WO2014045450A1 - Measurement system - Google Patents

Measurement system Download PDF

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Publication number
WO2014045450A1
WO2014045450A1 PCT/JP2012/074445 JP2012074445W WO2014045450A1 WO 2014045450 A1 WO2014045450 A1 WO 2014045450A1 JP 2012074445 W JP2012074445 W JP 2012074445W WO 2014045450 A1 WO2014045450 A1 WO 2014045450A1
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Prior art keywords
blood glucose
measurement
glucose level
determined
unit
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PCT/JP2012/074445
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French (fr)
Japanese (ja)
Inventor
虎井裕
望月智則
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テルモ株式会社
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Priority to PCT/JP2012/074445 priority Critical patent/WO2014045450A1/en
Publication of WO2014045450A1 publication Critical patent/WO2014045450A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455Measuring 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
    • A61B5/1459Measuring 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 invasive, e.g. introduced into the body by a catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02438Detecting, measuring or recording pulse rate or heart rate with portable devices, e.g. worn by the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1101Detecting tremor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/42Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4261Evaluating exocrine secretion production
    • A61B5/4266Evaluating exocrine secretion production sweat secretion

Definitions

  • the present invention relates to a measurement system that measures a blood glucose level of a subject and notifies a hypoglycemic state.
  • hypoglycemia In the treatment of diabetes, it is important to control blood sugar to improve hyperglycemia and bring the blood sugar level as close to normal as possible. If this blood sugar control is not successful, hypoglycemia is caused. In hypoglycemia, initial symptoms such as rapid heartbeat, cold sweat, and trembling of the hands appear, and if the blood glucose level is lowered further, disturbance of consciousness (coma) occurs. Accordingly, a diabetic patient must accurately grasp the occurrence of initial symptoms and take appropriate measures such as ingesting sugar when the symptoms occur.
  • Diabetic patients are usually able to cope with hypoglycemia as an early symptom, but patients who have been taking insulin therapy for a long time, patients with autonomic disorder, elderly patients etc. Unconsciousness may cause sudden consciousness disturbance (unconscious hypoglycemia).
  • Japanese Patent Application Laid-Open No. 2008-79993 discloses blood glucose measurement using a continuous blood glucose monitor (Continuous Glucose Monitoring: CGM) that continuously monitors a subject's blood sugar level.
  • CGM Continuous Glucose Monitoring
  • An apparatus is described that issues a warning when a blood sugar level reaches a first risk level and notifies a third party when the blood sugar level reaches a second risk level.
  • Japanese Patent Application Laid-Open No. 2008-79994 discloses a blood glucose measurement device using a continuous blood glucose monitor that continuously monitors a subject's blood glucose level, wherein When the difference from the blood glucose level measured this time is greater than or equal to the caution blood glucose change value, an alarm is issued if the blood glucose level measured this time is not less than or equal to the risk level blood glucose level, and if it is less than or equal to the risk level blood glucose level, a third party is notified. It is described to do.
  • hypoglycemia state cannot be accurately grasped only by monitoring the blood glucose level, for example, the level of the blood glucose level causing hypoglycemia varies among individuals.
  • the present invention has been made in view of such conventional problems, and an object of the present invention is to provide a measurement system for more accurately grasping and notifying a hypoglycemic state.
  • the present invention provides a measurement system, a plurality of measurement devices that measure a plurality of vital signs of different subjects, and a plurality of measurement values that are measurement results of the plurality of measurement devices. And a warning unit that warns the subject when the determination unit determines that the subject is in a hypoglycemic state. To do.
  • the subject can more accurately recognize that the subject is in a blood glucose state and can take an appropriate treatment.
  • the hypoglycemic state includes a plurality of hypoglycemic levels
  • the determination unit is configured for each vital sign based on the plurality of measurement values that are measurement results of the plurality of measurement devices. It is determined whether or not hypoglycemia, respectively, according to the number and type of the measured value of the vital sign determined to be hypoglycemia, to determine the subject's hypoglycemia level, the warning unit, According to the low blood glucose level determined by the determination unit, warning is performed by changing the alarm level.
  • the subject can recognize a low blood glucose level.
  • the warning unit outputs a warning sound at a volume corresponding to the low blood glucose level determined by the determination unit.
  • the subject can easily and intuitively recognize the low blood glucose level.
  • a threshold value is set for each of the plurality of vital signs, and the determination unit compares the measured value, which is a measurement result of the measuring device, with the threshold value, thereby obtaining the vital sign. It is characterized by each determining whether it is hypoglycemia every time.
  • the determination unit can easily and accurately determine whether or not there is hypoglycemia based on each measurement value.
  • the plurality of vital signs include blood glucose
  • the determination unit compares the blood glucose level that is the measurement value or a change amount of the blood glucose level with the threshold value, and the blood glucose level or the When the amount of change in blood glucose level is less than or equal to the threshold, it is determined that the blood glucose level is low.
  • the blood glucose level is hypoglycemia. For example, not only when the blood glucose level is equal to or lower than the threshold value, but also when the amount of change in the blood glucose level is equal to or lower than the threshold value, the blood glucose level is rapidly decreased. it can.
  • the determination unit when the determination unit determines that hypoglycemia is based on the blood glucose level, the determination unit raises the low blood glucose level higher than when it is not determined to be hypoglycemia based on the blood glucose level.
  • the hypoglycemia level can be determined with emphasis on the blood glucose level that directly indicates whether or not hypoglycemia, and the hypoglycemia level can be accurately determined.
  • the plurality of vital signs include pulsation, sweating, or hand tremor of the subject
  • the determination unit includes a heart rate, a sweating amount, or a hand as the measurement value.
  • the frequency of tremors is compared with the threshold, and if the heart rate, the amount of sweating, or the frequency is equal to or higher than the threshold, it is determined that the blood glucose is low.
  • the determination unit determines whether or not the blood glucose level is low for each vital sign based on the plurality of measurement values that are measurement results of the plurality of measurement devices, and the blood glucose level is low. When the number of the measured values of the vital sign determined to be equal to or greater than a certain number, it is determined that the subject is in a hypoglycemic state.
  • the present invention when measuring a plurality of vital signs different for a subject, determining a hypoglycemic state of the subject based on a plurality of measured values as measurement results, and determining a hypoglycemic state, since the warning is given to the subject, the subject can more accurately recognize that the subject is in a blood glucose state and can take appropriate measures.
  • FIG. 1 is a block diagram of a measurement system 10 according to an embodiment.
  • the measurement system 10 includes a blood glucose measurement device 12 that measures blood sugar, which is a type of vital sign of the subject, and a plurality of vital signs different from the subject other than the blood glucose level (for example, pulsation, sweating, hand tremor, etc.)
  • the reason for measuring pulsation, sweating of hands or feet, trembling of hands, etc. is usually that when the subject becomes hypoglycemic, the pulsation is faster, cold sweat is applied, and the hand shakes. So measure these vital signs.
  • the blood glucose measurement device 12 includes a measurement unit 20, a control unit 22, and a communication unit 24.
  • the measuring unit 20 is provided with a needle 20a for puncturing the subject's skin and placing it under the skin.
  • the needle 20a is a capillary that guides the blood to reach the measurement unit 20.
  • the measuring unit 20 measures the concentration of glucose contained in the blood sent from the needle 20a.
  • the measurement unit 30 includes a light receiving element such as a photodiode, a light emitting element such as a light emitting diode, and an indicator layer.
  • the indicator layer contains a fluorescent dye as a labeling compound, and the labeling compound captures glucose introduced by the needle 20a.
  • the indicator layer obtains fluorescence having an intensity corresponding to the glucose concentration.
  • the fluorescence from the indicator layer is photoelectrically converted by the light receiving element, and a light receiving signal (light receiving signal indicating the glucose concentration) is sent to the control unit 22.
  • the control unit 22 has a CPU and a memory (not shown), and controls the blood glucose measurement device 12 as a whole.
  • the control unit 22 converts the light reception signal sent from the measurement unit 20 into a digital signal, and calculates a glucose concentration value (hereinafter referred to as a blood glucose level) based on the converted light reception signal.
  • the control unit 22 outputs the calculated blood glucose level (measurement value) that is a measurement result to the communication unit 24.
  • the measurement unit 20 obtains a light reception signal indicating the glucose concentration at a constant cycle and outputs the received light signal to the control unit 22. Therefore, the control unit 22 performs blood glucose level at the constant cycle (a constant measurement cycle). Is calculated.
  • the communication unit 24 wirelessly communicates with the display device 16 to transmit the blood glucose level transmitted from the control unit 22 to the display device 16 by wireless communication.
  • the communication unit 24 performs wireless communication using Bluetooth, IrDA (Infrared Data Association), or the like.
  • the vital sign measurement device 14 includes a measurement unit 30, a control unit 32, and a communication unit 34.
  • the measuring unit 30 measures the heart rate of the subject, the sweating amount of the hand or foot, the vibration frequency of hand tremors, and the like. If the measurement unit 30 is for measuring a heart rate, the measurement unit 30 has an electrode for detecting an electrocardiogram signal, and if the measurement unit 30 measures the sweating amount of a hand or a foot, It has electrodes and detects the capacitance of the subject's skin. Moreover, when the measurement part 30 measures the vibration frequency of a hand tremor, the measurement part 30 has a gyro sensor which detects an angular velocity.
