in the present invention, optionally, the interaction module further includes an input unit configured to input information including wake-up time, sleep time, morning meal time, lunch meal time, dinner meal time or for At least one of the interactive question feedbacks. In this case, through the input unit of the interactive module, the wearer can input information such as wake-up time, sleep time, morning meal time, lunch meal time, dinner meal time, or feedback on interactive problems, thereby enabling more It is beneficial for the glucose monitoring system to analyze the wearer's glucose fluctuation type.

According to the glucose monitoring system involved in the present invention, optionally, the interaction module and the processing module are integrated into a mobile terminal, and the mobile terminal has an application program that cooperates with the interaction module and the processing module. In this case, it is convenient for the wearer to use the glucose monitoring system through the mobile terminal to manage blood sugar and improve the quality of life.

According to the glucose monitoring system involved in the present invention, optionally, the processing module is configured to obtain a preliminary judgment result based on the glucose concentration within the preset time interval, and obtain a glucose concentration based on the preliminary judgment result and the interaction result. Wave type. In this case, through the preliminary judgment result and the interaction result, the processing module can judge whether the type of glucose fluctuation is one of the somogyi phenomenon, dawn phenomenon, dusk phenomenon or late dusk phenomenon, so as to better allow the wearer to follow the guidance Information for managing blood sugar well.

According to the glucose monitoring system involved in the present invention, optionally, the processing module is configured to ask the wearer about the wearer's bedtime behavior, post-lunch behavior or post-dinner behavior based on the preliminary judgment result, and through the interaction The module displays the question asked. In this case, the processing module can more accurately judge the type of glucose fluctuation of the wearer through the preliminary judgment result and recording the wearer's bedtime behavior, post-lunch behavior or post-dinner behavior.

According to the glucose monitoring system involved in the present invention, optionally, the guidance information includes glucose fluctuation types, reasons related to the glucose fluctuation types, and behavior suggestions. In this case, the wearer can better manage blood sugar through the guidance information of the glucose monitoring system, thereby improving the quality of life.

According to the glucose monitoring system involved in the present invention, optionally, further comprising a storage module configured to store the data of the glucose concentration. In this case, the glucose monitoring system can record more data and interactive information of the wearer's glucose concentration, thereby facilitating the glucose monitoring system to better analyze the wearer's glucose fluctuation type.

According to the glucose monitoring system involved in the present invention, optionally, the sensing module is used to acquire the glucose concentration in the interstitial fluid, and the sensing module acquires the glucose concentration at a preset frequency. In this case, by obtaining the glucose concentration of the wearer's interstitial fluid at a preset frequency, the glucose monitoring system can help the wearer to better manage blood sugar.

According to the glucose monitoring system involved in the present invention, optionally, the communication module transmits the data of the glucose concentration to the processing module in a wireless or wired manner. In this case, it can facilitate the glucose monitoring system to obtain the wearer's glucose concentration and facilitate the wearer to use the glucose monitoring system to manage blood sugar.

According to the glucose monitoring system involved in the present invention, optionally, the wireless method includes at least one of Bluetooth, Wifi, 3G/4G/5G, NFC, UWB and Zig-Bee. In this case, it can facilitate the glucose monitoring system to obtain the wearer's glucose concentration and facilitate the wearer to use the glucose monitoring system to manage blood sugar.

According to the present invention, a glucose monitoring system for identifying blood sugar fluctuations can be provided, which can identify glucose fluctuation types such as Somogyi phenomenon and dawn phenomenon and intelligently output and explain the corresponding glucose fluctuation types, so as to better help diabetic patients monitor blood sugar and carry out Blood sugar management can improve the quality of life of diabetic patients.

Description of drawings

FIG. 1 is an application scene diagram of a glucose monitoring system according to an embodiment of the present invention;

2 is a system block diagram of a glucose monitoring system according to an embodiment of the present invention;

Fig. 3 is a structural block diagram of an interactive module in a glucose monitoring system according to an embodiment of the present invention;

Fig. 4 is a schematic diagram of an input unit of an interactive module involved in an embodiment of the present invention;

Fig. 5 is a schematic diagram of a display unit of an interactive module involved in an embodiment of the present invention;

Fig. 6 is a working flowchart of the glucose monitoring system involved in the embodiment of the present invention;

Fig. 7 is a working flow diagram of a possible glucose monitoring system corresponding to the dawn phenomenon according to an embodiment of the present invention;

FIG. 8 is a data dynamic curve of glucose concentration corresponding to the dawn phenomenon according to an embodiment of the present invention;

Fig. 9 is a working flow diagram of a possible glucose monitoring system corresponding to the Somogyi phenomenon according to an embodiment of the present invention;

Fig. 10 is the data curve of the glucose concentration corresponding to the Somogyi phenomenon involved in the embodiment of the present invention;

Fig. 11 is a working flow diagram of a glucose monitoring system that may correspond to the dusk phenomenon according to an embodiment of the present invention;

12 is a data curve of glucose concentration corresponding to the dusk phenomenon according to an embodiment of the present invention;

Fig. 13 is a working flow diagram of a possible glucose monitoring system corresponding to the late dusk phenomenon according to an embodiment of the present invention;

Fig. 14 is a data curve of glucose concentration corresponding to the late twilight phenomenon according to the embodiment of the present invention.

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

It should be noted that the terms "first", "second", "third" and "fourth" in the description and claims of the present invention and the above drawings are used to distinguish different objects, rather than using to describe a specific order. Furthermore, the terms "include" and "have", as well as any variations thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, system, product or device comprising a series of steps or units is not limited to the listed steps or units, but optionally also includes unlisted steps or units, or optionally further includes For other steps or units inherent in these processes, methods, products or apparatuses. In the following description, the same reference numerals are given to the same components, and repeated descriptions are omitted. In addition, the drawings are only schematic diagrams, and the ratio of dimensions between components, the shape of components, and the like may be different from the actual ones.

In the existing technology, if the system for monitoring glucose only obtains high and low glucose data to show the high and low levels of glucose to diabetic patients, it is not enough, it also needs to be able to analyze the data and be able to explain glucose fluctuations such as Somogyi phenomenon to diabetic patients Type, in order to better help diabetic patients with glucose management. Therefore, in the dynamic curve reflecting glucose fluctuations in CGMS, if recognition algorithms can be added to automatically output single-day glucose Glucose fluctuation types such as the dusk phenomenon can better help diabetic patients monitor glucose and manage glucose, thereby improving the quality of life of diabetic patients. In view of the deficiencies in the prior art, it is particularly important to provide a glucose monitoring system for identifying the aforementioned glucose fluctuation type and intelligently outputting an explanation for the corresponding glucose fluctuation type. To this end, the present invention provides a glucose monitoring system for identifying blood sugar fluctuations, which can identify glucose fluctuation types such as Somogyi phenomenon, dawn phenomenon, dusk phenomenon, late dusk phenomenon, etc., and intelligently output and explain the corresponding glucose fluctuation types, better Help diabetic patients monitor and manage glucose, thereby improving the quality of life of diabetic patients.

