Percutaneous glucose monitoring system

Abstract

A transcutaneous glucose monitoring system includes a glucose measuring device having a sensor with a predetermined duration of use, and a reading device including a processor, a wireless communication module, a memory, and a user interface configured for a user to set a pre-grace period and display data, wherein the processor is configured to execute the following steps according to the instruction: providing a pre-grace period which can be set by a user on a user interface, wherein the pre-grace period is configured to have an adjustable duration which can correspond to the reaction difference of different organisms to the implantation of the sensor; not displaying the data in the pre-grace period; when the pre-grace period expires, displaying the data, wherein the duration of the data display period is equal to the preset use duration; and when the data display period expires, the user interface stops displaying the data.

Description

Technical Field

[0001] The present invention relates to a transcutaneous glucose monitoring system, more specifically, to a transcutaneous glucose monitoring system that can avoid displaying readings during inaccurate periods in response to differences in different biological bodies' responses to sensor implantation, and even more specifically, to a transcutaneous glucose monitoring system that has a usable number of days that meets the product's claimed lifespan. Background Art

[0002] The common continuous glucose monitoring system (CGM system) currently available on the market for monitoring the patient's blood sugar / glucose concentration (level) includes a sensor and a transmitter. After the sensor is implanted, it senses physiological signals, transmits the physiological signals to the transmitter, and can issue an alarm when the physiological signals are abnormal.

[0003] However, before the sensor can measure correctly, it must be fully "wetted" or hydrated to reach equilibrium with the glucose in the patient's body. Therefore, after the sensor is implanted subcutaneously, a warm-up period must be allowed before the sensor can start measuring, so that the patient / user can read an accurate reading of the glucose concentration.

[0004] After being activated by a patient / user, current CGM systems typically require a warm-up period of 30 to 120 minutes (i.e., 0.02 to 0.08 days) before entering the measurement phase and displaying the measured glucose level reading on the CGM system's display.

[0005] In addition, after the biosensor is implanted in the patient's body, the possible trauma or even inflammation to the skin and / or subcutaneous tissue may also cause the sensor's monitoring signal to be unstable.

[0006] Typically, the accuracy of the sensor on the first to third day of implantation is poor, with the mean absolute relative difference (MARD) of the startup curve being greater than 10%, and even worse, reaching 19% to 38%. After implantation, the patient must wait for a certain warm-up period to allow the sensor to reach equilibrium with the glucose in the body, so that the continuous glucose sensor can stabilize and provide accurate readings.

[0007] As shown in Table 18 (Chinese translation is shown in Table 1 below) in the previous document "PMAP150021: FDA Summary of Safety and Effectiveness Data, Abbott Diabetes Care, Inc., September 23, 2016, pages 1-31", the average relative difference of CGM-CM on the first day and even on the second to fifth days is greater than 13%, and the measurement of the CGM system is still extremely inaccurate at this time. As written in the first paragraph of page 24 of the document, after wearing the CGM system, its measurement accuracy is extremely poor in the early stage, but gradually stabilizes.

[0008] Table 1: Differences between daily CGM systems and CM

[0009]

[0010] The service life of CGM systems on the market is usually claimed to be 3 days, 10 days, 14 days, or even 15 days. However, the service life claimed by various manufacturers, taking 15 days as an example, includes 0.02 days of warm-up period and at least 1 to 5 days of unstable period. The duration (or number of days) that can be accurately measured is actually only 9.72 to 13.72 days at most, that is, the number of days that can be normally measured is less than the product's claimed service life.

[0011] As the sensor approaches the end of its product life, the accuracy of the sensor may also decline. This is because, for example, electrode passivation, enzyme degradation, polymer membrane delamination, polymer membrane biofouling, cell fibrosis, and circuit failures may cause the late signal measured by the biosensor to be unstable. For details, please refer to the previous literature: "N. Wisniewski, M. Reichert, Methods for reducing biosensor membrane biofouling, Colloids and Surfaces B: Biointerfaces 18 (2000) pp. 197-219", such as the description of "1. Introduction" on pages 197-198 and Figure 1 shown.

[0012] Moreover, when the life of the first sensor expires, the second sensor needs to be replaced. How to keep the physiological signals measured by the second sensor consistent with the first sensor and maintain uninterrupted monitoring, and to provide timely warnings when the physiological signals are abnormal, is another problem that needs to be improved in the conventional CGM system.

[0013] In view of this, the present invention provides a transcutaneous glucose monitoring system, which can provide the user with a pre-grace period to respond to the differences in the responses of different organisms to the implantation of the sensor. During the pre-grace period, the measurement data is not displayed, but the data is displayed during the glucose data display period, and the duration of the glucose data display period is equal to the predetermined usage time. Good accuracy can be maintained during the service life, that is, the declared service life is truly equal to the actual number of days that can be used, so as to protect the rights and interests of users / consumers.

[0014] In addition, the present invention further provides a transcutaneous glucose monitoring system, when the first sensor fails and the second sensor is implanted to replace the first sensor, the second sensor does not need to be calibrated, and the monitored physiological signals / readings can be uninterrupted, so that when an abnormality occurs, a warning can be given in time and the accuracy of the measurement can be maintained. Therefore, the connection between the first and second sensors can be handled simply.

[0015] Therefore, the applicant discloses a transcutaneous glucose monitoring system to improve the above problems of the prior art.

[0016] In view of the deficiencies in the known technology, the applicant of this case, after careful experiments and research, and with a spirit of perseverance, finally conceived this case, which can overcome the deficiencies of the previous technology. The following is a brief description of this case. Summary of the invention

[0017] According to one aspect of the present invention, a transcutaneous glucose monitoring system is provided, comprising: a glucose measuring device, comprising a sensor, the sensor having a predetermined usage time defined by a factory, and at least a portion of the sensor being implanted under the skin of a living organism in contact with a biological fluid, for measuring a signal or data indicating a glucose level in the biological fluid; a reading device configured to receive and display the data or convert the signal into the data, and to provide a user-set pre-grace period in response to differences in the responses of different living organisms to the sensor implantation, wherein the reading device comprises: one or more processors; a wireless communication module configured to couple with the one or more processors and wirelessly receive the signal or the data from the sensor; a memory configured to couple with the one or more processors The one or more processors are configured to be coupled to and store an instruction; and a user interface configured to be coupled to the one or more processors and for the user to set the pre-grace period and display the data, wherein: the one or more processors are configured to perform the following steps according to the instruction: (a) providing the pre-grace period that can be set by the user in an option unit of the user interface, the pre-grace period being configured to be set to have an adjustable duration that can be adjusted according to the differences in the responses of different organisms to the sensor implantation; (b) not allowing the user interface to display the data during the pre-grace period; (c) when the pre-grace period expires, starting a glucose data display period to display the data, and the duration of the glucose data display period is equal to the predetermined usage duration; and when the glucose data display period expires, causing the user interface to stop displaying the data.