  • the control unit 32 includes a CPU and a memory (not shown), and controls the vital sign measurement device 14 as a whole.
  • the control unit 32 converts the signal sent from the measurement unit 30 into a digital signal, and calculates the heart rate, the amount of sweating, or the vibration frequency of hand tremor based on the converted digital signal.
  • the heart rate is calculated based on the electrocardiogram signal converted into a digital signal.
  • a signal (capacitance signal) indicating the capacitance of the subject's skin is sent from the measurement unit 30, the amount of sweating is calculated based on the capacitance signal converted into a digital signal.
  • the vibration frequency is calculated from the angular velocity signal detected by the gyro sensor from the measurement unit 30.
  • the control unit 32 outputs the calculated measurement value (heart rate, sweating amount, or vibration frequency), which is a measurement result, to the communication unit 34.
  • the measurement unit 30 obtains an electrocardiogram signal, an electrostatic capacity signal, an angular velocity signal, or the like at the fixed cycle and outputs the signal to the control unit 32. In the measurement cycle), the heart rate, the sweating amount of the hand or foot, and the vibration frequency of the hand tremor are calculated.
  • the communication unit 34 wirelessly communicates with the display device 16 to transmit the measurement value transmitted from the control unit 32 to the display device 16 by wireless communication.
  • the communication unit 34 performs wireless communication using Bluetooth, IrDA (Infrared Data Association), or the like.
  • a vital sign indicating whether or not the blood glucose is low at intervals shorter than the measurement cycle of the blood glucose measurement device 12. can be measured. Since the blood glucose measurement device 12 and the plurality of vital sign measurement devices 14 are not synchronized, the measurement timings of the blood glucose measurement device 12 and the plurality of vital sign measurement devices 14 are naturally shifted. In addition, the blood glucose measurement device 12 and the plurality of vital sign measurement devices 14 may perform the synchronization process to arbitrarily shift the measurement timing.
  • the display device 16 includes a communication unit 40, a storage unit 42, a control unit 44, a sound output unit 46, a display unit 48, and an operation unit 50.
  • the communication unit 40 wirelessly communicates with the blood glucose measurement device 12 and the plurality of vital sign measurement devices 14 to acquire measurement values such as blood glucose level, heart rate, sweating amount, and vibration frequency. Specifically, the measurement value is acquired by wirelessly communicating with the communication unit 24 of the blood glucose measurement device 12 and the communication unit 34 of the plurality of vital sign measurement devices 14.
  • the storage unit 42 stores a threshold value set for each vital sign (blood sugar, pulsation, cold sweat, hand tremor) measured by the blood glucose measurement device 12 and the vital sign measurement device 14.
  • the storage unit 42 stores threshold values corresponding to blood sugar level, heart rate, sweating amount, hand tremor frequency, and the like.
  • the storage unit 42 includes a plurality of storage areas for storing vital sign flags such as a blood glucose level flag, a heart rate flag, a sweating amount flag, and a vibration frequency flag.
  • the control unit 44 includes a CPU and a memory (not shown) and controls the entire display device 16.
  • the control unit 44 includes a determination unit 44a, and the determination unit 44a determines the hypoglycemia state of the subject based on the measured values such as blood glucose level, heart rate, and sweating amount received by the communication unit 40.
  • This hypoglycemic state has a plurality of hypoglycemic levels, and the determination unit 44a determines the hypoglycemic level of the subject using the received measured value of the vital sign and its type and threshold. The higher the hypoglycemia level, the higher the possibility that the subject is in a hypoglycemic state, and the lower the hypoglycemic level, the lower the possibility that the subject is in the hypoglycemic state.
  • control unit 44 includes a warning unit 44b, and the warning unit 44b outputs a warning sound from the sound output unit 46 such as a speaker at a volume corresponding to the low blood glucose level determined by the determination unit 44a. Alert the subject that they are hypoglycemic. Specifically, when the low blood glucose level is low, a warning sound is output at a low volume, and when the low blood glucose level is high, a warning sound is output at a high volume.
  • the warning unit 44b warns the subject that the blood glucose level is low by displaying a warning on the display unit 48 such as a liquid crystal display in a display mode according to the low blood glucose level determined by the determination unit 44a. Specifically, if the hypoglycemia level is low, that fact is displayed (for example, a character such as “There is a possibility of hypoglycemia” is displayed), and if the hypoglycemia level is high, that fact is displayed (for example, , “Likely hypoglycemic state is likely to be displayed.”
  • the warning unit 44b may change the brightness and color of the backlight of the display unit 48 according to the low blood sugar level. In short, the warning unit 44b may change the alarm level and issue a warning according to the low blood glucose level determined by the determination unit 44a.
  • the display unit 48 displays a blood glucose level measured by the blood glucose measurement device 12 and functions as a graphical user interface (GUI) in addition to displaying a warning.
  • GUI graphical user interface
  • the operation unit 50 is for the subject to perform various operations such as switching display contents of the display unit 48 and inputting predetermined information.
  • the operation of the measurement system 10 will be described.
  • the operation of the measurement system 10 for the sake of simplicity, it is assumed that there is one vital sign measuring device 14 and the vital sign measuring device 14 measures the amount of sweating.
  • the control unit 22 determines whether or not the measurement timing has arrived (step S1). This measurement timing arrives at a constant measurement cycle. If it is determined in step S1 that the measurement timing has not arrived, it remains in step S1 until it arrives. If it is determined that the measurement timing has arrived, the control unit 22 controls the measurement unit 20 so that the measurement unit 20 A light reception signal indicating the concentration of glucose is acquired (step S2).
  • control unit 22 calculates a blood glucose level based on the acquired light reception signal (step S3).
  • control part 22 may calculate the variation
  • the communication unit 24 transmits the blood glucose level calculated in step S3 to the display device 16 (step S4), and returns to step S1. If the change amount of the blood glucose level is calculated in step S3, the change amount of the blood glucose level may be transmitted to the display device 16.
  • the control unit 32 determines whether or not the measurement timing has arrived (step S11). This measurement timing arrives at a constant measurement cycle. If it is determined in step S11 that the measurement timing has not arrived, the process stays in step S11 until it arrives. If it is determined that the measurement timing has arrived, the control unit 32 controls the measurement unit 30 so that the measurement unit 30 A skin capacitance signal is acquired (step S12).
  • control unit 32 calculates the amount of sweating based on the acquired capacitance signal (step S13).
  • communication unit 34 transmits the sweating amount calculated in step S13 to the display device 16 (step S14), and returns to step S11.
  • the operation of the display device 16 of the measurement system 10 will be described with reference to the flowcharts of FIGS.
  • the operation of the display device 16 when a blood glucose level or a change amount of the blood glucose level is received will be described according to the flowchart of FIG. 4, and then the operation of the display device 16 when the perspiration amount is received will be described according to the flowchart of FIG. .
  • the determination unit 44a of the control unit 44 makes a hypoglycemia determination based on the blood glucose level (step S21 in FIG. 4). Specifically, the determination unit 44a compares the received blood glucose level with the threshold value of the blood glucose level stored in the storage unit 42, determines that the received blood glucose level is equal to or lower than the threshold, and determines that the blood glucose level is low. If the blood glucose level is greater than the threshold value, it is determined that the blood glucose level is not low.
  • the determination unit 44a receives the blood glucose level change amount and the received blood glucose level change amount and the blood glucose level change stored in the storage unit 42.
  • the received change amount of the blood sugar level is equal to or less than the threshold value, it is determined that the blood glucose level is lower than the threshold value. This is because when the amount of change in blood glucose level is equal to or lower than the threshold, it is desirable to determine that the blood glucose level has dropped sharply and hypoglycemia.
  • step S21 When it is determined in step S21 that the blood glucose level is low, the determination unit 44a sets a blood glucose level flag (step S22). That is, the blood glucose level flag is set by storing “1” in the storage area for storing the blood glucose level flag in the storage unit 42. If the blood sugar level flag has already been set, the operation of step S22 is not performed.
  • the determination unit 44a determines whether or not the sweating amount flag is set (step S23). That is, it is determined whether or not “1” is stored in the storage area for storing the sweating amount flag in the storage unit 42. As will be described in detail later, the determination unit 44a sets a perspiration amount flag when it is determined that hypoglycemia is determined by hypoglycemia based on the perspiration amount.
  • step S23 If it is determined in step S23 that the sweating amount flag is set, the determination unit 44a determines that the hypoglycemic state of the subject is the low blood glucose level 3 (step S24), and the warning unit 44b of the control unit 44 Warns at an alarm level corresponding to the low blood glucose level 3 (step S25), and ends the operation. For example, a warning sound is output from the sound output unit 46 at the volume 3, and a warning such as “it is a hypoglycemic state” is displayed on the display unit 48.
  • step S23 determines that the hypoglycemic state of the subject is the low blood glucose level 2 (step S26), and the warning unit 44b is low.