The "Sumogyi phenomenon" involved in the present invention refers to the phenomenon of hypoglycemia at night and hyperglycemia before breakfast in diabetic patients. The "Somogyi phenomenon" is characterized by low blood sugar at night and high blood sugar before breakfast. Simply put, it is the phenomenon of "low after high". It is mainly due to the nighttime hypoglycemia reaction caused by oral hypoglycemic drugs or excessive use of insulin. In order to protect itself, the body uses a negative feedback regulation mechanism to make hormones (such as glucagon, growth hormone, corticosteroids, etc.) Alcohol, etc.) secretion increases, and blood sugar rebounds.

The "dawn phenomenon" involved in the present invention refers to a kind of early morning high blood sugar caused by the unbalanced secretion of various hormones at dawn when the blood sugar control of diabetic patients is acceptable and stable at night, that is, without hypoglycemia. blood sugar status. Dawn phenomenon occurs mostly in diabetic patients, but it can also be seen in healthy people.

The "evening phenomenon" involved in the present invention refers to the phenomenon that the body's blood sugar rises in the evening. It is generally believed that the "twilight phenomenon" should be considered when the blood sugar before dinner is higher than the blood sugar 1-2mmol/L 2 hours after lunch.

The "late evening phenomenon" involved in the present invention refers to the phenomenon that the body's blood sugar rises before sleep time. It is generally believed that the blood sugar before going to bed is 1-2 mmol/L higher than the blood sugar 2 hours after dinner, and the "late evening phenomenon" should be considered.

FIG. 1 is an application scene diagram showing a glucose monitoring system 1 according to an embodiment of the present invention; FIG. 2 is a system block diagram showing a glucose monitoring system 1 according to an embodiment of the present invention.

In some examples, referring to FIG. 1 and FIG. 2 , the glucose monitoring system 1 may include: a sensing module 11 , an interaction module 131 , a communication module 12 and a processing module 133 . The sensing module 11 can be configured to continuously monitor the glucose concentration of the wearer 2; the communication module 12 can be configured to receive the glucose concentration and send it to the processing module 133; the interaction module 131 can be configured to interact with the wearer 2 to obtain an interaction result; The module 133 may be configured to judge the glucose fluctuation type of the wearer 2 based on the glucose concentration and the interaction result within a preset time interval, and generate guidance information.

In some examples, the interaction may include: determining the time node of the wearer 2 in a preset time interval (preset time interval), and asking the behavior of the wearer 2 based on the glucose concentration in the time interval.

In some examples, the interaction may include: obtaining a preset time interval including at least one of the first time interval, the second time interval, the third time interval, or the fourth time interval, and asking the wearer 2 based on the glucose concentration Behavior before going to bed, after lunch or after dinner; the processing module 133 can be configured to determine the type of glucose fluctuation of the wearer 2 based on the glucose concentration and interaction results within a preset time interval, and generate guidance information.

In this case, the blood sugar data of the wearer 2 (which may be diabetics, pre-diabetics, or healthy people) can be obtained through the sensing module 11, and the glucose monitoring system 1 can communicate with the wearer 2 through the interaction module 131. Interaction to obtain the interaction result, the glucose concentration is sent to the processing module 133 through the communication module 12, and the processing module 133 can judge the glucose fluctuation type of the wearer 2 based on the glucose concentration and the interaction result, and generate guidance information. Thus, when the wearer 2 has blood sugar fluctuations such as Somogyi phenomenon, dawn phenomenon, dusk phenomenon, and late twilight phenomenon, it can explain to the wearer 2 the fluctuation types corresponding to the Somogyi phenomenon, dawn phenomenon, twilight phenomenon, and late twilight phenomenon. Reasons and guidelines are provided to better help the wearer 2 monitor blood sugar and manage blood sugar so as to improve the quality of life of the wearer 2 .

In some examples, the data of glucose concentration may include the glucose concentration of multiple detection points and the detection time matching the multiple detection points. At the midpoint of the time, take any one of the two adjacent detection points as the sleep or meal detection point, if the sleep or meal time entered by the wearer 2 is not between the two adjacent detection points and is not in the corresponding detection point At the midpoint of the time, the detection point closest to the sleep or meal time recorded by the wearer 2 is taken as the sleep or meal detection point. In this case, the glucose monitoring system 1 can more accurately grasp the data of the glucose concentration of the wearer 2 to determine corresponding fluctuation characteristics.

In some examples, the sensing module 11 may be implanted or semi-implanted under the skin of the human body, generally under the skin of the abdomen, or other parts such as the arm. In some examples, the implanted part of the sensing module 11 may consist of a semipermeable membrane, glucose oxidase and microelectrodes. Preferably, the sensing module 11 may be an implantable glucose detection sensor. In this case, compared with the traditional way of collecting blood in the past, implantable or semi-implantable sensors can reduce the physical pain of the wearer 2, and have the advantages of short collection period, more sampling data, and continuous sampling. In some other examples, the sensing module 11 may also be a non-implantable sensor. In this case, the sampled patient needs to collect blood regularly, thereby improving the accuracy of the data.

In some examples, the sensing module 11 can measure the glucose concentration reflected in the subcutaneous interstitial fluid to obtain an electrical signal, which can then be processed and converted into a blood glucose value and sent or displayed on a mobile device terminal or a computer terminal. In this case, since the glucose concentration in the interstitial fluid is equal to or strictly corresponds to plasma glucose in a steady state, the rate of change of the blood glucose concentration in a short period of time after the intake of high-sugar food or glucose injection It is ahead of the interstitial fluid, so it can accurately reflect the glucose concentration of the object to be measured, that is, the glucose concentration of the interstitial fluid that can be measured by the glucose monitoring system 1 has a good correlation with the venous glucose concentration and finger glucose concentration , and can be used as an auxiliary glucose monitoring method to improve measurement accuracy.

In some examples, the sensing module 11 can acquire the glucose concentration at a preset frequency (or a preset collection frequency). In this case, a plurality of glucose concentrations can be obtained, so that an approximately continuous glucose concentration curve can be formed.

In some examples, the sensing module 11 can use any number of seconds from 0 to 10 seconds as the time interval for obtaining electrical signals and any time fraction from 1 to 5 minutes as the time interval for processing and converting blood glucose values .

In some examples, the glucose level can be continuously monitored for 24 hours by implanting the subcutaneous sensing module 11 . In some examples, the sensing module 11 can store at least 288 blood glucose values per day.

In some examples, the sensing module 11 can adjust the preset frequency. For example, when the glucose concentration of the wearer 2 varies little, the sensing module 11 can obtain the glucose concentration at a lower preset frequency. When the glucose concentration varies greatly, the sensing module 11 can acquire the glucose concentration at a higher preset frequency. In this case, the preset frequency of the sensing module 11 can be adjusted according to actual conditions.

In some examples, the sensing module 11 can also be used to acquire data of glucose concentration in other bodily fluids of the wearer 2 . For example, glucose concentration in urine.

In some examples, the sensing module 11 can detect the glucose concentration of the interstitial fluid of the wearer 2 through a sensor component capable of reacting with glucose. In this case, the glucose monitoring system 1 can obtain the required glucose concentration data of the wearer 2 from the sensor module 11 and analyze and process it, and then provide corresponding guidance information to the wearer 2 or the doctor.

In some examples, the sensing module 11 may be composed of bioactive substances and micro-electrodes. In this case, the bioactive substance is able to react with the glucose and there is a chemical signal on the tiny electrodes that creates an electrical signal and generates data.

In some examples, the data of the glucose concentration of the wearer 2 in the sensing module 11 can be sent to the mobile terminal or computer terminal through the communication module 12, and the analysis software can qualitatively and quantitatively describe the blood sugar or glucose status of the diabetic patient.