[0018] According to another aspect of the present invention, a transcutaneous glucose monitoring system is provided, comprising: a glucose measuring device, comprising a sensor, the sensor having a predetermined usage time defined by a factory, and at least a portion of the sensor being implanted under the skin of a living organism in contact with a biological fluid, for measuring a signal or data indicating a glucose level in the biological fluid; a reading device configured to receive and display the data or convert the signal into the data, and provide a user-set pre-grace period in response to the difference in the reaction of different living organisms to the implantation of the sensor, wherein the reading device comprises: one or more processors ; a wireless communication module, configured to be coupled to the one or more processors and to wirelessly receive the signal or the data from the sensor; a memory, configured to be coupled to the one or more processors and to store an instruction; and a user interface, configured to be coupled to the one or more processors and to allow the user to set the pre-grace period and display the data, wherein: the one or more processors are configured to provide the pre-grace period that can be set by the user in an option unit of the user interface according to the instruction, and the pre-grace period is configured to be set to have an adjustable duration that can be adjusted according to the different responses of different organisms to the sensor implantation.

[0019] According to another aspect of the present invention, a transcutaneous glucose monitoring system is provided, comprising: a glucose measuring device, comprising a sensor, the sensor having a predetermined usage time defined by a factory end, and at least a portion of the sensor being implanted under the skin of a living organism in contact with a biological fluid, for measuring a signal or data indicating a glucose level in the biological fluid; a reading device configured to receive and display the data or convert the signal into the data, and to provide a user-set pre-grace period in response to the difference in the reaction of different living organisms to the implantation of the sensor, wherein the reading device comprises: one or more processors; a wireless communication device; A module is configured to be coupled with the one or more processors and to wirelessly receive the signal or the data from the sensor; a memory is configured to be coupled with the one or more processors and to store an instruction; and a user interface is configured to be coupled with the one or more processors and to allow the user to set the pre-grace period and display the data, wherein: the one or more processors are configured according to the instruction to: when the pre-grace period expires, start a glucose data display period to display the data, and the duration of the glucose data display period is equal to the predetermined usage time; and when the glucose data display period expires, cause the user interface to stop displaying the data. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The above objects and advantages of the present invention will become more immediately apparent to those having ordinary knowledge in the art after referring to the following detailed description and the accompanying drawings.

[0021] [ Figure 1 ] is a schematic diagram of the composition of a transcutaneous glucose monitoring system for monitoring glucose in a patient according to an embodiment of the present invention;

[0022] [ Figure 2 ] is a schematic diagram of the working principle of the transcutaneous glucose monitoring system according to the present invention when measuring the glucose concentration of a patient;

[0023] [ Figure 3 ] is a schematic diagram of an embodiment of a reading device in a transcutaneous glucose monitoring system according to the present invention;

[0024] [ Figure 4A ]and[ Figure 4B ] are steps for implementing the processor configuration in the reading device of the transcutaneous glucose monitoring system according to the present invention;

[0025] [ Figure 5A ]、[ Figure 5B ]、[ Fig. 6A ]、[ Figure 6B ]、[ Figure 6C ]、[ Fig. 7A ]and[ Figure 7B] is a display screen on a user interface of a transcutaneous glucose monitoring system according to an embodiment of the present invention;

[0026] [ Figure 8 ] is a schematic diagram of installing a second sensor on a patient according to an embodiment of the present invention;

[0027] [ Fig. 9 ] is a schematic diagram of the time axis of the warm-up period, pre-grace period and display period of a sensor according to an embodiment of the present invention;

[0028] [ Fig.10 ] is a schematic diagram of a combination of a first sensor time axis and a second sensor time axis according to an embodiment of the present invention;

[0029] [ Fig.11 ] is a schematic diagram of a combination of a first sensor time axis and a second sensor time axis according to another embodiment of the present invention;

[0030] [ Fig.12 ] is a flowchart of steps executed by a processor according to an embodiment of the present invention; and

[0031] [ Fig.13 ] is a flowchart of the steps executed by a processor according to an embodiment of the present invention.

[0032] [ Fig.14 ] Fig.14 The continuous data displayed on the user interface of a transcutaneous glucose monitoring (CGM) system for monitoring the glucose of a patient according to an embodiment of the present invention and the point data displayed by a traditional glucose monitoring system (BGM) system are shown. DETAILED DESCRIPTION

[0033] The invention proposed in this case can be fully understood by the following embodiments, so that those with ordinary knowledge in the relevant technical field can complete it. However, the implementation of this case is not limited to its implementation form by the following embodiments. Those with ordinary knowledge in the relevant technical field can still deduce other embodiments based on the spirit of the embodiments other than those disclosed, and these embodiments should all fall within the scope of the present invention.

[0034] When reading the following detailed description, please refer to all the drawings of the present invention, wherein all the drawings of the present invention show different embodiments of the present invention through examples, and help those with ordinary knowledge in the relevant technical field understand how to implement the present invention. This case provides sufficient embodiments to illustrate the concept of the present invention, and the various embodiments do not conflict with each other, and new embodiments can be implemented through any combination thereof, that is, the present invention is not limited to the embodiments disclosed in this specification.

[0035] Unless otherwise limited in specific examples, the following definitions apply to terms used throughout the specification.

