WO2023121497A1 - Procédé de détermination non invasive du changement du contenu en glucose du sang d'une personne - Google Patents

Procédé de détermination non invasive du changement du contenu en glucose du sang d'une personne Download PDF

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WO2023121497A1
WO2023121497A1 PCT/RU2021/000586 RU2021000586W WO2023121497A1 WO 2023121497 A1 WO2023121497 A1 WO 2023121497A1 RU 2021000586 W RU2021000586 W RU 2021000586W WO 2023121497 A1 WO2023121497 A1 WO 2023121497A1
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blood
glucose
human
reflected light
person
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PCT/RU2021/000586
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English (en)
Russian (ru)
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Олег Олегович ТИХОНЕНКО
Злата Олеговна ТИХОНЕНКО
Даниил Олегович ТИХОНЕНКО
Владимир Павлович ЛОБКО
Александр Викторович КАЛАЧЕВ
Юрий Алексеевич КИРИЧЕК
Александр Васильевич ЧЕПУРНОЙ
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Аккофриск Технологии Лтд.
Олег Олегович ТИХОНЕНКО
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Priority to PCT/RU2021/000586 priority Critical patent/WO2023121497A1/fr
Publication of WO2023121497A1 publication Critical patent/WO2023121497A1/fr

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    • 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
    • A61B5/1455—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 using optical sensors, e.g. spectral photometrical oximeters

Definitions

  • the invention relates to medicine and technology, specifically to a method for non-invasive determination of changes in glucose in human blood and can be used to create diagnostic systems in medicine and technology, as well as to create socially-oriented systems for the early diagnosis of diabetes and concomitant diseases.
  • sugar in blood without wounds is currently determined by a large number of indirect methods.
  • electrochemical indicators of the skin through body temperature and pressure, through the light absorption of body tissues (optical method), etc.
  • body tissues optical method
  • places of control are also diverse: wrist, finger, earlobe, etc.
  • the method associated with the light absorption of tissues consists in using the optical characteristics (in particular, the ability to scatter light) of vessels with blood and lymph, as well as the optical characteristics of other tissues of the human body to determine changes in glucose in the body and, in particular, in the blood .
  • An analogue of the invention is a method for detecting blood sugar without wounds using a blood glucose sensor, which is the result of an integrated test for blood oxygen saturation and pulse rate (CN101390751A, publ. 03/25/2009).
  • Integrator sensor for non-invasive detection of glucose in blood contains a probe for determining the local rate of metabolism of a human finger and a probe for detecting oxygen in blood.
  • Also analogous is a method for measuring the metabolic rate based on non-invasive measurement of blood glucose (CN104287693A, publ. 21.01.2015).
  • a method for measuring metabolic rate based on non-invasive measurement of blood glucose by means of a temperature sensor, a humidity sensor and a thermal energy radiation sensor in three heat transfer modes, including convection, evaporation and radiation between the local surface of the human body and the environment.
  • Another analogue is the method of micro-calorimetric measurement of the rate of local tissue metabolism, water content in the intercellular tissue, the concentration of blood biochemical components and pressure in the cardiovascular system (RU2396897, publ. 20.08.2010).
  • the method consists in locally measuring the intensity of heat transfer through the surface of a limited area of the skin by measuring the density of the heat transfer heat flux due to the temperature gradient, the amount of heat transfer due to evaporative cooling in the process of imperceptible perspiration, control the amount of external pressure on the surface of the controlled area, and thus determine the value of heat production (thermal effect) and the rate of local metabolism in the volume of tissue located under the controlled area of the skin surface, using the calibration procedure.
  • the analogue refers to the control of blood glucose.
  • An analogue is also a method for measuring the rate of glucose metabolism in the blood (CN106361305A, publ. 02/01/2017).
  • the method includes: measuring the human skin surface temperature, the ambient temperature, the skin surface humidity and the ambient humidity, calculating the heat generated by the human metabolism; measurement of blood oxygen saturation and blood flow.
  • the rate of glucose metabolism in the human body is calculated. First determine blood flow rate, blood oxygen saturation and heat generated by human metabolism, and then determine the glucose metabolism rate according to the blood flow rate, blood oxygen saturation and heat generated by human metabolism.