  • a warning is given at an alarm level corresponding to blood glucose level 2 (step S27), and the operation is terminated.
  • a warning sound is output from the sound output unit 46 at a volume 2 smaller than the volume 3, and a warning is displayed by displaying characters such as “There is a high possibility of a hypoglycemic state. Do.
  • step S28 If it is determined in step S21 that the blood glucose level is not low, the determination unit 44a clears the blood glucose level flag (step S28). That is, the blood sugar level flag is cleared by storing “0” in the storage area for storing the blood sugar level flag in the storage unit 42. If the blood sugar level flag has already been cleared, the operation of step S28 is not performed.
  • the determination unit 44a determines whether or not the sweating amount flag is set (step S29). If it is determined in step S29 that the sweating amount flag is not set, the operation is terminated. If it is determined in step S29 that the sweating amount flag is set, the determination unit 44a determines that the subject's hypoglycemic state is low. It is determined that the blood glucose level is 1 (step S30), and the warning unit 44b warns at an alarm level corresponding to the low blood glucose level 1 (step S31) and ends the operation. For example, a warning sound is output from the sound output unit 46 at a volume 1 lower than the volume 2, and a warning such as “There is a possibility of hypoglycemia” is displayed on the display unit 48.
  • the determination unit 44a makes a hypoglycemic determination based on the sweating amount (step S51 in FIG. 5). Specifically, the determination unit 44a compares the received amount of sweating with a threshold value of the sweating amount stored in the storage unit 42, determines that the received sweating amount is equal to or higher than the threshold value, and determines that the blood glucose level is low. If the perspiration amount is less than the threshold, it is determined that the blood sugar is not hypoglycemic.
  • step S52 If it is determined in step S51 that the blood sugar level is low, the determination unit 44a sets a sweating amount flag (step S52). That is, by storing “1” in the storage area for storing the sweating amount flag of the storage unit 42, the sweating amount flag is set. When the sweating amount flag is already set, the operation of step S52 is not performed.
  • the determination unit 44a determines whether or not the blood sugar level flag is set (step S53). That is, it is determined whether or not “1” is stored in the storage area for storing the blood sugar level flag in the storage unit 42.
  • step S53 If it is determined in step S53 that the blood glucose level flag is set, the determination unit 44a determines that the hypoglycemic state of the subject is the low blood glucose level 3 (step S54), and the warning unit 44b A warning is given at an alarm level corresponding to level 3 (step S55), and the operation is terminated.
  • step S53 determines that the subject's hypoglycemia state is low blood glucose level 1 (step S56), and the warning unit 44b A warning is given at an alarm level corresponding to the low blood glucose level 1 (step S57), and the operation is terminated.
  • step S58 If it is determined in step S51 that the blood glucose level is not low, the determination unit 44a clears the sweating amount flag (step S58). That is, by storing “0” in the storage area for storing the sweating amount flag in the storage unit 42, the sweating amount flag is cleared. If the sweating amount flag has already been cleared, the operation of step S58 is not performed.
  • the determination unit 44a determines whether or not the blood sugar level flag is set (step S59). If it is determined in step S59 that the blood glucose level flag is not set, the operation is terminated. If it is determined in step S59 that the blood glucose level flag is set, the determination unit 44a determines that the subject has a low hypoglycemic state. It is determined that the blood sugar level is 2 (step S60), and the warning unit 44b warns at an alarm level corresponding to the low blood sugar level 2 (step S61) and ends the operation.
  • FIG. 6 is a diagram showing the hypoglycemia level determined based on the hypoglycemia determination based on the blood glucose level and the hypoglycemia determination based on one vital sign other than the blood glucose level, as shown in FIGS. 4 and 5.
  • hypoglycemia state is hypoglycemia level 3. Further, if the determination is affirmative based on the hypoglycemia determination based on the blood glucose level and the determination is negative (not hypoglycemia) based on the hypoglycemia determination based on a vital sign other than the blood glucose level, it is determined that the hypoglycemia state is the low blood glucose level 2.
  • the hypoglycemia state is the low blood glucose level 1.
  • the hypoglycemia level is determined according to the number of measured values determined to be hypoglycemia and the type thereof (blood glucose level, heart rate, sweat rate, hand tremor frequency). Note that the determination unit 44a determines that the hypoglycemia is determined based on the hypoglycemia based on the blood glucose level, and determines that the hypoglycemia state is not determined if the determination is based on the hypoglycemia determination based on vital signs other than the blood glucose level.
  • hypoglycemic state of the subject is determined based on the measured values of a plurality of vital signs (blood glucose level, heart rate, sweat rate, hand tremor frequency), and the hypoglycemic state is determined. Warns the subject so that the subject can more accurately recognize that the subject is in a hypoglycemic state. In other words, since vital signs other than blood glucose level are also measured, even if it is not determined that the blood glucose level is a hypoglycemic state alone, it is determined from the measured values of vital signs other than the blood glucose level that the blood sugar level is low. It becomes possible to do.
  • vital signs other than blood glucose level are also measured, even if it is not determined that the blood glucose level is a hypoglycemic state alone, it is determined from the measured values of vital signs other than the blood glucose level that the blood sugar level is low. It becomes possible to do.
  • hypoglycemia level is discriminated, and the alarm level is changed according to the discriminated hypoglycemia level to give a warning, so that the subject can recognize the level of the hypoglycemia state.
  • the warning sound is output at a volume corresponding to the low blood sugar level, the low blood sugar level can be easily and intuitively recognized.
  • a threshold is set for each vital sign, and by comparing the measured value with the threshold, it is determined whether the blood glucose is hypoglycemic for each vital sign. It can be performed easily and accurately.
  • Vital signs include blood sugar, compare blood sugar level or amount of change of blood sugar with a threshold value, and if blood sugar level or amount of change of blood sugar level is less than or equal to threshold value, it is determined that the blood sugar level is low. Hypoglycemia can be determined with high accuracy.
  • the hypoglycemia level is set higher than if the hypoglycemia is not determined based on the blood glucose level, so focus on the blood glucose level that directly indicates whether or not the hypoglycemia is present. Thus, the hypoglycemia level can be determined, and the hypoglycemia level can be accurately determined.
  • Vital signs include the subject's pulsation, sweating, or hand tremor, comparing the measured heart rate, sweating amount, or hand tremor vibration frequency with a threshold value, heart rate, sweating amount, Alternatively, when the frequency is equal to or higher than the threshold value, it is determined that the blood glucose is low, so it is possible to accurately determine whether the blood glucose is low even with vital signs other than the blood glucose level.
  • the determination unit 44a determines that the subject is hypoglycemic based on the hypoglycemia determination based on the blood glucose level, and determines that the subject is hypoglycemic based on the hypoglycemia determination based on the vital sign other than the blood glucose level. It may be determined that the blood glucose level is low, and the warning unit 44b may output a warning sound. In addition, the number of measured values of vital signs determined to be hypoglycemia (number of measured values of blood glucose level, heart rate, sweat rate, etc.) based on the hypoglycemia determination by a plurality of vital signs exceeds a certain number In this case, it may be determined that the subject is in a hypoglycemic state.
  • the subject when the subject can be surely determined to have hypoglycemia, the subject can be determined to be in a hypoglycemic state, and the subject can more accurately recognize that the subject is in a hypoglycemic state. can do.
  • the vital sign measurement values determined to be hypoglycemia do not include blood sugar levels In such a case (when the hypoglycemia is not determined by the hypoglycemia determination based on the blood glucose level), it is not necessary to determine that the subject is in a hypoglycemic state.

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  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

A measurement system (10) is provided with: a plurality of measurement devices (12, 14) for measuring a plurality of different vital signs of a subject; a discrimination unit (44a) for determining, on the basis of a plurality of measurement values which are the measurement results of the plurality of measurement devices (12, 14), the presence of a hypoglycemic state of the subject; and a warning unit (44b) which, in cases when the discrimination unit (44a) has determined there to be a hypoglycemic state, issues a warning to the subject. As a result, a subject can more accurately recognize the presence of a hypoglycemic state, and can take appropriate measure.

Description

測定システムMeasuring system
 本発明は、被検者の血糖値を測定して、低血糖状態を報知する測定システムに関する。 The present invention relates to a measurement system that measures a blood glucose level of a subject and notifies a hypoglycemic state.
 糖尿病の治療においては、高血糖を改善し、血糖値をできるだけ正常な数値に近づける血糖コントロールが重要であり、この血糖コントロールがうまくできないと、低血糖を引き起こしてしまう。低血糖では、心臓の拍動が早くなったり、冷汗をかいたり、手が震えたりする初期症状が発現し、その後更に血糖値が低下すると意識障害(昏睡)を起こす。従って、糖尿病患者は、初期症状の発生を正確に把握し、症状が発生した場合は、糖分等を摂取するなど適切な処置を行わなければならない。 In the treatment of diabetes, it is important to control blood sugar to improve hyperglycemia and bring the blood sugar level as close to normal as possible. If this blood sugar control is not successful, hypoglycemia is caused. In hypoglycemia, initial symptoms such as rapid heartbeat, cold sweat, and trembling of the hands appear, and if the blood glucose level is lowered further, disturbance of consciousness (coma) occurs. Accordingly, a diabetic patient must accurately grasp the occurrence of initial symptoms and take appropriate measures such as ingesting sugar when the symptoms occur.
