WO2022265613A1 - Blood-free continuous blood glucose meter - Google Patents

Blood-free continuous blood glucose meter Download PDF

Info

Publication number
WO2022265613A1
WO2022265613A1 PCT/TR2022/050607 TR2022050607W WO2022265613A1 WO 2022265613 A1 WO2022265613 A1 WO 2022265613A1 TR 2022050607 W TR2022050607 W TR 2022050607W WO 2022265613 A1 WO2022265613 A1 WO 2022265613A1
Authority
WO
WIPO (PCT)
Prior art keywords
data
digital
tissue
microcontroller
photosensor
Prior art date
Application number
PCT/TR2022/050607
Other languages
French (fr)
Inventor
Yusuf Furkan ISILDAK
Goksu YILMAZ
Caglar ARPALİ
Original Assignee
Cankaya Universitesi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cankaya Universitesi filed Critical Cankaya Universitesi
Publication of WO2022265613A1 publication Critical patent/WO2022265613A1/en

Links

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
    • 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
    • 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
    • A61B5/14532—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 for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6843—Monitoring or controlling sensor contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6844—Monitoring or controlling distance between sensor and tissue

Definitions

  • the present invention relates to a non-invasive blood glucose meter that provides blood-free and continuous blood glucose measurement.
  • glucometers Devices that measure glucose values in the blood are generally called glucometers.
  • the basic working principle of glucometers is to measure the level of sugar in the blood taken from the finger of the patient. Electrochemical measurement method is used in conventional glucometers. Device and consumables are required for the use of this method; and disposable measuring strips and finger pricking needles are used for each measurement.
  • Conventional glucometers have a high cost per measurement. It is necessary to carry the device and its accessories in order to make the measurement, and these materials must be prepared for the measurement to be made. It is not possible to measure if any of the consumables is missing. Also, since these devices provide measurement with an invasive method, the environment must be sterile. Although patients desire to measure constantly, constantly pricking their fingers with a needle both causes negative complications on the body and the high cost of measurement makes this impossible.
  • the prior art includes non-invasive blood glucose measurement methods.
  • a non-invasive blood glucose monitoring system based on distributed multi-sensor information fusion of multi-wavelength near infrared spectroscopy (NIR) is mentioned.
  • NIR near infrared spectroscopy
  • two measurement ideas continuous monitoring and distributed multi-wavelength measurements, are tested.
  • the light transmittance method was used in said study, it would be difficult to position it for continuous measurement.
  • laser diode is used as light source. This situation increases the cost of the product, makes it difficult to portability, and reduces the size of the product.
  • the non-invasive blood glucose meter which is in the prior art and of which trade name is called “GlucoTrack”, offers patients a comfortable and painless measurement.
  • this device can only be used by people with Type 2 diabetes.
  • the device is not suitable for continuous blood glucose measurement; when a measurement is desired, the measurement probe must be attached to the earlobe, which is a region with low blood density. This causes the measurement results not to contain up-to-date data. Therefore, it cannot be used by people with type 1 diabetes. The reason for this is that people with type 1 diabetes have more variable sugar levels than those with other diabetes.
  • Optical methods are not used for measurement in this device. In order for the device called “GlucoTrack” to continue measurements, the sensor probe must be changed every six months.
  • the present invention relates to a non-invasive blood glucose meter that provides blood-free and continuous blood glucose measurement.
  • the first object of the present invention is to provide a blood-free, painless, hygienic and complication-free measurement for patients.
  • the system according to present invention offers a comfortable measurement to patients as it uses non-invasive methods such as near infrared spectroscopy (NIR), scattering spectroscopy, photoacoustic spectroscopy, and bioimpedance.
  • NIR near infrared spectroscopy
  • the wrist with high blood density is used as the measurement site.
  • more up-to-date data can be obtained and higher accuracy results can be obtained compared to regions with low blood density, such as the earlobe.
  • the present invention is suitable for continuous blood glucose measurement in terms of the region used and can be carried on the arm/wrist all day long.
  • the lifetime of the sensor of the device according to the present invention is at least 1 year.
  • Another object of the present invention is to reduce the costs per measurement.
  • the present invention reduces the cost of measurement since it uses a non-invasive method and does not require consumables, thereby providing a more accurate control of the disease course by providing the opportunity to make more measurements for the patients.
  • the reflection method used in the present invention adds a function that facilitates the use of the device in daily life.
  • the device can be carried on the arm/wrist throughout the day and measurements can be taken all day long. With the use of LED as a light source in the invention, both ease of use and portability are provided, and in addition, the cost is reduced.
  • Another object of the present invention is to make continuous and multiple measurements at desired time and intervals. Measurements can be performed even when patients are asleep. It is possible to control the blood sugar of inpatients remotely by performing measurements continuously and at any time.
  • Another object of the present invention is to provide instant warning when abnormal levels are observed in blood sugar and to notify the necessary institutions or persons for emergencies. By means of the continuous measurement and warning system, it is ensured that the necessary intervention is made quickly in case of emergency.
  • tissue distance measurement is made by using a multisensor.
  • the multisensor consists of a combination of optical and force sensitive resistors. Green LED light with a peak wavelength of 530 nm and absorbed by the human skin is utilized to measure tissue distance. The light absorbed by the human skin is directly proportional to the tissue thickness. Thus, it can be calculated how far the near infrared light used in blood glucose measurement will travel in the tissue.
  • the pressure-force between the photosensors used for blood glucose measurement and the tissue is measured with the force sensor.
