A method for calculating the calibration sensitivity of a body-internal sensor.

Abstract

To accurately calculate the calibration sensitivity of a sensor for insertion into the body. [Solution] The present invention relates to a calibration sensitivity calculation method that stores past sensitivities and calculates the calibration sensitivity of a body-insertable sensor using at least one past sensitivities and a currently calculated sensitivity, thereby overcoming errors in biometric values ​​measured via a body-insertable sensor or errors in reference biometric values ​​measured via a biometric information measuring device, and accurately calibrating a user's biometric values. The present invention also relates to a calibration sensitivity calculation method that can accurately calculate the calibration sensitivity of a body-insertable sensor even if there is an error in the reference biometric value or the reference biometric value temporarily deviates from the user's normal biometric value range by determining whether the reference biometric value used in calculating the calibration sensitivity is within an acceptable range.

Description

[Technical Field]

[0001] The present invention relates to a method for calculating the calibration sensitivity of a body-insertable sensor, and more specifically, to a method for calculating the calibration sensitivity of a body-insertable sensor using at least one past sensitivity and a currently calculated sensitivity, thereby overcoming errors in a body-insertable sensor's measured biometric value or errors in a reference body-insertable sensor's measured biometric value, and accurately calibrating a user's biometric value. The present invention also relates to a method for calculating the calibration sensitivity of a body-insertable sensor, and more particularly, to a method for calculating the calibration sensitivity of a body-insertable sensor's measured biometric value by overcoming errors in a body-insertable sensor's measured biometric value or errors in a reference body-insertable sensor's measured biometric value, by determining whether the reference body-insertable sensor's measured biometric value is within an allowable range. [Background technology]

[0002] Diabetes is a chronic disease that commonly affects people today, affecting over 2 million people in Japan, or 5% of the total population.

[0003] Diabetes develops when there is an absolute or relative deficiency of insulin produced by the pancreas due to various causes such as obesity, stress, poor eating habits, and congenital genetics, which prevents the balance of sugar in the blood from being corrected, resulting in an absolute excess of sugar in the blood.

[0004] Blood normally contains a certain concentration of glucose, from which tissue cells obtain energy.

[0005] However, if glucose levels increase more than necessary, they are not properly stored in the liver, muscles, or fat cells, and instead accumulate in the blood. This causes diabetics to maintain blood sugar levels much higher than normal people, and the excess blood sugar passes through the tissues and is excreted in the urine, resulting in a shortage of sugar, which is absolutely necessary for each tissue in the body, and causing abnormalities in each tissue.

[0006] Diabetes is characterized by having almost no noticeable symptoms in the early stages, but as the disease progresses, symptoms specific to diabetes such as excessive drinking, eating, urination, weight loss, general fatigue, itchy skin, and persistent or prolonged wounds on the hands and feet appear.As the disease progresses further, complications appear, including vision impairment, high blood pressure, kidney disease, stroke, periodontal disease, muscle spasms and neuralgia, and gangrene.

[0007] In order to diagnose this type of diabetes and manage it so that it does not progress to complications, systematic blood glucose measurement and treatment must be carried out in parallel.

[0008] Diabetes requires regular blood glucose monitoring for management, and the demand for blood glucose monitoring devices is steadily increasing. Various studies have confirmed that when diabetic patients strictly control their blood glucose levels, the occurrence of diabetic complications is significantly reduced. Therefore, it is very important for diabetic patients to regularly monitor their blood glucose levels for blood glucose control.

[0009] The finger prick method is commonly used to monitor blood glucose levels in diabetic patients. However, while this method is useful for diabetic patients, it only displays the results at the time of measurement, making it difficult to accurately grasp blood glucose levels, which fluctuate frequently. Furthermore, blood sampling methods require blood sampling every time blood glucose levels are measured frequently throughout the day, placing a significant burden on diabetic patients.

[0010] Diabetics generally experience alternating hyperglycemia and hypoglycemia symptoms, but emergency situations occur during hypoglycemia. Hypoglycemia occurs when sugar levels are not maintained for a long period of time, and can lead to loss of consciousness or, in the worst case, death. Therefore, it is extremely important for diabetics to detect hypoglycemia symptoms promptly. However, blood sampling-type vital signs monitors, which measure blood glucose levels intermittently, have clear limitations.

[0011] To overcome the limitations of blood sampling-type vital signs measuring devices, a continuous glucose monitoring system (CGMS) has been developed that is inserted into the human body and measures blood glucose levels every few minutes, making it easy to manage diabetic patients and respond to emergency situations.

[0012] A continuous blood glucose monitoring system comprises a sensor transmitter that is attached to a user's body to extract body fluids and generate biometric information, and a communication terminal that calculates and outputs biometric values ​​from the transmitted biometric information. The sensor transmitter is equipped with a continuous blood glucose measurement sensor that is partially inserted into the human body, and the sensor extracts the user's body fluids while inserted for a certain period of time, for example, about 15 days. The sensor transmitter periodically generates biometric information from the extracted body fluids, and the communication terminal is equipped with a blood glucose management application that periodically receives biometric information from the sensor transmitter, calibrates the received biometric information, and outputs it to the user.

[0013] The sensor of the sensor transmitter is continuously inserted into the skin for a certain period of use, but the sensor sensitivity varies depending on the body part where the sensor is inserted, and the sensitivity of the sensor inserted into the skin changes over time even if the sensor insertion position on the body part is the same. Therefore, the biometric information generated by the sensor transmitter has errors, and it is necessary to calibrate the user's biometric value by applying a calibration sensitivity to the generated biometric information.

[0014] In order to provide accurate biometric values ​​to a user, the biometric information received from the sensor transmitter must be initially calibrated, and then continuously calibrated at regular calibration intervals during the use of the sensor transmitter. More specifically, during the initial calibration, a reference biometric value measured via a separate biometric information measuring device is input to the communication terminal to calibrate the biometric information received from the sensor transmitter to the reference biometric value, and then the biometric information received from the sensor transmitter must be continuously calibrated to the reference biometric value measured via the biometric information measuring device at regular calibration intervals during the use of the sensor transmitter.

[0015] Calibration sensitivity is calculated to calibrate the biological information measured by a sensor transmitter. Conventional calibration sensitivity is calculated from the ratio of the biological information measured by the sensor transmitter to the reference biological value measured by a biological information measuring device. For example, if the biological information measured by the sensor transmitter at a first time point is 5 and the reference biological value measured by the biological information measuring device via a test strip is 100, the calibration sensitivity is calculated as 0.05 (5 / 100). Biological information measured by the sensor transmitter after the first time point is calibrated using the calibration sensitivity.

[0016] Since a biological information meter or test strip has its own tolerance, the biological information measured by the sensor transmitter also has a certain error. Therefore, the calibration sensitivity calculated from the reference biological value and the biological information also has an error due to an error in the reference biological value measured by the blood glucose meter or an error in the biological information measured by the sensor transmitter. The error in the calibration sensitivity causes a large error in the calibrated biological value, which makes it difficult to accurately monitor the user's biological value. Summary of the Invention [Problem to be solved by the invention]

[0017] The present invention is intended to solve the problems of the conventional method for calculating the calibration sensitivity of a sensor to be inserted into the body described above, and an object of the present invention is to provide a method for calculating the calibration sensitivity of a sensor to be inserted into the body, which can store past sensitivity information and accurately calculate the calibration sensitivity of the sensor to be inserted into the body using the past sensitivity information and the currently calculated sensitivity.

[0018] Another object of the present invention is to provide a method for calculating calibration sensitivity that can determine whether a reference biological value used when calculating calibration sensitivity is within an acceptable range and accurately calculate the calibration sensitivity of a sensor to be inserted into the body using the reference biological value within the acceptable range. [Means for solving the problem]

[0019] In order to achieve the object of the present invention, a method for calculating the sensitivity of a body-insertable sensor according to the present invention includes the steps of acquiring a first reference biometric value indicating a user's biometric condition at a first time point, and calculating a first sensitivity from a ratio of the biometric information measured using the body-insertable sensor at the first time point to the first reference biometric value; extracting previously stored past sensitivity information used before the first time point; and calculating a calibration sensitivity for calibrating biometric information measured via the body-insertable sensor after the first time point from the first sensitivity and the past sensitivity information.

[0020] Here, the past sensitivity information is at least one calibration sensitivity used before the first time point or at least one sensitivity calculated before the first time point.

[0021] Here, the past sensitivity information is at least one calibration sensitivity that was used consecutively immediately before the first time point or at least one sensitivity that was calculated immediately before the first time point.

[0022] Here, the past sensitivity information is at least one calibration sensitivity randomly selected from among calibration sensitivity values ​​used during a past set period based on a first time point, or at least one sensitivity randomly selected from among sensitivity values ​​calculated during a past set period based on a first time point.

[0023] Preferably, the step of calculating the first sensitivity includes the steps of obtaining a first reference biometric value of the user indicating the user's biometric condition at a first time point via a test strip, determining biometric information measured at the first time point via a body-insertable sensor, and calculating the first sensitivity from the ratio of the biometric information to the first reference biometric value.

[0024] Here, a difference between the user's biometric value calculated from the biometric information and the first reference biometric value is calculated using the previous calibration sensitivity, and if the difference exceeds a critical range, the acquired first reference biometric value is deleted.

[0025] Preferably, in the step of acquiring the first reference biometric value, the calibration mode is selected from the first calibration mode and the second calibration mode based on whether the difference between the user's biometric value calculated from the biometric information using the past calibration sensitivity and the first reference biometric value exceeds a critical range.

[0026] Here, if the difference value is within the critical range, a first calibration mode is selected, and one reference biometric value measured at a first time point through the test strip in the first calibration mode is obtained as a first reference biometric value.

[0027] Here, if the difference value exceeds the critical range, a second calibration mode is selected, and in the second calibration mode, at least one additional reference biometric value is continuously acquired after the first time point through the test strip, and a first reference biometric value is acquired from the average value of the reference biometric value acquired at the first time point and the additional reference biometric value.

[0028] Here, the calibration sensitivity is calculated as the average value of the first sensitivity and the past sensitivity information.

[0029] Here, when a new reference vital sign value is acquired after the first time point, the first sensitivity is stored, and then the calibration sensitivity is newly calculated using the first sensitivity as the past sensitivity.

[0030] Preferably, the method further includes a step of determining whether a set calibration period will arrive after the first time point, and outputting a request message requesting input of a new reference biometric value if the set calibration period arrives, and if a new reference biometric value is acquired in response to the request message, storing the first sensitivity and then newly calculating the calibration sensitivity using the first sensitivity as a past sensitivity. [Effects of the Invention]

[0031] The method for calculating the sensitivity of a sensor to be inserted into the body according to the present invention has the following advantages.

[0032] The sensitivity calculation method for a body-insertable sensor according to the present invention stores past sensitivity information and calculates the calibration sensitivity of the body-insertable sensor using at least one past sensitivity information and the currently calculated sensitivity, thereby overcoming errors in the biometric information measured through the body-insertable sensor or errors in the reference biometric values ​​measured through a biometric information measuring device and accurately calibrating the user's biometric values.

[0033] In addition, the method for calculating the sensitivity of a body-insertable sensor according to the present invention determines whether the reference biometric value used in calculating the calibration sensitivity is within an acceptable range, so that the calibration sensitivity of the body-insertable sensor can be accurately calculated even if the reference biometric value contains an error or if the reference biometric value temporarily deviates from the user's normal biometric value range. [Brief explanation of the drawings]

[0034] [Figure 1] 1 is a schematic diagram illustrating a continuous blood glucose monitoring system according to one embodiment of the present invention. [Figure 2] FIG. 10 is a diagram for explaining an example of input of initial calibration information or periodic calibration information. [Figure 3] 1 is a functional block diagram for explaining a sensitivity calculation device for a body-insertable sensor according to the present invention; [Figure 4] FIG. 2 is a functional block diagram for explaining an example of a reference vital sign value acquiring unit according to the present invention. [Figure 5]1 is a flowchart illustrating a method for calculating the calibration sensitivity of a body-insertable sensor according to the present invention. [Figure 6] 10 shows an example of information about sensitivity stored in the storage unit. [Figure 7] 10 is a flowchart illustrating a pre-processing process of biometric information. [Figure 8] 1 is a flowchart illustrating an embodiment of a method for obtaining a first reference vital sign value in the present invention. [Figure 9] FIG. 10 is a diagram for explaining the time point at which a calibration sensitivity is generated. [Figure 10] 10 illustrates an example of a user interface screen displayed on a user terminal for selecting a calibration mode according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0035] It should be noted that the technical terms used in the present invention are merely used to describe specific embodiments and are not intended to limit the present invention. Furthermore, unless otherwise defined in the present invention, the technical terms used in the present invention should be interpreted as meanings commonly understood by a person of ordinary skill in the art to which the present invention belongs, and should not be interpreted in an overly comprehensive or overly narrow sense. Furthermore, when the technical terms used in the present invention are incorrect technical terms that cannot accurately express the idea of ​​the present invention, they should be replaced with technical terms that can be correctly understood by a person skilled in the art.

[0036] Furthermore, singular expressions used in the present invention include plural expressions unless the context clearly indicates otherwise. In the present invention, terms such as "comprise" or "include" should not be interpreted as including all of the components or steps described in the present invention, and should be interpreted as meaning that some of the components or steps may not be included, or that additional components or steps may be further included.

[0037] It should also be noted that the accompanying drawings are intended to facilitate understanding of the concept of the present invention, and should not be construed as limiting the concept of the present invention.

[0038] FIG. 1 is a schematic diagram illustrating a continuous blood glucose monitoring system according to one embodiment of the present invention.

[0039] Referring to FIG. 1, a continuous blood glucose monitoring system 1 according to one embodiment of the present invention includes a sensor transmitter 10 and a communication terminal 30.

[0040] The sensor transmitter 10 is attached to the body, and when the sensor transmitter 10 is attached to the body, one end of the sensor of the sensor transmitter 10 is inserted into the skin and periodically extracts body fluids from the human body to measure blood glucose information.

[0041] The communication terminal 30 is a terminal that can receive blood glucose information from the sensor transmitter 10 and display to the user the blood glucose level generated by calibrating the received blood glucose information, and can be a terminal that can communicate with the sensor transmitter 10, such as a smartphone, tablet PC, or laptop. Of course, the communication terminal 30 is not limited to these, and can be any type of terminal that has a communication function and can install programs and applications.

[0042] The sensor transmitter 10 transmits the measured blood glucose information to the communication terminal 30 in response to a request from the communication terminal 30 or periodically at set time intervals. For data communication between the sensor transmitter 10 and the communication terminal 30, the sensor transmitter 10 and the communication terminal 30 may be connected to each other by a wired connection such as a USB cable, or may be connected to each other by a wireless communication method such as infrared communication, NFC communication, or Bluetooth (registered trademark).

[0043] More specifically, when communication is established between the sensor transmitter 10 and the communication terminal 30, an initial calibration sensitivity is calculated using a reference blood glucose level measured by a separate biological information measuring device (not shown) after the sensor transmitter 10 has stabilized, and initial calibration of the blood glucose information is performed using the initial calibration sensitivity. Thereafter, the communication terminal 30 calibrates the blood glucose information received from the sensor transmitter 10 to the initial calibration sensitivity and outputs the calibrated blood glucose value to the user.

[0044] In order to accurately calibrate the blood glucose information measured by the sensor transmitter 10, the communication terminal 30 calculates a new calibration sensitivity using a reference blood glucose level measured periodically through another vital sign measuring device during the use of the sensor transmitter 10, calibrates the blood glucose information received from the sensor transmitter using the new calibration sensitivity, calculates the blood glucose level, and outputs the calculated blood glucose level to the user.

[0045] 2 is a diagram illustrating an example of inputting initial calibration information or periodic calibration information, where the calibration information is a user's reference blood glucose level measured with a test strip via a vital sign measuring device. Referring to FIG. 2, the sensor transmitter is stabilized until a set stabilization time TS has elapsed from the time T0 when the sensor transmitter and the communication terminal are communicatively connected.

[0046] Once the sensor transmitter has stabilized, initial calibration information I0 is input to the communication terminal. The initial calibration information I0 can be input multiple times to accurately calibrate the calibration sensitivity. The communication terminal calculates the initial calibration sensitivity using the initial calibration information and the blood glucose information measured by the sensor transmitter, and then calibrates the blood glucose information received from the sensor transmitter using the initial calibration sensitivity to calculate the user's blood glucose level.

[0047] After the sensor transmitter has stabilized, new calibration information I1, I2, I3, I4... is input to the communication terminal periodically, preferably every 12 hours, every day, etc., until the expiration time TE of the sensor transmitter's usage period. Each time new calibration information is input, the communication terminal calculates a new calibration sensitivity to be used to calibrate the blood glucose information received by the sensor transmitter from the time the new calibration information is input, and uses the new calibration sensitivity to calibrate the blood glucose information received from the sensor transmitter and calculate the user's blood glucose level.

[0048] Depending on the field to which the present invention is applied, blood glucose information is an example of biometric information, a blood glucose value calculated from the blood glucose information is an example of a biometric value, and a reference blood glucose value used to calculate the calibration sensitivity is an example of a reference biometric value.

[0049] FIG. 3 is a functional block diagram for explaining the sensitivity calculation device for a body-insertable sensor according to the present invention.

[0050] Here, the sensitivity calculation device can be implemented in a communication terminal, but can also be implemented in a sensor transmitter depending on the field to which the present invention is applied.

[0051] More specifically, with reference to FIG. 3, the acquisition unit 110 acquires a first reference biometric value from reference biometric values ​​measured via a biometric information measuring device at a user's request, either at a set calibration interval or regardless of the calibration interval.

[0052] Meanwhile, the biometric information acquisition unit 130 continuously receives biometric information from the sensor transmitter.

[0053] When a first reference biometric value is acquired, the sensitivity calculation unit 150 calculates a first sensitivity from the biometric information received from the sensor transmitter and the first reference biometric value, and calculates a calibration sensitivity used to calibrate the biometric information from the first sensitivity and at least one piece of past sensitivity information stored in the storage unit 170. Every time the sensitivity calculation unit 150 calculates a new calibration sensitivity, the sensitivity calculation unit 150 stores and manages the new sensitivity, the new calibration sensitivity, and information about the time when the new calibration sensitivity was calculated in the storage unit 170.

[0054] The calibration unit 190 determines whether a new calibration sensitivity is to be newly stored in the storage unit 170, and if a new calibration sensitivity is to be newly stored, calibrates and calculates a biometric value of the biometric information received from the sensor transmitter using the new calibration sensitivity, and outputs information about the calculated biometric value to a user through an output unit (not shown) such as a display or speaker.

[0055] Preferably, the reference biometric value acquiring unit 110 calculates a difference between a measured biometric value calculated using a previous calibration sensitivity from biometric information measured by a sensor transmitter and a reference biometric value measured at the same time by a biometric information measuring device, and acquires a first reference biometric value differently depending on whether the difference between the measured biometric value and the reference biometric value exceeds a critical range.

[0056] FIG. 4 is a functional block diagram for explaining an example of a reference vital sign value acquiring unit according to the present invention.

[0057] To explain this more specifically with reference to FIG. 4, the cycle determination unit 111 determines whether or not a set calibration cycle has arrived.

[0058] When a set calibration period arrives, the acquiring unit 113 acquires a reference biometric value from the biometric information measuring device. Preferably, when the calibration period arrives, the acquiring unit 113 generates a request message requesting input of a reference biometric value at a first time point when the calibration period arrives and outputs the request message to the output unit. The acquiring unit 113 can be input directly by a user via a user interface unit or can receive the reference biometric value from the biometric information measuring device via wireless or wired communication.

[0059] The difference value calculation unit 115 calculates a difference value between a measured biometric value calculated from biometric information measured by the sensor transmitter at the first time point using the calibration sensitivity used up to the first time point and a reference biometric value at the first time point. The mode determination unit 117 determines a mode for acquiring the first reference biometric value based on whether the difference value is within a critical range. The mode determination unit 117 determines the first mode if the difference value is within the critical range, and determines the second mode if the difference value exceeds the critical range. Here, the critical range may be a person's normal blood glucose range or a blood glucose range between the maximum and minimum blood glucose levels that a person can have.

[0060] The reference vital value calculation unit 119 calculates the first reference vital value according to the mode determined by the mode determination unit 117. In the first mode, the reference vital value calculation unit 119 determines the reference vital value at the first time point as the first reference vital value. However, in the second mode, the reference vital value calculation unit 119 acquires at least one additional reference vital value continuously from the vital information measurement device after the first time point through the acquisition unit 113, and calculates the first reference vital value as the average value of the reference vital value acquired at the first time point and the additional reference vital value.

[0061] FIG. 5 is a flowchart illustrating a method for calculating the calibration sensitivity of a body-insertable sensor according to the present invention.

[0062] More specifically, referring to FIG. 5, a first reference vital sign value representing a vital sign value of a user at a first time point is obtained using a vital sign measuring device (S110).

[0063] A first sensitivity is calculated from a ratio of the biological information measured by the sensor transmitter at a time point corresponding to the first time point to the first reference biological value (S130).

[0064] At least one previously stored piece of sensitivity information used before the first time point is extracted, and a calibration sensitivity is calculated from the first sensitivity and the extracted past sensitivity information to be applied to the biometric information measured by the sensor transmitter after the first time point to calibrate the user's biometric value (S150).

[0065] FIG. 6 shows an example of past sensitivity information stored in the storage unit. As shown in FIG. 6, information about the sensitivity, the calibrated sensitivity, and the time when the sensitivity or the calibrated sensitivity was generated is stored.

[0066] Here, the past sensitivity information is at least one calibration sensitivity or sensitivity used before a first point in time corresponding to a new calibration cycle, for example, a calibration cycle point after 9:13 AM on March 2, 2020. Preferably, the past sensitivity information according to one embodiment is a set number of calibration sensitivity or sensitivity values ​​used consecutively immediately before the first point in time. For example, if the set number is 2, the first and second calibration sensitivity values ​​used consecutively before the first point in time can be used as the past sensitivity information.