  • the analogue is a method that implements a device for non-invasive determination of the level of glucose in the fluid of the subject, usually the level of glucose in the blood (WO1999039627A1, publ. 12.08.1999).
  • the skin tissue impedance is measured and this measurement is used with the impedance measurements previously correlated with directly determined glucose levels to determine the glucose level from the newly measured impedance.
  • a non-invasive determination of the level of glucose in the liquid is carried out.
  • An analogue is a method that implements a device for non-invasive determination of blood sugar (CN101194838B, publ. 22.09.2010).
  • the device contains a housing, a movement mechanism in the inner part of the housing and a detecting head, which is connected to the housing.
  • the detection head consists of a temperature sensor at the front end and an ear notch attachment at the rear, while the ear notch attachment consists of a heat-sensitive RTD at the coated midsection.
  • the temperature sensor is connected to a conversion circuit that converts the temperature signal into an electrical signal and the preamplifier moves along the wire. Analog solves the problem of non-invasive determination of blood sugar levels.
  • An analogue is a method in which, in order to improve the accuracy of non-invasive glucose measurement, combinations of three non-invasive methods are used: ultrasonic, electromagnetic and thermal (US8235897B2, publ. 08/07/2012).
  • the method is implemented using a non-invasive glucose monitor, which includes a main unit that controls three different sensory channels (one for each method).
  • the main unit is designed to be attached to the patient's earlobe.
  • the ultrasonic piezo elements are placed on opposite parts of the ear clip and therefore on opposite sides of the earlobe.
  • the electromagnetic channel of the plate capacitors are located on opposite sides of the ear clip, and the earlobe serves as a dielectric.
  • the heat channel includes a heater and a sensor located on the ear clip in close proximity to the earlobe.
  • An analogue is also a method for non-invasive monitoring of physiological measurements (US11129556B2, publ. 09/28/2021).
  • a method for non-invasive monitoring of physiological measurements of a subject is implemented by operating a monitoring device to detect changes in measured physiological signals.
  • the monitoring device includes a measuring unit, which includes: two light indicators, radiation sources and a sensor for detecting light rays emitted by two light sources, and a computerized device associated with the monitoring device. At the same time, the monitoring device is made with the possibility of detachable attachment to the subject's body.
  • An analogue is the method implemented during the operation of a wireless portable non-invasive blood glucose detector (CN203220371U, publ. 02.10.2013).
  • the device is protected by a utility model patent.
  • the utility model discloses a wireless portable non-invasive blood glucose detector that includes a keyboard, a display screen, a device for non-invasive collection of blood glucose information, a signal conversion circuit, a filter circuit, a DSP processor, an electronic tag, and a wireless communication chip.
  • An analogue can be a method implemented during the operation of a non-invasive device for measuring blood sugar levels for insulin injection with feedback (CN1973768A, publ. 06/06/2007).
  • the non-invasive blood sugar monitor for insulin injection has a built-in radio communication module, an electrochemical electrode for extracting fluid from subcutaneous tissue for non-invasive blood sugar measurement, and an insulin pump for insulin injection.
  • the blood sugar monitor continuously and non-invasively extracts tissue fluid from the subcutaneous tissue.
  • the invention can relieve the pain of a diabetic and significantly improve his quality of life. Which is highly doubtful.
  • An analogue can also be the method of operation of a reflective type non-invasive blood glucose detector (CN104771181A, publ. 07/15/2015).
  • Reflective type non-invasive blood glucose detector refers to a detector for detecting blood glucose concentration based on an optical method, various physiological parameters, including oxygen saturation in the human body, pulse rate, and the like.
  • An analogue can also be the way the head of a non-invasive blood sugar level sensor works (CN100490743C, publ. 01/30/2008).
  • the sensor for non-invasive determination of blood sugar contains a temperature sensor, a humidity sensor and a radiation cavity.
  • the radiation cavity is equipped with a radiation sensor.
  • the non-invasive sensor head can quickly and accurately detect all the parameters used to calculate blood sugar without limiting the number of times.
  • An analogue can be a method for determining the level of glucose in the blood (CN202821361U, publ. 03/27/2013).