  • the pressure-force measured during the calibration is aimed to remain constant in each measurement, because the distance of the near infrared light is shortened when more pressure is applied, and on the contrary, it extends when less pressure is applied. This method is very important in terms of the correct use of the data taken during the calibration during the measurements.
  • the analog-digital converter, digital signal processing, and signal width modulation elements together with the microcontroller used in the invention are gathered on a single integrated, thereby providing the opportunity to reach more accurate results by reducing the noise on the measurement.
  • Another object of the present invention is to provide easy access to the blood sugar statistics of the patient. When these statistics are easily reached, a diet recommendation is made to the patient with machine learning by using the data. Thus, personalized diet programs can be prepared according to the values of the patients.
  • a blood glucose meter with high measurement precision that provides a comfortable measurement without blood, pain, and complications, that has a low cost per measurement, that is easy to use, and that enables continuous and numerous measurements at desired time and intervals, that gives instant warning when abnormal levels are observed in blood sugar and notifies the necessary institutions or persons for emergencies, that enables the disease course to be controlled more accurately compared to the prior art is developed by means of the present invention Description of the Figures
  • Figure 1 illustrates the blood glucose measurement system (A. Front view, B. Rear view, C. Side View).
  • Figure 2 illustrates wrist portable application of blood glucose measurement system.
  • Figure 3 illustrates the integrated internal structure of blood glucose measurement system.
  • Figure 4 illustrates the connection diagram of the elements of the blood glucose measurement system.
  • Optical Unit 20 Transimpedance Amplifier 30. Pressure-force sensor
  • Bluetooth Low Energy 100 Near Infrared LED Driver A. Tissue Detailed Description of the Invention
  • the present invention relates to a non-invasive blood glucose meter that provides blood-free and continuous blood glucose measurement.
  • the blood glucose meter comprises pressure-force sensor (30); optical unit (10) containing the photosensor (2), green LED, red LED, infrared LED, and near infrared LED (NIR), therein; electrode sensor (4); screen with indicators (1) thereon; microUSB port (3); power section; data processing section;near infrared LED driver (100); transimpedance amplifier (TIA) (20), microcontroller (MCU) (70); operational amplifier (OPAMP) (40), analog-to-digital converter (ADC) (50), digital signal processing (DSP) (60), and signal width modulation (PWM) (80) located on the microcontroller (70); and Bluetooth low energy (BLE) (90).
  • TIA transimpedance amplifier
  • MCU microcontroller
  • OPAMP operational amplifier
  • ADC analog-to-digital converter
  • DSP digital signal processing
  • PWM signal width modulation
  • BLE Bluetooth low energy
  • the optical unit (10) comprises a red LED (660 nm), a green LED (530 nm), an infrared LED (940nm), a near-infrared LED (940-2500nm) and a photosensor (2) (photodiode).
  • the photosensor (2) and LEDs red LED, green LED, infrared LED, near infrared LED
  • the photosensor (2) and LEDs are integrated, and it both sends light to the tissue (A) that is the measurement area and detects the light reflected from this tissue (A).
  • the LEDs green LED, red LED, infrared (IR) LED and near infrared (NIR) LED located in the optical unit (10) are activated by signal width modulation (80).
  • signal width modulation 80.
  • an electrode sensor (4) in at least one of the two cords that grip the wrist and directly contact with the wrist.
  • the electrode sensor (4) is located on the cord in contact with the wrist, that is, with the tissue (A).
  • Said electrode sensor (4) can also be located at any place that will contact the tissue (A). The important thing here is that the electrode sensor (4) makes the best contact with the tissue (A).
  • the conductivity changes in the tissue (A) are detected and blood sugar changes are measured by the electrode sensors (4) in the device according to the present invention.
  • the data received from the electrode sensors (4) is transferred to the analog-digital converter (50), and from there to the microcontroller (70).
  • the microcontroller (70) used in the blood glucose meter, together with the analog- digital converter (50), digital signal processing (60), signal width modulation (80) elements are gathered on a single integrated, and enables reducing the noise on the measurement, thereby providing more accurate results and a compact structure.
  • the device sends the light source at the near-infrared wavelength between 940 nm-2500 nm with the optical unit (10) to the tissue (A), which is the measurement area in the body.
  • the light reflected from the tissue (A) is collected by the optical unit (10), and it is analyzed and measurement is made.
  • the tissue (A) After light with a near-infrared wavelength between 940 nm and 2500 nm is sent to the tissue (A), which is the measurement area, by the LED, the thermal and acoustic changes occurring in the tissue (A) are detected by the photosensor (2) and the measurement is made.
  • the light reflected from the tissue (A) is measured by the photosensor (2).
  • the near infrared LED is absorbed by the sugar molecules in the tissue (A).
  • the amount of light reflected from the tissue (A) and measured by the photosensors (2) varies according to the density of the glucose amount in the blood and tissue (A).
  • a blood glucose value validated by the invasive method with calibration how much tissue (A) reflects near-infrared light is measured and taken as a reference.
  • the measuring device automatically calculates the light reflected from the tissue (A) in subsequent measurements with a formula and performs blood glucose measurement.
  • O2 (Oxygen) and heart rate measurements are also made with the red LED and infrared LED in the device.
  • the device sends the red LED and infrared LED light source to the tissue (A) in the body, which is the measurement area, with the optical unit (10). Red light and infrared light reflected from the tissue (A) are collected and processed by the photosensor (2).
  • 02 (oxygen) level is measured by proportioning the red and infrared reflected light reflected from the tissue (A).
  • tissue (A) distance measurement is made by using a multisensor.
  • the multisensor consists of a combination of photosensor (2) and pressure-force sensor (30).
  • the green LED and pressure-force sensor (30) (FSR) used with the photosensor (2) are utilized to ensure that the measurement conditions are the same each time.
  • FSR pressure-force sensor
  • the force applied to the tissue (A) by the device calibrates itself by measuring it with the pressure-force sensor (30) and green light.
