WO2022146164A1 - Système et procédé pour déterminer de manière non invasive la concentration de glucose dans le sang - Google Patents

Système et procédé pour déterminer de manière non invasive la concentration de glucose dans le sang Download PDF

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Publication number
WO2022146164A1
WO2022146164A1 PCT/RU2020/000783 RU2020000783W WO2022146164A1 WO 2022146164 A1 WO2022146164 A1 WO 2022146164A1 RU 2020000783 W RU2020000783 W RU 2020000783W WO 2022146164 A1 WO2022146164 A1 WO 2022146164A1
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WIPO (PCT)
Prior art keywords
blood
glucose
signal
carry out
peak
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PCT/RU2020/000783
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English (en)
Russian (ru)
Inventor
Владимир Андреевич КОЗЛОВ
Алексей АГАФОНОВ
Марина Александровна КОЗЛОВА
Анна Андреевна КОЗЛОВА
Original Assignee
Общество С Ограниченной Ответственностью "Энннигм"
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Priority to PCT/RU2020/000783 priority Critical patent/WO2022146164A1/fr
Publication of WO2022146164A1 publication Critical patent/WO2022146164A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06N—COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
    • G06N3/00—Computing arrangements based on biological models
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis

Definitions

  • the present technical solution relates to the field of medicine, in particular, to a method and system for non-invasive determination of blood glucose concentration.
  • an earphone with a glucose sensor including an earpiece housing, an intelligent control located inside the earphone housing, and a glucose sensor functionally associated with the intelligent control.
  • the smart control is configured to detect the earphone user's glucose level using a glucose sensor.
  • the earpiece may further include a wireless transceiver located within the earpiece housing operatively connected to the intelligent control.
  • the glucose sensor is non-invasive and based on near-infrared spectroscopy.
  • the headphone housing is designed to ensure the positioning of the glucose sensor against the wall of the external auditory canal.
  • the method of measuring blood glucose levels underlying its operation does not take into account the movement of blood in a living body, which can have a significant effect on the measurement results and adversely affect their accuracy. It is also worth noting that an important feature is the study of the earlobe, which allows irradiation "in the light", which gives higher accuracy and reproduction of the result.
  • the measurement takes place cyclically, at equal time intervals, selected individually for each patient, depending on the pulse rate (the duration of the measurement cycle is set step by step as an integer multiple of the pulse duration).
  • the light transmission or scattering ability of the blood is repeatedly recorded at two values of the wavelengths of the incident radiation in the near infrared region of the spectrum (selected from the range of 1560-1630 nm, and 790-815 nm, respectively), taking into account the temperature of the blood, which is also continuously measured.
  • Statistical averaging of the measured multiple values is performed in each cycle with the calculation of the indicator value, according to which the concentration of glucose in the blood is determined by comparing it with the data of a predetermined calibration table.
  • the technical problem to be solved by the proposed technical solution is the impossibility in domestic conditions, without time delay, without the involvement of medical personnel, to carry out with high accuracy continuous continuous non-invasive monitoring of the state of glucose metabolism in a patient with diabetes mellitus, and also, on the basis of monitoring, to issue personal recommendations for control and management of human nutrition, physical activity of a person and the emotional state of a person.
  • Constant monitoring of the patient's glucose concentration allows you to quickly respond to critical situations and provide the possibility of much better control of glucose levels, which leads to the possibility of avoiding long-term complications and critical situations (for example, hypoglycemic coma).
  • the technical result consists in creating a method for continuous determination of the concentration of glucose in the patient's blood in a non-invasive way, which would solve the above problems.
  • An additional technical result is providing recommendations for the control and management of human nutrition, physical activity of a person and the emotional state of a person.
  • the claimed technical result is achieved through the implementation of a method for non-invasive determination of the concentration of glucose in the patient's blood, including the steps at which: continuous irradiation of the skin area in the area of accumulation of blood vessels, in the volume of blood, is carried out for a predetermined time, by means of an optical radiation source in the passing or reflected light detected by a photodetector; converting the received at least one luminous flux into an electrical signal, the resulting electrical signal is converted into a digital signal by means of an analog-to-digital converter; carry out digital processing of the registered signal, carry out analysis and allocate peaks of the pulse wave on the processed registered signal, while the peak of maximum absorption corresponds to the peak of the pulse wave; carry out, by means of a processing unit, pre-processing of the received digital signal, in real time, while combining data and performing smoothing of the received data, if the measuring unit was displaced relative to the skin surface in the process of signal removal; carry out post-processing of the obtained pre-processed digital code, in real
  • the irradiation area is 0.1 - 4.0 cm2.
  • the value of the glucose level is calculated from several consecutive measurements.
  • the claimed technical result is also achieved through the implementation of a method for monitoring the dynamics of the concentration of glucose in the patient's blood, including the steps at which: continuous irradiation of the skin area in the area of accumulation of blood vessels, in the volume of blood, is carried out for a predetermined time, by means of an optical radiation source in the passing or reflected light detected by a photodetector; converting the received at least one luminous flux into an electrical signal, the resulting electrical signal is converted into a digital signal by means of an analog-to-digital converter; carry out digital processing of the registered signal, carry out analysis and extract peaks on the processed registered signal pulse wave, while the peak of maximum absorption corresponds to the peak of the pulse wave; build a graph that reflects the dynamics of changes in the concentration of glucose in the blood by absorption, at the time of the peak of the pulse wave, from time to time; recommendations are given to the user on the basis of the received schedule.