[0036] In one embodiment of the present invention, if the service life of the sensor can reach 18 to 21 days, as mentioned above, if the commercially available product provides a product life of 15 days, if the warm-up period plus the data instability period is 1 day, the actual data for the 2nd to 15th day of measurement can be presented (a total of 14 days). In contrast, the display method of the measurement value of the present invention is to display the sensor after implantation, through the setting of a pre-grace period, such as setting a time of 1 day, and display the measurement value from the 2nd to the 16th day (at least a total of 15 days), so that the user can enjoy the most essential period of product accuracy. Through the operation method of the present invention, accurate measurement readings can be provided throughout the measurement period (i.e., the data display period), and the product can meet the declared number of days of use to protect the rights and interests of users. Furthermore, since the service life of the sensor of the present invention can reach 18 to 21 days, it means that the sensor of the present invention can still operate normally after the 16th day. The extra period from the 16th to the 18th day (three days in total) or the 16th to the 21st day (six days in total) can be used as a reserved period, which can be used to set a post-grace period (or grace period) for continuous measurement during the warm-up process after the next sensor (or the second sensor) is installed, or for increasing the time range of the adjustable pre-grace period.

[0037] Figure 1 and Figure 2 , is a schematic diagram of the composition and working principle of a transcutaneous glucose monitoring system 1 for monitoring glucose in a patient according to an embodiment of the present invention. Figure 1 As shown, the transcutaneous glucose monitoring system 1 of the present invention includes a glucose measuring device 10, which includes a sensor module 11 (including a sensor 11a implanted under the skin of a patient) and a transmitter 12 connected to the sensor module 11 after at least a portion of the sensor 11a is implanted and used to transmit physiological signals (or simply signals) / physiological data (or simply data) sensed by the sensor 11a, an implanter 13 for implanting the sensor 11a under the skin, a reader device 14 for receiving the physiological signals / physiological data from the transmitter 12 (which may be, for example, a mobile phone or a receiver with a related APP installed), and a charger 15 for charging the transmitter 12. The frequency of the sensor 11a measuring the physiological signal may be, for example, every minute, every 2 minutes, every 5 minutes, every 10 minutes, every 15 minutes, every 30 minutes, every hour, etc. Figure 2 The schematic diagram of the working principle of the glucose measuring device 10 according to the present invention when measuring the glucose concentration of a patient is shown. Figure 2As shown, at least a portion of the sensor 11a is implanted into the biological body through the implanter 13, passing through the skin 6 and contacting the biological fluid 5 in the subcutaneous tissue 2 (for example, the tissue fluid that penetrates from the blood vessel 3 to the subcutaneous tissue), and a voltage is applied through the transmitter 12 to measure the electrochemical reaction between the electrode (not shown) on the sensor 11a and the glucose 4 in the biological fluid 5, so as to measure the physiological signal representing the concentration of glucose 4. Then, the transmitter 12 transmits the physiological signal measured by the sensor 11a, or further converts the physiological signal into physiological data (depending on the design of the transmitter and the receiver for signal conversion and transmission functions) to the reading device 14, and the reading device 14 is used to receive the physiological data from the transmitter 12, or convert the physiological signal into physiological data, and display the physiological data on the user interface of the reading device 14. In another embodiment, the sensor 11a can be implanted subcutaneously together with a micro-transmitter.

[0038] Figure 3 This is a schematic diagram of an embodiment of a reading device according to the present invention. Figure 3 As shown, the reading device 14 of the present invention includes a user interface 31, a communication module 32 (which can be wired or wireless), a memory 33 and a processor 34. The user interface 31 is, for example, a mobile phone or other handheld human-machine interface. The communication module 32 is configured to communicate with the user through a wired or wireless (e.g., Bluetooth The sensor 11a is connected to the transmitter 12 in the glucose measuring device 10 by a wireless or Wi-Fi method to obtain the physiological signal (or simply signal) or physiological data (or simply data). The processor 34 is connected to the user interface 31, the memory 33 and the communication module 32 respectively. The processor 34 in the reading device 14 converts the physiological signal obtained from the communication module 32 into physiological data, or stores the obtained physiological data in the memory 33, and displays the processed or unprocessed physiological data on the user interface 31. The signal measured by the sensor 11a is a glucose measurement signal, and the data is a glucose reading converted from the glucose measurement signal.

[0039] Figure 4A-4B The steps for implementing the processor configuration in the reading device of the transcutaneous glucose monitoring system according to the present invention). Please refer to Figures 1 to 3According to one embodiment of the present invention, a transcutaneous glucose monitoring system 1 includes a glucose measuring device 10 and a reading device 14. The glucose measuring device 10 includes a sensor module 11 having a predetermined (predetermined or presumed) usage time defined by the factory, and at least a portion of the sensor 11a of the sensor module 11 is implanted subcutaneously in a biological body in contact with a biological fluid 5 to measure a signal indicating the level of glucose 4 in the biological fluid 5. The reading device 14 is used to pair with the transmitter 12 of the glucose measuring device 10. When the glucose monitoring system 1 is set up, the reading device 14 is configured to receive the signal or convert the signal into data and display the data, and provide a user-set pre-grace period (pre-grace period or observation period) in response to the difference in the reaction of different biological bodies to the sensor implantation. The reading device 14 includes one or more processors 34, a wireless communication module 32, a memory 33, and a user interface 31. The wireless communication module 32 is configured to couple with the one or more processors 34 and wirelessly receive the signal or the data from the sensor module 11. The memory 33 is configured to be coupled to the one or more processors 34 and store instructions. The user interface 31 is configured to be coupled to the one or more processors 34 and allow the user to set the pre-grace period and display the data, wherein the one or more processors 34 are configured to execute the following according to the instructions: Figure 4A The steps shown include completing the setting of the glucose measuring device 10 (S40); providing the pre-grace period that can be set by the user on the user interface 31, and the pre-grace period is configured to be set to have an adjustable duration that can be adjusted according to the difference in the reaction of different organisms to the implantation of the sensor 11a (S41); not allowing the user interface 31 to display the data during the pre-grace period (S42); when the pre-grace period expires, starting the glucose data display period to display the data (S43); and when the glucose data display period expires, stopping the user interface 31 from displaying the data (S44). In addition, if Figure 4B As shown, in another embodiment, before the step (S41), the following steps may also be included: providing the user with a warm-up period, and the user interface does not display the data during the warm-up period (S41a). The warm-up period is usually a fixed value built into the system, and in another embodiment it is a user-adjustable time.