In some examples, the sensing module 11 can be integrated with the communication module 12 .

Fig. 3 is a block diagram showing the structure of the interaction module 131 in the glucose monitoring system 1 according to the embodiment of the present invention; Fig. 4 is a schematic diagram showing the input unit 301 of the interaction module 131 according to the embodiment of the present invention; 5 is a schematic diagram showing the display unit 302 of the interactive module 131 according to the embodiment of the present invention.

In some examples, the interaction module 131 can be configured to interact with the wearer 2 to obtain an interaction result and send the interaction result to the processing module 133. Preset time intervals, and ask the wearer 2 about bedtime behavior based on the glucose concentration within the preset time intervals. In some examples, as shown in FIG. 3 and FIG. 5 , the interaction module 131 includes a display unit 302 configured to display at least one of guidance information, interactive questions, glucose concentration curves, and glucose fluctuation types. In this case, through the display unit 302 of the interaction module 131, information such as guidance information, interactive questions, glucose concentration curves, and glucose fluctuation types can be intuitively displayed to the wearer 2, so that the wearer 2 can better follow the guidance information Manage blood sugar.

In some examples, as shown in FIG. 3 and FIG. 4 , the interaction module 131 further includes an input unit 301, which is used to input the input unit 301 when the glucose monitoring system 1 is used to determine whether the wearer 2 has a dawn phenomenon, a somogyi phenomenon, a dusk phenomenon or a late dusk phenomenon Configured to enter at least one of a wake-up time, a sleep time, a morning meal time, a lunch meal time, a dinner meal time, or feedback for a question for the interaction. In this case, through the input unit 301 of the interaction module 131, it is possible for the wearer 2 to input at least one of the wake-up time, sleep time, morning meal time, lunch meal time, dinner meal time, or feedback on interactive questions. and other information, thus, it can be more beneficial for the glucose monitoring system 1 to analyze the glucose fluctuation type of the wearer 2 .

In some examples, as shown in FIG. 5 , the display unit 302 may also be configured to display at least one of guidance information, glucose concentration curve and fluctuation type. The display unit 302 can also be integrated in the mobile terminal 13, in other words, the display module can be the display interface of the mobile terminal 13.

In some examples, the interaction module 131 and the processing module 133 are integrated in the mobile terminal 13 , and the mobile terminal 13 has an application program that cooperates with the interaction module 131 and the processing module 133 . In this case, it is convenient for the wearer 2 to use the glucose monitoring system 1 through the mobile terminal 13 to manage blood sugar and improve the quality of life.

In some examples, the interaction module 131 and the processing module 133 can also be integrated with other processing devices, such as desktop computers, portable computers, or dedicated terminals, which can be implemented by apps for smart phones and software for computers.

In some examples, the entry unit 301 can automatically identify the meal time according to the glucose concentration. In this case, the operation steps of the wearer 2 can be reduced, thereby improving the convenience of the glucose monitoring system 1 .

In some examples, the input unit 301 can also input at least one of the food name, food type, and food amount of the meal. Wherein, the food type can be carbohydrate, fat or protein. In some examples, the input unit 301 may also input whether there is exercise, exercise time or exercise type before and after meals. For example, the wearer 2 can enter his diet-related information in the mobile terminal 13 of the glucose monitoring system 1 through the entry module, such as check-in time, diet menu, and the like.

In some examples, when the glucose monitoring system 1 is used to determine whether the wearer 2 has the dawn phenomenon, the Somogyi phenomenon, the twilight phenomenon or the late twilight phenomenon, the interactive results may include the wearer 2's sleep time, bedtime behavior, sleep state, lunch time, etc. , at least one of post-lunch behavior, post-lunch state, dinner time, post-dinner behavior, or post-dinner state. In this case, at least one of wearer 2's sleep time, behavior before going to bed, sleep status, lunch time, post-lunch behavior, post-lunch status, dinner time, post-dinner behavior or post-dinner status is obtained through the interaction module 131. This kind of information can be more beneficial for the glucose monitoring system 1 to analyze the glucose fluctuation type of the wearer 2, thus, it can better help the wearer 2 to monitor blood sugar and perform blood sugar management to improve the quality of life of the wearer 2.

In some examples, the wearer 2 can interact with the glucose monitoring system 1 through active input or passive input. Active input may refer to information input methods such as typing by the wearer 2 or voice input. Passive input can refer to the information collection method of monitoring the wearer 2 to obtain information through various sensors installed on the wearer 2 or in the living environment in the glucose monitoring system 1. The sensors can be, for example, motion sensors, sleep sensors, etc. Monitoring devices, blood glucose meters, etc.

In some examples, bedtime behavior may include one of medication behavior, eating behavior, exercise behavior, or state of mind. In some examples, the post-lunch behavior and the post-dinner behavior may include one of a medication behavior, a snack behavior, or an exercise behavior.

In some examples, the preset time interval may include a first time interval, a second time interval, a third time interval or a fourth time interval. In some examples, the first time interval may be from the time when the wearer falls asleep at night to the time when he wakes up in the morning. In some examples, the second time interval may be from the time when the wearer wakes up in the morning to the time when he eats in the morning. In some examples, the third time interval may be 2 hours after the wearer's lunch to dinner time. In some examples, the fourth time interval may be 2 hours after the wearer's dinner to sleep time. In this case, by analyzing the wearer's glucose concentration in the first time interval and the second time interval, it can be judged whether the wearer's glucose fluctuation type conforms to the fluctuation type of Somogyi phenomenon and dawn phenomenon. The wearer's glucose concentration in the time interval and the fourth time interval, so that it can be judged whether the wearer's glucose fluctuation type conforms to the fluctuation type of dusk phenomenon and late dusk phenomenon, and can provide corresponding guidance information to the wearer according to the judgment result Help them better manage blood sugar.

In some examples, the first time interval can be used to analyze whether the blood sugar of the wearer 2 is high at night, so as to further determine whether the wearer 2 has Somogyi phenomenon or other phenomena that can cause blood sugar to rise. In some examples, the second time interval may be used to analyze whether the blood sugar of the wearer 2 at night is low, or remains low, or first decreases and then increases. From this, it can be preliminarily judged that the blood sugar fluctuation of the wearer 2 belongs to the dawn phenomenon, and further combined with the interactive results to further judge whether the blood sugar fluctuation of the wearer 2 belongs to the somogyi phenomenon or the dawn phenomenon.

In some examples, when the glucose monitoring system 1 is used to determine whether the wearer 2 has twilight phenomenon or late twilight phenomenon, the interaction result may include the eating behavior of the wearer 2 in the third time interval or the fourth time interval. In this case, obtaining the eating behavior of the wearer 2 through the interaction module 131 can be more conducive to the glucose monitoring system 1 to analyze the type of glucose fluctuation of the wearer 2, thus, it can better help the wearer 2 to monitor blood sugar and carry out blood sugar monitoring. Management in turn improves the quality of life of the wearer 2 .

In some examples, the eating behavior may include at least one of eating time, food type, and food portion.