 糖尿病患者は、通常、初期症状で低血糖になったことを自覚して対処することができるが、インスリン療法を長期に行っている患者、自律神経障害を持つ患者、高齢患者等は初期症状に気付かず、突然意識障害を起こしてしまう場合がある(無自覚性低血糖)。 Diabetic patients are usually able to cope with hypoglycemia as an early symptom, but patients who have been taking insulin therapy for a long time, patients with autonomic disorder, elderly patients etc. Unconsciousness may cause sudden consciousness disturbance (unconscious hypoglycemia).
 このような、無自覚性低血糖を予防するため、特開2008-79993号公報には、被検者の血糖値を連続的にモニタリングする持続血糖モニタ(Continuous Glucose Monitoring : CGM)を用いた血糖測定装置であって、血糖値が第1危険レベルに達すると警報を発し、第2危険レベルに達すると第三者に通知することが記載されている。 In order to prevent such unconscious hypoglycemia, Japanese Patent Application Laid-Open No. 2008-79993 discloses blood glucose measurement using a continuous blood glucose monitor (Continuous Glucose Monitoring: CGM) that continuously monitors a subject's blood sugar level. An apparatus is described that issues a warning when a blood sugar level reaches a first risk level and notifies a third party when the blood sugar level reaches a second risk level.
 また、特開2008-79994号公報には、被検者の血糖値を連続的にモニタリングする持続血糖モニタを用いた血糖測定装置であって、過去一定時間分の血糖値の履歴における最大値と今回測定した血糖値との差が、注意血糖変化値以上の場合に、今回測定した血糖値が危険レベル血糖値以下でない場合は警報を発し、危険レベル血糖値以下の場合は第三者に通知することが記載されている。 Japanese Patent Application Laid-Open No. 2008-79994 discloses a blood glucose measurement device using a continuous blood glucose monitor that continuously monitors a subject's blood glucose level, wherein When the difference from the blood glucose level measured this time is greater than or equal to the caution blood glucose change value, an alarm is issued if the blood glucose level measured this time is not less than or equal to the risk level blood glucose level, and if it is less than or equal to the risk level blood glucose level, a third party is notified. It is described to do.
 しかしながら、低血糖が引き起こされる血糖値のレベルには個人差がある等、血糖値をモニタリングするだけでは、低血糖状態を正確に把握することができない。 However, the hypoglycemia state cannot be accurately grasped only by monitoring the blood glucose level, for example, the level of the blood glucose level causing hypoglycemia varies among individuals.
 本発明は、係る従来の問題点に鑑みてなされたものであり、低血糖状態をより正確に把握して報知する測定システムを提供することを目的とする。 The present invention has been made in view of such conventional problems, and an object of the present invention is to provide a measurement system for more accurately grasping and notifying a hypoglycemic state.
 上記目的を達成するために、本発明は、測定システムであって、被検者の異なる複数のバイタルサインを測定する複数の測定装置と、前記複数の測定装置の測定結果である複数の測定値に基づいて、前記被検者の低血糖状態を判別する判別部と、前記判別部が低血糖状態と判別した場合は、前記被検者に警告を行う警告部と、を備えることを特徴とする。 In order to achieve the above object, the present invention provides a measurement system, a plurality of measurement devices that measure a plurality of vital signs of different subjects, and a plurality of measurement values that are measurement results of the plurality of measurement devices. And a warning unit that warns the subject when the determination unit determines that the subject is in a hypoglycemic state. To do.
 上記の構成によれば、前記被検者は、血糖状態であることをより正確に認識することができ、適切な処置を施すことができる。 According to the above configuration, the subject can more accurately recognize that the subject is in a blood glucose state and can take an appropriate treatment.
 前記測定システムであって、前記低血糖状態は、複数の低血糖レベルを含み、前記判別部は、前記複数の測定装置の測定結果である前記複数の測定値に基づいて、前記バイタルサイン毎に低血糖か否かをそれぞれ判断し、低血糖であると判断された前記バイタルサインの前記測定値の数及び種類に応じて、前記被検者の低血糖レベルを判別し、前記警告部は、前記判別部が判別した低血糖レベルに応じて、警報レベルを変更して警告を行うことを特徴とする。 In the measurement system, the hypoglycemic state includes a plurality of hypoglycemic levels, and the determination unit is configured for each vital sign based on the plurality of measurement values that are measurement results of the plurality of measurement devices. It is determined whether or not hypoglycemia, respectively, according to the number and type of the measured value of the vital sign determined to be hypoglycemia, to determine the subject's hypoglycemia level, the warning unit, According to the low blood glucose level determined by the determination unit, warning is performed by changing the alarm level.
 上記構成によれば、前記被検者は、低血糖レベルを認識することができる。 According to the above configuration, the subject can recognize a low blood glucose level.
 前記測定システムであって、前記警告部は、前記判別部が判別した低血糖レベルに応じた音量で警告音を出力することを特徴とする。 In the measurement system, the warning unit outputs a warning sound at a volume corresponding to the low blood glucose level determined by the determination unit.
 上記構成によれば、前記被検者は、低血糖レベルを直感的に簡単に認識することができる。 According to the above configuration, the subject can easily and intuitively recognize the low blood glucose level.
 前記測定システムであって、前記複数のバイタルサイン毎に閾値が設定されており、前記判別部は、前記測定装置の測定結果である前記測定値と前記閾値とを比較することで、前記バイタルサイン毎に低血糖か否かをそれぞれ判断することを特徴とする。 In the measurement system, a threshold value is set for each of the plurality of vital signs, and the determination unit compares the measured value, which is a measurement result of the measuring device, with the threshold value, thereby obtaining the vital sign. It is characterized by each determining whether it is hypoglycemia every time.
 上記構成によれば、前記判別部は、各前記測定値による低血糖か否かの判断を簡単に且つ精度よく行うことができる。 According to the above configuration, the determination unit can easily and accurately determine whether or not there is hypoglycemia based on each measurement value.
 前記測定システムであって、前記複数のバイタルサインは、血糖を含み、前記判別部は、前記測定値である血糖値又は前記血糖値の変化量と前記閾値とを比較し、前記血糖値又は前記血糖値の変化量が前記閾値以下の場合は、低血糖であると判断することを特徴とする。 In the measurement system, the plurality of vital signs include blood glucose, and the determination unit compares the blood glucose level that is the measurement value or a change amount of the blood glucose level with the threshold value, and the blood glucose level or the When the amount of change in blood glucose level is less than or equal to the threshold, it is determined that the blood glucose level is low.
 上記構成によれば、前記血糖値による低血糖か否かの判断を精度良く行うことができる。例えば、前記血糖値が前記閾値以下の場合のみならず、前記血糖値の変化量が前記閾値以下の場合は、前記血糖値が急激に下がっているので、係る場合も低血糖と判断することができる。 According to the above configuration, it is possible to accurately determine whether or not the blood glucose level is hypoglycemia. For example, not only when the blood glucose level is equal to or lower than the threshold value, but also when the amount of change in the blood glucose level is equal to or lower than the threshold value, the blood glucose level is rapidly decreased. it can.
 前記測定システムであって、前記判別部は、前記血糖値に基づいて低血糖と判断した場合は、前記血糖値に基づいて低血糖と判断しなかった場合より低血糖レベルを高くすることを特徴とする。 In the measurement system, when the determination unit determines that hypoglycemia is based on the blood glucose level, the determination unit raises the low blood glucose level higher than when it is not determined to be hypoglycemia based on the blood glucose level. And
 上記構成によれば、低血糖か否かをダイレクトに示す前記血糖値に重点をおいて、低血糖レベルを判別することができ、正確に低血糖レベルを判別することができる。 According to the above configuration, the hypoglycemia level can be determined with emphasis on the blood glucose level that directly indicates whether or not hypoglycemia, and the hypoglycemia level can be accurately determined.
 前記測定システムであって、前記複数のバイタルサインは、前記被検者の拍動、発汗、又は、手の震えを含み、前記判別部は、前記測定値である心拍数、発汗量、又は手の震えの振動数と前記閾値とを比較し、前記心拍数、前記発汗量、又は前記振動数が前記閾値以上の場合は、低血糖であると判断することを特徴とする。 In the measurement system, the plurality of vital signs include pulsation, sweating, or hand tremor of the subject, and the determination unit includes a heart rate, a sweating amount, or a hand as the measurement value. The frequency of tremors is compared with the threshold, and if the heart rate, the amount of sweating, or the frequency is equal to or higher than the threshold, it is determined that the blood glucose is low.
 上記構成によれば、精度よく血糖以外の他のバイタルサインでも低血糖であるか否かを判断することができる。 According to the above configuration, it is possible to accurately determine whether the blood glucose level is low even with vital signs other than blood glucose.