[0040] The adjustable time is within the range of no more than 1 day, no more than 2 days, no more than 3 days or no more than 5 days. Preferably, the adjustable time is at least 20 minutes. In addition, the setting of the adjustable time of the pre-grace period is determined based on the biological body's response to the sensor implantation, the sensor life, the predetermined usage time, at least a function of a sensor system parameter, or a combination thereof. The sensor system parameter is determined based on at least a sensitivity of the sensor.

[0041] The setting range of the adjustable duration of the pre-grace period can be defined by the factory.

[0042] The length of the pre-grace period may be defined as an upper limit and / or a lower limit based on the sensor life, the standard usage days, and a function of sensor system parameters, and the adjustable length of time may be in the range of half a day to one day.

[0043] The user interface is at least configured to display an option unit for the user to reject, or accept and set the adjustable duration. In addition, the adjustable duration can be selected from a plurality of preset fixed durations or set from a user-defined duration.

[0044] The difference in the organism's response to sensor implantation is the difference in the biological and immunological response of the organism's body to at least part of the sensor after the organism contacts the sensor, including changes in the physiological environment, sensor electrode passivation, or sensor cell fibrosis wrapping.

[0045] Figure 5A to Figure 7B A reference according to the present invention Figure 4B The embodiment of the transcutaneous glucose monitoring system is a display screen on the user interface. The embodiment described below is applicable to a mode in which a warm-up period is first started after at least a portion of the sensor 11a is implanted, and then whether to enter a pre-grace period is set. However, since the settings of the sensor related to the warm-up period and the pre-grace period can be combined or matched in various ways, this embodiment is an embodiment of the present invention, which is used to make the reader understand it simply, but the embodiments of the present invention are not limited thereto.

[0046] like Figure 5B As shown, after the user interface 31 is turned on and the matching application (App) is entered, the warm-up period of the sensor 11a has begun, and the words "Device warming up" appear in the display box 141 in the display area 140 of the user interface 14, and "Warm-up completion time" and the scheduled completion time of the warm-up (for example, 10:41 am) appear in the display box 142. At the same time, "Set start monitoring time" and a switch icon 144 (switch icon) for the user to select appear in the option unit 143. When the selection button 145 is located on the left side of the switch icon 144, it means that the user does not intend to set the start monitoring time (indicating that the user chooses to reject the setting and the pre-grace period is 0); if the selection button 145 is moved to the right side in the switch icon 144, as shown in FIG. Fig. 6AAs shown, it means that the user intends to set the start monitoring time (indicating that the user chooses to set the pre-grace period time). At this time, the display box 146 will show the settable start monitoring time range for the user to set, for example, set it to 10:41 tomorrow, and then press the "Save" button in the display box 146 to complete the storage and setting of the start monitoring time. In this way, the start monitoring time is 10:41 the next day, indicating that the set pre-grace period is 24 hours. In addition, during this period (i.e., in the aforementioned step (S41)), the user interface does not display the data during the warm-up period when the one or more processors are activated.

[0047] Alternatively, when the selection button 145 is moved to the right in the switch icon 144, as shown in FIG. Figure 6B As shown, the display box 146 will show the start monitoring time to be set, such as a time point after a period of time from the warm-up period, and then press the "Save" button in the display box to complete the storage and setting of the start monitoring time. Assuming that the start monitoring time is set to 24 hours (after warm-up), the sensor will have a 24-hour grace period, and the start measurement time is 10:41 the next day.

[0048] In other words, if in the step (S41), the user chooses to accept, then the step (S41) further includes the following steps: allowing the user interface to confirm the adjustable duration of the pre-grace period set by the user; and allowing the user interface to display a required time for the pre-grace period, wherein a display form of the required time is an expiration time, a countdown, a countdown, or a combination thereof.

[0049] like Figure 5B , Fig. 6A and Figure 6B The display frame 147 shown in the figure includes one or more function selection buttons (for example, return to home page, log, report, more, next page, return to previous page, etc.), which are adapted to the design of the App for users to use and are not described in detail here.

[0050] like Figure 6C As shown, the user intends to set the start monitoring time (indicating that the user chooses to set the pre-grace period time). At this time, the display frame 146 will appear a selection unit 148, and the selection unit 148 has a vertical sliding selection bar (a horizontal selection bar is also acceptable). The selection bar shows that the user can slide to select the number of hours after the warm-up period ends and the measurement is started. For example, 24 hours after warm-up is selected, and then the "save" button in the display frame 146' is pressed to complete the storage and setting of the start monitoring time. In this way, the pre-grace period set is 24 hours. In addition, during this period (i.e., in the aforementioned step (S41)), the user interface does not display the data during the warm-up period when the one or more processors are activated.

[0051] In addition, if Figure 4A As shown, in another embodiment, the step of providing the user with a warm-up period and the user interface not displaying the data during the warm-up period (S40) is omitted, such as Figure 5A For other pre-grace period settings, please refer to Figures 6A to 6C In another embodiment, providing the user with a warm-up period, and the user interface not displaying the data during the warm-up period (S40) can be performed after step (S41).

[0052] When the sensor 11a (hereinafter referred to as the first sensor 11a) expires, at least a portion of the second sensor 11a' needs to be implanted into the patient (or organism) 500 for continuous monitoring of glucose levels. The pairing and connection between the second sensor 11a' and the user interface 14 are omitted here.

[0053] In order to ensure that the glucose monitoring and warning of the patient (or organism) 500 is not interrupted, when the first sensor 11a is about to expire (for example, at 16:10 tomorrow) (for example, 24 hours ago), the reference Figure 4A and Fig. 7A As shown, the user interface 14 will have an option unit 148. The prompts that appear in the option unit 148 include the monitoring end time of the first sensor 11a, a "send automatic start time" button, and a "do not set" button. If the user intends to set the second sensor 11a' to start monitoring after the second grace period (for example, 24 hours later), then press the "send automatic start time" button in the option unit 148 to complete the storage and setting of the start monitoring time. Figure 4B and Figure 7B As shown, the user interface 14 will have an option unit 148. The prompts that appear in the option unit 148 include the monitoring end time of the first sensor 11a, a "Send Auto Start Time" button, and a "Do Not Set" button, which can be used to pre-set the second pre-grace period of the second sensor 11a'. If the user intends to set the second pre-grace period of the second sensor 11a' so that the monitoring starts after a period of time (for example, 24 hours) after the second warm-up period, then press the "Send Auto Start Time" button in the option unit 148 to complete the storage and setting of the start monitoring time. For example, if the period of time is set to 24 hours (after warm-up), the second sensor 11a' will have a 24-hour second pre-grace period, and the start measurement time will be 16:10 the next day. If the user does not intend to set the second pre-grace period, the "Do Not Set" button in the option unit 148 can be pressed to allow the second sensor to skip the pre-grace period and directly enter the measurement period from the warm-up period. Fig. 7A or Figure 7BThe method for setting the length of the pre-grace period is only one example, and reference may be made to the aforementioned variant implementation manner, so it will not be repeated here.