  • the pressure-force sensor (30) measures the pressure of the tissue (A) against the photosensor (2). Since the thickness of the tissue (A) will decrease when more pressure is applied, it is necessary to create the same pressure in the measurements made during the calibration and the measurements to be made later, or to measure the differences in these pressures.
  • a green LED (530nm) is used to measure tissue distance. Since the green LED is absorbed by the human skin tissue (A), which is the area to be measured, it is used in the measurement of tissue (A) thickness, which is the area to be measured.
  • the device sends the green LED light source to the tissue (A), which is the measurement area in the body, by means of the optical unit (10).
  • the light absorbed by the tissue (A) is directly proportional to the tissue thickness. Thus, it is calculated how far the near infrared light used in blood glucose measurement travels in the tissue (A).
  • Calibration data is determined by each user's pre-use measurements with invasive methods. These calibration data are how much near-infrared light is reflected from the tissue (A) or the response of the user tissue (A). The difference between the preferred value range for calibration and the calibrated value is ⁇ 5%.
  • non-invasive near infrared spectroscopy and scattering spectroscopy methods are used for glucose detection. Said device is calibrated before the measurement process. The following processes are performed to calibrate the device of the present invention:
  • the user wears the device, which is the subject of the invention, on the wrist on which he/she is measuring blood glucose, tightly enough not to hinder the blood flow.
  • the device In the calibration mode, the device is operated, and the measured value is entered to the interface on the mobile phone with the invasive method.
  • Calibration is performed with at least thirty pieces.
  • the device of the present invention learns the response of the user's tissue to near infrared light at different glucose values.
  • the device is attached to the wrist during measurement as seen in Figure 2. Said device performs the measurement with the following steps indicated in Figure 4: • Before the device starts measuring blood glucose at user-selected periods (for example: 10min-20min-30min-1hr.), the green LED is activated by signal width modulation (80).
  • the absorption rate of the light sent to the tissue (A) by the green LED is measured by collecting the green light reflected from the tissue (A) by the photosensor (2) located in the optical unit (10).
  • the received data is converted to digital by the analog-to-digital converter (50).
  • the microcontroller (70) processes this digital data and the processed data is compared with the calibration data to verify that the data is in the same range.
  • the data received by the pressure-force sensor (30) is converted to digital with the analog-to-digital converter (50).
  • the microcontroller (70) processes this digital data and the processed data is compared with the calibration data to verify that the data is in the same range.
  • the red LED is activated by signal width modulation (80).
  • the red LED sends light to the tissue (A) and the reflected red light is measured by the photosensor (2).
  • the data coming from the photosensor (2) is converted to voltage by the transimpedance amplifier (20).
  • the data converted to voltage is filtered and the filtered data is converted to digital by the analog-to-digital converter (50).
  • the microcontroller (70) processes this digital data.
  • Infrared (940nm) LED signal is activated by width modulation (80).
  • An infrared (940nm) LED sends light to the tissue (A) and the reflected light is measured by the photosensor (2).
  • the data coming from the photosensor (2) is converted to voltage by the transimpedance amplifier (20).
  • the data converted to voltage is filtered and the filtered data is converted to digital by the analog-to-digital converter (50).
  • the microcontroller (70) processes this digital data.
  • the microcontroller (70) performs the pulse measurement with the data reflected from the red light.
  • the microcontroller 70 measures the O2 level (SpC ) in the blood by proportioning the data reflected from red and near infrared light.
  • SpC O2 level
  • Near infrared LED (940-2500nm) is activated by signal width modulation (80), the near infrared LED (940-2500nm) sends light to the tissue, and the reflected light is measured by the photosensor (2).
  • the data coming from the photosensor (2) is converted to voltage by the transimpedance amplifier (20).
  • the data converted to voltage is filtered and the filtered data is converted to digital by the analog-to-digital converter (50).
  • the converted digital data is filtered and the filtered data is processed in the digital signal processing unit (60).
  • the microcontroller (70) compares this digital data with the calibration data.
  • the equation resulting from the calibration and the blood glucose value are stored in the memory.
  • Bluetooth low energy (90) transmits data to the device with which it is paired.
  • the measured value can be viewed on the mobile phone.
  • blood glucose can be controlled at intervals that can be determined by the user.
  • the unit that controls this pairing and the determined measurement intervals is the microcontroller (70).
  • the device of the present invention can measure blood glucose and report the blood glucose level even when the patient is asleep.
  • the invention has the feature of sharing the blood glucose statistics of diabetics with their doctors with their consent. Also, it notifies the user or the emergency call line about sudden increases or decreases in blood glucose. All blood glucose measurement results can be reported via the application written specifically for the smart device with which the measuring device of the present invention is paired.
  • the unit using machine learning technology is realized on the application on the smart device.
  • the device of the present invention processes the data obtained as a result of the measurement and makes dietary recommendations to the user with machine learning technology.
  • the calibration process before the device is ready for measurement forms the basis of the blood glucose measurement algorithm.
  • the value taken by the invention from the tissue is considered as a reference.
  • the formulation of the polynomial graph created with reference values begins to be used in each measurement.
  • it can be determined whether the carbohydrate rate that the patient should take is more or less, and the device of the present invention can make a diet recommendation by processing the data via the application on the smart device.
  • the amount of carbohydrates that the user has taken must be entered into the application on the smart device.
  • the application learns the reaction of the user to carbohydrates by processing the changes in blood glucose by the carbohydrate data received.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Optics & Photonics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Emergency Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