  • the analog provides a multifunctional system for determining blood glucose.
  • the multifunctional blood glucose detection system contains a device for collecting and processing signals, a display device.
  • the multi-functional blood glucose detection system is capable of performing multi-parameter glucose detection, without injury and with high detection speed.
  • An analogous method for determining the level of glucose in the blood is known, implemented by a non-invasive sensor based on infrared light with a telecast function (CN205031270U, publ. 17.02.2016).
  • This utility model discloses the construction of a non-invasive infrared light blood glucose sensor with a telecast function.
  • the sensor includes an infrared light emitting module, an infrared optical receiver module and an STM32 microprocessor, a pressure control module with a pressure sensor and a drive module.
  • a finger is placed inside the sensitive inductive element of the NMR analyzer and measure the time of spin-lattice relaxation of the nuclei, creating a low-frequency asymmetric modulation, twice during the period, the NMR absorption signals are recorded and the glucose concentration is determined by the calibration mark.
  • An analogue of the invention is also a method (patent RU2537085, publ. 07/20/2013), in which: using a matrix of sensors, multiple readings of electromagnetic impedance are repeatedly measured in the epidermal layer of the patient and in one of the layers, including the skin layer or subcutaneous layer of the patient, until the difference between readings will not exceed the threshold value; calculate the impedance value representing the specified difference, with using an equivalent circuit model and individual correction factor data specific to the physiological characteristics of the patient; and determining the blood metabolite level of the patient based on the impedance value and the blood metabolite level determination algorithm, in which the blood metabolite level data is compared with the corresponding electromagnetic impedance data value of the patient.
  • a group of inventions is known for determining and monitoring the level of glucose in the blood (patent RU2506893 dated September 25, 2012) in the diagnosis of carbohydrate metabolism disorders.
  • the sound vibrations of a person's voice are recorded, their hardware conversion is carried out to obtain a parameter corresponding to the content of glucose in the blood, and the glucose content in the human blood is determined during the registration of sound vibrations.
  • the intensity of the peaks of the sound frequencies of the oscillations of the human voice is used as the indicated intensity parameter, the ratio between the intensities of the peaks of the selected low and high frequencies is used.
  • a device for determining the level of glucose in human blood includes a recorder of sound vibrations of a person's voice, an audio spectrum analyzer with filters for selecting spectrum peaks in the low and high frequencies, a data processing unit from the spectrum analyzer, and a block for determining the value of glucose depending on the change in intensity selected spectrum peaks.
  • a known method of operating a device for measuring blood parameters and physiological characteristics on the finger (US 8.489,165 B2, publ. 07/16/2013) by passing light through the tissue of a human finger.
  • the device includes a lower finger recess provided in the main body of the device; a closable lid attached on hinges, which has an upper finger recess configured to deploy at least one finger stabilizing member while the lid is locked in a closed position; a finger stabilizing member made of a material having flexible-soft plastic characteristics so that it tightly engages with the top of the finger; a light source that is placed in an inclined end wall of the lower finger groove near the bottom of the fingertip; and an end cap that can unfold at the open end of the device when the cover is in the closed position, allowing the device to be calibrated with minimal light wave "noise" from ambient light.
  • an optical sensor device Patent US8,792,948 B2, published in 2014
  • an image processing unit for measuring biophysical parameters.
  • the device consists of optical sensors, an image processing device and serves to detect biophysical parameters, chemical concentrations, chemical saturation and blood analysis.
  • the imaging device receives a live still or video electronic image. Examples of physiological parameters include: pulse rate, blood pressure, glucose, internal or external tissue volume (eg skin).
  • the sensor contains a substrate, a first optical waveguide layer formed on the surface of the substrate, an input grating and an output grating, which are formed in contact with the first optical waveguide layer and spaced apart from each other, and the second optical waveguide layer located between the input grating and the output grating, being in contact with the first layer of the optical waveguide has a higher refractive index than that of the first layer of the optical waveguide, and a functioning layer containing an enzyme and a coloring reagent, which is formed on the second layer of the optical waveguide.
  • a method and device are known (Patent US 5,448,992, published in 1995) for non-invasive measurement of blood glucose concentration, based on the creation of a polarized-modulated laser beam through a polarizing frequency converter, measuring the phase difference introduced, for example, by a finger or an earlobe of a subject, measuring the difference phases between the reference signal and the probe signal and processing the received data, which is then presented as the concentration of glucose in the blood.
  • the device for the above measurements includes an infrared laser source, a polarized frequency converter that produces a polarized-modulated infrared laser beam, a piezoelectric converter for driving the polarization frequency converter, and an optical converter with a head for measuring glucose.
  • the finger is inserted into the glucose measuring unit, and after passing through the finger, the optical beam of the probe is converted into an electrical signal compared to the electrical reference signal, and the resulting phase difference is processed by an electronic signal processing unit, which presents the results as a blood glucose concentration.
  • a non-invasive method for assessing the change in the level of glucose in human blood is known (Patent RU2477074, published in 2013) in the interval At time, which includes the steps in which: the first tetrapolar electrode device is placed parallel to the direction of the muscle fibers in contact with the skin of the said person covering a part of the soft tissue, including muscle fibers; placing the second tetrapolar electrode device perpendicular to the direction of the muscle fibers in contact with the skin of said person covering said part of the soft tissue; measured during the interval At time:
  • An analogue of the claimed invention is a method for non-invasive measurement of blood glucose concentration (Patent RU2515410, published in 2014), which consists in irradiating the zone of maximum accumulation of blood vessels with a laser beam, receiving and instrumental transformation by highlighting the orientation of the polarization vector and the intensity of backscattered radiation and calculating the concentration from them blood glucose.
  • the intensity and polarization of the backscattered light field are recorded by two channels located symmetrically with respect to the laser beam, the receiving channel analyzers are preliminarily adjusted at angles of ⁇ 45° relative to the polarizer transmission plane, at the same time, the dynamics of blood microcirculation in the skin area under study is recorded, measurements are carried out directly from the skin surface.
  • the sensor contains a needle reference electrode and at least a needle working electrode, which contains a conductive layer and an enzyme film layer, and is characterized in that the sensor also contains a stand, a plug and an adhesive element; the needle reference electrode and the working electrode are located on one side of the stand, and the plug is located on the other side of the stand; the plug leads are connected to the needle electrode; and the attachment member is located on one side of the base and is located on the same side as the needle electrode.
  • the above sources can be used for non-invasive measurement of blood glucose concentration. However, all of them are difficult to implement.
  • the prototype of the invention is the method of operation of the device Combo Glucometer (CoG). (httDs://cnogacare.co/.
  • the device is a non-invasive glucometer with an optical sensor from the Israeli company CNOGA Medical.
  • the measurement method used in the Combo Glucometer is based on the photoplethysmography method, which evaluates changes in the state of blood vessels inside the user's finger when it is illuminated light of different wavelengths.
  • the method of operation of the device is as follows.Several LEDs shine in the range of wavelengths from visual to infrared through the fingertip.When the light passes through it, part of the radiation is absorbed and the reflected light signal is changed.Sensor built into the camera device in real time detects changes in the light signal The instrument analyzes the correlation between the signal and biological parameters to obtain the blood glucose level and its change over a certain period of time.
  • the prototype is characterized by the following features that coincide with the features of the invention: a method for non-invasive determination of changes in the glucose content in human blood, in which blood vessels and tissues on the human arm are irradiated using a light source and receive reflected light signals using a light-receiving element, while, when comparing characteristics of the reflected light signals determine the increase or decrease in the level of glucose in the blood,
  • the device will have to be calibrated in order to take into account the individual characteristics (skin color, thickness, etc.) of each person, measuring blood sugar levels using the traditional invasive method using test strips. These strips are inserted into the Combo Glucometer, where the results of their analysis are compared with the measurement data obtained using photoplethysmography. After a "training" period of about 3 days, during which the device learns to correlate the optical characteristics of the user's skin with camera readings, the device works quickly, accurately, which makes it easier to track and comply with the requirements of patients living with diabetes. Such calibration must be carried out periodically in order to constantly maintain the accuracy of measurements at a high level.
  • the meter is equipped with wireless communication technologies that allow you to transfer information to a companion application, and has a large internal memory - it stores up to 2000 test results. At the same time, it can give results in mg / dl and mmol / l. Measurement time - about 40 sec.