In some examples, the processing module 133 is configured to obtain a preliminary judgment result based on the glucose concentration within a preset time interval, and obtain a glucose fluctuation type based on the preliminary judgment result and the interaction result. In this case, through the preliminary judgment result and the interaction result, the processing module 133 can judge whether the glucose fluctuation type is one of the somogyi phenomenon, the dawn phenomenon, the dusk phenomenon, and the late dusk phenomenon, so as to better let the wearer 2 Manage your blood sugar as directed.

In some examples, the processing module 133 is configured to ask the wearer 2 about the behaviors of the wearer 2 before going to bed, after lunch or after dinner based on the preliminary judgment result, and display the queried questions through the interaction module 131 . In this case, the processing module 133 can more accurately determine the type of glucose fluctuation of the wearer 2 through the preliminary judgment result and recording the behavior of the wearer 2 before going to bed, after lunch or after dinner.

In some examples, preferably, the processing module 133 can be integrated into the mobile terminal 13 . For example, a personal mobile phone, a laptop, a computer, a custom processor, etc. In this case, observers such as the wearer 2 or a doctor can conveniently and quickly obtain the data of the glucose concentration of the wearer 2 .

In some examples, the processing module 133 may also be a device utilizing cloud processing. In this case, the processing module 133 can simultaneously monitor the glucose concentration of each wearer 2 .

In some examples, the guidance information includes glucose excursion types, reasons associated with glucose excursion types, and behavioral recommendations. In this case, the wearer 2 can better manage blood sugar through the guidance information of the glucose monitoring system 1, thereby improving the quality of life. For example, when the type of glucose fluctuation is the somogyi phenomenon, the glucose monitoring system 1 can automatically explain the cause of the somogyi phenomenon to the wearer 2 by displaying text or voice output, and can guide the wearer 2 to change the behavior before going to bed, such as changing the dosage Or exercise and other methods to prevent the Somogyi phenomenon from continuing to help the wearer 2 improve blood sugar management and reduce psychological stress.

In some examples, as shown in FIG. 2 , the glucose monitoring system 1 further includes a storage module 132 configured to store glucose concentration data. In this case, the glucose monitoring system 1 can record more glucose concentration data and interactive information of the wearer 2, thereby facilitating the glucose monitoring system 1 to better analyze the glucose fluctuation type of the wearer 2.

In some examples, the storage module 132 may be disposed on the sensing module 11 . In this case, the data on the glucose concentration acquired by the sensing module 11 can be temporarily stored in the storage module 132. In some examples, the storage module 132 may be disposed in the processing module 133 . In this case, the glucose concentration data from the sensing module 11 is collected and stored in the storage module 132 for a long time. In other words, the storage module 132 may include a first storage module and a second storage module, the first storage module is integrated in the sensing module 11, the second storage module is integrated in the mobile terminal 13, and the first storage module can be used to temporarily store the glucose concentration data, and transmit the glucose concentration data of the first storage module to the second storage module when the communication module 12 is working normally.

In some examples, the storage module 132 may overwrite the old glucose concentration data with the new glucose concentration data, and the detection time difference between the new glucose concentration data and the old glucose concentration data may be more than 14 days. In this case, the storage space of the storage module 132 can be fully utilized.

In some examples, the sensing module 11 is used to obtain the glucose concentration in the interstitial fluid, and the sensing module 11 obtains the glucose concentration at a preset frequency. In this case, by acquiring the glucose concentration of the interstitial fluid of the wearer 2 at a preset frequency, the glucose monitoring system 1 can help the wearer 2 better manage blood sugar.

In some examples, the communication module 12 transmits the data of the glucose concentration to the processing module 133 in a wireless or wired manner. In this case, it can facilitate the glucose monitoring system 1 to obtain the glucose concentration of the wearer 2 and facilitate the wearer 2 to use the glucose monitoring system 1 to manage blood sugar.

In some examples, the wireless manner includes at least one of Bluetooth, Wifi, 3G/4G/5G, NFC, UWB, and Zig-Bee. In this case, it can facilitate the glucose monitoring system 1 to obtain the glucose concentration of the wearer 2 and facilitate the wearer 2 to use the glucose monitoring system 1 to manage blood sugar.

FIG. 6 is a flowchart showing the operation of the glucose monitoring system 1 according to the embodiment of the present invention.

In some examples, as shown in FIG. 6 , the workflow of the glucose monitoring system may include: obtaining the data of the wearer's glucose concentration through a sensing module worn by the wearer (step S100); identifying the data that needs to be analyzed for the glucose concentration The time period, that is, the selected time interval (step S200); the fluctuation type of the glucose concentration data corresponding to the selected time interval is judged to obtain a preliminary judgment result (step S300); based on the preliminary judgment result, the wearer is interacted (step S400); continue to output guidance information to the wearer based on the interaction information and may end the interaction (step S500).

In some examples, in step S001, the data of the wearer's glucose concentration may be data of a single day or multiple days. In some examples, the data of the wearer's glucose concentration may be a curve fitted to the data of a plurality of consecutive glucose concentrations of the day.

In some examples, in step S200, the selected time interval may be a preset time interval. In some examples, the preset time interval may include a first time interval, a second time interval, a third time interval, and a fourth time interval. The first time interval can be from the time when the wearer falls asleep at night to the time when he wakes up in the morning, the second time interval can be from the time when the wearer wakes up in the morning to the time of eating in the morning, and the third time interval can be from 2 hours after lunch to the start time of dinner. The four time intervals can be 2 hours after dinner to the beginning of sleep.

In some examples, in step S300 , the glucose fluctuation type (ie, the fluctuation type of the glucose concentration data) may include phenomena such as Somogyi phenomenon, dawn phenomenon, dusk phenomenon, and late dusk phenomenon.

In some examples, in step S400, the interaction may include the mobile terminal in the glucose monitoring system asking and answering the wearer and inputting the answer by the wearer. For example, the glucose monitoring system can initially describe blood sugar fluctuations to the wearer through the mobile terminal and ask "Your fasting blood sugar is high, which may be caused by the dawn phenomenon. Almost half of sugar lovers will have this phenomenon. Did you stay up late last night? What about insomnia, extra meals, and late-night snacks?" At this point, the wearer can enter "yes" or "no".

In some examples, in step S500, based on the interaction in step S400, the mobile terminal of the glucose monitoring system can output guidance information, for example, the question in the interaction in step S400 is "Your fasting blood sugar is too high, it may be caused by the dawn phenomenon." Yes, almost half of sugar lovers have this phenomenon. Did you stay up late last night, suffer from insomnia, add meals, or eat late-night snacks?" If the wearer inputs "yes", the mobile terminal can continue to output "insomnia, stay up late" in step S500 It may affect the release of glycemic hormones at night, causing fasting blood sugar to rise. Adding meals at night, eating supper, food can raise blood sugar for 3-8 hours or even longer, which may cause fasting blood sugar to rise the next day." Guidance or answer information and can end the interaction.

Fig. 7 is a workflow diagram showing a possible glucose monitoring system corresponding to the dawn phenomenon according to an embodiment of the present invention; Fig. 8 is a data curve showing a glucose concentration corresponding to the dawn phenomenon according to an embodiment of the present invention .

In the glucose monitoring system, firstly, the data of the glucose concentration of the wearer in the first time interval and the second time interval are obtained through the sensing module worn by the wearer, that is, from the time of falling asleep in the evening to the time of getting up in the morning and from the time of getting up in the morning to the time of getting up in the morning. Data on glucose concentration at morning meal time. Second, identify data on glucose concentrations during the nighttime period and during the fasting period.