The present invention relates to a non-invasive blood glucose meter that provides blood-free and continuous blood glucose measurement. A blood glucose meter with high measurement precision that provides a comfortable measurement without blood, pain, and complications, that has a low cost per measurement, that is easy to use, and that enables continuous and numerous measurements at desired time and intervals, that gives instant warning when abnormal levels are observed in blood sugar and notifies the necessary institutions or persons for emergencies, that enables the disease course to be controlled more accurately compared to the prior art is developed by means of the present invention.

Description

BLOOD-FREE CONTINUOUS BLOOD GLUCOSE METER Technical Field of the Invention
The present invention relates to a non-invasive blood glucose meter that provides blood-free and continuous blood glucose measurement.
State of the Art Devices that measure glucose values in the blood are generally called glucometers. The basic working principle of glucometers is to measure the level of sugar in the blood taken from the finger of the patient. Electrochemical measurement method is used in conventional glucometers. Device and consumables are required for the use of this method; and disposable measuring strips and finger pricking needles are used for each measurement. Conventional glucometers have a high cost per measurement. It is necessary to carry the device and its accessories in order to make the measurement, and these materials must be prepared for the measurement to be made. It is not possible to measure if any of the consumables is missing. Also, since these devices provide measurement with an invasive method, the environment must be sterile. Although patients desire to measure constantly, constantly pricking their fingers with a needle both causes negative complications on the body and the high cost of measurement makes this impossible.
The prior art includes non-invasive blood glucose measurement methods. In a study by Zeng et al. , a non-invasive blood glucose monitoring system based on distributed multi-sensor information fusion of multi-wavelength near infrared spectroscopy (NIR) is mentioned. In this non-invasive blood glucose monitoring system, two measurement ideas, continuous monitoring and distributed multi-wavelength measurements, are tested. However, since the light transmittance method was used in said study, it would be difficult to position it for continuous measurement. In addition, here laser diode is used as light source. This situation increases the cost of the product, makes it difficult to portability, and reduces the size of the product. l The non-invasive blood glucose meter, which is in the prior art and of which trade name is called “GlucoTrack”, offers patients a comfortable and painless measurement. However, this device can only be used by people with Type 2 diabetes. The device is not suitable for continuous blood glucose measurement; when a measurement is desired, the measurement probe must be attached to the earlobe, which is a region with low blood density. This causes the measurement results not to contain up-to-date data. Therefore, it cannot be used by people with type 1 diabetes. The reason for this is that people with type 1 diabetes have more variable sugar levels than those with other diabetes. Optical methods are not used for measurement in this device. In order for the device called “GlucoTrack” to continue measurements, the sensor probe must be changed every six months.
There is a need to develop a blood glucose meter with high measurement precision that provides a comfortable measurement without blood, pain and complications, that has a low cost per measurement, that is easy to use, and that enables continuous and numerous measurements at desired time and intervals, that gives instant warning when abnormal levels are observed in blood sugar and notifies the necessary institutions or persons for emergencies, that enables the disease course to be controlled more accurately compared to the prior art due to reasons such as the fact that the blood glucose meters in the state of the art are not suitable for many measurements, and cause complications when excessive measurements are made, and the need for consumables and the cost of measurement, the insufficiency of regular control of the sugar levels of the patients, and the inadequacy of the necessary intervention in state of emergency. Brief Description and Objects of the Invention
The present invention relates to a non-invasive blood glucose meter that provides blood-free and continuous blood glucose measurement.
The first object of the present invention is to provide a blood-free, painless, hygienic and complication-free measurement for patients. The system according to present invention offers a comfortable measurement to patients as it uses non-invasive methods such as near infrared spectroscopy (NIR), scattering spectroscopy, photoacoustic spectroscopy, and bioimpedance. In the present invention, the wrist with high blood density is used as the measurement site. Thus, more up-to-date data can be obtained and higher accuracy results can be obtained compared to regions with low blood density, such as the earlobe. The present invention is suitable for continuous blood glucose measurement in terms of the region used and can be carried on the arm/wrist all day long. Since it is wearable, it is suitable for daily use of all patients. Optical methods with higher accuracy rates (near infrared spectroscopy) are used as the primary measurement method. There is no discrimination between the users of the product, the product can be used by all diabetics. The lifetime of the sensor of the device according to the present invention is at least 1 year. Another object of the present invention is to reduce the costs per measurement. The present invention reduces the cost of measurement since it uses a non-invasive method and does not require consumables, thereby providing a more accurate control of the disease course by providing the opportunity to make more measurements for the patients. The reflection method used in the present invention adds a function that facilitates the use of the device in daily life. Thus, the device can be carried on the arm/wrist throughout the day and measurements can be taken all day long. With the use of LED as a light source in the invention, both ease of use and portability are provided, and in addition, the cost is reduced.
Another object of the present invention is to make continuous and multiple measurements at desired time and intervals. Measurements can be performed even when patients are asleep. It is possible to control the blood sugar of inpatients remotely by performing measurements continuously and at any time.
Another object of the present invention is to provide instant warning when abnormal levels are observed in blood sugar and to notify the necessary institutions or persons for emergencies. By means of the continuous measurement and warning system, it is ensured that the necessary intervention is made quickly in case of emergency.
Another object of the present invention is to provide a precise measurement with a reduced probability of error. The possibility of error is minimized and reliable results are obtained with the use of multisensors. In order to increase the accuracy in the invention, tissue distance measurement is made by using a multisensor. The multisensor consists of a combination of optical and force sensitive resistors. Green LED light with a peak wavelength of 530 nm and absorbed by the human skin is utilized to measure tissue distance. The light absorbed by the human skin is directly proportional to the tissue thickness. Thus, it can be calculated how far the near infrared light used in blood glucose measurement will travel in the tissue. The pressure-force between the photosensors used for blood glucose measurement and the tissue is measured with the force sensor. The pressure-force measured during the calibration is aimed to remain constant in each measurement, because the distance of the near infrared light is shortened when more pressure is applied, and on the contrary, it extends when less pressure is applied. This method is very important in terms of the correct use of the data taken during the calibration during the measurements. In addition, the analog-digital converter, digital signal processing, and signal width modulation elements together with the microcontroller used in the invention are gathered on a single integrated, thereby providing the opportunity to reach more accurate results by reducing the noise on the measurement.