 前記測定システムであって、前記判別部は、前記複数の測定装置の測定結果である前記複数の測定値に基づいて、前記バイタルサイン毎に低血糖か否かをそれぞれ判断し、低血糖であると判断された前記バイタルサインの前記測定値の数が一定数以上の場合は、前記被検者が低血糖状態であると判別することを特徴とする。 In the measurement system, the determination unit determines whether or not the blood glucose level is low for each vital sign based on the plurality of measurement values that are measurement results of the plurality of measurement devices, and the blood glucose level is low. When the number of the measured values of the vital sign determined to be equal to or greater than a certain number, it is determined that the subject is in a hypoglycemic state.
 上記構成によれば、確実に被検者が低血糖であると判断できる時に、被検者が低血糖状態であると判別することでき、前記被検者は、低血糖状態であることをより正確に認識することができる。 According to the above configuration, when it can be reliably determined that the subject is hypoglycemic, it can be determined that the subject is hypoglycemic, and the subject is more hypoglycemic. It can be recognized accurately.
 本発明によれば、被検者の異なる複数のバイタルサインを測定し、測定結果である複数の測定値に基づいて、被検者の低血糖状態を判別し、低血糖状態と判別した場合は、被検者に警告を行うので、被検者は、血糖状態であることをより正確に認識することができ、適切な処置を施すことができる。 According to the present invention, when measuring a plurality of vital signs different for a subject, determining a hypoglycemic state of the subject based on a plurality of measured values as measurement results, and determining a hypoglycemic state, Since the warning is given to the subject, the subject can more accurately recognize that the subject is in a blood glucose state and can take appropriate measures.
実施の形態にかかる測定システムのブロック図である。It is a block diagram of the measurement system concerning an embodiment. 図1に示す測定システムの血糖測定装置の動作を示すフローチャートである。It is a flowchart which shows operation | movement of the blood glucose measurement apparatus of the measurement system shown in FIG. 図1に示す測定システムのバイタルサイン測定装置の動作を示すフローチャートである。It is a flowchart which shows operation | movement of the vital sign measuring apparatus of the measuring system shown in FIG. 血糖値又は血糖値の変化量を受信した時の表示装置の動作を示すフローチャートである。It is a flowchart which shows operation | movement of the display apparatus when the blood glucose level or the variation | change_quantity of a blood glucose level is received. 発汗量を受信した時の表示装置の動作を示すフローチャートである。It is a flowchart which shows operation | movement of the display apparatus when the amount of perspiration is received. 血糖値による低血糖判断と血糖値以外の1つのバイタルサインによる低血糖判断とに基づいて判別される低血糖レベルを表す図である。It is a figure showing the hypoglycemia level discriminate | determined based on the hypoglycemia determination by a blood glucose level and the hypoglycemia determination by one vital sign other than a blood glucose level.
 本発明に係る測定システムについて、好適な実施の形態を掲げ、添付の図面を参照しながら以下、詳細に説明する。 DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A measurement system according to the present invention will be described in detail below with reference to preferred embodiments and referring to the accompanying drawings.
 図1は、実施の形態にかかる測定システム10のブロック図である。測定システム10は、被検者のバイタルサインの一種である血糖を測定する血糖測定装置12と、血糖値以外の被検者の異なる複数のバイタルサイン(例えば、拍動、発汗、手の震え等)を測定する複数のバイタルサイン測定装置14と、表示装置16とを有する。なお、拍動、手又は足の発汗、手の震え等を測定する理由としては、通常、被検者が低血糖になると、拍動が早くなったり、冷汗をかいたり、手が震えたりするので、これらのバイタルサインを測定する。 FIG. 1 is a block diagram of a measurement system 10 according to an embodiment. The measurement system 10 includes a blood glucose measurement device 12 that measures blood sugar, which is a type of vital sign of the subject, and a plurality of vital signs different from the subject other than the blood glucose level (for example, pulsation, sweating, hand tremor, etc.) A plurality of vital sign measuring devices 14 and a display device 16. The reason for measuring pulsation, sweating of hands or feet, trembling of hands, etc. is usually that when the subject becomes hypoglycemic, the pulsation is faster, cold sweat is applied, and the hand shakes. So measure these vital signs.
 血糖測定装置12は、測定部20と、制御部22と、通信部24とを有する。測定部20には、被検者の皮膚を穿刺して皮下に留置する針20aが設けられる。針20aは、測定部20に血液が届くように誘導する毛細管である。 The blood glucose measurement device 12 includes a measurement unit 20, a control unit 22, and a communication unit 24. The measuring unit 20 is provided with a needle 20a for puncturing the subject's skin and placing it under the skin. The needle 20a is a capillary that guides the blood to reach the measurement unit 20.
 測定部20は、針20aから送られてきた血液に含まれるグルコースの濃度を測定する。測定部30は、図示しないが、フォトダイオード等の受光素子、発光ダイオード等の発光素子、及びインジケータ層を有する。このインジケータ層は、標識化合物としての蛍光色素を含んでおり、該標識化合物は、針20aによって導入されたグルコースを捕捉する。前記発光素子を発光させて、前記インジケータに光を入射させると、該インジケータ層は、グルコースの濃度に応じた強度の蛍光を得る。このインジケータ層からの蛍光は受光素子によって光電変換され、受光信号(グルコースの濃度を示す受光信号)が制御部22に送られる。 The measuring unit 20 measures the concentration of glucose contained in the blood sent from the needle 20a. Although not shown, the measurement unit 30 includes a light receiving element such as a photodiode, a light emitting element such as a light emitting diode, and an indicator layer. The indicator layer contains a fluorescent dye as a labeling compound, and the labeling compound captures glucose introduced by the needle 20a. When the light emitting element is caused to emit light and light is incident on the indicator, the indicator layer obtains fluorescence having an intensity corresponding to the glucose concentration. The fluorescence from the indicator layer is photoelectrically converted by the light receiving element, and a light receiving signal (light receiving signal indicating the glucose concentration) is sent to the control unit 22.
 制御部22は、図示しないCPU及びメモリ等を有し、血糖測定装置12全体を制御する。制御部22は、測定部20から送られてきた受光信号をデジタル信号に変換すると共に、該変換したデジタル信号の受光信号に基づいてグルコースの濃度値(以下、血糖値という)を算出する。制御部22は、測定結果である算出した血糖値(測定値)を通信部24に出力する。なお、測定部20は、一定の周期で、グルコースの濃度を示す受光信号を得て、制御部22に出力するので、制御部22は、前記一定の周期(一定の測定周期)で、血糖値を算出する。 The control unit 22 has a CPU and a memory (not shown), and controls the blood glucose measurement device 12 as a whole. The control unit 22 converts the light reception signal sent from the measurement unit 20 into a digital signal, and calculates a glucose concentration value (hereinafter referred to as a blood glucose level) based on the converted light reception signal. The control unit 22 outputs the calculated blood glucose level (measurement value) that is a measurement result to the communication unit 24. The measurement unit 20 obtains a light reception signal indicating the glucose concentration at a constant cycle and outputs the received light signal to the control unit 22. Therefore, the control unit 22 performs blood glucose level at the constant cycle (a constant measurement cycle). Is calculated.
 通信部24は、表示装置16と無線通信することで、制御部22から送られてきた血糖値を無線通信により表示装置16に送信する。通信部24は、Bluetooth、IrDA(Infrared Data Association)等を用いて無線通信を行う。 The communication unit 24 wirelessly communicates with the display device 16 to transmit the blood glucose level transmitted from the control unit 22 to the display device 16 by wireless communication. The communication unit 24 performs wireless communication using Bluetooth, IrDA (Infrared Data Association), or the like.
 バイタルサイン測定装置14は、測定部30と、制御部32と、通信部34とを有する。測定部30は、被検者の心拍数、手又は足の発汗量、又は、手の震えの振動数等を測定するものである。測定部30が心拍数を測定するものである場合は、測定部30は、心電信号を検出する電極を有し、手又は足の発汗量を測定するものであれば、測定部30は、電極を有し、被検者の皮膚の静電容量を検出する。また、測定部30が手の震えの振動数を測定するものである場合は、測定部30は、角速度を検出するジャイロセンサを有する。 The vital sign measurement device 14 includes a measurement unit 30, a control unit 32, and a communication unit 34. The measuring unit 30 measures the heart rate of the subject, the sweating amount of the hand or foot, the vibration frequency of hand tremors, and the like. If the measurement unit 30 is for measuring a heart rate, the measurement unit 30 has an electrode for detecting an electrocardiogram signal, and if the measurement unit 30 measures the sweating amount of a hand or a foot, It has electrodes and detects the capacitance of the subject's skin. Moreover, when the measurement part 30 measures the vibration frequency of a hand tremor, the measurement part 30 has a gyro sensor which detects an angular velocity.
 制御部32は、図示しないCPU及びメモリ等を有し、バイタルサイン測定装置14全体を制御する。制御部32は、測定部30から送られてきた信号をデジタル信号に変換すると共に、該変換したデジタル信号に基づいて、心拍数、発汗量、又は、手の震えの振動数を算出する。 The control unit 32 includes a CPU and a memory (not shown), and controls the vital sign measurement device 14 as a whole. The control unit 32 converts the signal sent from the measurement unit 30 into a digital signal, and calculates the heart rate, the amount of sweating, or the vibration frequency of hand tremor based on the converted digital signal.