In some examples, the data of the glucose concentration in the nighttime period may refer to the data of the glucose concentration in the first time interval, and the data of the glucose concentration in the fasting period may refer to the data of the glucose concentration in the second time interval. In some examples, the method for identifying the first time interval may include: 1. The wearer fills in or sets the time from falling asleep at night to the time of getting up in the morning; 2. The wearer clocks in or records the time from falling asleep at night to the time of getting up in the morning. In some examples, the method for identifying the second time interval may include: 1. The wearer fills in or sets the daily morning wake-up time to morning meal time; 2. The wearer clocks in or records the morning wake-up time to morning meal time.

As shown in FIG. 7 , in some examples, the working process of the glucose monitoring system with possible dawn phenomenon may include: obtaining the data of the glucose concentration of the wearer at night through the sensing module worn by the wearer (step S111); Two time intervals, i.e. the time to wake up in the morning to the meal time in the morning (step S211); whether the fluctuation type of the data of the glucose concentration corresponding to the second time interval is determined to be the dawn phenomenon (step S311) based on the judgment logic of the dawn phenomenon fluctuation type (step S311); It is the interactive information of the dawn phenomenon, such as asking the wearer's bedtime behavior (step S411); waiting for the wearer to input feedback information (step S511); based on the wearer's feedback information, continue to output guidance information explaining the dawn phenomenon and can end the interaction (step S611).

In some examples, if step S311 is negative, the glucose monitoring system has no output (ie step S412).

Referring to the data curve of glucose concentration shown in Figure 8, wherein T is time, the judgment logic or algorithm of the dawn phenomenon can be summarized as follows: if the fasting glucose concentration is not less than the first preset value and the lowest glucose concentration is greater than the second preset value, And if the difference between the fasting glucose concentration and the minimum glucose concentration is not less than the third preset value, it is determined that the wearer has the dawn phenomenon. Specifically, it may include: judging whether the highest glucose concentration in the glucose concentration data of the fasting period (that is, the first time interval), that is, the fasting glucose concentration, is greater than or equal to the first preset value, and the first preset value may be 7mmol/L .

Further, if the fasting glucose concentration is greater than or equal to the first preset value, it is judged whether the lowest glucose concentration in the glucose concentration data of the sleep period (that is, the second time interval) is greater than the second preset value, and the second preset value can be It is 3.9mmol/L; if the lowest glucose concentration in the data of glucose concentration during the sleep period is greater than the second preset value, then further, it is judged whether the difference between the lowest glucose concentration in the data of the fasting glucose concentration and the glucose concentration of the sleep period is Greater than or equal to the third preset value, the third preset value may be 3.3mmol/L; further, if the difference between the fasting glucose concentration and the lowest glucose concentration in the data of glucose concentration during sleep is greater than or equal to the third preset value, output the preliminary judgment result to wearer 2 as "dawn phenomenon is possible" and interact with wearer 2.

Further, the interaction may include the mobile terminal in the glucose monitoring system 1 asking the wearer 2 questions and the wearer 2 entering answers. For example, "Your fasting glucose is high, which may be caused by the dawn phenomenon. Almost half of the sugar lovers will have this phenomenon. Did you stay up late last night, suffer from insomnia, add meals, or eat late-night snacks?" At this time, the wearer 2 You can input "yes" or "no". If "yes", the mobile terminal will continue to output "insomnia, staying up late may affect the release of glycemic hormones at night, causing fasting glucose to rise. Adding meals at night, eating supper, the food sugar rising time can be If it reaches 3-8 hours or even longer, it may cause an increase in fasting glucose the next day." The guidance information or answer information can end the interaction; if "No", the mobile terminal will continue to output "Consider that you have the dawn phenomenon, everyone They will continue to produce glucose-increasing hormones, which have the effect of increasing glucose. The morning is the biggest peak of glucose-increasing hormones. If insulin secretion is insufficient, fasting glucose may increase, causing the dawn phenomenon." The guidance information or answer information can end Interactive; no continuing output if no input.

In other examples, the above-mentioned first preset value, second preset value, and third preset value can all be adjusted according to the results of clinical verification, and the order of judgment is not limited. Describe in detail.

Fig. 9 is a workflow diagram illustrating a possible glucose monitoring system corresponding to the Somogyi phenomenon according to an embodiment of the present invention; Fig. 10 is a data curve showing a glucose concentration corresponding to the Somogyi phenomenon according to an embodiment of the present invention .

As shown in FIG. 9 , in some examples, the working process of the glucose monitoring system with the possibility of Somogyi phenomenon may include: obtaining the data of the glucose concentration of the wearer at night through the sensing module worn by the wearer (step S101); A time interval, that is, the time to get up in the morning to the meal time in the morning (step S201); judge whether the fluctuation type of the data of glucose concentration corresponding to the second time interval is a Somogyi phenomenon (step S301) based on the judging logic of the fluctuation type of the Somogyi phenomenon (step S301); It is the interaction information of Somogyi phenomenon, such as asking the wearer's behavior before going to bed (step S401); waiting for the wearer to input feedback information (step S501); based on the wearer's feedback information, continue to output guidance information explaining Somogyi phenomenon and can end the interaction (step S601).

In some examples, if step S301 is negative, the glucose monitoring system has no output (that is, step S402).

Referring to the data curve of glucose concentration shown in Figure 10, the judgment logic or algorithm of the Somogyi phenomenon can be: if the fasting glucose concentration is not less than the first preset value and the lowest glucose concentration is not greater than the second preset value, then it is determined to wear If the wearer has the somogyi phenomenon; if the fasting glucose concentration is less than the first preset value and the lowest glucose concentration is greater than the second preset value, it is determined that the wearer does not have the somogyi phenomenon. Specifically can include:

It is judged whether the highest glucose concentration in the glucose concentration data of the fasting period (ie, the first time interval), that is, the fasting glucose concentration, is greater than or equal to a first preset value, which may be, for example, 7mmol/L.

Further, if the fasting glucose concentration is greater than or equal to the first preset value and the lowest glucose concentration in the glucose concentration data of the night time period (that is, the second time interval) is less than or equal to the second preset value, the second preset value can be For example, if it is 3.9mmol/L, it will output a preliminary judgment result to the wearer as "Somogyi phenomenon is possible" and interact with the wearer.

Further, the interaction may include the mobile terminal in the glucose monitoring system asking the wearer questions and the wearer entering answers. For example, "Your fasting glucose is high, which may be caused by the Somogyi phenomenon. Do you know when your glucose is low at night, and do you have any extra meals?" At this time, the wearer can enter "Have extra meals" or "No extra meals" , if "There is a meal", the mobile terminal will continue to output "Your high glucose on an empty stomach is considered to be caused by too many snacks when the glucose is low in the middle of the night. When the glucose is low at night, it is suitable to eat some fast-rising food to correct the low glucose. Such as 10-12 grams of glucose tablets, or 100-120ml of cola, and then eat some slow-rising sugar, such as milk, eggs, nuts, to prevent low glucose in the morning." The guidance or answer information can end the interaction; ", then the mobile terminal continues to output "Your fasting high glucose is considered to be caused by the Somogyi phenomenon. The Somogyi phenomenon is caused by low glucose in the middle of the night. The body protects itself. It will produce glucose-rising hormones to increase glucose to prevent severe low glucose. Excessive hormone production will cause rebound fasting high glucose." The guidance information or answer information can end the interaction; if there is no input, there will be no further output.