Another object of the present invention is to provide easy access to the blood sugar statistics of the patient. When these statistics are easily reached, a diet recommendation is made to the patient with machine learning by using the data. Thus, personalized diet programs can be prepared according to the values of the patients.
A blood glucose meter with high measurement precision that provides a comfortable measurement without blood, pain, and complications, that has a low cost per measurement, that is easy to use, and that enables continuous and numerous measurements at desired time and intervals, that gives instant warning when abnormal levels are observed in blood sugar and notifies the necessary institutions or persons for emergencies, that enables the disease course to be controlled more accurately compared to the prior art is developed by means of the present invention Description of the Figures
Figure 1 illustrates the blood glucose measurement system (A. Front view, B. Rear view, C. Side View).
Figure 2: illustrates wrist portable application of blood glucose measurement system.
Figure 3: illustrates the integrated internal structure of blood glucose measurement system. Figure 4: illustrates the connection diagram of the elements of the blood glucose measurement system.
Description of Elements/Parts of the Invention The parts and components in the figures are enumerated for a better explanation of the blood glucose meter developed with the present invention, and correspondence of every number is given below:
1. Screen
2. Photosensor 3. MicroUSB Port
4. Electrode Sensor
10. Optical Unit 20. Transimpedance Amplifier 30. Pressure-force sensor
40. Operational Amplifier 50. Analog-to-Digital Converter 60. Digital Signal Processor 70. Microcontroller 80. Signal Width Modulation
90. Bluetooth Low Energy 100. Near Infrared LED Driver A. Tissue Detailed Description of the Invention
The present invention relates to a non-invasive blood glucose meter that provides blood-free and continuous blood glucose measurement.
The blood glucose meter according to present invention comprises pressure-force sensor (30); optical unit (10) containing the photosensor (2), green LED, red LED, infrared LED, and near infrared LED (NIR), therein; electrode sensor (4); screen with indicators (1) thereon; microUSB port (3); power section; data processing section;near infrared LED driver (100); transimpedance amplifier (TIA) (20), microcontroller (MCU) (70); operational amplifier (OPAMP) (40), analog-to-digital converter (ADC) (50), digital signal processing (DSP) (60), and signal width modulation (PWM) (80) located on the microcontroller (70); and Bluetooth low energy (BLE) (90). The optical unit (10) comprises a red LED (660 nm), a green LED (530 nm), an infrared LED (940nm), a near-infrared LED (940-2500nm) and a photosensor (2) (photodiode). The photosensor (2) and LEDs (red LED, green LED, infrared LED, near infrared LED) are integrated, and it both sends light to the tissue (A) that is the measurement area and detects the light reflected from this tissue (A).
The LEDs (green LED, red LED, infrared (IR) LED and near infrared (NIR) LED) located in the optical unit (10) are activated by signal width modulation (80). As seen in Figure 2, In an embodiment of the device according to present invention that is in the form of a wearable device and can be carried on the wrist, there is an electrode sensor (4) in at least one of the two cords that grip the wrist and directly contact with the wrist. The electrode sensor (4) is located on the cord in contact with the wrist, that is, with the tissue (A). Said electrode sensor (4) can also be located at any place that will contact the tissue (A). The important thing here is that the electrode sensor (4) makes the best contact with the tissue (A). The conductivity changes in the tissue (A) are detected and blood sugar changes are measured by the electrode sensors (4) in the device according to the present invention. The data received from the electrode sensors (4) is transferred to the analog-digital converter (50), and from there to the microcontroller (70).
The microcontroller (70) used in the blood glucose meter, together with the analog- digital converter (50), digital signal processing (60), signal width modulation (80) elements are gathered on a single integrated, and enables reducing the noise on the measurement, thereby providing more accurate results and a compact structure. The device sends the light source at the near-infrared wavelength between 940 nm-2500 nm with the optical unit (10) to the tissue (A), which is the measurement area in the body. The light reflected from the tissue (A) is collected by the optical unit (10), and it is analyzed and measurement is made. After light with a near-infrared wavelength between 940 nm and 2500 nm is sent to the tissue (A), which is the measurement area, by the LED, the thermal and acoustic changes occurring in the tissue (A) are detected by the photosensor (2) and the measurement is made. The light reflected from the tissue (A) is measured by the photosensor (2). The near infrared LED is absorbed by the sugar molecules in the tissue (A). The amount of light reflected from the tissue (A) and measured by the photosensors (2) varies according to the density of the glucose amount in the blood and tissue (A). In a blood glucose value validated by the invasive method with calibration, how much tissue (A) reflects near-infrared light is measured and taken as a reference. By the formulation created as a result of the calibration, the measuring device automatically calculates the light reflected from the tissue (A) in subsequent measurements with a formula and performs blood glucose measurement.
O2 (Oxygen) and heart rate measurements are also made with the red LED and infrared LED in the device. The device sends the red LED and infrared LED light source to the tissue (A) in the body, which is the measurement area, with the optical unit (10). Red light and infrared light reflected from the tissue (A) are collected and processed by the photosensor (2). 02 (oxygen) level is measured by proportioning the red and infrared reflected light reflected from the tissue (A). By using a multisensor consisting of a photosensor (2) and a pressure-force sensor (30), the present invention provides more accurate results by collecting and processing more data simultaneously by taking the accuracy of more than one measurement technique as reference, without referencing the accuracy of a single measurement technique. In order to increase the measurement accuracy of the device according to the present invention, tissue (A) distance measurement is made by using a multisensor. The multisensor consists of a combination of photosensor (2) and pressure-force sensor (30). The green LED and pressure-force sensor (30) (FSR) used with the photosensor (2) are utilized to ensure that the measurement conditions are the same each time. During the calibration, it is aimed to keep the pressure-force measured by the pressure-force sensor (30) constant in every measurement. When more pressure is applied to the tissue (A) the distance of the near-infrared light becomes shorter, and when less-pressure is applied, the distance of the near-infrared light becomes longer. Pressure-force measurement and tissue (A) thickness measurement are very important for the correct use of the data taken during the calibration during the measurements. The force applied to the tissue (A) by the device calibrates itself by measuring it with the pressure-force sensor (30) and green light. The pressure-force sensor (30) measures the pressure of the tissue (A) against the photosensor (2). Since the thickness of the tissue (A) will decrease when more pressure is applied, it is necessary to create the same pressure in the measurements made during the calibration and the measurements to be made later, or to measure the differences in these pressures. A green LED (530nm) is used to measure tissue distance. Since the green LED is absorbed by the human skin tissue (A), which is the area to be measured, it is used in the measurement of tissue (A) thickness, which is the area to be measured. The device sends the green LED light source to the tissue (A), which is the measurement area in the body, by means of the optical unit (10). The light absorbed by the tissue (A) is directly proportional to the tissue thickness. Thus, it is calculated how far the near infrared light used in blood glucose measurement travels in the tissue (A). Calibration data is determined by each user's pre-use measurements with invasive methods. These calibration data are how much near-infrared light is reflected from the tissue (A) or the response of the user tissue (A). The difference between the preferred value range for calibration and the calibrated value is ± 5%.