  • a measuring unit including: at least one radiation source, configured to irradiate the skin surface in transmitted light, in the blood volume, for a predetermined time ; at least one photodetector configured to convert radiation into an electrical signal; at the same time, at least one source of infrared or light radiation and at least one photodetector are in a static state relative to each other and relative to the tissues on the surface of the skin in the process of removing the signal; at least one signal amplifier; at least one analog-to-digital converter configured to convert the electrical signal into a digital code; at least one processing unit, configured to carry out the steps of claim 1; computing device.
  • a measuring unit including: at least one radiation source, configured to irradiate the skin surface in transmitted light, in the blood volume, for a predetermined time ; at least one photodetector configured to convert radiation into an electrical signal; at the same time, at least one source of infrared or light radiation and at least one photodetector are in a static state relative to each other and
  • the irradiation area is 0.1 - 4.0 cm2.
  • the radiation source is made in the form of LEDs or a laser.
  • the system is made in the form of a clip.
  • the system is made in the form of a clip on the wing of the nose.
  • the system is made in the form of an earpiece that is inserted into the auricle.
  • the system is made in the form of a suppository, which is inserted into the body cavity.
  • the system is an integral part of the system for monitoring and managing human physical activity, including personal recommender systems and decision support systems for managing human physical activity.
  • the system is an integral part of a system for monitoring and managing a person's emotional state, including personal recommender systems and decision support systems for managing a person's emotional state.
  • Figure 1 illustrates an example of the proposed system for non-invasive determination of the concentration of glucose in the blood.
  • Fig.3 illustrates a graph of the correlation of data from an invasive glucometer with the proposed solution.
  • Fig. 4 illustrates an example of a general design of a computing device.
  • the proposed solution is presented in the form of a hardware-software complex, which consists of two main parts: the hardware in the form of a device for collecting and processing information and a software complex that processes and interprets the data collected by the hardware.
  • the hardware of the complex is shown in figure 1 and consists of a measuring unit, which is based on spectroscopic methods, and a processing unit.
  • Spectroscopic methods using infrared (IR) radiation are known in the prior art and are widely used for non-invasive measurement of the concentration of substances in the body.
  • IR infrared
  • infrared energy is absorbed by glucose, glycosylated hemoglobin and free plasma glucose, the intensity of which corresponds to the concentration of glucose in the blood.
  • the measuring hardware unit includes the following parts: at least one source of optical radiation made in the form of an LED or laser radiation source in the frequency range of infrared radiation from 800 to 2500 nm, namely the intervals of 800-1200 nm, 1300-1700nm and 2000-2400nm infrared areas; at least one photodetector configured to convert radiation into an electrical signal.
  • the photodetector is at least one photodiode or photoresistor for converting radiation into photocurrents.
  • the photodiodes of the photodetector are configured to detect laser radiation obtained as a result of selective absorption of laser beams by glycosylated hemoglobin and free plasma glucose present in the blood of biological tissue; at least one radiation source and at least one photodetector are in a static state relative to each other and relative to the tissues on the detection area during the signal acquisition process, i.e. they do not move during the measurement process, since the device is fixed during the measurement process on the human body stationary, the skin surface irradiated by the light flux does not change during the measurement process, that is, the volume of blood in the irradiated area remains the same.
  • This arrangement provides conditions for continuous recording of data, which are subsequently converted into a blood glucose value.
  • the photodetectors are located opposite the radiation sources in order to detect the signal in a through mode. If the device is made in the form of a clip, which is attached to the earlobe, the photodecors and radiation sources are located in different cases of the clip, on opposite sides of the earlobe. It is also possible to register a signal by reflected light, when the photodetectors and radiation sources are located in the same plane (for example, a bracelet, a ring).
  • the hardware processing unit includes a processing module containing at least one photodetector amplifier, an analog-to-digital converter (ADC), and at least one amplifier with a digital output.
  • Processing unit provides processing the received data from the photodetectors into a digital code and extracting a periodic signal (pulse) and the amplitude of the pulse wave.
  • the hardware of the complex contains a data storage module configured to store various data to support the operation of the system.
  • the software part of the complex contains a calculation module that converts the digital code into a glucose level.
  • the software part on which the data is processed can represent a computing device or a cloud server, the glucose level value is stored on the computing device and displayed in the software (application).
  • the conversion of the digital code into a glucose level can be carried out in the processing unit of the hardware of the complex.
  • the computing device which is a device containing an application, receives the value of the glucose level to display all the received data and stores it in a database.
  • the measuring unit and the processing unit are in functional and structural unity and are located, for example, but not limited to, in a clip worn on the earlobe, in the form of a finger ring, in the form of a bracelet on the wrist, in the form of a clip on the wing of the nose, in the form of an earpiece, which is inserted into the auricle, in the form of a suppository, which is inserted into the body cavity.
  • the proposed method for non-invasive determination of the concentration of glucose in the patient's blood includes the following steps.
  • the hardware part can be made, for example, but not limited to, in the form of a clip, where the two halves of the body are located on one and the other side of the lobe, working with transmitted light or reflected light (when the sensor and the source are on the same side), while the clip fixed on the earlobe with a needle (similar to an earring) or without a needle, in the form of a ring on a finger, in the form of a bracelet on the wrist, in the form of a clip on the wing of the nose, in the form of an earpiece that is inserted into the auricle, in the form of a suppository that is inserted into the body cavity.