 例えば、測定部30から心電信号が送られてきた場合は、デジタル信号に変換された心電信号に基づいて心拍数を算出する。また、測定部30から被検者の皮膚の静電容量を示す信号(静電容量信号)が送られてきた場合は、デジタル信号に変換された静電容量信号に基づいて発汗量を算出する。また、測定部30からジャイロセンサが検出した角速度信号から振動数を算出する。制御部32は、測定結果である算出した測定値(心拍数、発汗量、又は振動数)を通信部34に出力する。なお、測定部30は、前記一定の周期で、心電信号、静電容量信号、又は、角速度信号等を得て、制御部32に出力するので、制御部32は、前記一定の周期(一定の測定周期)で、心拍数、手又は足の発汗量、手の震えの振動数を算出する。 For example, when an electrocardiogram signal is sent from the measurement unit 30, the heart rate is calculated based on the electrocardiogram signal converted into a digital signal. Further, when a signal (capacitance signal) indicating the capacitance of the subject's skin is sent from the measurement unit 30, the amount of sweating is calculated based on the capacitance signal converted into a digital signal. . Further, the vibration frequency is calculated from the angular velocity signal detected by the gyro sensor from the measurement unit 30. The control unit 32 outputs the calculated measurement value (heart rate, sweating amount, or vibration frequency), which is a measurement result, to the communication unit 34. Note that the measurement unit 30 obtains an electrocardiogram signal, an electrostatic capacity signal, an angular velocity signal, or the like at the fixed cycle and outputs the signal to the control unit 32. In the measurement cycle), the heart rate, the sweating amount of the hand or foot, and the vibration frequency of the hand tremor are calculated.
 通信部34は、表示装置16と無線通信することで、制御部32から送られてきた測定値を無線通信により表示装置16に送信する。通信部34は、Bluetooth、IrDA(Infrared Data Association)等を用いて無線通信を行う。 The communication unit 34 wirelessly communicates with the display device 16 to transmit the measurement value transmitted from the control unit 32 to the display device 16 by wireless communication. The communication unit 34 performs wireless communication using Bluetooth, IrDA (Infrared Data Association), or the like.
 ここで、血糖測定装置12の測定タイミングと、複数のバイタルサイン測定装置14の測定タイミングとをずらすことで、血糖測定装置12の測定周期より短い間隔で低血糖であるかどうかを示すバイタルサインを測定することができる。血糖測定装置12及び複数のバイタルサイン測定装置14は同期処理が行われていないので、血糖測定装置12及び複数のバイタルサイン測定装置14の測定タイミングは自然にずれることになる。なお、血糖測定装置12及び複数のバイタルサイン測定装置14が同期処理を行うことで、測定タイミングを任意にずらすようにしてもよい。 Here, by shifting the measurement timing of the blood glucose measurement device 12 and the measurement timings of the plurality of vital sign measurement devices 14, a vital sign indicating whether or not the blood glucose is low at intervals shorter than the measurement cycle of the blood glucose measurement device 12. Can be measured. Since the blood glucose measurement device 12 and the plurality of vital sign measurement devices 14 are not synchronized, the measurement timings of the blood glucose measurement device 12 and the plurality of vital sign measurement devices 14 are naturally shifted. In addition, the blood glucose measurement device 12 and the plurality of vital sign measurement devices 14 may perform the synchronization process to arbitrarily shift the measurement timing.
 表示装置16は、通信部40、記憶部42、制御部44、音出力部46、表示部48、及び操作部50を有する。通信部40は、血糖測定装置12及び複数のバイタルサイン測定装置14と無線通信して、血糖値、心拍数、発汗量、振動数等の測定値を取得する。詳しくは、血糖測定装置12の通信部24及び複数のバイタルサイン測定装置14の通信部34と無線通信して、測定値を取得する。 The display device 16 includes a communication unit 40, a storage unit 42, a control unit 44, a sound output unit 46, a display unit 48, and an operation unit 50. The communication unit 40 wirelessly communicates with the blood glucose measurement device 12 and the plurality of vital sign measurement devices 14 to acquire measurement values such as blood glucose level, heart rate, sweating amount, and vibration frequency. Specifically, the measurement value is acquired by wirelessly communicating with the communication unit 24 of the blood glucose measurement device 12 and the communication unit 34 of the plurality of vital sign measurement devices 14.
 記憶部42は、血糖測定装置12及びバイタルサイン測定装置14が測定するバイタルサイン(血糖、拍動、冷汗、手の震え)毎に設定された閾値が記憶されている。言い換えるならば、記憶部42には、血糖値、心拍数、発汗量、及び手の震えの振動数等に対応する閾値がそれぞれ記憶されている。また、記憶部42は、血糖値フラグ、心拍数フラグ、発汗量フラグ、振動数フラグ等のバイタルサインのフラグを記憶する記憶領域を複数有する。 The storage unit 42 stores a threshold value set for each vital sign (blood sugar, pulsation, cold sweat, hand tremor) measured by the blood glucose measurement device 12 and the vital sign measurement device 14. In other words, the storage unit 42 stores threshold values corresponding to blood sugar level, heart rate, sweating amount, hand tremor frequency, and the like. The storage unit 42 includes a plurality of storage areas for storing vital sign flags such as a blood glucose level flag, a heart rate flag, a sweating amount flag, and a vibration frequency flag.
 制御部44は、図示しないCPU及びメモリ等を有し、表示装置16全体を制御する。制御部44は、判別部44aを有し、判別部44aは、通信部40が受信した血糖値、心拍数、発汗量等の測定値に基づいて、被検者の低血糖状態を判別する。この低血糖状態は、複数の低血糖レベルを有し、判別部44aは、受信したバイタルサインの測定値及びその種類と閾値とを用いて、被検者の低血糖レベルを判別する。低血糖レベルが高い程、被検者が低血糖状態である可能性が高いことを示し、低血糖レベルが低い程、被検者が低血糖状態である可能性が低いことを示している。 The control unit 44 includes a CPU and a memory (not shown) and controls the entire display device 16. The control unit 44 includes a determination unit 44a, and the determination unit 44a determines the hypoglycemia state of the subject based on the measured values such as blood glucose level, heart rate, and sweating amount received by the communication unit 40. This hypoglycemic state has a plurality of hypoglycemic levels, and the determination unit 44a determines the hypoglycemic level of the subject using the received measured value of the vital sign and its type and threshold. The higher the hypoglycemia level, the higher the possibility that the subject is in a hypoglycemic state, and the lower the hypoglycemic level, the lower the possibility that the subject is in the hypoglycemic state.
 また、制御部44は、警告部44bを有し、警告部44bは、判別部44aが判別した低血糖レベルに応じた音量で、スピーカ等の音出力部46から警告音を出力することで、低血糖状態であることを被検者に警告する。詳しくは、低血糖レベルが低い場合は小さい音量で警告音を出力し、低血糖レベルが高い場合は大きい音量で警告音を出力する。 Further, the control unit 44 includes a warning unit 44b, and the warning unit 44b outputs a warning sound from the sound output unit 46 such as a speaker at a volume corresponding to the low blood glucose level determined by the determination unit 44a. Alert the subject that they are hypoglycemic. Specifically, when the low blood glucose level is low, a warning sound is output at a low volume, and when the low blood glucose level is high, a warning sound is output at a high volume.
 また、警告部44bは、判別部44aが判別した低血糖レベルに応じた表示態様で、液晶ディスプレイ等の表示部48に警告表示させることで、低血糖状態であることを被検者に警告する。詳しくは、低血糖レベルが低い場合はその旨を表示させ(例えば、「低血糖状態の可能性があります」等の文字を表示させ)、低血糖レベルが高い場合はその旨を表示させる(例えば、「低血糖状態の可能性が高いです 注意して下さい」等の文字を表示させる)。また、警告部44bは、低血糖レベルに応じて表示部48のバックライトの明るさや色を変えたりしてもよい。要は、警告部44bは、判別部44aが判別した低血糖レベルに応じて、警報レベルを変更して警告を行なえばよい。 The warning unit 44b warns the subject that the blood glucose level is low by displaying a warning on the display unit 48 such as a liquid crystal display in a display mode according to the low blood glucose level determined by the determination unit 44a. . Specifically, if the hypoglycemia level is low, that fact is displayed (for example, a character such as “There is a possibility of hypoglycemia” is displayed), and if the hypoglycemia level is high, that fact is displayed (for example, , “Likely hypoglycemic state is likely to be displayed.” The warning unit 44b may change the brightness and color of the backlight of the display unit 48 according to the low blood sugar level. In short, the warning unit 44b may change the alarm level and issue a warning according to the low blood glucose level determined by the determination unit 44a.
 表示部48は、上述したように、警告表示を行う他に、血糖測定装置12が測定した血糖値を表示したり、グラフィカルユーザインターフェース(GUI)として機能する。操作部50は、表示部48の表示内容の切り替え、所定情報の入力等の各種操作を被検者等が行うためのものである。 As described above, the display unit 48 displays a blood glucose level measured by the blood glucose measurement device 12 and functions as a graphical user interface (GUI) in addition to displaying a warning. The operation unit 50 is for the subject to perform various operations such as switching display contents of the display unit 48 and inputting predetermined information.
 次に、測定システム10の動作を説明する。測定システム10の動作の説明においては、説明を簡単にするため、バイタルサイン測定装置14は1つとし、該バイタルサイン測定装置14は、発汗量を測定するものとする。 Next, the operation of the measurement system 10 will be described. In the description of the operation of the measurement system 10, for the sake of simplicity, it is assumed that there is one vital sign measuring device 14 and the vital sign measuring device 14 measures the amount of sweating.
 まず、測定システム10の血糖測定装置12の動作を図2のフローチャートに従って説明する。制御部22は、測定タイミングが到来したか否かを判断する(ステップS1)。この測定タイミングは、一定の測定周期で到来する。ステップS1で、測定タイミングが到来していないと判断すると、到来するまでステップS1に留まり、測定タイミングが到来したと判断すると、制御部22は、測定部20を制御することで、測定部20からグルコースの濃度を示す受光信号を取得する(ステップS2)。 First, the operation of the blood glucose measurement device 12 of the measurement system 10 will be described with reference to the flowchart of FIG. The control unit 22 determines whether or not the measurement timing has arrived (step S1). This measurement timing arrives at a constant measurement cycle. If it is determined in step S1 that the measurement timing has not arrived, it remains in step S1 until it arrives. If it is determined that the measurement timing has arrived, the control unit 22 controls the measurement unit 20 so that the measurement unit 20 A light reception signal indicating the concentration of glucose is acquired (step S2).
 次いで、制御部22は、取得した受光信号に基づいて血糖値を算出する(ステップS3)。なお、制御部22は、今回算出した血糖値と一定時間前に算出した血糖値とに基づいて血糖値の変化量を算出してもよい。この変化量は、今回算出した血糖値から一定時間前に算出した血糖値を減算することで求めることができる。従って、血糖値が減少傾向にある場合は、変化量は負の値となる。 Next, the control unit 22 calculates a blood glucose level based on the acquired light reception signal (step S3). In addition, the control part 22 may calculate the variation | change_quantity of a blood glucose level based on the blood glucose level calculated this time and the blood glucose level calculated for the fixed time ago. This amount of change can be obtained by subtracting the blood glucose level calculated a certain time ago from the blood glucose level calculated this time. Therefore, when the blood glucose level tends to decrease, the amount of change becomes a negative value.
 次いで、通信部24は、ステップS3で算出した血糖値を表示装置16に送信して(ステップS4)、ステップS1に戻る。なお、ステップS3で血糖値の変化量が算出された場合は、該血糖値の変化量を表示装置16に送信してもよい。 Next, the communication unit 24 transmits the blood glucose level calculated in step S3 to the display device 16 (step S4), and returns to step S1. If the change amount of the blood glucose level is calculated in step S3, the change amount of the blood glucose level may be transmitted to the display device 16.
 次に、測定システム10のバイタルサイン測定装置14の動作を図3のフローチャートに従って説明する。制御部32は、測定タイミングが到来したか否かを判断する(ステップS11)。この測定タイミングは、一定の測定周期で到来する。ステップS11で、測定タイミングが到来していないと判断すると、到来するまでステップS11に留まり、測定タイミングが到来したと判断すると、制御部32は、測定部30を制御することで、測定部30から皮膚の静電容量信号を取得する(ステップS12)。 Next, the operation of the vital sign measurement device 14 of the measurement system 10 will be described with reference to the flowchart of FIG. The control unit 32 determines whether or not the measurement timing has arrived (step S11). This measurement timing arrives at a constant measurement cycle. If it is determined in step S11 that the measurement timing has not arrived, the process stays in step S11 until it arrives. If it is determined that the measurement timing has arrived, the control unit 32 controls the measurement unit 30 so that the measurement unit 30 A skin capacitance signal is acquired (step S12).
 次いで、制御部32は、取得した静電容量信号に基づいて発汗量を算出する(ステップS13)。次いで、通信部34は、ステップS13で算出した発汗量を表示装置16に送信して(ステップS14)、ステップS11に戻る。 Next, the control unit 32 calculates the amount of sweating based on the acquired capacitance signal (step S13). Next, the communication unit 34 transmits the sweating amount calculated in step S13 to the display device 16 (step S14), and returns to step S11.
 次に、測定システム10の表示装置16の動作を図4及び図5のフローチャートに従って説明する。まず、血糖値又は血糖値の変化量を受信した時の表示装置16の動作を図4のフローチャートに従って説明した後、発汗量を受信した時の表示装置16の動作を図5のフローチャートに従って説明する。 Next, the operation of the display device 16 of the measurement system 10 will be described with reference to the flowcharts of FIGS. First, the operation of the display device 16 when a blood glucose level or a change amount of the blood glucose level is received will be described according to the flowchart of FIG. 4, and then the operation of the display device 16 when the perspiration amount is received will be described according to the flowchart of FIG. .
 通信部40が血糖測定装置12から血糖値を受信すると、制御部44の判別部44aは、血糖値による低血糖判断を行う(図4のステップS21)。詳しくは、判別部44aは、受信した血糖値と、記憶部42に記憶されている血糖値の閾値とを比較し、受信した血糖値が閾値以下の場合は低血糖であると判断し、受信した血糖値が閾値より大きい場合は低血糖でないと判断する。 When the communication unit 40 receives the blood glucose level from the blood glucose measurement device 12, the determination unit 44a of the control unit 44 makes a hypoglycemia determination based on the blood glucose level (step S21 in FIG. 4). Specifically, the determination unit 44a compares the received blood glucose level with the threshold value of the blood glucose level stored in the storage unit 42, determines that the received blood glucose level is equal to or lower than the threshold, and determines that the blood glucose level is low. If the blood glucose level is greater than the threshold value, it is determined that the blood glucose level is not low.
 なお、血糖値の変化量を受信した場合は、判別部44aは、血糖値の変化量を受信した場合は、受信した血糖値の変化量と、記憶部42に記憶されている血糖値の変化量の閾値とを比較し、受信した血糖値の変化量が閾値以下の場合は、低血糖であると判断し、受信した変化量が閾値より大きい場合は、低血糖でないと判断する。血糖値の変化量が閾値以下の場合は、血糖値が急激に下がっており、低血糖であると判断することが望ましいからである。 When the blood glucose level change amount is received, the determination unit 44a receives the blood glucose level change amount and the received blood glucose level change amount and the blood glucose level change stored in the storage unit 42. When the received change amount of the blood sugar level is equal to or less than the threshold value, it is determined that the blood glucose level is lower than the threshold value. This is because when the amount of change in blood glucose level is equal to or lower than the threshold, it is desirable to determine that the blood glucose level has dropped sharply and hypoglycemia.
 ステップS21で、低血糖であると判断すると、判別部44aは、血糖値フラグをセットする(ステップS22)。つまり、記憶部42の血糖値フラグを記憶する記憶領域に「1」を記憶することで、血糖値フラグをセットする。既に血糖値フラグがセットされている場合は、ステップS22の動作を行なわない。 When it is determined in step S21 that the blood glucose level is low, the determination unit 44a sets a blood glucose level flag (step S22). That is, the blood glucose level flag is set by storing “1” in the storage area for storing the blood glucose level flag in the storage unit 42. If the blood sugar level flag has already been set, the operation of step S22 is not performed.
 次いで、判別部44aは、発汗量フラグがセットされているか否かを判断する(ステップS23)。つまり、記憶部42の発汗量フラグを記憶する記憶領域に「1」が記憶されているか否かを判断する。詳しくは後述するが、判別部44aは、発汗量により低血糖判断で低血糖と判断されると発汗量フラグをセットする。 Next, the determination unit 44a determines whether or not the sweating amount flag is set (step S23). That is, it is determined whether or not “1” is stored in the storage area for storing the sweating amount flag in the storage unit 42. As will be described in detail later, the determination unit 44a sets a perspiration amount flag when it is determined that hypoglycemia is determined by hypoglycemia based on the perspiration amount.
 ステップS23で、発汗量フラグがセットされていると判断すると、判別部44aは、被検者の低血糖状態が低血糖レベル3であると判別し(ステップS24)、制御部44の警告部44bは、低血糖レベル3に応じた警報レベルで警告して(ステップS25)、動作を終了する。例えば、音量3で警告音を音出力部46から出力すると共に、「低血糖状態です」等の文字を表示部48に表示することで警告を行う。 If it is determined in step S23 that the sweating amount flag is set, the determination unit 44a determines that the hypoglycemic state of the subject is the low blood glucose level 3 (step S24), and the warning unit 44b of the control unit 44 Warns at an alarm level corresponding to the low blood glucose level 3 (step S25), and ends the operation. For example, a warning sound is output from the sound output unit 46 at the volume 3, and a warning such as “it is a hypoglycemic state” is displayed on the display unit 48.