In some examples, the first preset value and the second preset value are set according to the standard of clinical guidance, for example, the first preset value can be set to any value in 5-7.8mmol/L, and the second preset value It can be set to any value in 2.9～4.9mmol/L. In some examples, the determination order of the aforementioned preset values may not be limited.

Fig. 11 is a workflow diagram showing a possible glucose monitoring system corresponding to dusk phenomenon according to an embodiment of the present invention; Fig. 12 is a data showing glucose concentration corresponding to dusk phenomenon according to an embodiment of the present invention; Fig. 13 is a flowchart showing the possible glucose monitoring system corresponding to the late twilight phenomenon according to the embodiment of the present invention; Fig. 14 is a graph showing the glucose concentration corresponding to the late twilight phenomenon according to the embodiment of the present invention data curve.

In some examples, the glucose monitoring system may also be used to identify the wearer's glucose concentration for the third time interval and the fourth time interval. In some examples, the third time interval may be from 2 hours after lunch to the start of dinner, and the fourth time interval may be from 2 hours after dinner to the start of sleep. By monitoring the third time interval and the fourth time interval, it can help the wearer identify the glucose fluctuation type of the twilight phenomenon and the late twilight phenomenon, and help them better manage blood sugar and improve the quality of life.

In the glucose monitoring system, the data of the wearer's glucose concentration in the third time interval and the fourth time interval are first obtained through the sensing module worn by the wearer, that is, from 2 hours after lunch to the start of dinner and 2 hours after dinner. Glucose concentration data from hour to sleep onset time.

Second, the data for glucose concentrations during the evening and late evening hours are identified. In some examples, the data of glucose concentration in the evening period may refer to the data of glucose concentration in the third time interval, and the data of glucose concentration in late evening may refer to the data of glucose concentration in the fourth time interval.

In some examples, the third time interval may be the time interval between 14:00 and 18:00 pm automatically selected by the glucose monitoring system. In other words, the third time interval may not be obtained through interactive actions, and in this case, the operations of the wearer 2 can be reduced.

In some examples, the third time interval can be clocked or recorded by the wearer from 2 hours after lunch to the start time of dinner. Specifically, the wearer's lunch time and dinner time can be acquired through the interaction between the interaction module 131 and the wearer 2 . In this case, the specific time of 2 hours after the lunch of the wearer 2 can be calculated, and then the scope of the third time interval can be determined.

In some examples, the fourth time interval may be the time interval between 20:00 and 22:00 in the evening automatically selected by the glucose monitoring system. In other words, the fourth time interval may not be obtained through interactive actions, and in this case, the operations of the wearer 2 can be reduced.

In some examples, the fourth time interval can be clocked or recorded by the wearer from 2 hours after dinner to the time when sleep begins. Specifically, the fourth time interval may be from 2 hours after dinner to the time when sleep begins. In some examples, the wearer's dinner time can be obtained through the interaction between the interaction module 131 and the wearer 2 . In this case, the specific time of 2 hours after the dinner of the wearer 2 can be calculated, and then the range of the fourth time interval can be determined.

As shown in FIG. 11 , in some examples, the workflow of the glucose monitoring system 1 for identifying the dusk phenomenon may include: obtaining the data of the glucose concentration of the wearer 2 through the sensing module worn by the wearer 2 (step S121); Identify the evening time period, that is, identify the preset time interval. The evening time period can be the time period corresponding to the dinner time from 2 hours after lunch, that is, the third time interval (step S221); judge the corresponding period of the evening period based on the judgment logic of the evening phenomenon. Whether the glucose fluctuation type is dusk phenomenon (step S321); output the interactive information corresponding to dusk phenomenon, such as asking wearer 2 about his post-lunch behavior (step S421); wait for wearer 2 to input feedback information (step S521); 2, continue to output guidance information explaining the dusk phenomenon and end the interaction (step S621).

In some examples, if step S321 is negative, the glucose monitoring system has no output (ie step S422).

In some examples, in step S121, the glucose concentration may include an evening maximum glucose concentration and an evening minimum glucose concentration.

In some examples, in step S221, the dusk time period (that is, the preset time interval) may be the time period corresponding to the dinner time from 2 hours after lunch and not greater than the fifth preset value (that is, the time of the preset time interval) length is not greater than the fifth preset value), the fifth preset value can be, for example, 4 hours, 4.5 hours or 5 hours. In addition, in some examples, the fifth preset value may also be defined according to clinical standards, the present invention is not limited thereto, and details will not be described here. In addition, in some examples, in order to improve the accuracy of identification, in the judgment logic or algorithm of the dusk phenomenon, usually the time corresponding to the highest glucose concentration in the dusk period (that is, the highest glucose concentration in the dusk) is the same as the time corresponding to the lowest glucose concentration in the dusk period (that is, the lowest glucose concentration in the dusk). Glucose concentration) The time period between the corresponding moments is not less than the sixth preset value, the sixth preset value can be 1 hour, 1.5 hours, or 2 hours, etc., and the sixth preset value can be adjusted according to different precision requirements , the present invention is not limited thereto. In other examples, the sixth preset value may not be set or judged, that is, the time corresponding to the highest glucose concentration in the dusk period may be close to the time corresponding to the lowest glucose concentration in the dusk period (for example, 1 minute, 5 minutes or 10 minutes, etc.), and the glucose monitoring system 1 can have a preprocessing algorithm, and can identify and eliminate the highest glucose concentration and the lowest glucose concentration that are close to each other in the glucose concentration data, thereby eliminating the abnormal situation of the data and improving the accuracy. sex.

Referring to the data curve of glucose concentration shown in Figure 12, the judgment logic or algorithm of the dusk phenomenon can be: if the difference between the highest glucose concentration at dusk and the lowest glucose concentration at dusk is not less than the fourth preset value, and the preset time interval is not greater than The fifth preset value, and the time period between the time corresponding to the highest glucose concentration at dusk and the time corresponding to the lowest glucose concentration at dusk is not less than the sixth preset value, then it is determined that the wearer has dusk phenomenon. Or, if the difference between the highest glucose concentration at dusk and the lowest glucose concentration at dusk is not less than the fourth preset value, and the preset time interval is not greater than the fifth preset value, and the time corresponding to the highest glucose concentration at dusk is to the time corresponding to the lowest glucose concentration at dusk If the rate of change of glucose concentration between the times is greater than the seventh preset value, it is determined that the wearer has dusk phenomenon.

Specifically, it may include: first judging whether there is a rapid rising fluctuation in the dusk period.

If there is a rapid rising fluctuation in the dusk, it is judged whether the increase is greater than or equal to the fourth preset value. The fourth preset value can be, for example, 2mmol/L, that is, the highest glucose concentration in the dusk and the lowest glucose concentration in the dusk. Whether the difference is greater than or equal to the fourth preset value, and the time period between the time corresponding to the highest glucose concentration at dusk and the time corresponding to the lowest glucose concentration at dusk is not less than the sixth preset value, the sixth preset value can be, for example, 2 Hour. In some other examples, it is also possible to judge whether the dusk phenomenon occurs through the change speed (that is, the rising speed) of the glucose concentration. Greater than the seventh preset value, the seventh preset value can be, for example, 0.5mmol/L/h, and the seventh preset value can be the ratio of the fourth preset value to the fifth preset value; if the rising speed is greater than the seventh preset value Set the value, then output the preliminary judgment result to the wearer 2 as "the dusk phenomenon is possible" and interact with the wearer 2.