[0054] Therefore, the reading device of the present invention, wherein at the end or the end of the glucose data display period described in step (S43) executed by the processor, causes the user interface to prompt the user to prepare for the installation of the second sensor, and after the second sensor is installed, provides a second pre-grace period that can be set by the user.

[0055] In addition, at the end of the glucose data display period in the aforementioned step (S43), the user interface is made to display a post-grace period setting option unit (although not shown in the figure, it is understood by those with ordinary knowledge in the same field). When the setting option in the post-grace period setting option unit is selected and accepted by the user, the data continues to be displayed for a period of time when the glucose data display period expires. The post-grace period can be set, for example, to 24 hours or less or 12 hours or less.

[0056] Figure 8 FIG. 1 is a schematic diagram of installing a second sensor on a patient according to an embodiment of the present invention. Figure 8 As shown, the first sensor has been installed on the arm of the patient 500. Before the usage days of the first sensor 11a expire, the user interface prompts the user to prepare for the installation of the second sensor. For example, the second sensor 11a' can be installed on the other arm of the patient. In this way, before the second sensor 11a' can correctly display the data, the first sensor 11a can still display the data, so that the glucose monitoring of the patient 500 is not interrupted.

[0057] Fig. 9 FIG. 1 is a schematic diagram of the time axis of the warm-up period, pre-grace period and display period of a sensor according to an embodiment of the present invention. Fig. 9 As shown, time axis 1 includes a first warm-up period (Tw1), a preset first pre-grace period (Tg1) and a first display period (Td1). Time axis 1-1 and time axis 1-2 are variations of time axis 1, wherein time axis 1-1 is different from time axis 1 in that its pre-grace period is a first pre-grace period (Tg1-1) set by a user, and second time axis 1-2 is different from time axis 1 in that the first pre-grace period (Tg1-1) is executed first and the warm-up period (Tw1) is executed later.

[0058] Fig.10 FIG. 1 is a schematic diagram of a combination of a first sensor time axis and a second sensor time axis according to an embodiment of the present invention. Fig.10As shown, time axis 1 includes the first warm-up period (Tw1) of the first sensor, the preset first pre-grace period (Tg1) and the first display period (Td1), time axis 2 to time axis 4 include the preset second pre-grace period (Tg2) or the second pre-grace period (Tg2-1) set by the user, the second warm-up period (Tw2) of the second sensor, and different forms of the second display period (Td2). Time axis 2 includes the second pre-grace period (Tg2), the second warm-up period (Tw2) and the second display period (Td2) set by the user, wherein the end time of the second warm-up period (Tw2) is the same as the end time of the first display period (Td1) of the first sensor, and the patient's glucose can be monitored uninterruptedly. The difference between time axis 3 and time axis 2 is that the end time of the second warm-up period (Tw2) is later than the end time of the first display period of the first sensor, which may be caused by the user installing the second sensor too late, resulting in interrupted monitoring. The difference between time axis 4 and time axis 2 is that the second pre-grace period (Tg2-1) set by the user is shorter than the second pre-grace period (Tg2) of time axis 2, but the end time of the second warm-up period (Tw2) can be maintained to be the same as the end time of the first display period of the first sensor, so that the patient's glucose can be monitored uninterruptedly. Of course, the order of the second pre-grace period and the second warm-up period of the second sensor can be interchanged without further explanation.

[0059] Fig.11 FIG. 2 is a schematic diagram of a combination of a first sensor time axis and a second sensor time axis according to another embodiment of the present invention. Fig.11As shown, time axis 1 includes a first warm-up period (Tw1) of a first sensor, a preset first pre-grace period (Tg1) and a first display period (Td1), time axis 2 and time axes 5 to 8 include a preset second pre-grace period (Tg2) or a second pre-grace period (Tg2-2) set by a user, a second warm-up period (Tw2) of a second sensor, and different aspects of a second display period (Td2). Time axis 2 includes a second pre-grace period (Tg2), a second warm-up period (Tw2) and a second display period (Td2) set by a user, wherein the end time of the second warm-up period (Tw2) is the same as the end time of the first display period (Td1) of the first sensor, so that the patient's glucose can be monitored uninterruptedly. The difference between time axis 5 and time axis 2 is that the second pre-grace period (Tg2-2) set by the user is shorter than the second pre-grace period (Tg2) of time axis 2, but the end time of the second warm-up period (Tw2) can be maintained to be the same as the end time of the first display period (Td1) of the first sensor, so that the patient's glucose can be monitored uninterruptedly. The difference between time axis 6 and time axis 2 is that the end time of the second warm-up period (Tw2) is later than the end time of the first display period (Td1) of the first sensor, which may be caused by the user installing the second sensor too late, resulting in interrupted monitoring. The difference between time axis 7 and time axis 2 is that the end time of the second warm-up period (Tw2) is earlier than the end time of the first display period (Td1) of the first sensor. The difference between the time axis 7 and the time axis 2 is that the end time of the second warm-up period (Tw2) of the time axis 7 is earlier than the end time of the first display period (Td1) of the first sensor, and is also slightly earlier than the end time of the second warm-up period (Tw2) of the time axis 2. Of course, the order of the second pre-grace period (Tg2) and the second warm-up period (Tw2) of the second sensor can be interchanged without further explanation.

[0060] Fig.12 The flowchart is a step executed by a processor according to an embodiment of the present invention, wherein if the sensor has both a warm-up period and a pre-grace period, the warm-up period is before the pre-grace period. Fig.12 As shown, first, it is determined whether each installed sensor (whether the first sensor or the second sensor) has a preset warm-up period (S121). If not, the user sets the warm-up period (S122) and then starts the warm-up period (S123). If yes, the warm-up period is directly started (S123). After the warm-up period is started, the user interface does not display data (S124) until the warm-up period expires (S125).

[0061] The next step is to set the pre-grace period. First, determine whether the user chooses to set the adjustable length of the pre-grace period (S126): if not, display the data on the user interface (S130); if so, start the pre-grace period (S127), during which the user interface does not display the data (S128), until the pre-grace period expires (S129), then display the data on the user interface (S130).

[0062] According to another embodiment of the present invention, in the process of displaying data (S130) on the user interface, the display time can be accumulated (S130) to remind the user to prepare and install the second sensor after a certain time (i.e., the reminder time point is reached). Therefore, it is determined whether the accumulated display time reaches the reminder time point (S131): if not, the data is continuously displayed (S130); if so, the user is reminded to prepare a new sensor (S132), and the accumulated display time is continued to be determined to determine whether the accumulated display time reaches the service life of the sensor (S133): if not, the accumulated display time is continuously accumulated; if so, the user is provided with the option to extend the display time (S134): if not, the data is stopped from being displayed (S137); if so, the data is continuously displayed (S135), and it is determined whether the display is expired (i.e., the extended display time is reached) (S136): if not, the data is continuously displayed (S135); if so, the data is stopped from being displayed (S137).

[0063] Fig.13 The flowchart is a step executed by a processor according to an embodiment of the present invention, wherein if the sensor has both a warm-up period and a pre-grace period, the warm-up period is after the pre-grace period. Fig.13 As shown, first, the user determines whether the pre-grace period is set for each installed sensor (whether the first sensor or the second sensor) (S126): if not, determine whether the warm-up period has been set (S12), and then start the warm-up period (S123); if so, directly start the warm-up period (S123). After the warm-up period is started, the user interface does not display data (S124) until the warm-up period expires (S125), and then the data is displayed on the user interface (S130).

[0064] Then, similarly, according to another embodiment of the present invention, in the process of displaying data (S130) on the user interface, the display time can be accumulated (S130) to remind the user to prepare and install the second sensor after a certain time (i.e., reaching the reminder time point). Therefore, it is determined whether the accumulated display time reaches the reminder time point (S131): if not, the data is continuously displayed (S130); if so, the user is reminded to prepare a new sensor (S132), and the display time is continuously accumulated to determine whether the accumulated display time reaches the service life of the sensor (S133): if not, the accumulated display time is continuously accumulated; if so, the user is provided with the option of extending the display time (S134): if not, the data is stopped from being displayed (S137); if so, the data is continuously displayed (S135), and it is determined whether the display is expired (i.e., the extended display time is reached) (S136): if not, the data is continuously displayed (S135); if so, the data is stopped from being displayed (S137).

[0065] In addition, if the mean absolute relative difference (MARD) is used to evaluate the difference between the CGM system reading and the reference measurement value, it can be used as an indicator of data accuracy. According to the present invention, during the glucose data display period (i.e., the measurement period), the MARD value of the data displayed by the sensor during its survival period is ≤10%, the preferred MARD value is ≤9%, and the more preferred MARD value is ≤8%. The sensor survival period refers to the time during which the glucose measurement device 10 can operate normally during use during the glucose data display period, that is, the period during which the sensor adheres to the skin and operates effectively.

[0066] Fig.14 The continuous data (curve) displayed on the user interface of a transcutaneous glucose monitoring (CGM) system for monitoring the glucose of a patient according to an embodiment of the present invention and the point data displayed by a traditional glucose monitoring system (Blood Glucose Monitoring, BGM) system. Fig.14 As shown, the horizontal axis is time, and the vertical axis is glucose concentration. The data measured by the transcutaneous glucose monitoring system of the present invention represented by a curve can continuously and regularly present the patient's glucose concentration at each time point, and issue an alarm when an abnormality occurs; while the traditional glucose monitoring system can only rely on the patient or caregiver to measure the glucose concentration each time after sampling the patient's blood. During the period between two samplings, it is impossible to timely know that the glucose concentration is abnormal. Taking the first sensor as an example, during the life period Tlife of the first sensor, at least 95% of the data will be within 25% of the glucose reference value, such as Fig.14As shown, better accuracy can be maintained during the glucose data display period. In addition, the left side of the displayed data is the pre-grace period Tg1, for example, which is preset to 24 hours (i.e., 1.44 thousand minutes), the middle is the data display period Td1, for example, 15 days (i.e., 21.6 thousand minutes), and the reserved period Tspare on the right can be used for the post-grace period. In practice, the post-grace period will not occupy the entire reserved period Tspare. In this way, the pre-grace period Tg1 can be set by the user to be greater than 24 hours, which means that the user can have greater flexibility in setting the pre-grace period Tg1.

[0067] In a glucose monitoring system according to an embodiment of the present invention, the processor does not display the data indicating the glucose level within a pre-grace period, and the pre-grace period can be preset as 1 day.

[0068] After at least a portion of the sensor of the present invention is implanted subcutaneously, a warm-up period can be set. The warm-up period depends on the individual's physical condition and can be preset or set by the user to 1 hour to 3 days. During the warm-up period, the reading of the measurement data is not displayed.

[0069] The measurement data is pre-calibrated by the factory or by the reference instrument and then displayed. When the warm-up period is over or the grace period is over (whichever is later), the measurement period starts and the data is displayed, and the usage days start to be counted until the preset usage days expire.

[0070] According to an embodiment of the present invention, when the sensor is in the warm-up period and / or pre-grace period, the user can be notified on the user interface, and the measurement data is not displayed. In addition, the actual number of days of effective measurement and display data is consistent with the product's claimed usage days.

[0071] According to an embodiment of the present invention, the data used to calibrate the second sensor does not come from the data of the first sensor.

[0072] According to an embodiment of the present invention, the glucose measuring device 10 applies a pulse voltage to the sensor 11a during the pre-grace period to accelerate the sensor 11a to reach optimization, so as to ensure that the user can obtain the best sensor data output performance during use.