  • the prototype is a combined method that requires a long, repeated adjustment of the usual invasive method.
  • the device does not allow continuous monitoring of glucose concentration, its increase or decrease, especially in case of hyperglycemia and hypoglycemia.
  • Hyperglycemia is an increase (often sharp) in blood glucose compared to the norm up to 11.5 mmol / l and higher, up to 16.5 mmol / l.
  • hypoglycemia is a decrease in blood glucose compared to the norm to 3.0 mmol / l and below.
  • real-time recording of changes in blood glucose throughout the day is also an important task in the treatment of diabetes mellitus. The solution of this problem will ensure successful diagnosis and treatment of diabetes, prompt changes in the composition of food taken by patients.
  • the present invention is based on the solution of the problem of creating a method for non-invasive determination of changes in the glucose content in human blood.
  • the method is based on the use of optical sounding of vessels and capillaries with blood, as well as other tissues using light sources, coupled with the reception of a reflected light signal with high accuracy.
  • the implementation of the method is carried out at night and in the morning before breakfast during a person's sleep.
  • the objective of the invention is to create a method for non-invasive real-time determination at night and in the morning before breakfast during a person's sleep, changes in the glucose content in human blood, and also does not require complex and expensive medical equipment.
  • the objective of the invention is solved by implementing a method for non-invasive determination of changes in the glucose content in human blood, in which blood vessels and tissues on the human arm are irradiated using a light source and receiving reflected light signals using a light-receiving element, while comparing the characteristics of the reflected light signals determine increase or decrease in the level of glucose in the blood, and differs from the prototype in that as a characteristic of each of the reflected light signals, the maximum peak of the spectrum of the dependence of the intensity on the wavelength of the reflected light signal is used, while the maximum peak of the spectrum is fixed at the time of maximum filling of the vessels with blood in the area of irradiation of blood vessels with light or the maximum peak of the spectrum is fixed at the time of the minimum filling of vessels with blood in the area of irradiation of blood vessels with light; at the same time, blood vessels and tissues on the human arm, in the wrist area are irradiated with a light source; and non-invasive determination of changes in blood glucose is carried out at night and in the
  • hyperglycemia high blood sugar
  • hypoglycemia low blood sugar
  • the device-bracelet for measuring the pulse rate (HR - heart rate) is taken as the basis.
  • This device is equipped with an LED that emits monochromatic coherent light in a narrow frequency range.
  • the measurement of the pulse is based on the reception by the photodiode of the radiation reflected from the subcutaneous capillaries, which changes synchronously with the pulse.
  • the capillary When the capillary is full, it absorbs light strongly; when it is not filled, it absorbs light weakly.
  • a device that implements the claimed method can be mounted on the basis of Google Android and bracelets based on it, as well as Apple Watch and is completely non-invasive.
  • the device has been upgraded as follows.
  • the software of the device has been improved in such a way that, using the existing light source, simultaneously with the process of measuring the pulse, in which the human wrist is irradiated and the reflected signal is received, the changes in blood and lymph parameters in the vessels, as well as parameters of other human tissues, are determined by the parameters of the reflected signal.
  • an increase or decrease in the level of glucose in the blood is determined, since an increase in glucose levels is associated with a change in the parameters of blood and lymph in the vessels, as well as parameters of other human tissues.
  • the claimed method allows a very quick assessment of a person's condition and diagnosing and monitoring blood glucose levels, as well as making recommendations to eliminate identified problems in real time. At the same time, a completely operational, reasonable and documented conclusion is made about the state of a person, which may be of importance for medicine.
  • the claimed method reduces external interference and measurement errors, since non-invasive determination of changes in blood glucose is carried out at night and in the morning before breakfast during a person's sleep. No additional complex devices are required to assess the glucose level, there is no need to pierce the patient's skin and attach sensors to the body, it is convenient for the patient, it allows you to evaluate the glucose level several times a minute, signal a sharp increase or decrease in the glucose level remotely, for example, to the doctor's computer .
  • the device analyzes the correlation between the signal and biological parameters to obtain the blood glucose level and its change over a certain period of time.