In the blood glucose meter of the present invention, during blood glucose measurement, instead of using the invasive electrochemical method used by conventional blood glucose meters, non-invasive near infrared spectroscopy and scattering spectroscopy methods are used for glucose detection. Said device is calibrated before the measurement process. The following processes are performed to calibrate the device of the present invention:
• The user measures the blood glucose measurement with an invasive method.
• The user wears the device, which is the subject of the invention, on the wrist on which he/she is measuring blood glucose, tightly enough not to hinder the blood flow.
• In the calibration mode, the device is operated, and the measured value is entered to the interface on the mobile phone with the invasive method.
• Calibration is performed with at least thirty pieces. Thus, the device of the present invention learns the response of the user's tissue to near infrared light at different glucose values.
After the calibration process, in one embodiment of the invention, the device is attached to the wrist during measurement as seen in Figure 2. Said device performs the measurement with the following steps indicated in Figure 4: • Before the device starts measuring blood glucose at user-selected periods (for example: 10min-20min-30min-1hr.), the green LED is activated by signal width modulation (80).
• The absorption rate of the light sent to the tissue (A) by the green LED is measured by collecting the green light reflected from the tissue (A) by the photosensor (2) located in the optical unit (10). The received data is converted to digital by the analog-to-digital converter (50). The microcontroller (70) processes this digital data and the processed data is compared with the calibration data to verify that the data is in the same range.
• The data received by the pressure-force sensor (30) is converted to digital with the analog-to-digital converter (50). The microcontroller (70) processes this digital data and the processed data is compared with the calibration data to verify that the data is in the same range.
• The next processes are continued if the difference between the data coming from the pressure-force sensor (30) and the green light and the appropriate value range preferred for calibration and the calibrated value is ± 5%; if the difference between the suitable value range preferred for calibration and the calibrated value is not ± 5%, the user is informed that it is not suitable, and the process is repeated until the conditions are met.
• The red LED is activated by signal width modulation (80). The red LED sends light to the tissue (A) and the reflected red light is measured by the photosensor (2). The data coming from the photosensor (2) is converted to voltage by the transimpedance amplifier (20). The data converted to voltage is filtered and the filtered data is converted to digital by the analog-to-digital converter (50). The microcontroller (70) processes this digital data.
• Infrared (940nm) LED signal is activated by width modulation (80). An infrared (940nm) LED sends light to the tissue (A) and the reflected light is measured by the photosensor (2). The data coming from the photosensor (2) is converted to voltage by the transimpedance amplifier (20). The data converted to voltage is filtered and the filtered data is converted to digital by the analog-to-digital converter (50). The microcontroller (70) processes this digital data.
• The microcontroller (70) performs the pulse measurement with the data reflected from the red light. • The microcontroller 70 measures the O2 level (SpC ) in the blood by proportioning the data reflected from red and near infrared light. By means of the near infrared LED driver (100), it is ensured that it can draw more current while the near infrared LEDs are activated.
• Near infrared LED (940-2500nm) is activated by signal width modulation (80), the near infrared LED (940-2500nm) sends light to the tissue, and the reflected light is measured by the photosensor (2).
• The data coming from the photosensor (2) is converted to voltage by the transimpedance amplifier (20). The data converted to voltage is filtered and the filtered data is converted to digital by the analog-to-digital converter (50). The converted digital data is filtered and the filtered data is processed in the digital signal processing unit (60). The microcontroller (70) compares this digital data with the calibration data. The equation resulting from the calibration and the blood glucose value are stored in the memory.
• Blood glucose data communicates with Bluetooth low energy (90) over serial microcontroller (70).
• Bluetooth low energy (90) transmits data to the device with which it is paired.
• The measured value can be viewed on the mobile phone.
Throughout the day, blood glucose can be controlled at intervals that can be determined by the user. By pairing the device of the present invention with the Bluetooth of a smart device, both the measurement results can be seen and the measurement intervals of the device can be changed via the application written specifically for the device. The unit that controls this pairing and the determined measurement intervals is the microcontroller (70). The device of the present invention can measure blood glucose and report the blood glucose level even when the patient is asleep. The invention has the feature of sharing the blood glucose statistics of diabetics with their doctors with their consent. Also, it notifies the user or the emergency call line about sudden increases or decreases in blood glucose. All blood glucose measurement results can be reported via the application written specifically for the smart device with which the measuring device of the present invention is paired. Since it is constantly connected to the measuring device, emergency calls can be made via smart devices such as mobile phones in an emergency. The unit using machine learning technology is realized on the application on the smart device. In addition, the device of the present invention processes the data obtained as a result of the measurement and makes dietary recommendations to the user with machine learning technology.
The calibration process before the device is ready for measurement forms the basis of the blood glucose measurement algorithm. During calibration with the invasive value, the value taken by the invention from the tissue is considered as a reference. The formulation of the polynomial graph created with reference values begins to be used in each measurement. According to the average course of blood glucose measurements taken after the calibration, it can be determined whether the carbohydrate rate that the patient should take is more or less, and the device of the present invention can make a diet recommendation by processing the data via the application on the smart device. In order to perform this, the amount of carbohydrates that the user has taken must be entered into the application on the smart device. The application learns the reaction of the user to carbohydrates by processing the changes in blood glucose by the carbohydrate data received.