  • the hardware-software complex is calibrated, which includes two stages.
  • Information is received about the patient's clinical data, which is entered into an application installed on a computing device: gender, age, data on the patient's diagnosis, information about physiological parameters.
  • the received data contribute to an application on a computing device that is synchronized with the server and is also connected to the machine via a wireless network such as Bluetooth, NFC, Wi-Fi.
  • the entered data is stored in the storage module.
  • Calibration may not be carried out if it is necessary to track the dynamics of changes in glucose levels according to a graph or other methods known from the prior art to track dynamics, for example, but not limited to, notification of sharp jumps, exit from the corridor with a given percentage of deviation, and so on.
  • the skin area in the area of accumulation of blood vessels is continuously irradiated with a source of optical radiation in the near infrared wavelength range and the light flux that has passed through this area of the skin is recorded by means of a photodetector, for example, but not limited to, for 10 seconds with an interval of 30 seconds in the area of maximum accumulation of blood vessels.
  • a photodetector for example, but not limited to, for 10 seconds with an interval of 30 seconds in the area of maximum accumulation of blood vessels.
  • vessels in a private version, irradiate the surface of the earlobe.
  • Exposure time and exposure interval are set by programming the built-in hardware microcontroller prior to operation.
  • the irradiation time was chosen empirically, since this time is enough for the data to become correct, taking into account the "warming up" of the system and reaching the optimal operating mode of the complex.
  • the obtained data is converted, with the help of at least one photodetector, of the received at least one light flux into an electrical signal.
  • Data from the photodetector is amplified by at least one photodetector amplifier.
  • After data is transmitted to at least one analog-to-digital converter configured to convert an electrical signal to a digital code, then the digitized signal passes through one or more digital output amplifiers.
  • the digital code is a periodic signal - an absorption curve versus time.
  • the amplitude of one of the periods of the curve is detected, and it is taken as the initial value, at the moment of which the data is taken for further processing.
  • Peak pulse measurement provides a more accurate measurement of blood glucose levels.
  • the peak of the pulse wave is characterized by maximum blood filling, i.e. it is at the peak of the pulse wave that more material can be obtained for research and the absorption can be calculated more accurately. Measurement at the peak of the pulse wave also allows you to standardize the reading of data, since the volume of blood is the same from measurement to measurement.
  • the resulting glucose value is calculated from several measurements taken in a row, and not just one, i.e. carry out, for example, 10 measurements in a row, every 30 seconds, and the numerical value of the glucose level is given to the user every 3.0 - 3.5 minutes, averaging it over this period.
  • each measurement can be issued for processing to determine the value of the glucose level.
  • the digital code is transmitted to the software part of the complex, where, by means of a processing unit, using mathematical operations, the digital code of the peak of the pulse wave is converted into the value of the glucose level.
  • the glucose value is obtained.
  • Intermediate data are intermediate values, i.e. raw raw data needed to carry out the final conversion to glucose.
  • the transformation of the taken (initial) values is as follows: initial values -> transformed data1 -> transformed data2 -> transformed data3 -> ... -> transformed data N -> glucose values.
  • the conversion of a digital code into a glucose level value includes a pre-processing step, which consists in combining (smoothing out) sharp data changes that can occur, for example, if the measuring unit has moved relative to the skin surface area during signal acquisition.
  • a pre-processing step which consists in combining (smoothing out) sharp data changes that can occur, for example, if the measuring unit has moved relative to the skin surface area during signal acquisition.
  • the hardware part of the complex made in the form of a clip, which is attached on the earlobe, can move along the surface of the earlobe, when running, a sharp change in the position of the head.
  • the obtained preprocessed data are converted, for example, but not limited to, using the Bouguer-Lambert-Beer law, where A, B, C, D are some coefficients, depending, in particular, on the component base and the implementation of the hardware, the conditions for conducting the study, etc.
  • the transformed data is smoothed using mathematical operations, for example, but not limited to, using a combination of lowpass and highpass filtering.
  • the obtained value of the homing coefficient is transmitted to the computing device, where it is stored. All the results obtained in the previous steps are multiplied by the saved multiplication factor. After each of the multiplications by the multiplication factor, the glucose level at the current time is obtained. New multiplication - new glucose level. The resulting variant of the glucose value is given to the user with an interval of 3.0 - 3.5 minutes.
  • the acquired transmitted light or absorbance data may be used to track blood glucose trends in an absorbance versus time plot, without explicit conversion to glucose, or from data obtained from any of the processing steps. For example, you can show the user a graph obtained after reading the data and warn that the angle of the graph is large in one direction or another (for example, if there is a sharp increase, then we can warn that it is time to stop eating, if there is a sharp drop, then on the contrary, offer to eat). Or you can calculate the area under the graph, in arbitrary units, in order to compare with how the body reacts to different foods.
  • the user connects the clip to a “receiver” of data (in this case, a mobile device with Bluetooth and a special application that allows you to receive and save data in real time).
  • a “receiver” of data in this case, a mobile device with Bluetooth and a special application that allows you to receive and save data in real time.
  • the clip begins to take measurements (in this case, every 30 seconds), each of which is stored in the database with reference to time and date.
  • the proposed solution can also be an integral part of a system for monitoring and managing human nutrition, including personal recommender systems, personal mapping of metabolic and nutritional characteristics of a person, monitoring and managing human physical activity, including personal recommender systems and decision support systems for management of a person's physical activity, control and management of a person's emotional state, including personal recommender systems and decision support systems for managing a person's emotional state.