[0073] According to one embodiment of the present invention, the reading device 14 provides automatic detection of the best time, built-in fixed time or setting according to the user's lifestyle in the pre-grace period option unit to output the pre-grace period time for the user to confirm. The pre-grace period is set according to the user's behavior pattern, and the system can automatically set the pre-grace period by analyzing the user's lifestyle. For example, if the system finds that the user usually performs a specific activity within a specific time period, a longer pre-grace period can be set in the time period, or if it is detected that the user is in a highly active state, the pre-grace period can be automatically extended or shortened to ensure that the user has enough time to complete the pre-grace period.

[0074] According to an embodiment of the present invention, a method for displaying data indicating the glucose level in the biological fluid on a user interface of a reading device, at least a portion of the sensor has a first stable measurement period after being implanted in a first biological body, and at least a portion of the sensor has a second stable measurement period after being implanted in a second biological body, and there is a difference between the first and second stable measurement periods, the method comprises the following steps (a) and / or (c), or includes steps (a) to (d):

[0075] (a) providing a user with the ability to set or reject a pre-grace period on the user interface, the pre-grace period being set to have an adjustable duration to accommodate the difference;

[0076] (b) not causing the user interface to display the data during the pre-grace period;

[0077] (c) when the pre-grace period expires, causing the user interface to display the data during the first stable measurement period, wherein the duration of the first stable measurement period is equal to the predetermined usage duration; and

[0078] (d) When the first stable measurement period expires, causing the user interface to stop displaying the data.

[0079] As in the aforementioned method, the user interface is at least configured to display the option unit for the user to reject, or accept and set the adjustable time length.

[0080] As in the aforementioned method, the adjustable duration can be selected from a plurality of preset fixed durations or set from a user-defined duration.

[0081] As in the aforementioned method, the adjustable duration of the pre-grace period is within a range from half a day to one day.

[0082] As in the aforementioned method, the adjustable time length is within a range of no more than 1 day, no more than 2 days, no more than 3 days or no more than 5 days.

[0083] As in the aforementioned method, wherein the adjustable time length is at least 20 minutes.

[0084] As in the aforementioned method, the setting of the adjustable duration of the pre-grace period is determined based on an implantation reaction of the organism to the sensor, a sensor lifespan, the predetermined usage duration, a function of at least one sensor system parameter, or a combination thereof.

[0085] As in the aforementioned method, the difference in the organism's response to sensor implantation is caused by a biological and immunological response of the organism's body to the sensor after the organism contacts the sensor, including a difference in a physiological environment change, a sensor electrode passivation, or a sensor cell fibrosis wrapping.

[0086] As in the aforementioned method, if the user chooses to reject in the step (a), the one or more processors initiate a warm-up period for the sensor, and the user interface does not display the data during the warm-up period.

[0087] As the aforementioned method, before the step (a), the following step is also included: providing the user with an option unit for setting a warm-up period and the user interface does not display the data during the warm-up period.

[0088] As in the aforementioned method, at the end or the end of the glucose data display period in step (c), the user interface prompts the user to prepare for the installation of a second sensor, and after the second sensor is installed, provides a second pre-grace period that can be set by the user.

[0089] As in the method described above, at the end or the end of the glucose data display period in step (c), the user interface displays a post-grace period setting option unit. When the setting option of the post-grace period setting option unit is selected and set by the user, the data continues to be displayed for a period of time when the glucose data display period expires.

[0090] As in the aforementioned method, the signal output by the sensor is a glucose measurement signal, and the data is a glucose reading converted from the glucose measurement signal.

[0091] As in the aforementioned method, if the user chooses to accept in step (a), then step (a) also includes the following steps: allowing the user interface to confirm the adjustable duration of the pre-grace period set by the user; and allowing the user interface to display a required time for the pre-grace period, wherein a display form of the required time is an expiration time, a countdown, a countdown, or a combination thereof.

[0092] As in the method described above, during the glucose data display period, the data displayed is within a 10% range of a mean absolute relative difference (MARD) of a data set formed by the data over a life span of the sensor.

[0093] In summary, the present invention has the following effects: (1) Providing the option of setting the pre-grace period allows the user to adapt according to the different responses of different organisms to the sensor implantation, thereby improving the applicability and effectiveness of the monitoring system and achieving better monitoring results: the customized pre-grace period can better reflect the adaptation of the sensor in the organism. This can ensure that the monitoring results are more accurate and reliable. (2) The current sensor claims a service life of a specific number of days (e.g., 15 days), but it is usually difficult to provide accurate measurement readings during the first hour to 3 days after installation. Therefore, the actual service life that users can enjoy is obviously insufficient, resulting in the sacrifice of user rights. Through the present invention, effective measurement data can be provided throughout the measurement period, and the product can meet the claimed service life to protect the user's rights. (3) Before the first sensor expires, the patient / user can be reminded to implant the second sensor in time, so that the patient / user's glucose level monitoring will not be interrupted, and thus any abnormality will not be missed. (4) The calibration data of the second sensor does not use the data from the first sensor to calibrate the second sensor, so there is no need for the patient / user to perform complex operations. These effects are unpredictable or unachievable with conventional technology.

[0094] Although the present invention has been described according to what are currently considered to be the most practical and preferred embodiments, it should be understood that the present invention is not limited to the disclosed embodiments. On the contrary, it is intended to cover various modifications and similar configurations included in the spirit and scope of the appended claims, which should be consistent with the broadest interpretation to cover all such modifications and similar structures.

[0095]

Explanation of symbols

[0096] 1Transcutaneous Glucose Monitoring System

[0097] 2 Subcutaneous tissue

[0098] 3 Blood vessels

[0099] 4 Glucose

[0100] 5Biological fluids

[0101] 6 Skins

[0102] 10Glucose measuring device

[0103] 11Sensor module

[0104] 11a Sensor (first sensor)

[0105] 11a' Second sensor

[0106] 12 Transmitters

[0107] 13 Implant

[0108] 14Reading device

[0109] 15. Charger

[0110] 31User Interface

[0111] 32 communication modules

[0112] 33 Memory

[0113] 34 processors

[0114] 140 display area

[0115] 141~142、146~147 display frame

[0116] 143, 148, 149 option units

[0117] 144 switch icon

[0118] 145 selection button

[0119] 500 patients (or organisms)