Claims

1. A non-invasive blood glucose meter, characterized in that, it comprises;
• optical unit (10) that has photosensor (2), green LED, red LED, infrared LED, and near infrared LED therein, that sends light to the measurement area and detects the light reflected from the measurement area,
• screen (1 ) with the indicators thereon,
• microUSB port (3),
• electrode sensor (4) that is connected to the micro USB port (3), that detects the conductivity changes in the measurement area and enables the measurement of blood glucose changes,
• near infrared LED driver (100) (4),
• data processing section,
• pressure-force sensor (30) that measures the pressure of the measuring area against the photosensor (2),
• near infrared LED driver (100);
• transimpedance amplifier (20) that converts the data from the photosensor (2) to voltage;
• Microcontroller (70) that has signal width modulation (80) thereon that enables the operational amplifier (40), digital signal processing (60), analog-to-digital converter (50), green LED, red LED, infrared LED and near infrared LED to be activated, that processes digital data, and that measures heart rate and oxygen level in blood;
• Bluetooth low energy (90)
2. Working method of the device that provides non-invasive blood glucose measurement according to Claim 1, characterized in that, it comprises the process steps of; • Calibrating the device,
• Collecting and measuring the absorption rate of the green LED sent to the tissue (A) and activated by signal width modulation (80) by the tissue (A) by photosensors (2), converting data to digital with an analog-to-digital converter (50), verifying the data processed by the microcontroller (70) with the calibration data,
• Measuring the pressure of the photosensor (2) on the tissue (A) by the pressure-force sensor (30), and converting the received data to digital with an analog to digital converter (50), comparing the data processed by the microcontroller (70) with the calibration data,
• Collecting and measuring the amount of light reflected from the tissue (A) of the Red LED sent to the tissue (A) and activated by signal width modulation (80) by photosensors (2), converting the data coming from the photosensor (2) to voltage by the transimpedance amplifier (20), converting the data converted to voltage to digital by the analog-to-digital converter (50), processing the data and measuring the heart rate with the microcontroller (70),
• Collecting and measuring the amount of light reflected from the tissue (A) of the Infrared LED sent to the tissue (A) and activated by signal width modulation (80) by photosensors (2), converting the data coming from the photosensor (2) to voltage by the transimpedance amplifier (20), converting the data converted to voltage to digital by the analog-to-digital converter (50), processing the data by microcontroller (70),
• Measuring the oxygen level in the blood by the microcontroller (70) by proportioning the data received from the red and near infrared LEDs reflected from the tissue (A), relative to each other,
• Collecting and measuring the amount of light reflected from the tissue (A) of the Near Infrared LED sent to the tissue (A) and activated by signal width modulation (80) by photosensors (2), converting the data coming from the photosensor (2) to voltage by the transimpedance amplifier (20), converting the data converted to voltage to digital by the analog-to-digital converter (50), processing the data by microcontroller (70), • Comparing the data processed by the microcontroller (70) with the calibration data, and completing the glucose measurement if the difference between the preferred value range for calibration and the calibrated value is ± 5%.
3. Working method of the device that provides non-invasive blood glucose measurement according to Claim 1 or Claim 2, characterized in that, it comprises the process steps of;
• Calibrating the device,
• Activating the green LED by signal width modulation (80) before starting the blood glucose measurement in the periods selected by the user,
• Sending a green light to the tissue (A) that is the measurement area by the green LED,
• Measuring the absorption rate of the transmitted green LED by collecting the green light reflected from the tissue with the photosensor (2); converting the received data to , digital by the analog-digital converter (50), processing this digital data by the microcontroller (70), and verifying that the processed data is in the same range by comparing it with the calibration data,
• Converting pressure-force sensor (30) data to digital with analog-to-digital converter (50), processing this digital data by the microcontroller (70), and verifying that the processed data is in the same range by comparing it with the calibration data,
• continuing with the next processes if the difference between the data from the pressure-force sensor (30) and the green light and the calibrated value of the appropriate value range preferred for calibration is ± 5%, and notifying the user that it is not suitable and repeating the process until the appropriate calibrated value is obtained if the difference between the calibrated value and the preferred range of suitable values for calibration is not ± 5%,
• Activating the red LED by the signal width modulation (80),
• Sending light to the tissue (A) via the red LED and measuring the reflected red light by the photosensor (2); converting the data coming from the photosensor (2) to voltage with the transimpedance amplifier (20), filtering the data converted to voltage, and after the filtered data is converted to digital by the analog-digital converter (50), processing the digital data by the microcontroller (70)
• Activating the infrared LED by the signal width modulation (80),
• Sending light to the tissue (A) via the infrared LED and measuring the reflected infrared light by the photosensor (2); converting the data coming from the photosensor (2) to voltage with the transimpedance amplifier (20), filtering the data converted to voltage, and after the filtered data is converted to digital with the analog-digital converter (50), processing the digital data by the microcontroller (70),
• Performing the heart rate measurement with the data reflected from the red light by the microcontroller (70),
• Measuring the oxygen level (SpC ) in the blood by proportioning the data reflected from red and near infrared lights, by the microcontroller (70),
• Activating the near infrared LED by the signal width modulation (80),
• Sending light via the infrared LED and measuring the reflected infrared light by the photosensor (2); converting the data coming from the photosensor (2) to voltage with the transimpedance amplifier (20), filtering the data converted to voltage, and filtering the converted digital data after converting the filtered data to digital with the analog-to-digital converter (50), and processing the filtered data in the digital signal processing (60); comparing this digital data with the calibration data by the microcontroller (70).
PCT/TR2022/050607 2021-06-18 2022-06-16 Blood-free continuous blood glucose meter WO2022265613A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2021009942 2021-06-18
TR2021/009942 2021-06-18