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  • Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Ce groupe d'inventions se rapporte au domaine de la médecine, et concerne notamment un procédé et un système pour déterminer de manière non invasive la concentration de glucose dans le sang. Cette invention consiste en une unité de mesure et au moins une unité de traitement capable de réaliser les étapes du procédé. L'unité de mesure comprend: au moins une source de rayonnement capable d'émettre à la surface de la peau dans la lumière traversante et dans le volume sanguin pendant une durée prédéterminée; au moins un photodétecteur capable de convertir le rayonnement en un signal électrique, au moins une source de rayonnement infrarouge ou lumineux et au moins un photodétecteur se trouvant à l'état statique l'un par rapport à l'autre et par rapport aux tissus à la surface de la peau pendant le processus de capture du signal; au moins un amplificateur de signal; au moins un convertisseur analogique-numérique capable de convertir le signal électrique en code numérique; et un dispositif informatique. Le résultat technique consiste en la création d'un procédé pour déterminer en continu la concentration de glucose dans le sang d'un patient selon un procédé indépendant qui permet de résoudre les problème listés dans la description.
PCT/RU2020/000783 2020-12-30 2020-12-30 Système et procédé pour déterminer de manière non invasive la concentration de glucose dans le sang WO2022146164A1 (fr)

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PCT/RU2020/000783 WO2022146164A1 (fr) 2020-12-30 2020-12-30 Système et procédé pour déterminer de manière non invasive la concentration de glucose dans le sang

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PCT/RU2020/000783 WO2022146164A1 (fr) 2020-12-30 2020-12-30 Système et procédé pour déterminer de manière non invasive la concentration de glucose dans le sang

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017096318A1 (fr) * 2015-12-02 2017-06-08 Echo Labs, Inc. Systèmes et procédés de détection de l'utilisation d'un dispositif de photopléthysmographie
US20170209055A1 (en) * 2016-01-22 2017-07-27 Fitbit, Inc. Photoplethysmography-based pulse wave analysis using a wearable device
US20200000412A1 (en) * 2014-07-30 2020-01-02 Valencell, Inc. Physiological monitoring devices and methods using optical sensors

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200000412A1 (en) * 2014-07-30 2020-01-02 Valencell, Inc. Physiological monitoring devices and methods using optical sensors
WO2017096318A1 (fr) * 2015-12-02 2017-06-08 Echo Labs, Inc. Systèmes et procédés de détection de l'utilisation d'un dispositif de photopléthysmographie
US20170209055A1 (en) * 2016-01-22 2017-07-27 Fitbit, Inc. Photoplethysmography-based pulse wave analysis using a wearable device

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