[0120] Steps S40 to S44, S121 to S137

[0121] Td1, Td2 display period

[0122] Tg1, Tg1-1, Tg2, Tg2-1, Tg2-2 pre-grace period

[0123] Tlife survival period

[0124] Tspare reservation period

[0125] Tw1, Tw2 warm-up period

Claims

1. A transcutaneous glucose monitoring system, comprising: Glucose measuring device, comprising: A sensor having a predetermined usage time defined by a factory, wherein at least a portion of the sensor is implanted subcutaneously in a living body and in contact with a biological fluid, and is used to output a signal or data indicating a glucose level in the biological fluid; and A reading device configured to receive and display the data or convert the signal into the data, and provide a user with a pre-grace period to set in response to the difference in the reaction of different organisms to the implantation of the sensor, wherein the reading device comprises: one or more processors; a wireless communication module configured to be coupled to the one or more processors and to wirelessly receive the signal or the data from the sensor; a memory configured to be coupled to the one or more processors and to store instructions; and A user interface configured to be coupled to the one or more processors and to allow the user to set the pre-grace period and display the data, wherein: The one or more processors are configured according to the instructions to perform the following steps: (a) providing the pre-grace period that can be set by the user in an option unit of the user interface, wherein the pre-grace period is configured to be set to have an adjustable duration that can be adapted to the differences in the responses of different living organisms to the sensor implantation; (b) not causing the user interface to display the data during the pre-grace period; (c) when the pre-grace period expires, starting a glucose data display period to display the data, and the duration of the glucose data display period is equal to the predetermined usage time; and (d) When the glucose data display period expires, causing the user interface to stop displaying the data.

2. The transcutaneous glucose monitoring system of claim 1, wherein the user interface is configured to at least display the option unit for the user to reject, or accept and set the adjustable time period.

3. The transcutaneous glucose monitoring system of claim 2, wherein the adjustable time period can be selected from a plurality of preset fixed time periods or set from a user-defined time period.

4. The transcutaneous glucose monitoring system of claim 1, wherein the adjustable duration of the pre-grace period is in the range of half a day to one day.

5. The transcutaneous glucose monitoring system of claim 1, wherein the adjustable time period is within the range of no more than 1 day, no more than 2 days, no more than 3 days or no more than 5 days.

6. The transcutaneous glucose monitoring system of claim 1, wherein the adjustable time period is at least 20 minutes.

7. A transcutaneous glucose monitoring system as described in claim 1, wherein the setting of the adjustable time length of the pre-grace period is determined based on the biological body's response to the implantation of the sensor, the sensor life, the predetermined usage time, a function of at least a sensor system parameter, or a combination thereof.

8. The transcutaneous glucose monitoring system of claim 1, wherein the difference in the organism's response to sensor implantation is caused by the biological and immunological response of the organism's body to the sensor after the organism contacts the sensor, including differences in physiological environment changes, sensor electrode passivation, or sensor cell fibrosis wrapping.

9. The transcutaneous glucose monitoring system of claim 1, wherein if the user chooses to reject in step (a), the one or more processors initiate a warm-up period for the sensor, and the user interface does not display the data during the warm-up period.

10. The transcutaneous glucose monitoring system of claim 1, further comprising the following step before step (a): providing the user with an option unit for setting a warm-up period and the user interface does not display the data during the warm-up period.

11. The transcutaneous glucose monitoring system of claim 1 , wherein at the end or the end of the glucose data display period in step (c), the user interface prompts the user to prepare for the installation of a second sensor, and after the second sensor is installed, provides a second pre-grace period that can be set by the user.

12. The transcutaneous glucose monitoring system of claim 1 , wherein at the end or the end of the glucose data display period in step (c), the user interface displays a post-grace period setting option unit, and when the setting option of the post-grace period setting option unit is selected and set by the user, the data continues to be displayed for a period of time when the glucose data display period expires.

13. The transcutaneous glucose monitoring system of claim 1, wherein the signal output by the sensor is a glucose measurement signal, and the data is a glucose reading converted from the glucose measurement signal.

14. A transcutaneous glucose monitoring system as described in claim 1, wherein if the user chooses to accept in the step (a), the step (a) further includes the following steps: allowing the user interface to confirm the adjustable duration of the pre-grace period set by the user; and allowing the user interface to display the required time of the pre-grace period, wherein the required time is displayed in the form of an expiration time, a countdown, a countdown, or a combination thereof.

15. The transcutaneous glucose monitoring system of claim 1, wherein during the glucose data display period, the data displayed is within 10% of the mean absolute relative difference (MARD) of the data set formed by the data over the life of the sensor.

16. A transcutaneous glucose monitoring system comprising: A glucose measuring device, comprising a sensor, wherein the sensor has a predetermined usage time defined by a factory, and the sensor is implanted subcutaneously in a living body to contact a biological fluid, and is used to output a signal or data indicating a glucose level in the biological fluid; as well as A reading device configured to receive and display the data or convert the signal into the data, and provide a user with a pre-grace period to set in response to the difference in the reaction of different organisms to the implantation of the sensor, wherein the reading device comprises: one or more processors; a wireless communication module configured to be coupled to the one or more processors and to wirelessly receive the signal or the data from the sensor; a memory configured to be coupled to the one or more processors and to store instructions; and A user interface configured to be coupled to the one or more processors and to allow the user to set the pre-grace period and display the data, wherein: The one or more processors are configured to provide the pre-grace period that can be set by the user on the user interface according to the instructions, and the pre-grace period is configured to be set to have an adjustable duration that can cope with the differences in the responses of different organisms to the sensor implantation.

17. A transcutaneous glucose monitoring system comprising: A glucose measuring device, comprising a sensor, wherein the sensor has a predetermined usage time defined by a factory, and the sensor is implanted subcutaneously in a living body to contact a biological fluid, and is used to output a signal or data indicating a glucose level in the biological fluid; as well as A reading device configured to receive and display the data or convert the signal into the data, and provide a user with a pre-grace period to set in response to the difference in the reaction of different organisms to the implantation of the sensor, wherein the reading device comprises: one or more processors; a wireless communication module configured to be coupled to the one or more processors and to wirelessly receive the signal or the data from the sensor; a memory configured to be coupled to the one or more processors and to store instructions; and A user interface configured to be coupled to the one or more processors and to allow the user to set the pre-grace period and display the data, wherein: The one or more processors are configured according to the instructions to: when the pre-grace period expires, start a glucose data display period to display the data, and the duration of the glucose data display period is equal to the predetermined usage time.

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