Further, the interaction may include the mobile terminal in the glucose monitoring system 1 asking and answering the wearer 2 and the wearer 2 inputting the answer. For example, "You may have twilight phenomenon. Have you eaten or added meals in the afternoon?" At this time, the wearer 2 can input "yes" or "no". If "yes", the mobile terminal will continue to output "lunch is late , the protein and fat content of lunch is high, the extra meal in the afternoon will cause the glucose in the afternoon to rise, and it is better to eat lunch early, and low-oil cooking is better." And the interaction can be ended; if "No", the mobile terminal will continue to output "If there is no meal in the afternoon, add If you eat a meal, your glucose will rise by itself. Consider the dusk phenomenon. In the afternoon, there will be a peak of glucose-rising hormones. If your own insulin and other hypoglycemic factors are insufficient, it is easy to cause an increase in blood sugar. Exercise after lunch can help reduce the dusk phenomenon." Guidance or answer information and can end the interaction.

In some other examples, the above-mentioned fourth preset value, fifth preset value, sixth preset value and seventh preset value can all be adjusted according to clinical verification results. It is generally believed that the glucose before dinner is 1-2 mmol/L higher than the glucose 2 hours after lunch, and the "twilight phenomenon" should be considered. For example, the fourth preset value can be 1-2mmol/L, correspondingly, the fifth preset value can be 2-4h, and the sixth preset value can be 0.5-2 hours. The fifth preset value correspondingly obtains the seventh preset value which may be 0.25-1 mmol/L/h, and the present invention will not be described in detail here.

As shown in FIG. 13 , in some examples, the workflow of the glucose monitoring system 1 for identifying the late dusk phenomenon may include: Obtaining the data of the glucose concentration of the wearer 2 through the sensing module worn by the wearer 2 (step S131 ) Identify the late dusk period, that is, select the preset time interval, the late dusk period can be the corresponding time period from 2 hours after dinner to the time before sleep, that is, the fourth time interval (step S231); based on the judgment of the late dusk phenomenon Logically judge whether the glucose fluctuation type corresponding to the late dusk period is the late dusk phenomenon (step S331); output interactive information corresponding to the late dusk phenomenon, for example, ask the wearer 2 about his post-dinner behavior (step S431); wait for the wearer 2 to input feedback information (step S531); based on the feedback information from the wearer 2, continue to output guidance information explaining the late dusk phenomenon and may end the interaction (step S631).

In some examples, in step S131, the glucose concentration may include a late evening maximum glucose concentration and a late evening minimum glucose concentration.

In some examples, in step S231, the late dusk time period (that is, the preset time interval) may be the time period corresponding to the time from 2 hours after dinner to the time before sleep and is not greater than the ninth preset value (that is, the preset time interval The length of time is not greater than the ninth preset value), the ninth preset value can be, for example, 4 hours, 4.5 hours or 5 hours. In addition, in some examples, the ninth preset value can also be defined according to clinical standards, the present invention is not limited thereto, and details will not be described here. In addition, in some examples, in order to improve the accuracy of identification, in the judgment logic or algorithm of the late dusk phenomenon, usually the time corresponding to the highest glucose concentration in the late dusk (that is, the aforementioned highest glucose concentration in the late dusk) is the same as the time corresponding to the lowest glucose concentration in the late dusk. The time period between the moments corresponding to the concentration (that is, the minimum glucose concentration in the aforementioned late evening) is not less than the tenth preset value, the tenth preset value can be 1 hour, 1.5 hours, or 2 hours, etc., and the tenth preset value can be Adjustments are made according to different precision requirements, and the present invention is not limited thereto. In some other examples, the tenth preset value may not be set or judged, that is, the time corresponding to the highest glucose concentration in the late evening period may be close to the time corresponding to the lowest glucose concentration in the late evening period (for example, 1 minute, 5 minutes or 10 minutes, etc.), and the glucose monitoring system 1 can have a preprocessing algorithm, and can identify and eliminate the highest glucose concentration and the lowest glucose concentration that are close to each other in the glucose concentration data, thereby eliminating the abnormal situation of the data, Improve accuracy.

In some examples, if step S331 is negative, the glucose monitoring system has no output (ie step S432).

Referring to the data curve of glucose concentration shown in Figure 14, the judgment logic or algorithm of the late dusk phenomenon can be as follows: if the difference between the highest glucose concentration in late dusk and the lowest glucose concentration in late dusk is not less than the eighth preset value, and the preset time interval If it is not greater than the ninth preset value, and the time period between the time corresponding to the highest glucose concentration at dusk and the time corresponding to the lowest glucose concentration in dusk is not less than the tenth preset value, then it is determined that the wearer has the late dusk phenomenon. If the difference between the highest glucose concentration at dusk and the lowest glucose concentration at dusk is not less than the eighth preset value, and the preset time interval is not greater than the ninth preset value, and the time corresponding to the highest glucose concentration at dusk reaches the lowest glucose concentration at dusk If the rate of change of the glucose concentration between the time points corresponding to the concentration is greater than the eleventh preset value, it is determined that the wearer has late twilight phenomenon.

Specifically, it may include: first judging whether there is a rapid rising fluctuation in the late evening period (that is, the preset time interval). If there is a rapid rising fluctuation in the late evening period, it is judged whether the increase is greater than or equal to the eighth preset value. The eighth preset value can be, for example, 2mmol/L, that is, the highest glucose concentration in the late evening period and the lowest in the late evening period Whether the difference in glucose concentration is greater than or equal to the eighth preset value, and the time period between the time corresponding to the highest glucose concentration in late evening and the time corresponding to the lowest glucose concentration in late evening is not less than the tenth preset value, the tenth preset A value can be, for example, 2 hours. In some other examples, it is also possible to judge whether the late dusk phenomenon occurs by the rate of change of the glucose concentration (that is, the rate of increase). Whether the speed is greater than the eleventh preset value, the eleventh preset value can be, for example, 0.5mmol/L/h, and the eleventh preset value can be the ratio of the eighth preset value to the ninth preset value; If the speed is greater than the eleventh preset value, the preliminary judgment result is output to the wearer 2 as "possible late dusk phenomenon" and the wearer 2 interacts.

Further, the interaction may include the mobile terminal in the glucose monitoring system 1 asking and answering the wearer 2 and the wearer 2 inputting the answer. For example, "You may have late twilight phenomenon, the twilight phenomenon that occurs later, commonly known as late twilight phenomenon, have you eaten or added meals at night?" At this time, the wearer 2 can input "yes" or "no", if "Yes", the mobile terminal will continue to output "Dinner is eaten late, and the protein and fat content of dinner is high. Adding meals at night will cause the glucose before going to bed to rise, which may affect the fasting glucose at night or the next day. Eat dinner earlier and eat less at night. Things are better." and the interaction can be ended; if "No", the mobile terminal will continue to output "If there is no meal or extra meal in the evening, the glucose will rise by itself. Considering the phenomenon of late dusk, it is generally the second peak of the glucose-rising hormone in the afternoon It occurs late or lasts for a long time, manifested as an increase in glucose before going to bed, and evening exercise can help alleviate the late dusk phenomenon." Guidance or answer information can end the interaction.