Publications (1)

Publication Number Publication Date
WO2022265613A1 true WO2022265613A1 (en) 2022-12-22

Family

ID=84526335

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2022/050607 WO2022265613A1 (en) 2021-06-18 2022-06-16 Blood-free continuous blood glucose meter

Country Status (1)

Country Link
WO (1) WO2022265613A1 (en)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019049116A2 (en) * 2017-09-11 2019-03-14 Gopalakrishnan Muralidharan Non-invasive multifunctional telemetry apparatus and real-time system for monitoring clinical signals and health parameters
WO2019138382A1 (en) * 2018-01-14 2019-07-18 Gopalakrishnan Muralidharan Non-invasive blood sugar level monitoring apparatus integrated with real-time health support system
CN210843062U (en) * 2019-04-10 2020-06-26 加康康健有限公司 Multi-parameter acquisition intelligent watch based on noninvasive blood glucose detection
CN111870236A (en) * 2020-09-01 2020-11-03 广州中金育能教育科技有限公司 Body sign data monitoring and analyzing system and analyzing method
KR102185556B1 (en) * 2020-02-18 2020-12-02 박영권 Non-Invasive Glucose Sensor

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019049116A2 (en) * 2017-09-11 2019-03-14 Gopalakrishnan Muralidharan Non-invasive multifunctional telemetry apparatus and real-time system for monitoring clinical signals and health parameters
WO2019138382A1 (en) * 2018-01-14 2019-07-18 Gopalakrishnan Muralidharan Non-invasive blood sugar level monitoring apparatus integrated with real-time health support system
CN210843062U (en) * 2019-04-10 2020-06-26 加康康健有限公司 Multi-parameter acquisition intelligent watch based on noninvasive blood glucose detection
KR102185556B1 (en) * 2020-02-18 2020-12-02 박영권 Non-Invasive Glucose Sensor
CN111870236A (en) * 2020-09-01 2020-11-03 广州中金育能教育科技有限公司 Body sign data monitoring and analyzing system and analyzing method

Similar Documents

Publication Publication Date Title
US11666703B2 (en) System and method for health monitoring by an ear piece
JP6275237B2 (en) Collection of personal health data
US7179228B2 (en) Cuffless system for measuring blood pressure
US6553242B1 (en) Physiological stress detector device and method
US6968221B2 (en) Low-cost method and apparatus for non-invasively measuring blood glucose levels
US20160313176A1 (en) User-wearable devices including uv light exposure detector with calibration for skin tone
KR102033914B1 (en) method for measuring blood glucose and wearable type apparatus for the same
EP3359038B1 (en) Device for non-invasive measurement of blood sugar level
US20030229276A1 (en) Physiological stress detector device and system
US20060009698A1 (en) Hand-held monitor for measuring vital signs
JP2011062335A (en) Blood sugar level monitoring apparatus
CN111683597A (en) System and method for non-invasively monitoring hemoglobin
KR102062646B1 (en) wearable type apparatus for measuring bio signals and system for medical assistance using the same
KR20190056871A (en) Apparatus and method for measuring bio-information
EP1077635A1 (en) Apparatus and method for noninvasive glucose measurement
CN209899402U (en) Reflection type oximeter
CN111698943B (en) Systems and methods for non-invasively monitoring hematocrit concentration
WO2022265613A1 (en) Blood-free continuous blood glucose meter
Selsiya et al. Non-Invasive Blood Glucose Measurement Using Ire Sensor
US20220190188A1 (en) Electro-optical physiologic sensor
US20230039857A1 (en) Improved ppg measurement
JP7133576B2 (en) Continuous blood pressure measurement system by phase difference method
Yoon et al. Development of a compact home health monitor for telemedicine
Liu et al. Wearable monitoring system with multiple physiological parameters
Vittal et al. A pilot study on patch sensor based Photo Plethysmography (PPG) for heart rate measurements

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22825462

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE