CN114145738B - Analyte concentration data generation method and device, and system for monitoring analyte level - Google Patents

Analyte concentration data generation method and device, and system for monitoring analyte level Download PDF

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CN114145738B
CN114145738B CN202210123121.XA CN202210123121A CN114145738B CN 114145738 B CN114145738 B CN 114145738B CN 202210123121 A CN202210123121 A CN 202210123121A CN 114145738 B CN114145738 B CN 114145738B
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time
sensitivity
data set
analyte concentration
concentration data
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CN114145738A (en
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韩洋
雷大鹏
那姣龙
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Diascience Medical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1468Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
    • A61B5/1473Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1495Calibrating or testing of in-vivo probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7221Determining signal validity, reliability or quality
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0223Operational features of calibration, e.g. protocols for calibrating sensors
    • A61B2560/0228Operational features of calibration, e.g. protocols for calibrating sensors using calibration standards

Abstract

The invention relates to the field of continuous analyte concentration data generation, and provides an analyte concentration data generation method and device and a system for monitoring an analyte level, wherein the method comprises the following steps: obtaining a first data set of a user, the first data set including first analyte concentration data and a target measurement time corresponding thereto; acquiring a second data group of the user; determining a proportional relationship based on the first data set and the second data set; determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; determining a second sensitivity based on the proportional relation and a first weight value corresponding to the proportional relation as well as the first sensitivity and a second weight value corresponding to the first sensitivity; a second analyte concentration data set for the first time period is generated based on the second sensitivity and a second data set for the user. The invention can simultaneously take account of the proportional relation and the consistency of the sensitivity of each time, and can generate a second analyte concentration data set which is dynamically adjusted and more accurate through the second sensitivity.

Description

Analyte concentration data generation method and device, and system for monitoring analyte level
Technical Field
The present invention relates to the field of continuous analyte concentration data generation, and more particularly, to a method and apparatus for generating analyte concentration data and a system for monitoring analyte levels.
Background
Some diseases require continuous monitoring of analyte concentrations, for example diabetes is a disease in which the pancreas is unable to produce insulin, resulting in abnormal blood glucose concentration data (type 1 diabetes) or inefficient insulin secretion and action (type 2 diabetes). Users affected by diabetes need to monitor Blood Glucose (BG) levels throughout the day to control blood glucose and take countermeasures to keep it as normal as possible. Diabetic users are forced to take exogenous insulin infusions or medications, the schedules and doses of which are determined from BG measurements.
According to current measurement standards, BG measurements can be collected in two main ways: i) in daily life, finger blood is taken out by pricking a finger through a capillary vessel and is measured by test paper, namely, the blood sugar is self-monitored for 4-5 times at most every day; ii) in-patient clinical trials, measurements were made by a finger-blood associated glucometer. Both BG monitoring systems are fairly accurate. However, the level of change in blood glucose concentration used cannot be continuously and dynamically monitored, blood sampling can only be done infrequently, and rapid fluctuations in the user's glucose concentration may result in blindness.
In the past decades, Continuous Glucose Monitoring (CGM) systems have been introduced. Unlike BG measurement systems, these CGM devices can measure blood glucose in interstitial fluid, thereby reducing the frequency of finger stick invasion into the body and allowing visualization of real-time blood glucose concentration values every 1-5 minutes for many consecutive days. The CGM system provides a more complete glucose fluctuation map, demonstrating key events that cannot be detected using the BG system. However, CGM systems still suffer from some inaccuracies. In fact, the results of CGM tests sometimes show transient or systemic underestimation/overestimation compared to the results of BG tests. CGM has a much higher temporal resolution (displayed every 1-5 minutes) than BG, but sometimes shows a systematic underestimation/overestimation of true blood glucose concentration. Obviously, the accuracy of CGM is insufficient to impair its clinical application, and currently, the research community has recognized a bottleneck in the actual clinical application of the accuracy of CGM.
In the process of implementing the embodiment of the invention, the inventor finds that at least the following defects exist in the background art: the following factors are not considered when optimizing frequent, continuous measurements of analyte concentration data by using a small, sparse but accurate reference sample (which may be, for example, BG values obtained by a blood glucose meter): i) sensitivity attenuation occurs in the continuous analyte concentration monitoring process, but the current optimization mode is to calibrate the analyte concentration data output by the continuous analyte concentration data measuring equipment by using a reference sample, the sensitivity before the measurement time is not considered during calibration, the consistency of the sensitivity before and after calibration cannot be maintained, unreasonable and abrupt analyte concentration data can be generated due to reasons such as poor reference samples, and the like, so that after calibration, the data output by the continuous analyte concentration data measuring equipment cannot reflect the actual analyte concentration data at the actual measurement time of each original value. ii) in one case, the data measured by the continuous analyte concentration data measuring device is still output in real time, so that inappropriate or unreasonable error data (adjusted by not adopting a reference sample) exists in the output data, the actual analyte concentration level of a user cannot be reflected certainly, the actual analyte concentration level cannot be practically applied to clinic, even the error data misleads experts and users, and the diagnosis and treatment effect is further influenced; in another case, a continuous analyte concentration data measurement device worn by the user continuously collects original values related to analyte concentration, but due to inconvenience in operation, avoidance of erroneous data from the above situations, and the like, the user has no receiving device or is not allowed to view the analyte concentration data using the receiving device, can only view the individual analyte concentration situation (a small, sparse but accurate reference sample) intermittently, and cannot generate a continuous report that can reflect the user's true analyte concentration level.
Disclosure of Invention
The invention provides an analyte concentration data generation method and device and an analyte level monitoring system, which are used for solving the technical defects in the prior art.
The invention provides an analyte concentration data generation method, which comprises the following steps:
obtaining a first data set of a user, the first data set obtained by a first device, the first data set including first analyte concentration data and a corresponding target measurement time;
obtaining a second data set of the user, the second data set including a raw value associated with an analyte concentration obtained by a second device and a timestamp thereof;
determining a proportional relationship based on the first data set and the second data set; the proportional relationship is a ratio of the original value at a target time to the first analyte concentration data at the target measurement time, the target time being at or closest to the target measurement time;
determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is the sensitivity at a first moment, and the first moment is between the last measurement moment and the target measurement moment;
determining a second sensitivity based on the proportional relation, a first weight value corresponding to the proportional relation, the first sensitivity and a second weight value corresponding to the first sensitivity;
generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, the first time period extending from the target measurement time to a second time, the second time being subsequent to the target measurement time.
Preferably, the analyte concentration data generating method, wherein the raw values comprise data acquired by the second device for determining the second analyte concentration data set.
Preferably, the analyte concentration data generating method, wherein the raw values include current values for determining the second analyte concentration data set, the current values being obtained after an electrochemical reaction between a sensor in the second device and a specific solution is generated; the particular solution is the solution in which the sensor is located.
Preferably, the analyte concentration data generating method, wherein the determining a first weight value and a second weight value based on a rate of change of the proportional relationship with respect to the first sensitivity includes:
determining a rate of change R of the proportional relationship with respect to the first sensitivity using the following equation:
Figure 433509DEST_PATH_IMAGE001
determining the first weight value and the second weight value by using the following formulas:
b=f(R,t)
a=1-b
wherein I represents an original value acquired at the target measurement time, and G represents a first value of the target measurement timeAnalyte concentration data, SoldRepresenting a first sensitivity for determining a third analyte concentration data set at the last measurement time, t representing a target time difference between a generation time of the first sensitivity and the target measurement time, f (R, t) representing a function with R and t as parameters, a representing a first weight value corresponding to the proportional relationship, b representing a second weight value corresponding to the first sensitivity, wherein a and b satisfy: a + b = 100%.
Preferably, the analyte concentration data generating method is further characterized in that the second weight value is an initial preset value, zero or an empirical preset value.
Preferably, the analyte concentration data generating method is performed, wherein the first sensitivity is a preset sensitivity.
Preferably, the analyte concentration data generation method further includes the step of generating a second time difference between the target measurement time and the second time, wherein the second time is a previous time before the target measurement time, and the second time difference is a sampling period of the second apparatus for acquiring the original value.
Preferably, the analyte concentration data generating method, wherein the determining a second sensitivity based on the proportional relationship and a first weight value corresponding thereto, and the first sensitivity and a second weight value corresponding thereto, includes: determining the second sensitivity using the following equation:
Figure 852989DEST_PATH_IMAGE002
wherein S represents the second sensitivity.
Preferably, the analyte concentration data generating method, wherein generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set of the user, comprises:
and dividing a second data set corresponding to each display period of the first time period by the second sensitivity to generate a second analyte concentration data set of the first time period, wherein the display period is the period of displaying the second analyte concentration data set by the second device.
Preferably, the analyte concentration data generating method further comprises, after generating the second analyte concentration data set for the first time period based on the second sensitivity and the second data set of the user, generating the second analyte concentration data set for the first time period, the step of:
and displaying the second analyte concentration data set according to the display period.
Preferably, the analyte concentration data generating method, wherein the display period is not less than 1 minute.
Preferably, the analyte concentration data generating method is a method in which the first data set is obtained by performing pre-screening based on a preset rule.
Preferably, the analyte concentration data generating method further includes: when a plurality of groups of different first equipment exist, screening out a group of data of the first equipment with the highest credibility as a first data group, wherein the credibility is determined based on the model of the first equipment or the regular quality control maintenance record.
Preferably, in the analyte concentration data generation method, the second time is located at or before a third time, the third time is a next measurement time after the target measurement time, and a second time difference between the third time and the second time is not less than one display period.
Preferably, in the analyte concentration data generation method, the second time is located at or before a fourth time, which is a measurement completion time after the target measurement time.
Preferably, the analyte concentration data generating method further comprises:
visualizing the second analyte concentration data set using at least one display module;
and/or acquiring the first data group and the second data group of the user by utilizing at least one acquisition module.
The present invention also provides an analyte concentration data generating apparatus comprising:
a first data set acquisition module for acquiring a first data set of a user, the first data set being acquired by a first device, the first data set including first analyte concentration data and a target measurement time corresponding thereto;
a second data set acquisition module for acquiring a second data set of the user, the second data set including a raw value associated with an analyte concentration acquired by a second device and a timestamp thereof;
the proportional relation determining module is used for determining a proportional relation based on the first data group and the second data group; the proportional relationship is a ratio of the original value at a target time to the first analyte concentration data at the target measurement time, the target time being at or closest to the target measurement time;
the weight value determining module is used for determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is the sensitivity at a first moment, and the first moment is between the last measurement moment and the target measurement moment;
the sensitivity updating module is used for determining second sensitivity based on the proportional relation, a first weight value corresponding to the proportional relation, the first sensitivity and a second weight value corresponding to the first sensitivity;
an analyte concentration data generation module to generate a second analyte concentration data set for a first time period based on the second sensitivity and a second data set of the user, the first time period extending from the target measurement time to a second time, the second time being after the target measurement time.
The present invention also provides a system for monitoring analyte levels, comprising:
a sensor configured to acquire a second data set;
a wireless transmitter to transmit the second data set;
and
a mobile computing device, comprising:
a receiving device configured to receive a first data group and a second data group;
a memory to store data including the first and second data sets;
a processor to process the data, and a software application including instructions stored in the memory that, when executed by the processor, obtain a first data set of a user, the first data set obtained by a first device, the first data set comprising first analyte concentration data and its corresponding target measurement time;
obtaining a second data set of the user, the second data set including a raw value associated with an analyte concentration obtained by a second device and a timestamp thereof;
determining a proportional relationship based on the first data set and the second data set; the proportional relation is a ratio of an original value at a target time to first analyte concentration data at a target measurement time, wherein the target time is the target measurement time or a time closest to the target measurement time;
determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is the sensitivity at a first moment, and the first moment is between the last measurement moment and the target measurement moment;
determining a second sensitivity based on the proportional relation and a first weight value corresponding to the proportional relation as well as the first sensitivity and a second weight value corresponding to the first sensitivity;
generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, the first time period extending from the target measurement time to a second time, the second time being subsequent to the target measurement time.
The present invention also provides an electronic device comprising a memory, a processor and a computer program stored on the memory and executable on the processor, wherein the processor implements the steps of the method for generating analyte concentration data as described in any of the above when executing the program.
The present invention also provides a non-transitory computer readable storage medium having stored thereon a computer program which, when executed by a processor, carries out the steps of the analyte concentration data generation method as any one of the above.
The present invention combines a first data set acquired by a first device and a second data set acquired by a second device of a user to determine a proportional relationship, wherein the proportional relationship is a ratio of an original value at or closest to the target measurement time to first analyte concentration data; and determining a first weight value and a second weight value based on the change rate of the proportional relationship relative to the first sensitivity, and further determining a second sensitivity of a second analyte concentration data set for generating the first time period, wherein the second sensitivity can consider the proportional relationship corresponding to the target measurement time, can keep consistency with the first sensitivity, and avoids generating unreasonable and abrupt second sensitivity. Based on the dynamically adjusted second sensitivity, the second sensitivity of each time period can be kept to more reasonably restore the real situation of each original value actual measurement time, the generated second sensitivity is very close to the real sensitivity of each original value actual measurement time, the second device can be enabled to generate a more accurate second analyte concentration data set in a first time period after the target measurement time, and output data of the second device with high sensitivity and high measurement accuracy are achieved. The invention can eliminate the error caused by the fact that the real analyte concentration data at the actual measurement moment of each original value cannot be reflected due to sensitivity attenuation in the continuous analyte monitoring process of the second equipment, can also directly output the dynamically adjusted and more accurate second analyte concentration data set, and avoids misleading to a user caused by the fact that the second equipment outputs data which is not adjusted by the first data set.
Drawings
In order to more clearly illustrate the technical solutions of the present invention or the prior art, the following briefly introduces the drawings needed for the embodiments or the prior art descriptions, and obviously, the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
Fig. 1 is a schematic diagram of an implementation environment according to various embodiments of the present invention.
FIG. 2 is a schematic flow diagram of a method of generating analyte concentration data provided by the present invention.
FIG. 3 is a graphical representation of the sensitivity of different time periods in an implementation of a method of analyte concentration data generation provided by the present invention.
FIG. 4 is a schematic comparison of blood glucose concentration for a method of generating analyte concentration data according to the present invention, after implementation, and without implementation of the analyte concentration data generation method.
Fig. 5 is a schematic structural view of an analyte concentration data generating apparatus according to the present invention.
Fig. 6 is a schematic structural diagram of an electronic device provided in the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings, and it is obvious that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The analytes in the present invention may be blood sugar, blood ketone, ethanol, lactic acid, creatinine (an analyte related to kidney function), uric acid, an analyte causing heart failure (BNP), various analytes of infectious origin (e.g., C-reactive protein, procalcitonin, serum amyloid a, interleukin 6, etc.), etc., each of which may have a device for continuously measuring the concentration and a device for more precisely and discontinuously measuring the concentration.
Referring to fig. 1, a schematic diagram of an implementation environment according to various embodiments of the present invention is shown. The implementation environment includes: a first device 100 and a second device 200, and/or a server 300.
The first device 100 may be a device with blood glucose testing capabilities, such as a blood glucose meter, a blood glucose monitoring device, a blood glucose testing device, etc. that tests blood glucose concentration data by collecting finger blood.
The second device 200 may be a continuous ambulatory blood glucose monitoring (CGM) system configured to continuously monitor a person's blood glucose. CGM systems may be configured with CGM sensors, for example, that are subcutaneously inserted into the skin of a person and detect an analyte indicative of the blood glucose of the person. The CGM system can continuously generate glucose measurements based on the detected analyte. As used herein, the term "continuous" is near-continuous such that continuous glucose monitoring produces measurements at intervals supported by the resources (e.g., battery life, processing power, communication power, etc.) of the CGM system, the continuously monitored blood glucose concentration data being obtained without manual interaction, such as finger prick and finger blood collection. By continuously monitoring glucose levels, CGM systems not only allow users to make better informed decisions about their treatment, but also continue to monitor glucose levels while allowing them to calibrate the CGM system with a finger prick and finger blood collection. The CGM system may include a receiving device having a data processing capability, and the receiving device may be a mobile phone, a tablet pc, an e-book reader, an MP3 player (Moving Picture Experts Group Audio Layer III, mpeg compression standard Audio Layer 3), an MP4 player (Moving Picture Experts Group Audio Layer IV, mpeg compression standard Audio Layer 4), a laptop portable computer, a desktop computer, or the like. The receiving device may be installed with an application client, or installed with a browser, and the web page client of the application is accessed through the browser. The application client and the web page client are collectively referred to as the client in the embodiments of the present invention, and are not specifically stated below.
The server 300 may be a near-end or far-end server, or a server cluster composed of several servers, or a cloud computing service center. When the second device 200 and the server 300 simultaneously process the service related to the present invention, the server 300 may be used to provide the service related to the present invention in interaction with the second device 200. The server 300 is a server corresponding to the client, and the two can combine to realize various functions provided by the client, and are generally set up by an internet service provider.
The second device 200 and the first device 100 can be connected through a wireless network or a wired network to realize data transmission; the second device 200 and the first device 100 may also be connected to the server 300 via a wireless network or a wired network, respectively, for data transmission.
A method of analyte concentration data generation according to the present invention is described below with reference to fig. 2, the method comprising: s1, obtaining a first data set of the user, the first data set being obtained by the first device 100, the first data set including first analyte concentration data and a corresponding target measurement time.
The first device 100 may have only one device, or may have multiple different brands or different models of the same brand, and each set of the first data sets corresponds to one brand or one model, or each set of the first data sets is data collected at a specific target measurement time by one brand or one model, and includes the first blood glucose concentration data and the corresponding target measurement time.
S2, a second data set of the user is acquired, the second data set including the original value associated with the analyte concentration acquired by the second device 200 and its timestamp.
The user and the second device 200 are pre-associated, and the first data set used by the first device 100 for calibration corresponds to the same user as the second device 200. The first device 100 may be associated with a plurality of users, and accordingly, data of each user is transmitted to the second device 200 associated with each user in advance. In one case, the trustworthiness of each first data set may be high, which may limit the first device 100 to test the first data set by collecting finger blood in a non-continuous manner. In one case, when the original value relating to the blood glucose concentration is in an abnormal state (i.e., the original value at the target measurement time or closest to the target measurement time is in an abnormal state), the generation of the second blood glucose concentration data set is suspended, and in the case where the original value relating to the blood glucose concentration is in a normal state, the generation of the second blood glucose concentration data set is continued. That is, when the state is abnormal, it is considered that it is meaningless to generate the second blood glucose concentration data set at this time, and when the second device 200 is to be in the normal operation state, the second blood glucose concentration data set is generated.
S3, determining a proportional relation based on the first data group and the second data group; the proportional relationship is a ratio of the original value at a target time, which is the target measurement time or a time closest to the target measurement time, to the first analyte concentration data at the target measurement time.
In one case, the first data set includes the time value of the target measurement time and the first blood glucose concentration data of the target measurement time, that is, the first blood glucose concentration data with the time stamp. When the target time is the target measurement time, the original value of the second device 200 at the target measurement time may be the current value at the target measurement time, when there is no original value at the target measurement time (since the original value is a continuous value collected in a certain period (sampling period), the sampling period is generally several seconds to several minutes, there is a possibility that there is no original value at the target measurement time), at this time, the original value closest to the target measurement time may be selected, for example, the original value located three seconds before or fifteen seconds after the target measurement time may be selected, when there are original values located three seconds before and fifteen seconds after the target measurement time, the original value located three seconds before the target measurement time may be selected, or the original value whose time difference from the target measurement time is less than one sampling period may be selected for determining the proportional relationship, the closer the target time is to the original value of the target measurement time, the better the referential of the proportional relationship is determined, and therefore the original value at or closest to the target measurement time is selected. And further determining the target measurement time and a second sensitivity after the target measurement time by using the ratio of the original value at the target measurement time or the position closest to the target measurement time to the first blood glucose concentration data at the target measurement time.
S4, determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is a sensitivity at a first time, and the first time is located between a last measurement time and the target measurement time.
In one case, the first time is a time before the target measurement time, and may be a time having the first sensitivity in a last sampling period for acquiring the original value before the target measurement time. Based on a change rate of the proportional relationship relative to the first sensitivity, a change size of the proportional relationship relative to the first sensitivity can be determined, and then a first weight value and a second weight value are determined according to the change rate, wherein the first weight value corresponds to the proportional relationship, the second weight value corresponds to the first sensitivity, and the first weight value and the second weight value are dynamically adjusted based on the change rate when the analyte concentration data generation method is executed each time. For example, when the change rate between the proportional relation and the target measurement time is large, the second weight value may be increased, and at this time, more consideration is needed to keep consistency with the first sensitivity, and no sudden change of the sensitivity occurs; when the change rate between the proportional relation and the target measurement time is small, the first weight value can be increased, and at the moment, the proportional relation obtained by the target measurement time needs to be considered more so as to further optimize the second change rate; the first weight value and the second weight value may be the same or different.
And S5, determining a second sensitivity based on the proportional relation and the corresponding first weight value thereof, and the first sensitivity and the corresponding second weight value thereof.
By giving the proportional relation, the first sensitivity, the dynamically adjusted first weight value and the dynamically adjusted second weight value, the determined second sensitivity can be considered that the proportional relation obtained at the current target measurement time can be a certain time with the first sensitivity in the last sampling period of the original value collected before the target measurement time, and the consistency with the first sensitivity can be considered at the same time.
S6, generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, the first time period extending from the target measurement time to a second time, the second time being after the target measurement time.
In one case, a second blood glucose concentration data set for the first time period is generated based on the second sensitivity and a second data set of the user (i.e., an original value of the first time period related to blood glucose concentration and a time stamp thereof), the second blood glucose concentration data set including a blood glucose concentration value for display and a time stamp thereof. By adopting the above mode, errors caused by the fact that real blood glucose concentration data at the actual measurement time of each original value cannot be reflected due to sensitivity attenuation in the continuous blood glucose monitoring process of the second device 200 can be eliminated.
In one case, the second device 200 does not output the blood glucose concentration data in real time, thereby avoiding inappropriate or unreasonable error data in the data output in real time, and further avoiding the situation that the diagnosis and treatment effect are influenced due to misleading experts and users by the error data.
In one case, when there are a plurality of target measurement time instants located at different times in a longer second time period (which may include the first time period), the above S1 to S6 may be performed for each target measurement time instant, and the second sensitivity of each sub time period in the second time period is obtained based on the first data group and the second data group of each target measurement time instant and the first sensitivity before each target measurement time instant, so as to generate the second blood glucose concentration data group of each sub time period (for example, one of the sub time periods may be the first time period). Each of the last first sensitivities with respect to the second sensitivities may be inherited with a certain weight, and the generation of the second blood glucose concentration data set for each time segment can take into account more or less the initial sensitivities and the sensitivities located before each of the first time segments at the respective different time instants. The second blood glucose concentration data sets of each sub-time period are combined together to form a second blood glucose concentration data set of the second time period, the second blood glucose concentration data set can form an overall report of the second time period to generate a continuous report capable of reflecting the real blood glucose concentration level of the user, and the overall report can more reasonably restore the real blood glucose concentration condition of the user and can achieve the clinical practical application effect.
In one case, the execution subject of the present invention is other device having data processing capability, such as the second device 200 or the server 300. The invention combines a first data set acquired by a first device and a second data set acquired by a second device of a user to determine a proportional relationship, wherein the proportional relationship is a ratio of an original value at or closest to the target measurement time to first blood glucose concentration data; and determining a first weight value and a second weight value based on the change rate of the proportional relationship relative to the first sensitivity, and further determining a second sensitivity for generating a second blood glucose concentration data set of the first time period, wherein the second sensitivity can consider the proportional relationship corresponding to the target measurement time, can keep consistency with the first sensitivity, and avoids generating unreasonable and abrupt second sensitivity. Based on the dynamically adjusted second sensitivity, the second sensitivity of each time period can be kept to more reasonably restore the real situation of each original value actual measurement time, the generated second sensitivity is very close to the real sensitivity of each original value actual measurement time, the second device 200 can be enabled to generate a more accurate second blood glucose concentration data set in a first time period after the target measurement time, and output data of the second device 200 with high sensitivity and high measurement accuracy is achieved. The invention can eliminate the error caused by the fact that the real blood glucose concentration data of each original value at the actual measurement time cannot be reflected due to the sensitivity attenuation of the second device 200 in the continuous blood glucose monitoring process, and can also directly output the dynamically adjusted and more accurate second blood glucose concentration data set, thereby avoiding the misguidance of a user caused by the fact that the second device 200 outputs data which is not adjusted by the first data set.
In a preferred embodiment, the raw values comprise data collected by the second device 200 for determining the second analyte concentration data set. Preferably, the raw values include current values for determining the second analyte concentration data set, the current values being obtained after an electrochemical reaction between a sensor in the second apparatus 200 and a particular solution (e.g., blood, interstitial or other solution in the body of the user, etc.); the particular solution is the solution in which the sensor is located.
In a preferred embodiment, the determining a first weight value and a second weight value based on a rate of change of the proportional relationship with respect to the first sensitivity includes: determining a rate of change R of the proportional relationship with respect to the first sensitivity using the following equation:
Figure 328969DEST_PATH_IMAGE001
determining the first weight value and the second weight value by using the following formulas:
b= f(R,t)
a=1-b
wherein I represents the original value acquired at the target measurement time, G represents the first analyte concentration data at the target measurement time, SoldRepresenting a first sensitivity for determining a third analyte concentration data set at said last measurement instant, t representing a target time difference between the generation instant of the first sensitivity and said target measurement instant, f (R, t) representing a function with R and t as parametersThe function indicates that the second weight value is related to R, t, a represents a first weight value corresponding to the proportional relation, b represents a second weight value corresponding to the first sensitivity, wherein a and b satisfy: a + b = 100%.
In one case, depending on the nature of the sensor included in the second device 200, there is a maximum value of the sensitivity change rate per minute in different time periods within the active working time of the sensor, and when the proportional relationship is large (larger than the proportional threshold), it may be that the measurement of the first data set of the first device 100 at the target measurement time is wrong or deviated due to human operation, and at this time b may be increased, a may be decreased, or a =0 and b =100% may be set, so as to eliminate such a mistake or error.
The first sensitivity has certain available value for the newly generated second sensitivity, the first sensitivity can be considered and given a second weight value, the difference between the second sensitivity and the first sensitivity can be properly reduced, the sensitivity is more smoothly converted, and data mutation cannot be generated in the first time period. If the proportional relationship is more, the first weight value can be set to be larger than the second weight value, if the reference to the first sensitivity is more, the first weight value can be set to be not larger than the second weight value, and if the proportional relationship and the second sensitivity are considered to be equally important, the first weight value can be set to be equal to the second weight value. Specifically, the first weight value and the second weight value may be set according to a rate of change of the proportional relationship with respect to the first sensitivity, a target time difference between a generation time of the first sensitivity and the target measurement time.
In a preferred embodiment, the second weight value is an initial preset value, zero or an empirical preset value.
That is, in one case, b is dynamically adjustable, and the initial value of b may be 0 or an initial preset value, an empirical preset value.
In a preferred embodiment, the first sensitivity is a preset sensitivity.
In one case, the predetermined sensitivity may be an initial sensitivity of the sensor or a predetermined sensitivity determined based on the method of the present invention to satisfy a predetermined condition.
In a preferred embodiment, the first time is a previous time before the target measurement time, and a first time difference between the target measurement time and the first time is a sampling period for the second device 200 to acquire the original value.
In one case, the first time is a previous time before the target measurement time, so as to ensure that the first sensitivity is the sensitivity of the previous time closest to the target measurement time, which is more meaningful for reference.
In a preferred embodiment, the determining the second sensitivity based on the proportional relationship and the first weight value corresponding thereto, and the first sensitivity and the second weight value corresponding thereto includes: determining the second sensitivity using the following equation:
Figure 150295DEST_PATH_IMAGE002
wherein S represents the second sensitivity.
In one case, the first sensitivity acts on the original value between the first sensitivity generation timing to the next sensitivity (second sensitivity) generation timing of the first sensitivity; the second sensitivity acts on the original value in the first period, i.e., from the second sensitivity generation timing to the next sensitivity (third sensitivity) generation timing of the second sensitivity.
In a preferred embodiment, said generating a second analyte concentration data set for a first time period based on said second sensitivity and a second data set for said user comprises: and dividing the second data set corresponding to each display period of the first time period by the second sensitivity to generate a second analyte concentration data set of the first time period, wherein the display period is a period of displaying the second analyte concentration data set by the second device 200.
The raw value corresponding to each display cycle divided by the second sensitivity may generate a second blood glucose concentration data set for the first time period.
In a preferred embodiment, the generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, after generating a second analyte concentration data set for a first time period, comprises: and displaying the second analyte concentration data set according to the display period.
In one case, after the second blood glucose concentration data set is generated, the second blood glucose concentration data set may be output and displayed in a display cycle, the output and displayed data each being data closer to the user's true blood glucose level. The display period is not less than 1 minute. The display period is preferably 2-3 minutes, and in general, the time interval for data display by the CGM system, that is, the display period is 2-3 minutes.
In a preferred embodiment, the first data set is obtained by performing pre-screening based on a preset rule. The preset rules include: when a plurality of different sets of first devices 100 exist, a set of data of one first device 100 with the highest trustworthiness is screened out as a first data set, and the trustworthiness is determined based on the model of the first device 100 or the regular quality control maintenance record.
In one case, a set of data of a first device 100 with the highest trustworthiness is selected as the first data set, possibly a glucose meter of a certain brand or model with the highest trustworthiness. The first device 100 may refer to a plurality of different brands or different models of the same brand, and may be Roche, Yueje, or other brands. When different brands of blood glucose meters are used, data obtained by the blood glucose meters used by the user in history is preferred, for example, the same user can use the same first device 100 for calibration each time during the blood glucose monitoring process; the error can also be reduced by selecting a specific device among a plurality of devices. The blood glucose meter generally needs to be calibrated and maintained regularly, maintenance records are reserved, some data such as test accuracy and the like can be contained in the maintenance records, and the credibility can be confirmed based on the maintenance records. If the calibration and quality control maintenance is not carried out for a long time, and the credibility of the equipment which does not check the calibration and quality control maintenance record is lower, the equipment is not adopted, and the credibility of the commonly adopted blood glucose meter is greater than the CGM.
In a preferred embodiment, the second time is located at or before a third time, the third time is a next measurement time after the target measurement time, and a second time difference between the third time and the second time is not less than one display period.
In one case, when the second time is located at a third time, that is, the first period (that is, the application period of the second sensitivity) continues from the target measurement time to the next measurement time. In another case, when the second time is before the third time, i.e. the first time period (i.e. the application time period of the second sensitivity) lasts from the target measurement time to a time before the next measurement time, the determination of a time may be based on the target time difference, e.g. the target time difference is larger than 12 hours, and from the time after the time there may be other updated sensitivities available, etc. That is, the effective period of the second sensitivity may be set based on the attenuation characteristic of the sensor performance.
In a preferred embodiment, the second time is located at or before a fourth time, which is an end measurement time after the target measurement time.
In one case, when the second timing is located at the fourth timing, that is, the first period (that is, the application period of the second sensitivity) continues from the target measurement timing to the end measurement timing (preferably, the end measurement timing of the CGM to the original value). In another case, when the second time is before the fourth time, that is, the first time period (that is, the application time period of the second sensitivity) continues from the target measurement time to another time before the end measurement time, the determination of another time may be based on the target time difference, for example, the target time difference is greater than 12 hours, and then there may be other updated sensitivities available from the another time. That is, the effective period of the second sensitivity may be set based on the attenuation characteristic of the sensor performance.
In a preferred embodiment, the method further comprises:
visualizing the second analyte concentration data set using at least one display module;
and/or acquiring the first data group and the second data group of the user by utilizing at least one acquisition module.
To further illustrate the analyte concentration data generation methods of the present invention, the following specific examples are provided in connection with various implementation scenarios.
In one scenario, a first sensitivity is generated at noon 12:00 # 1, and in the first case, 12:01 # 3 at noon two days later (the target measurement time), another first blood glucose concentration data is presented by the blood glucose meter, separated by more than 48 hours. At this time, noon 12 is calculated No. 3: 01 to the first blood glucose concentration data, and calculating a rate of change R between the proportional relationship and the first sensitivity:
Figure 358422DEST_PATH_IMAGE001
the weighted value of the current proportional relation and the last first sensitivity is influenced by R, and the larger R is, the larger the difference between the current proportional relation and the last sensitivity is. However, since the change in sensitivity does not change abruptly or greatly within a certain period of time due to the properties of the sensor, it is necessary to consider whether the current ratio is affected by noise, and in order to limit the abrupt change in the second blood glucose concentration data set and to consider the mutual influence of the sensitivity of the sensor, the second sensitivity is a weighted average of the relationship between the first sensitivity and the current ratio.
The influence degree of the last sensitivity in the current sensitivity calculation is influenced by time and a change rate, and the time is the time difference between the generation time of the last sensitivity and the generation time of the current proportional relation. If a large change larger than the threshold value occurs in a short time, the proportional relation is considered to be greatly influenced by noise, so that the influence factor b of the previous sensitivity is large; the determination of b is based on a combination of R and t and can therefore be written as:
b= f(R,t)
a=1-b。
one preset way to obtain b may be as shown in table 1 below.
Table 1 Preset manner of obtaining b
Figure 874986DEST_PATH_IMAGE003
As can be seen from table 1, since the intermediate interval is more than 48 hours and R is 0 to 10%, b =0 can be set, and a =1 is set.
In another scenario, the second device 200 worn by the user continuously acquires the original value related to the blood glucose concentration. But due to the inconvenience of operation, the user has no receiving device or is not allowed to view the blood glucose concentration data and/or enter a calibration using a receiving device; at the same time, the first device 100 (blood glucose meter) is used to intermittently view the individual's blood glucose condition.
When the monitoring is finished, the first device 100 sends at least one first data group to the second device 200 (a receiving device or an electronic device included in the second device 200) through the first network; each set of first data sets contains the blood glucose concentration measured by the first device 100 and its corresponding measurement time. The receiving device or the electronic device calculates a second sensitivity for the first time period from the measurement time in the original value or the data at the closest target measurement time, the data of the corresponding measurement time in the first data group, and the first sensitivity at the previous time.
The last moment is before the measuring moment, and the time difference value between the last moment and the measuring moment is less than one display period; calculating blood glucose concentration data of a first time period by using the first sensitivity; the starting time of the first time interval is the measuring time, and the ending time is the next time for receiving the first data group. When all available first data sets are used, a complete second blood glucose data set in the monitoring process is obtained and can be used for generating a user report.
Referring to fig. 3, in one scenario, based on the analyte concentration data generation method provided by the embodiment of the present invention, based on the first data set, the second sensitivity (represented by the ordinate) obtained for each time period is obtained after dynamic adjustment of the measurement time of the blood glucose meter.
Referring to fig. 4, the abscissa represents time, and the ordinate represents original value (a curve corresponding to only the original value) or blood glucose concentration (other curves), in one scenario, the second blood glucose concentration set of each time period can be obtained by using the second sensitivity (determined based on the data of the first data set and the like) and the original value obtained in each time period in fig. 3, and by comparing with the CGM blood glucose concentration set which is not adjusted and automatically generated by the second device 200, it can be determined that the adjusted second blood glucose concentration data set is closer to the true glucose level of the user than the unadjusted CGM blood glucose concentration data set, and the second blood glucose concentration data set adjusted by the method of the present invention is more medically referential.
Referring to fig. 5, an analyte concentration data generating apparatus provided by the present invention will be described below, and an analyte concentration data generating apparatus described below and an analyte concentration data generating method described above may be referred to in correspondence with each other, the analyte concentration data generating apparatus including: a first data set obtaining module 10, configured to obtain a first data set of a user, where the first data set is obtained by the first device 100, and the first data set includes first analyte concentration data and a corresponding target measurement time.
The first device 100 may have only one device, or may have multiple different brands or different models of the same brand, and each set of the first data sets corresponds to one brand or one model, or each set of the first data sets is data collected at a specific target measurement time of the same brand or one model, and includes the first blood glucose concentration data and the corresponding target measurement time.
A second data set acquisition module 20 for acquiring a second data set of the user, the second data set comprising the original value associated with the analyte concentration acquired by the second device 200 and a time stamp thereof.
The user and the second device 200 are pre-associated, and the first data set used for calibration by the first device 100 and the second device 200 correspond to the same user. The first device 100 may be associated with a plurality of users, and accordingly, data of each user is transmitted to the second device 200 with which each user is previously associated. In one case, the trustworthiness of each first data set may be high, which may limit the first device 100 to test the first data set by collecting finger blood in a discontinuous manner. In one case, when the original value relating to the blood glucose concentration is in an abnormal state (i.e., the original value at the target measurement time or closest to the target measurement time is in an abnormal state), the generation of the second blood glucose concentration data set is suspended, and in the case where the original value relating to the blood glucose concentration is in a normal state, the generation of the second blood glucose concentration data set is continued. That is, when the state is abnormal, it is considered that it is meaningless to generate the second blood glucose concentration data set at this time, and when the second device 200 is to be in a normal operation state, the second blood glucose concentration data set is generated.
A proportional relationship determining module 30, configured to determine a proportional relationship based on the first data group and the second data group; the proportional relationship is a ratio of the original value at a target time, which is the target measurement time or a time closest to the target measurement time, to the first analyte concentration data at the target measurement time.
In one case, the first data set includes the time value of the target measurement time and the first blood glucose concentration data of the target measurement time, that is, the first blood glucose concentration data with the time stamp. When the target time is the target measurement time, the original value of the second device 200 at the target measurement time may be the current value at the target measurement time, when there is no original value at the target measurement time (since the original value is a continuous value collected in a certain period (sampling period), the sampling period is generally several seconds to several minutes, there is a possibility that there is no original value at the target measurement time), at this time, the original value closest to the target measurement time may be selected, for example, the original value located three seconds before or fifteen seconds after the target measurement time may be selected, when there are original values located three seconds before and fifteen seconds after the target measurement time, the original value located three seconds before the target measurement time may be selected, or the original value whose time difference from the target measurement time is less than one sampling period may be selected for determining the proportional relationship, the closer the target time is to the original value of the target measurement time, the better the referential of the proportional relationship is determined, and therefore the original value at or closest to the target measurement time is selected. And further determining the target measurement time and a second sensitivity after the target measurement time by using the ratio of the original value at the target measurement time or the position closest to the target measurement time to the first blood glucose concentration data at the target measurement time.
A weight value determining module 40, configured to determine a first weight value and a second weight value based on a change rate of the proportional relationship with respect to the first sensitivity; the first sensitivity is a sensitivity at a first time, and the first time is located between a last measurement time and the target measurement time.
In one case, the first time is a time before the target measurement time, and may be a time having the first sensitivity in a last sampling period for acquiring the original value before the target measurement time. Based on a change rate of the proportional relationship relative to the first sensitivity, a change size of the proportional relationship relative to the first sensitivity can be determined, and then a first weight value and a second weight value are determined according to the change rate, wherein the first weight value corresponds to the proportional relationship, the second weight value corresponds to the first sensitivity, and the first weight value and the second weight value are dynamically adjusted based on the change rate when the analyte concentration data generating device is used every time. For example, when the change rate between the proportional relation and the target measurement time is large, the second weight value may be increased, and at this time, more consideration is needed to keep consistency with the first sensitivity, and no sudden change of the sensitivity occurs; when the change rate between the proportional relation and the target measurement time is small, the first weight value can be increased, and at the moment, the proportional relation obtained by the target measurement time needs to be considered more so as to further optimize the second change rate; the first weight value and the second weight value may be the same or different.
A sensitivity updating module 50, configured to determine a second sensitivity based on the proportional relationship and a first weight value corresponding to the proportional relationship, and the first sensitivity and a second weight value corresponding to the first sensitivity;
by giving the proportional relation, the first sensitivity, the dynamically adjusted first weight value and the dynamically adjusted second weight value, the determined second sensitivity can be considered that the proportional relation obtained at the current target measurement time can be a certain time with the first sensitivity in the last sampling period of the original value collected before the target measurement time, and the consistency with the first sensitivity can be considered at the same time.
An analyte concentration data generating module 60 configured to generate a second analyte concentration data set for a first time period based on the second sensitivity and a second data set of the user, the first time period extending from the target measurement time to a second time, the second time being after the target measurement time.
In one case, a second blood glucose concentration data set for the first time period is generated based on the second sensitivity and a second data set of the user (i.e., an original value of the first time period related to blood glucose concentration and a time stamp thereof), the second blood glucose concentration data set including a blood glucose concentration value for display and a time stamp thereof. By adopting the above mode, errors caused by the fact that real blood glucose concentration data at the actual measurement time of each original value cannot be reflected due to sensitivity attenuation in the continuous blood glucose monitoring process of the second device 200 can be eliminated.
In one case, the second device 200 does not output the blood glucose concentration data in real time, thereby avoiding inappropriate or unreasonable error data in the data output in real time, and further avoiding the situation that the diagnosis and treatment effect are influenced due to misleading experts and users by the error data.
In one case, when there are a plurality of target measurement time instants located at different times in a longer second time period (which may include the first time period), then when the analyte concentration data generating device is used for each target measurement time instant, the second sensitivity of each sub-time period in the second time period is obtained based on the first data set of each target measurement time instant, the second data set and the first sensitivity before each target measurement time instant, so as to generate the second blood glucose concentration data set of each sub-time period (for example, one of the sub-time periods may be the first time period). Each of the first sensitivities, which are the last of the second sensitivities, may be inherited with a certain weight, and the second blood glucose concentration data set for each time segment may be generated with more or less consideration of the initial sensitivity and the sensitivities located before each of the first time segments and at different respective time instants. The second blood glucose concentration data sets of each sub-period are combined together to form a second blood glucose concentration data set of the second period, the second blood glucose concentration data set can form an overall report of the second period to generate a continuous report capable of reflecting the real blood glucose concentration level of the user, and the overall report can more reasonably restore the real blood glucose concentration condition of the user and can achieve the clinical practical application effect.
The invention combines a first data set acquired by a first device and a second data set acquired by a second device of a user to determine a proportional relationship, wherein the proportional relationship is a ratio of an original value at or closest to the target measurement time to first blood glucose concentration data; and determining a first weight value and a second weight value based on the change rate of the proportional relationship relative to the first sensitivity, and further determining a second sensitivity for generating a second blood glucose concentration data set of the first time period, wherein the second sensitivity can consider the proportional relationship corresponding to the target measurement time, can keep consistency with the first sensitivity, and avoids generating unreasonable and abrupt second sensitivity. Based on the dynamically adjusted second sensitivity, the second sensitivity of each time period can be kept to more reasonably restore the real situation of each original value actual measurement time, the generated second sensitivity is very close to the real sensitivity of each original value actual measurement time, the second device 200 can be enabled to generate a more accurate second blood glucose concentration data set in a first time period after the target measurement time, and output data of the second device 200 with high sensitivity and high measurement accuracy is achieved. The invention can eliminate the error caused by the fact that the real blood glucose concentration data of each original value at the actual measurement time cannot be reflected due to the sensitivity attenuation of the second device 200 in the continuous blood glucose monitoring process, and can also directly output the dynamically adjusted and more accurate second blood glucose concentration data set, thereby avoiding the misguidance of a user caused by the fact that the second device 200 outputs data which is not adjusted by the first data set.
In a preferred embodiment, the raw values comprise data collected by the second device 200 for determining the second analyte concentration data set. Preferably, the raw values include current values for determining the second analyte concentration data set, the current values being obtained after an electrochemical reaction between a sensor in the second apparatus 200 and a particular solution (e.g., blood, interstitial or other solution in the body of the user, etc.); the particular solution is the solution in which the sensor is located.
In a preferred embodiment, the weight value determining module 40 is configured to: determining a rate of change R of the proportional relationship with respect to the first sensitivity using the following equation:
Figure 561182DEST_PATH_IMAGE001
determining the first weight value and the second weight value by using the following formulas:
b= f(R,t)
a=1-b
wherein I represents an original value acquired at the target measurement time, and G represents a first value of the target measurement timeAnalyte concentration data, SoldRepresenting a first sensitivity for determining the third analyte concentration data set at the last measurement time, t representing a target time difference between a generation time of the first sensitivity and the target measurement time, f (R, t) representing a function with R and t as parameters, the function representing that a second weight value is related to R, t, a representing a first weight value corresponding to the proportional relationship, b representing a second weight value corresponding to the first sensitivity, wherein a and b satisfy: a + b = 100%.
In one case, depending on the nature of the sensor included in the second device 200, there is a maximum value of the sensitivity change rate per minute in different time periods within the active working time of the sensor, and when the proportional relationship is large (larger than the proportional threshold), it may be that the measurement of the first data set of the first device 100 at the target measurement time is wrong or deviated due to human operation, and at this time b may be increased, a may be decreased, or a =0 and b =100% may be set, so as to eliminate such a mistake or error.
The first sensitivity has a certain available value for the newly generated second sensitivity, the first sensitivity can be considered and given a second weighted value, the difference between the second sensitivity and the first sensitivity can be properly reduced, the sensitivity is more smoothly converted, and data mutation is not generated in the first time period. If the proportional relationship is more, the first weight value can be set to be larger than the second weight value, if the reference to the first sensitivity is more, the first weight value can be set to be not larger than the second weight value, and if the proportional relationship and the second sensitivity are considered to be equally important, the first weight value can be set to be equal to the second weight value. Specifically, the first weight value and the second weight value may be set according to a rate of change of the proportional relationship with respect to the first sensitivity, a target time difference between a generation time of the first sensitivity and the target measurement time.
In a preferred embodiment, the second weighting value is an initial preset value, zero or an empirical preset value.
That is, in one case, b is dynamically adjustable, and the initial value of b may be 0 or an initial preset value, an empirical preset value.
In a preferred embodiment, the first sensitivity is a preset sensitivity.
In one case, the predetermined sensitivity may be an initial sensitivity of the sensor or a predetermined sensitivity determined based on the method of the present invention to satisfy a predetermined condition.
In a preferred embodiment, the first time is a previous time before the target measurement time, and a first time difference between the target measurement time and the first time is a sampling period for the second device 200 to acquire the original value.
In one case, the first time is a previous time before the target measurement time, so as to ensure that the first sensitivity is the sensitivity of the previous time closest to the target measurement time, which is more meaningful for reference.
In a preferred embodiment, the sensitivity update module 50 is configured to: determining the second sensitivity using the following equation:
Figure 237014DEST_PATH_IMAGE002
wherein S represents the second sensitivity.
In one case, the first sensitivity acts on the original value between the first sensitivity generation timing to the next sensitivity (second sensitivity) generation timing of the first sensitivity; the second sensitivity acts on the original value in the first period, i.e., from the second sensitivity generation timing to the next sensitivity (third sensitivity) generation timing of the second sensitivity.
In a preferred embodiment, the analyte concentration data generation module 60 is configured to: and dividing the second data set corresponding to each display period of the first time period by the second sensitivity to generate a second analyte concentration data set of the first time period, wherein the display period is a period of displaying the second analyte concentration data set by the second device 200.
The corresponding raw value for each display cycle divided by the second sensitivity may generate a second blood glucose concentration data set for the first time period.
In a preferred embodiment, the apparatus further comprises an output module for: and displaying the second analyte concentration data set according to the display period.
In one case, after the second blood glucose concentration data set is generated, the second blood glucose concentration data set may be output and displayed in a display cycle, the output and displayed data each being data closer to the user's true blood glucose level. The display period is not less than 1 minute. The display period is preferably 2-3 minutes, and in general, the time interval for data display by the CGM system, that is, the display period is 2-3 minutes.
In a preferred embodiment, the first data set is obtained by performing pre-screening based on a preset rule. The preset rules include: when a plurality of different sets of first devices 100 exist, a set of data of one first device 100 with the highest trustworthiness is screened out as a first data set, and the trustworthiness is determined based on the model of the first device 100 or the regular quality control maintenance record.
In one case, a set of data of a first device 100 with the highest trustworthiness is selected as the first data set, possibly a glucose meter of a certain brand or model with the highest trustworthiness. The first device 100 may refer to a plurality of different brands or different models of the same brand, and may be Roche, Yueje, or other brands. When different brands of blood glucose meters are used, data obtained by the blood glucose meters used by the user in history is preferred, for example, the same user can use the same first device 100 for calibration each time during the blood glucose monitoring process; the error can also be reduced by selecting a specific device among a plurality of devices. The blood glucose meter generally needs to be calibrated and maintained regularly, maintenance records are reserved, some data such as test accuracy and the like can be contained in the maintenance records, and the credibility can be confirmed based on the maintenance records. If the calibration and quality control maintenance is not carried out for a long time, and the credibility of the equipment which does not find the calibration and quality control maintenance record is lower, the equipment is not adopted, and the credibility of the commonly adopted glucometer is more than CGM.
In a preferred embodiment, the second time is located at or before a third time, the third time is a next measurement time after the target measurement time, and a second time difference between the third time and the second time is not less than one display period.
In one case, when the second time is located at a third time, that is, the first period (that is, the application period of the second sensitivity) continues from the target measurement time to the next measurement time. In another case, when the second time is before the third time, i.e. the first time period (i.e. the application time period of the second sensitivity) lasts from the target measurement time to a time before the next measurement time, the determination of a time may be based on the target time difference, e.g. the target time difference is larger than 12 hours, and from the time after the time there may be other updated sensitivities available, etc. That is, the effective period of the second sensitivity may be set based on the attenuation characteristic of the sensor performance.
In a preferred embodiment, the second time is located at or before a fourth time, which is an end measurement time after the target measurement time.
In one case, when the second timing is located at the fourth timing, that is, the first period (that is, the application period of the second sensitivity) continues from the target measurement timing to the end measurement timing (preferably, the end measurement timing of the CGM to the original value). In another case, when the second time is before the fourth time, that is, the first time period (that is, the application time period of the second sensitivity) continues from the target measurement time to another time before the end measurement time, the determination of another time may be based on the target time difference, for example, the target time difference is greater than 12 hours, and then there may be other updated sensitivities available from the another time. That is, the effective period of the second sensitivity may be set based on the attenuation characteristic of the sensor performance.
In a preferred embodiment, the apparatus further comprises:
at least one display module configured for enabling visualization of the second analyte concentration data set;
and/or, at least one acquisition module configured to acquire the first data set and the second data set of the user.
The present invention also provides a system for monitoring analyte levels, comprising:
a sensor configured to acquire a second data set;
a wireless transmitter to transmit the second data set;
and
a mobile computing device, comprising:
a receiving device configured to receive a first data group and a second data group;
a memory to store data including the first and second data sets;
a processor to process the data, and a software application including instructions stored in the memory that, when executed by the processor, obtain a first data set of a user, the first data set obtained by the first apparatus 100, the first data set including first analyte concentration data and its corresponding target measurement time;
acquiring a second data set of the user, the second data set comprising a raw value associated with the analyte concentration acquired by the second device 200 and a timestamp thereof;
determining a proportional relationship based on the first data set and the second data set; the proportional relationship is a ratio of the original value at a target time to the first analyte concentration data at the target measurement time, the target time being at or closest to the target measurement time;
determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is the sensitivity at a first moment, and the first moment is between the last measurement moment and the target measurement moment;
determining a second sensitivity based on the proportional relation and a first weight value corresponding to the proportional relation as well as the first sensitivity and a second weight value corresponding to the first sensitivity;
generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, the first time period extending from the target measurement time to a second time, the second time being subsequent to the target measurement time.
Fig. 6 illustrates a physical structure diagram of an electronic device, which may include: a processor (processor)610, a communication Interface (Communications Interface)620, a memory (memory)630 and a communication bus 640, wherein the processor 610, the communication Interface 620 and the memory 630 communicate with each other via the communication bus 640. Processor 610 may invoke logic instructions in memory 630 to perform a method of analyte concentration data generation, the method comprising: s1, obtaining a first data set of the user, the first data set being obtained by a first device, the first data set including first analyte concentration data and a corresponding target measurement time.
S2, obtaining a second data set of the user, the second data set including a raw value associated with the analyte concentration obtained by the second device and a timestamp thereof.
S3, determining a proportional relation based on the first data group and the second data group; the proportional relationship is a ratio of the original value at a target time, which is the target measurement time or a time closest to the target measurement time, to the first analyte concentration data at the target measurement time.
S4, determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is a sensitivity at a first time, and the first time is located between a last measurement time and the target measurement time.
And S5, determining a second sensitivity based on the proportional relation, the first weight value corresponding to the proportional relation, the first sensitivity and the second weight value corresponding to the first sensitivity.
S6, generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, the first time period extending from the target measurement time to a second time, the second time being subsequent to the target measurement time.
In addition, the logic instructions in the memory 630 may be implemented in the form of software functional units and stored in a computer readable storage medium when the logic instructions are sold or used as independent products. Based on such understanding, the technical solution of the present invention or a part thereof which substantially contributes to the prior art may be embodied in the form of a software product, which is stored in a storage medium and includes several instructions for causing a computer device (which may be a personal computer, a server, or a network device) to execute all or part of the steps of the method according to the embodiments of the present invention. And the aforementioned storage medium includes: a U-disk, a removable hard disk, a Read-Only Memory (ROM), a Random Access Memory (RAM), a magnetic disk or an optical disk, and other various media capable of storing program codes.
In another aspect, the present invention also provides a computer program product comprising a computer program stored on a non-transitory computer readable storage medium, the computer program comprising program instructions which, when executed by a computer, enable the computer to perform the analyte concentration data generating method provided by the above methods, the method comprising: s1, obtaining a first data set of the user, the first data set being obtained by a first device, the first data set including first analyte concentration data and a corresponding target measurement time.
S2, obtaining a second data set of the user, the second data set including the original value associated with the analyte concentration obtained by the second device and its timestamp.
S3, determining a proportional relation based on the first data group and the second data group; the proportional relationship is a ratio of the original value at a target time, which is the target measurement time or a time closest to the target measurement time, to the first analyte concentration data at the target measurement time.
S4, determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is a sensitivity at a first time, and the first time is located between a last measurement time and the target measurement time.
And S5, determining a second sensitivity based on the proportional relation and the corresponding first weight value thereof, and the first sensitivity and the corresponding second weight value thereof.
S6, generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, the first time period extending from the target measurement time to a second time, the second time being subsequent to the target measurement time.
In yet another aspect, the present invention also provides a non-transitory computer readable storage medium having stored thereon a computer program which, when executed by a processor, implements a method of analyte concentration data generation provided by the methods described above, the method comprising: s1, obtaining a first data set of the user, the first data set being obtained by a first device, the first data set including first analyte concentration data and a corresponding target measurement time.
S2, obtaining a second data set of the user, the second data set including a raw value associated with the analyte concentration obtained by the second device and a timestamp thereof.
S3, determining a proportional relation based on the first data group and the second data group; the proportional relationship is a ratio of the original value at a target time, which is the target measurement time or a time closest to the target measurement time, to the first analyte concentration data at the target measurement time.
S4, determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is a sensitivity at a first time, and the first time is located between a last measurement time and the target measurement time.
And S5, determining a second sensitivity based on the proportional relation, the first weight value corresponding to the proportional relation, the first sensitivity and the second weight value corresponding to the first sensitivity.
S6, generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, the first time period extending from the target measurement time to a second time, the second time being subsequent to the target measurement time.
The above-described embodiments of the apparatus are merely illustrative, and the units described as separate parts may or may not be physically separate, and parts displayed as units may or may not be physical units, may be located in one position, or may be distributed on multiple network units. Some or all of the modules may be selected according to actual needs to achieve the purpose of the solution of the present embodiment. One of ordinary skill in the art can understand and implement it without inventive effort.
Through the above description of the embodiments, those skilled in the art will clearly understand that each embodiment can be implemented by software plus a necessary general hardware platform, and certainly can also be implemented by hardware. Based on the understanding, the above technical solutions substantially or otherwise contributing to the prior art may be embodied in the form of a software product, which may be stored in a computer-readable storage medium, such as ROM/RAM, magnetic disk, optical disk, etc., and includes several instructions for causing a computer device (which may be a personal computer, a server, or a network device, etc.) to execute the method according to the various embodiments or some parts of the embodiments.
Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.

Claims (18)

1. A method of generating analyte concentration data, comprising:
obtaining a first data set of a user, the first data set obtained by a first device, the first data set including first analyte concentration data and a corresponding target measurement time;
obtaining a second data set of the user, the second data set including a raw value associated with an analyte concentration obtained by a second device and a timestamp thereof;
determining a proportional relationship based on the first data set and the second data set; the proportional relationship is a ratio of the original value at a target time to the first analyte concentration data at the target measurement time, the target time being at or closest to the target measurement time;
determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is the sensitivity at a first moment, and the first moment is between the last measurement moment and the target measurement moment;
determining a second sensitivity based on the proportional relation and a first weight value corresponding to the proportional relation as well as the first sensitivity and a second weight value corresponding to the first sensitivity;
generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, the first time period extending from the target measurement time to a second time, the second time being subsequent to the target measurement time; generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, comprising:
and dividing a second data set corresponding to each display period of the first time period by the second sensitivity to generate a second analyte concentration data set of the first time period, wherein the display period is the period of displaying the second analyte concentration data set by the second device.
2. The analyte concentration data generation method of claim 1, wherein the raw values comprise data collected by the second device for determining the second analyte concentration data set.
3. The analyte concentration data generating method of claim 2, wherein the raw values comprise current values for determining the second analyte concentration data set, the current values being obtained after an electrochemical reaction between a sensor in the second device and a particular solution; the particular solution is the solution in which the sensor is located.
4. The method of generating analyte concentration data according to claim 1, wherein determining the first and second weight values based on the rate of change of the proportional relationship with respect to the first sensitivity comprises:
determining a rate of change R of the proportional relationship with respect to the first sensitivity using the following equation:
Figure DEST_PATH_IMAGE001
determining the first weight value and the second weight value by using the following formulas:
b= f(R,t)
a=1-b
wherein I represents the original value acquired at the target measurement time, G represents the first analyte concentration data at the target measurement time, SoldIndicating a first sensitivityT represents a target time difference between the generation time of the first sensitivity and the target measurement time, f (R, t) represents a function with R and t as parameters, a represents a first weight value corresponding to the proportional relation, b represents a second weight value corresponding to the first sensitivity, wherein a and b satisfy: a + b = 100%.
5. The analyte concentration data generating method of claim 1, wherein the first sensitivity is a preset sensitivity.
6. The analyte concentration data generating method of claim 1, wherein the first time is a previous time before the target measurement time, and a first time difference between the target measurement time and the first time is a sampling period for the second device to acquire the original value.
7. The method of generating analyte concentration data according to claim 4, wherein determining a second sensitivity based on the proportional relationship and a first weight value corresponding thereto, and the first sensitivity and a second weight value corresponding thereto comprises: determining the second sensitivity using the following equation:
Figure 999890DEST_PATH_IMAGE002
wherein S represents the second sensitivity.
8. The method of generating analyte concentration data according to claim 1, wherein generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set of the user comprises:
and displaying the second analyte concentration data set according to the display period.
9. The analyte concentration data generating method of claim 8, wherein the display period is not less than 1 minute.
10. The method of claim 1, wherein the first data set is pre-screened based on a predetermined rule.
11. The analyte concentration data generating method of claim 10, wherein the preset rule comprises: when a plurality of groups of different first equipment exist, screening out a group of data of the first equipment with the highest credibility as a first data group, wherein the credibility is determined based on the model of the first equipment or the regular quality control maintenance record.
12. The analyte concentration data generation method according to claim 1, wherein the second time is located at or before a third time, the third time is a next measurement time after the target measurement time, and a second time difference between the third time and the second time is not less than one display period.
13. The analyte concentration data generation method of claim 1, wherein the second time is at or before a fourth time, which is an end measurement time after the target measurement time.
14. The analyte concentration data generation method of claim 1, further comprising:
visualizing the second analyte concentration data set using at least one display module;
and/or acquiring the first data group and the second data group of the user by utilizing at least one acquisition module.
15. An analyte concentration data generating apparatus, comprising:
a first data set acquisition module for acquiring a first data set of a user, the first data set being acquired by a first device, the first data set including first analyte concentration data and a target measurement time corresponding thereto;
a second data set acquisition module for acquiring a second data set of the user, the second data set including a raw value associated with an analyte concentration acquired by a second device and a timestamp thereof;
a proportional relationship determination module for determining a proportional relationship based on the first data group and the second data group; the proportional relationship is a ratio of the original value at a target time to the first analyte concentration data at the target measurement time, the target time being at or closest to the target measurement time;
the weight value determining module is used for determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is the sensitivity at a first moment, and the first moment is between the last measurement moment and the target measurement moment;
the sensitivity updating module is used for determining a second sensitivity based on the proportional relation and a first weight value corresponding to the proportional relation as well as the first sensitivity and a second weight value corresponding to the first sensitivity;
an analyte concentration data generation module configured to generate a second analyte concentration data set for a first time period based on the second sensitivity and a second data set of the user, the first time period extending from the target measurement time to a second time, the second time being after the target measurement time; generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, comprising:
and dividing a second data set corresponding to each display period of the first time period by the second sensitivity to generate a second analyte concentration data set of the first time period, wherein the display period is the period of displaying the second analyte concentration data set by the second device.
16. A system for monitoring analyte levels, comprising:
a sensor configured to acquire a second data set;
a wireless transmitter to transmit the second data set;
and
a mobile computing device, comprising:
a receiving device configured to receive a first data group and a second data group;
a memory to store data including the first and second data sets;
a processor to process the data, and a software application including instructions stored in the memory that, when executed by the processor, obtain a first data set of a user, the first data set obtained by a first device, the first data set comprising first analyte concentration data and its corresponding target measurement time;
obtaining a second data set of the user, the second data set including a raw value associated with an analyte concentration obtained by a second device and a timestamp thereof;
determining a proportional relationship based on the first data set and the second data set; the proportional relation is a ratio of an original value at a target time to first analyte concentration data at a target measurement time, wherein the target time is the target measurement time or a time closest to the target measurement time;
determining a first weight value and a second weight value based on the change rate of the proportional relation relative to the first sensitivity; the first sensitivity is the sensitivity at a first moment, and the first moment is between the last measurement moment and the target measurement moment;
determining a second sensitivity based on the proportional relation and a first weight value corresponding to the proportional relation as well as the first sensitivity and a second weight value corresponding to the first sensitivity;
generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, the first time period extending from the target measurement time to a second time, the second time being subsequent to the target measurement time; generating a second analyte concentration data set for a first time period based on the second sensitivity and a second data set for the user, comprising:
and dividing a second data set corresponding to each display period of the first time period by the second sensitivity to generate a second analyte concentration data set of the first time period, wherein the display period is the period of displaying the second analyte concentration data set by the second device.
17. An electronic device comprising a memory, a processor and a computer program stored on the memory and executable on the processor, wherein the processor when executing the program performs the steps of the analyte concentration data generating method of any one of claims 1 to 14.
18. A non-transitory computer-readable storage medium, on which a computer program is stored, which, when being executed by a processor, carries out the steps of the analyte concentration data generating method according to any one of claims 1 to 14.
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