[0067] Preferably, in another embodiment, the past sensitivity information is a set number of sensitivities or calibration sensitivities randomly selected from among the sensitivities or calibration sensitivities used during a set period of time in the past based on the first point in time. For example, if the set number is 2 and the set period of time in the past is five calibration periods, two sensitivities randomly selected from the first through fifth sensitivities used consecutively before the first point in time can be used as the past sensitivity information.

[0068] Referring again to FIG. 5, after the first time point, until the next calibration period arrives or until a new reference biometric value is input by the user, calibration sensitivity is applied to the biometric information measured by the sensor transmitter to calibrate the biometric value, and the calibrated biometric value is output to the user (S170).

[0069] Here, when the calibration sensitivity is calculated using the past calibration sensitivity as the past sensitivity information, the calibration sensitivity can be calculated more accurately by taking into account more past sensitivities.

[0070] The biometric information measured by the sensor transmitter is pre-processed by the sensor transmitter, the communication terminal, or the sensor transmitter and the communication terminal before being calibrated to a biometric value. Figure 7 is a flowchart explaining the pre-processing process of the biometric information.

[0071] 7, when biological information is measured by the sensor transmitter, a first pre-processing step is performed on the measured biological information (S171). The first pre-processing step is one of steps for processing noise in the biological information measured by the sensor transmitter. Preferably, the first pre-processing step may be performed in the sensor transmitter.

[0072] The first pre-processing process calculates an average value of the measured biometric information to process noise. For example, the average value used in the first pre-processing process may be a truncated average value, which calculates the average after truncating the largest and smallest parts of the measured biometric information by a certain percentage. However, the average value used in the first pre-processing process is not limited thereto, and any one of a population average, a sample average, a weighted average, a geometric mean, a harmonic mean, and a power mean may be used.

[0073] Taking the first pre-processing step as an example, 30 pieces of biometric information converted into digital signals are averaged using a cutting average method, and one average value is calculated every 10 seconds. In this case, the top 7 pieces of information and the bottom 7 pieces of information are removed from the 30 pieces of biometric information, and the average value (A) of the remaining 16 pieces of information is calculated. The cutting average value (A) calculated in this way can be generated every 10 seconds, and six cutting average values ​​(A1 to A6) can be generated per minute. By processing the biometric information measured through the first pre-processing step, noise in the measured biometric information can be removed.

[0074] In addition, the first pre-processing process generates six cutting average values ​​(A1 to A6) per minute, and then generates a secondary cutting average value (B1) using the six generated cutting average values ​​(A1 to A6). In this case, the generated secondary cutting average value (B1) is calculated by removing the largest and smallest values ​​from the six cutting average values ​​(A1 to A6) and averaging the remaining four values. Therefore, the first pre-processing process generates one secondary cutting average value (B) per minute.

[0075] After the first pre-processing process, an outlier filtering process is performed to find and process blood glucose information data that does not meet predetermined conditions from the biological information (S173). In order to determine biological information having an outlier, multiple previous biological information items are used based on one biological information item to determine whether the biological information has an outlier.

[0076] For example, among the biometric information B1 to B6, the biometric information B1 to B5 is used to determine whether B6 is singular value biometric information. In this case, the average gradient of B1 to B5 can be used to determine whether B6 is singular value biometric information, and if the value of B6 exceeds a predetermined range from the average gradient of B1 to B5, it can be determined to be a singular value.

[0077] Alternatively, the gradient change values ​​of B1 to B5 can be used to determine whether B6 is singular value biometric information. If the value of B6 exceeds a predetermined range from the gradient change values ​​of B1 to B5, it can be determined to be a singular value.

[0078] Alternatively, the average and standard deviation of B1 to B5 can be used to determine whether B6 is singular value biometric information. Therefore, if the value of B6 exceeds the standard deviation of B1 to B5, it can be determined to be a singular value.

[0079] If B6 is determined to be biometric information having a singular value, the biometric information can be removed before processing. However, this is not limited to this, and B6 having a singular value can be calibrated as needed to fall within the range of values ​​of B1 to B5.

[0080] A low pass filtering process may be performed on the blood glucose information data after singular value processing (S175). The low pass filtering process may be a process for removing components corresponding to high bands and leaving only biological information corresponding to low bands.

[0081] The blood glucose biological information that has undergone the low-pass filtering process may then undergo a second pre-processing process (S177). The second pre-processing process may calculate and process an average value for the low-pass filtered biological information. In this embodiment, the second pre-processing process may use a truncated average value, as in the first pre-processing process.