  • a glucometer that implements the claimed method is equipped with wireless data transmission technologies that allow information to be transmitted to an accompanying application, and has a large internal memory - it remembers up to 2000 measurement results. At the same time, it can give results in mg / dl and mmol / l. Measurement time - up to 40 sec.
  • Figure 1 shows a circuit diagram of a device that implements the claimed method.
  • Figure 2 and Figure 3 shows a device that implements the claimed method.
  • the design of the strap provides for adjusting the force of pressing the light source to the human hand by means of a clamping device.
  • Figure 4 shows a plot of the intensity versus wavelength of the incident and reflected light signal. The peaks of the incident and reflected light signals are shown.
  • the method for non-invasive determination of changes in glucose in human blood is as follows. Using a light source 4 (see Fig.1) irradiate the blood vessels and tissues on the arm of a person and receive using a light-receiving element (photodiode) 6 reflected light signals.
  • the maximum peak 19 (see Fig. 4) of the dependence spectrum of the intensity (axis 16, Fig. 4) on the wavelength (axis 17, Fig. 4) of the reflected light signal is used.
  • the maximum peak of the spectrum is fixed at the time of maximum filling of blood vessels in the area of blood vessels irradiation with light, or the maximum peak of the spectrum is fixed at the time of minimum filling of vessels with blood in the area of blood vessels irradiated with light.
  • blood vessels and tissues on the human arm, in the wrist area are irradiated with light source 4, and non-invasive determination of changes in blood glucose is carried out at night and in the morning before breakfast during human sleep.
  • a red light LED with a wavelength of 650 nm or an infrared radiation emitter with a wavelength of 940 nm is used as a light source.
  • the adjustment of the force of pressing the light source to the human hand is carried out by means of a clamping device - an elastic strap 11 covering the wrist, with a plurality of holes 12, 13, 14 and a fixing bracket 15 for adjusting the pressing of the strap and the light source to the human wrist.
  • Calibration of the device for the implementation of the method of non-invasive determination of changes in glucose in human blood is carried out by correlating the reflected light signal from the blood vessels and tissue on the human arm and the blood glucose level obtained invasively during device calibration.
  • Calibration of the device and subsequent non-invasive determination of changes in glucose in human blood is carried out with the same pressing force of the strap and the light source to the human wrist.
  • glucose control is carried out on the display 10.
  • Each device consists of:
  • Figure 1 shows the contact of the master oscillator, position 3 in figure 1;
  • Figure 1 shows the contact of the charger, position 9 in figure 1.
  • Figure 1 shows a schematic diagram of the device.
  • a red light LED with a wavelength of 650 nm is used as the light source 4.
  • an emitter (LED) of infrared radiation with a wavelength of 940 nm is used as a light source 4.
  • the term "light” includes the visible, infrared, and ultraviolet regions of the spectrum.
  • a light source is understood as radiation with wavelengths of visible, infrared and ultraviolet radiation.
  • the device works as follows.
  • the device Wear the device on your wrist. Using the holes 12, 13,14 and the fixing bracket 15 on the strap 11, the device is pressed against the surface of the body.
  • the clamp should be comfortable for the person.
  • Capacitor 2 is charged from battery 1 with contact 9 closed. After the capacitor is charged, contact 9 is opened and contact 3 is closed. The capacitor is discharged to LED 2 and resistance 5.
  • the light signal 18 (see Fig.4) from LED 4 enters the human body, is partially reflected from parts of the human body and enters photodiode 6. In other words, the device sends an electrical impulse to the LED and measures the resulting signal (electrical pulse) on the photodiode 6.
  • Calibration is necessary to develop a highly accurate algorithm for calculating blood sugar.
  • it is necessary to perform a complete study in which the level of sugar in a person's blood is measured, observed and recorded using an invasive device with simultaneous recording of data by a device that implements the claimed method.
  • the FreeStyle Libre device https://www.freestylelibre.ru/libre/ was used as an invasive device.
  • the spectrum is understood as the distribution of the values of a physical quantity, namely, the dependence of the intensity on the wavelength of the light signal.