In some other examples, the eighth preset value, the ninth preset value, the tenth preset value and the eleventh preset value mentioned above can all be adjusted according to the results of clinical verification. It is generally believed that the glucose before going to bed is 1-2mmol/L higher than the glucose 2 hours after dinner, and the "late evening phenomenon" should be considered, that is, the eighth preset value can be 1-2mmol/L, and correspondingly, the ninth preset value can be is 2 to 4 hours, the tenth preset value can be 0.5 to 2 hours, and the eleventh preset value obtained correspondingly from the eighth and ninth preset values can be 0.25 to 1 mmol/L/h. The present invention It will not be described in detail here.

According to the present invention, a glucose monitoring system for identifying blood sugar fluctuations can be provided, which can identify glucose fluctuation types such as Somogyi phenomenon, dawn phenomenon, dusk phenomenon, and late dusk phenomenon, and intelligently output and explain corresponding fluctuation phenomena, so as to better help Diabetics monitor blood sugar and manage blood sugar to improve the quality of life of diabetic patients.

Although the present invention has been specifically described above with reference to the drawings and examples, it should be understood that the above description does not limit the present invention in any form. Those skilled in the art can make modifications and changes to the present invention as required without departing from the true spirit and scope of the present invention, and these modifications and changes all fall within the scope of the present invention.

Claims

A glucose monitoring system, characterized in that it includes a sensing module, an interaction module, a communication module and a processing module,

the sensing module is configured to continuously monitor the wearer's glucose concentration;

the communication module is configured to receive and transmit a glucose concentration to the processing module;

The interaction module is configured to interact with the wearer to obtain an interaction result, and the interaction includes: obtaining a preset time including at least one of the first time interval, the second time interval, the third time interval, or the fourth time interval Intervals and ask the wearer about their bedtime behavior, post-lunch behavior or post-dinner behavior based on glucose concentration;

The processing module is configured to determine whether the wearer has a glucose fluctuation type among dawn phenomenon, somogyi phenomenon, dusk phenomenon or late dusk phenomenon based on the glucose concentration in the preset time interval and the interaction result, and generate a guide information.
The glucose monitoring system according to claim 1, characterized in that:

The interaction result includes at least one of the wearer's sleep time, pre-bedtime behavior, sleep state, lunch time, post-lunch behavior, post-lunch state, dinner time, post-dinner behavior or post-dinner state.
The glucose monitoring system according to claim 1, characterized in that:

The first time interval is from the time when the wearer falls asleep in the evening to the time to wake up in the morning, the second time interval is from the time when the wearer wakes up in the morning to the time of eating in the morning, and the third time interval is 2 hours after the wearer's lunch From dinner time, the fourth time interval is from 2 hours after dinner to sleep time of the wearer.
The glucose monitoring system according to claim 3, characterized in that:

The glucose concentration includes the fasting glucose concentration located in the first time interval, the lowest glucose concentration located in the second time interval, the highest evening glucose concentration and the evening lowest glucose concentration located in the third time interval, and the evening glucose concentration located in the third time interval. Late evening maximum glucose concentration and late evening minimum glucose concentration in four time intervals.
The glucose monitoring system according to claim 4, characterized in that:

If the fasting glucose concentration is not less than a first preset value, the minimum glucose concentration is greater than a second preset value, and the difference between the fasting glucose concentration and the minimum glucose concentration is not less than a third preset value, then It is judged that the wearer has the dawn phenomenon.
The glucose monitoring system according to claim 4, characterized in that:

If the fasting glucose concentration is not less than the first preset value and the minimum glucose concentration is not greater than the second preset value, it is determined that the wearer has the somogyi phenomenon;

If the fasting glucose concentration is less than the first preset value and the minimum glucose concentration is greater than the second preset value, it is determined that the wearer does not have the somogyi phenomenon.
The glucose monitoring system according to claim 4, characterized in that:

If the difference between the highest glucose concentration at dusk and the lowest glucose concentration at dusk is not less than the fourth preset value, and the preset time interval is not greater than the fifth preset value, and the time corresponding to the highest glucose concentration at dusk If the time period between the time corresponding to the minimum glucose concentration at dusk is not less than the sixth preset value, then it is determined that the wearer has the twilight phenomenon; or, if the difference between the maximum glucose concentration at dusk and the minimum glucose concentration at dusk Not less than the fourth preset value, and the preset time interval is not greater than the fifth preset value, and the glucose concentration change speed between the time corresponding to the highest glucose concentration in the evening and the time corresponding to the lowest glucose concentration in the evening If it is greater than the seventh preset value, it is determined that the wearer has dusk phenomenon.
The glucose monitoring system according to claim 4, characterized in that:

If the difference between the late evening maximum glucose concentration and the late evening minimum glucose concentration is not less than the eighth preset value, and the preset time interval is not greater than the ninth preset value, and the late evening maximum glucose concentration If the time period between the corresponding moment and the moment corresponding to the lowest glucose concentration in late evening is not less than the tenth preset value, it is determined that the wearer has a late evening phenomenon; or, if the highest glucose concentration in late evening and the evening The difference between the lowest glucose concentration at dusk is not less than the eighth preset value, and the preset time interval is not greater than the ninth preset value, and the time corresponding to the highest glucose concentration at dusk to the time corresponding to the lowest glucose concentration at dusk is If the rate of change of glucose concentration between the times is greater than the eleventh preset value, it is determined that the wearer has a late dusk phenomenon.
The glucose monitoring system according to claim 1, characterized in that:

The interaction module includes a display unit configured to display at least one of guidance information, interactive questions, glucose concentration curves, and glucose fluctuation types.
The glucose monitoring system according to claim 1, characterized in that:

The interaction module further includes an entry unit configured to enter at least one of wake-up time, sleep time, morning meal time, lunch meal time, dinner meal time, or feedback for interactive questions.
The glucose monitoring system according to claim 1, characterized in that:

The interaction module and the processing module are integrated in a mobile terminal, and the mobile terminal has an application program that cooperates with the interaction module and the processing module.
The glucose monitoring system according to claim 1, characterized in that:

The processing module is configured to obtain a preliminary judgment result based on the glucose concentration within the preset time interval, and obtain a glucose fluctuation type based on the preliminary judgment result and the interaction result.
The glucose monitoring system according to claim 12, characterized in that:

The processing module is configured to ask the wearer about the wearer's bedtime behavior, after-lunch behavior or after-dinner behavior based on the preliminary judgment result, and display the queried question through the interaction module.
The glucose monitoring system according to claim 1, characterized in that:

The guidance information includes glucose excursion types, reasons associated with glucose excursion types, and behavioral recommendations.
The glucose monitoring system according to claim 1, characterized in that:

Also included is a storage module configured to store data of the glucose concentration.
The glucose monitoring system according to claim 1, characterized in that:

The sensing module is used to acquire the glucose concentration in the interstitial fluid, and the sensing module acquires the glucose concentration at a preset frequency.
The glucose monitoring system according to claim 1, characterized in that:

The communication module wirelessly transmits the data of the glucose concentration to the processing module.
The glucose monitoring system according to claim 17, characterized in that:

The wireless mode includes at least one of Bluetooth, Wifi, 3G/4G/5G, NFC, UWB and Zig-Bee.