[0082] Thereafter, it is determined whether the blood glucose information data that has undergone the second pre-processing process is reliable in S178. This is a step of verifying whether the biological information that has undergone the second pre-processing process is reliable. In this step, verification data is generated using the biological information that has undergone the low-pass filtering process, and if the generated verification data is within a set range, it is determined that the biological information that has undergone the second pre-processing process is reliable.

[0083] If the biometric information data that has undergone the second pre-processing step is deemed to be reliable, the deemed biometric information is calibrated (S179).

[0084] However, if the biometric information that has undergone the second preprocessing process is not deemed reliable, a linear regression filtering process is performed on the biometric information that has undergone the second preprocessing process. The linear regression filtering process can modify the data value using multiple past biometric information items based on one piece of biometric information from the biometric information that has undergone the second preprocessing process. Therefore, when the biometric information is modified through linear regression filtering in this way, the modified biometric information is deemed reliable. In this way, calibration can be performed on the biometric information that has been deemed reliable through linear regression filtering.

[0085] FIG. 8 is a flowchart illustrating an embodiment of a method for obtaining a first reference vital sign value in the present invention.

[0086] 8, it is determined whether a new reference biometric value has been input at the user's request (S111). A new reference biometric value is usually input at each calibration cycle, but a new reference biometric value for calculating the calibration sensitivity may be input at the user's request even before the calibration cycle arrives.

[0087] If new reference vital signs have not been input at the user's request, it is determined whether the set calibration period has arrived (S112). If the set calibration period has arrived, a message requesting new reference vital signs at the first time point when the calibration period has arrived is output to the user, and the reference vital signs measured by the vital signs measuring device at the first time point is obtained (S113).

[0088] A difference value between the measured biometric value calculated from the biometric information measured by the sensor transmitter at the first time point using the calibration sensitivity used up to the first time point and the reference biometric value at the first time point is calculated, and it is determined whether the calculated difference value is within a critical range (S114).

[0089] If the difference value is within the critical range, it is determined to be the first mode (S115), and the reference biometric value acquired at the first time point is calculated as the first reference biometric value (S116).

[0090] However, if the difference value exceeds the critical range, it is determined to be the second mode (S117), and at least one additional reference vital value is obtained through the vital information measuring device after the first time point (S119). If it is determined to be the second mode, the average value of the reference vital value at the first time point and the additional reference vital value is calculated as the first reference vital value (S116).

[0091] Figure 9 is a diagram for explaining the time when the calibration sensitivity is generated. As shown in Figure 9(a), a first sensitivity is calculated from a first reference vital sign value at each set calibration period TP, and a new calibration sensitivity is generated from the first sensitivity and at least one or more past sensitivity information.

[0092] In addition to the set calibration period, a new calibration sensitivity can be generated before the set calibration period arrives at the user's request. As shown in Figure 9(b), a first reference biometric value is acquired at the user's request at time t2' before the set calibration period arrives, a first sensitivity is calculated from the first reference biometric value, and a new calibration sensitivity can be generated from the first sensitivity and at least one past sensitivity information. The time when the new calibration sensitivity is generated is initialized to the set calibration period, and then the new calibration sensitivity is generated at the set calibration period.

[0093] FIG. 10 shows an example of a user interface screen displayed on a user terminal for selecting a calibration mode according to another embodiment of the present invention.

[0094] As shown in FIG. 10(a), an input window for inputting a reference vital sign value measured by a vital sign measuring device at a first time point in a calibration period is activated.

[0095] As shown in Fig. 10(b), if the difference between the reference biometric value input in the input window and the measured biometric value exceeds a first critical range, another input window is activated for inputting multiple reference biometric values ​​measured at different times after the first time point. Depending on the field to which the present invention is applied, at least one or more separate input windows may be activated. When multiple reference biometric values ​​measured at different times are input, a first reference biometric value is obtained using the multiple reference biometric values.

[0096] Meanwhile, the above-described embodiments of the present invention can be created as a computer-executable program, and can be embodied in a general-purpose digital computer that runs the program using a computer-readable recording medium.

[0097] Computer-readable recording media include magnetic recording media (e.g., ROMs, floppy disks, hard disks, etc.), optically readable media (e.g., CD-ROMs, DVDs, etc.), and carrier waves (e.g., transmitted over the Internet).

[0098] Although the present invention has been described with reference to the embodiments shown in the drawings, these are merely illustrative, and those skilled in the art will appreciate that various modifications and equivalent embodiments are possible. Therefore, the true technical scope of protection of the present invention should be determined by the technical spirit of the appended claims.