  • this sign can be written as follows: as a characteristic of each of the reflected light signals, the area under the curve of the spectrum of the dependence of the intensity on the wavelength of the reflected light signal is used. Also, as a characteristic of each of the reflected light signals, it is possible to use a comparison of the amount of electrical energy used to power the light source and the amount of electrical energy received from the photodiode.
  • this sign can be written as follows: as a characteristic of each of the reflected light signals, the amount of electricity of the reflected light signal is used.
  • a graph of the dependence of the intensity on the wavelength of the incident and reflected light signal is shown in Fig.4.
  • the peaks of the incident 18 and reflected light signals 19 are shown.
  • Coordinates: the y-axis 16 is the intensity of the light signals, the abscissa 17 is the wavelength of the light signal.
  • Tables 1-5 present the results of experiments with a device equipped with a red LED.
  • the tables present real-time operational fixation of the development of hyperglycemia (tables 1-4) and hypoglycemia (tables 5 and 6) at night and in the morning before breakfast.
  • the experiments involved 6 people of different ages.
  • the intensity of the received infrared signal is 9-10% higher than the intensity of the received red light signal.
  • a method has been created for non-invasive real-time determination at night and in the morning before breakfast during human sleep of changes in the glucose content in human blood.
  • the implementation of the method does not require complex and expensive medical equipment.
  • the device used to implement the method will look like a traditional modern fitness bracelet.
  • EFFECT ease of implementation of the method in the form of operation of a "smart" bracelet on the wrist and operational fixation in real time of the process of development of hyperglycemia and hypoglycemia at night and in the morning before breakfast during a person's sleep.
  • the intensity of the incident light signal is assumed to be 100%.
  • the wavelength of the light signal is 650 nm.
  • the intensity of the received light signal is the average value after 5 measurements, rounded to the nearest whole number.

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Abstract

L'invention se rapporte au domaine de la médecine et des techniques connexes, et concerne plus précisément un procédé de détermination non invasive du changement du contenu en glucose du sang d'une personne. Le but de la présente invention est atteint par la mise en oeuvre d'un procédé de détermination non invasive du changement contenu en glucose du sang d'une personne, lequel consiste à utiliser une source de lumière afin d'illuminer les vaisseaux sanguins et les tissus dans la main d'une personne, et recevoir des signaux lumineux réfléchis à l'aide d'un élément récepteur de lumière; on détermine lors de la comparaison des caractéristiques des signaux lumineux réfléchis, on détermine une augmentation ou une diminution du niveau de glucose dans le sang, et on utilise comme caractéristique de chacun des signaux lumineux réfléchis un pic maximal du spectre de dépendance de l'intensité par rapport à la longueur d'onde du signal lumineux réfléchi; on utilise comme source de lumière une LED à rayonnement rouge et infrarouge, et le procédé consiste à ajuster la force de compression de la source de lumière contre la main de la personne. Le résultat technique de l'invention consiste en une simplicité de mise en oeuvre du procédé, consistant à utiliser un bracelet sur le poignet et à enregistrer fonctionnellement en temps réel le processus de développement d'hyperglycémie ou d'hypoglycémie de nuit et le matin avant le petit-déjeuner pendant le sommeil de la personne.
PCT/RU2021/000586 2021-12-21 2021-12-21 Procédé de détermination non invasive du changement du contenu en glucose du sang d'une personne WO2023121497A1 (fr)

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US20200000345A1 (en) * 2013-05-23 2020-01-02 Medibotics Llc Wearable Ring of Optical Biometric Sensors
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US20200196865A1 (en) * 2018-12-19 2020-06-25 Dexcom, Inc. Intermittent monitoring

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060264719A1 (en) * 2004-08-11 2006-11-23 Schurman Matthew J Method for data reduction and calibration of an OCT-based blood glucose monitor
US20200000345A1 (en) * 2013-05-23 2020-01-02 Medibotics Llc Wearable Ring of Optical Biometric Sensors
US20180279892A1 (en) * 2015-09-30 2018-10-04 Xin Qi Device and method for measuring a vital signal
US20200077961A1 (en) * 2018-09-11 2020-03-12 Samsung Electronics Co., Ltd. Apparatus and method for health care
US20200196865A1 (en) * 2018-12-19 2020-06-25 Dexcom, Inc. Intermittent monitoring

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