Claims

1. 1. A method for calculating a calibration sensitivity of a body-insertable sensor, comprising: acquiring a first reference biometric value indicating a biometric condition of a user at a first time point, and calculating a first sensitivity from a ratio of biometric information obtained by measuring the biometric condition of the user using the body-insertable sensor at the first time point to the first reference biometric value; extracting previously stored past sensitivity information used before the first time point; calculating a calibration sensitivity for calibrating biological information measured via the body-insertable sensor after the first time point from the first sensitivity and the past sensitivity information, the past sensitivity information is a plurality of calibration sensitivities set; Biometric information obtained by measuring the user's biological condition using the internally inserted sensor at the first time point and biometric information measured through the internally inserted sensor after the first time point, The biometric information is generated through a first pre-processing step of calculating an average value of biometric information measured from a user and removing noise, a singular value processing filtering step of removing biometric information corresponding to singular values ​​from the biometric information that has undergone the first pre-processing step, a band filtering step of filtering biometric information included in a set band from the biometric information that has undergone the singular value processing filtering step, a second filtering step of calculating an average value of the biometric information that has undergone the band filtering step and removing noise, and a reliability determination step of determining reliability based on verification data of the biometric information that has undergone the second filtering step. A method for calculating the calibration sensitivity of a sensor inserted into the body.

2. The past sensitivity information is The calibration sensitivity is set to a plurality of values ​​previously used at the first time point or a plurality of values ​​previously calculated at the first time point. The calibration sensitivity calculation method for a body-insertable sensor according to claim 1 .

3. The past sensitivity information is The calibration sensitivity is a set of multiple values ​​that have been used consecutively immediately before the first time point, or a set of multiple values ​​that have been calculated immediately before the first time point. The calibration sensitivity calculation method for a body-insertable sensor according to claim 2.

4. The past sensitivity information is The calibration sensitivity is set to a plurality of randomly selected calibration sensitivities from among calibration sensitivities used during a period previously set based on the first time point, or is set to a plurality of randomly selected sensitivities from among sensitivities calculated during a period previously set based on the first time point. The calibration sensitivity calculation method for a body-insertable sensor according to claim 2.

5. The step of calculating the first sensitivity includes: acquiring a first reference biometric value of the user representing the biometric status of the user at a first time point via the test strip; determining biological information measured at the first time point via the body-insertable sensor; calculating a first sensitivity from a ratio between the biological information and the first reference biological value; Contains The calibration sensitivity calculation method for a body-insertable sensor according to claim 2.

6. A difference value between the user's biometric value calculated from the biometric information and the first reference biometric value is calculated using the past calibration sensitivity, and if the difference value exceeds a critical range, the acquired first reference biometric value is deleted. The calibration sensitivity calculation method for a body-insertable sensor according to claim 5.

7. In the step of acquiring the first reference biometric value, one of a first calibration mode and a second calibration mode is selected based on whether a difference between the user's biometric value calculated from the biometric information using a past calibration sensitivity and the first reference biometric value exceeds a critical range. The calibration sensitivity calculation method for a body-insertable sensor according to claim 5.

8. If the difference value is within the critical range, a first calibration mode is selected, and one reference biometric value measured at a first time point through a test strip in the first calibration mode is acquired as a first reference biometric value. The calibration sensitivity calculation method for a body-insertable sensor according to claim 7.

9. If the difference value exceeds a critical range, a second calibration mode is selected, and at least one additional reference biometric value is continuously acquired after the first time point through the test strip in the second calibration mode; A third reference vital sign value is obtained from an average value of the reference vital sign value obtained at the first time point and the additional reference vital sign value. The calibration sensitivity calculation method for a body-insertable sensor according to claim 7.

10. The calibration sensitivity is Calculate the average value of the first sensitivity and the past sensitivity information. The calibration sensitivity calculation method for a body-insertable sensor according to claim 2.

11. If a new reference biometric value is acquired after the first time point, the first sensitivity is stored and then a new calibration sensitivity is calculated using the first sensitivity as a past sensitivity. The calibration sensitivity calculation method for the body-insertable sensor according to any one of claims 2 to 10.

12. The method further includes determining whether a set calibration period has arrived after the first time point, and outputting a request message requesting input of new reference vital signs if the set calibration period has arrived; If a new reference biometric value is acquired in response to the request message, the first sensitivity is stored, and then a new calibration sensitivity is calculated using the first sensitivity as a past sensitivity. The calibration sensitivity calculation method for a body-insertable sensor according to claim 11.

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