 一方、ステップS23で、発汗量フラグがセットされていない判断すると、判別部44aは、被検者の低血糖状態が低血糖レベル2であると判別し(ステップS26)、警告部44bは、低血糖レベル2に応じた警報レベルで警告して(ステップS27)、動作を終了する。例えば、音量3より小さい音量2で警告音を音出力部46から出力すると共に、「低血糖状態の可能性が高いです 注意して下さい」等の文字を表示部48に表示することで警告を行う。 On the other hand, if it is determined in step S23 that the sweating amount flag is not set, the determination unit 44a determines that the hypoglycemic state of the subject is the low blood glucose level 2 (step S26), and the warning unit 44b is low. A warning is given at an alarm level corresponding to blood glucose level 2 (step S27), and the operation is terminated. For example, a warning sound is output from the sound output unit 46 at a volume 2 smaller than the volume 3, and a warning is displayed by displaying characters such as “There is a high possibility of a hypoglycemic state. Do.
 ステップS21で、低血糖でないと判断すると、判別部44aは、血糖値フラグをクリアにする(ステップS28)。つまり、記憶部42の血糖値フラグを記憶する記憶領域に「0」を記憶することで、血糖値フラグをクリアにする。既に血糖値フラグがクリアにされている場合は、ステップS28の動作を行なわない。 If it is determined in step S21 that the blood glucose level is not low, the determination unit 44a clears the blood glucose level flag (step S28). That is, the blood sugar level flag is cleared by storing “0” in the storage area for storing the blood sugar level flag in the storage unit 42. If the blood sugar level flag has already been cleared, the operation of step S28 is not performed.
 次いで、判別部44aは、発汗量フラグがセットされているか否かを判断する(ステップS29)。ステップS29で、発汗量フラグがセットされていないと判断すると動作を終了し、ステップS29で、発汗量フラグがセットされていると判断すると、判別部44aは、被検者の低血糖状態が低血糖レベル1であると判別し(ステップS30)、警告部44bは、低血糖レベル1に応じた警報レベルで警告して(ステップS31)、動作を終了する。例えば、音量2より小さい音量1で警告音を音出力部46から出力すると共に、「低血糖状態の可能性があります」等の文字を表示部48に表示することで警告を行う。 Next, the determination unit 44a determines whether or not the sweating amount flag is set (step S29). If it is determined in step S29 that the sweating amount flag is not set, the operation is terminated. If it is determined in step S29 that the sweating amount flag is set, the determination unit 44a determines that the subject's hypoglycemic state is low. It is determined that the blood glucose level is 1 (step S30), and the warning unit 44b warns at an alarm level corresponding to the low blood glucose level 1 (step S31) and ends the operation. For example, a warning sound is output from the sound output unit 46 at a volume 1 lower than the volume 2, and a warning such as “There is a possibility of hypoglycemia” is displayed on the display unit 48.
 また、通信部40がバイタルサイン測定装置14から発汗量を受信すると、判別部44aは、発汗量による低血糖判断を行う(図5のステップS51)。詳しくは、判別部44aは、受信した発汗量と、記憶部42に記憶されている発汗量の閾値とを比較し、受信した発汗量が閾値以上の場合は低血糖であると判断し、受信した発汗量が閾値未満の場合は低血糖でないと判断する。 Further, when the communication unit 40 receives the sweating amount from the vital sign measurement device 14, the determination unit 44a makes a hypoglycemic determination based on the sweating amount (step S51 in FIG. 5). Specifically, the determination unit 44a compares the received amount of sweating with a threshold value of the sweating amount stored in the storage unit 42, determines that the received sweating amount is equal to or higher than the threshold value, and determines that the blood glucose level is low. If the perspiration amount is less than the threshold, it is determined that the blood sugar is not hypoglycemic.
 ステップS51で、低血糖であると判断すると、判別部44aは、発汗量フラグをセットする(ステップS52)。つまり、記憶部42の発汗量フラグを記憶する記憶領域に「1」を記憶することで、発汗量フラグをセットする。既に発汗量フラグがセットされている場合は、ステップS52の動作を行なわない。 If it is determined in step S51 that the blood sugar level is low, the determination unit 44a sets a sweating amount flag (step S52). That is, by storing “1” in the storage area for storing the sweating amount flag of the storage unit 42, the sweating amount flag is set. When the sweating amount flag is already set, the operation of step S52 is not performed.
 次いで、判別部44aは、血糖値フラグがセットされているか否かを判断する(ステップS53)。つまり、記憶部42の血糖値フラグを記憶する記憶領域に「1」が記憶されているか否かを判断する。 Next, the determination unit 44a determines whether or not the blood sugar level flag is set (step S53). That is, it is determined whether or not “1” is stored in the storage area for storing the blood sugar level flag in the storage unit 42.
 ステップS53で、血糖値フラグがセットされていると判断すると、判別部44aは、被検者の低血糖状態が低血糖レベル3であると判別し(ステップS54)、警告部44bは、低血糖レベル3に応じた警報レベルで警告して(ステップS55)、動作を終了する。 If it is determined in step S53 that the blood glucose level flag is set, the determination unit 44a determines that the hypoglycemic state of the subject is the low blood glucose level 3 (step S54), and the warning unit 44b A warning is given at an alarm level corresponding to level 3 (step S55), and the operation is terminated.
 一方、ステップS53で、血糖値フラグがセットされていないと判断すると、判別部44aは、被検者の低血糖状態が低血糖レベル1であると判別し(ステップS56)、警告部44bは、低血糖レベル1に応じた警報レベルで警告して(ステップS57)、動作を終了する。 On the other hand, if it is determined in step S53 that the blood glucose level flag is not set, the determination unit 44a determines that the subject's hypoglycemia state is low blood glucose level 1 (step S56), and the warning unit 44b A warning is given at an alarm level corresponding to the low blood glucose level 1 (step S57), and the operation is terminated.
 ステップS51で、低血糖でないと判断すると、判別部44aは、発汗量フラグをクリアにする(ステップS58)。つまり、記憶部42の発汗量フラグを記憶する記憶領域に「0」を記憶することで、発汗量フラグをクリアにする。既に発汗量フラグがクリアにされている場合は、ステップS58の動作を行なわない。 If it is determined in step S51 that the blood glucose level is not low, the determination unit 44a clears the sweating amount flag (step S58). That is, by storing “0” in the storage area for storing the sweating amount flag in the storage unit 42, the sweating amount flag is cleared. If the sweating amount flag has already been cleared, the operation of step S58 is not performed.
 次いで、判別部44aは、血糖値フラグがセットされているか否かを判断する(ステップS59)。ステップS59で、血糖値フラグがセットされていないと判断すると動作を終了し、ステップS59で、血糖値フラグがセットされていると判断すると、判別部44aは、被検者の低血糖状態が低血糖レベル2であると判別し(ステップS60)、警告部44bは、低血糖レベル2に応じた警報レベルで警告して(ステップS61)動作を終了する。 Next, the determination unit 44a determines whether or not the blood sugar level flag is set (step S59). If it is determined in step S59 that the blood glucose level flag is not set, the operation is terminated. If it is determined in step S59 that the blood glucose level flag is set, the determination unit 44a determines that the subject has a low hypoglycemic state. It is determined that the blood sugar level is 2 (step S60), and the warning unit 44b warns at an alarm level corresponding to the low blood sugar level 2 (step S61) and ends the operation.
 図6は、図4及び図5で示す様に、血糖値による低血糖判断と血糖値以外の1つのバイタルサインによる低血糖判断とに基づいて判別される低血糖レベルを表す図である。 FIG. 6 is a diagram showing the hypoglycemia level determined based on the hypoglycemia determination based on the blood glucose level and the hypoglycemia determination based on one vital sign other than the blood glucose level, as shown in FIGS. 4 and 5.
 血糖値による低血糖判断により肯(低血糖である)と判断し、血糖値以外のバイタルサイン(図4及び図5では発汗量)による低血糖判断により肯(低血糖である)と判断すると、低血糖状態が低血糖レベル3であると判別する。また、血糖値による低血糖判断により肯と判断し、血糖値以外のバイタルサインによる低血糖判断により否(低血糖でない)と判断すると、低血糖状態が低血糖レベル2であると判別する。また、血糖値による低血糖判断により否と判断し、血糖値以外のバイタルサインによる低血糖判断により肯と判断すると、低血糖状態が低血糖レベル1であると判別する。 If it is determined to be positive (hypoglycemia) by hypoglycemia determination based on blood glucose level, and if it is determined to be positive (hypoglycemia) by hypoglycemia determination based on vital signs other than blood glucose level (sweat amount in FIGS. 4 and 5), It is determined that the hypoglycemia state is hypoglycemia level 3. Further, if the determination is affirmative based on the hypoglycemia determination based on the blood glucose level and the determination is negative (not hypoglycemia) based on the hypoglycemia determination based on a vital sign other than the blood glucose level, it is determined that the hypoglycemia state is the low blood glucose level 2. Further, if the determination is negative based on the hypoglycemia determination based on the blood glucose level and the determination is affirmative based on the hypoglycemia determination based on a vital sign other than the blood glucose level, it is determined that the hypoglycemia state is the low blood glucose level 1.
 このように、低血糖であると判断された測定値の数及びその種類(血糖値、心拍数、発汗量、手の震えの振動数)に応じて、低血糖レベルが判別される。なお、判別部44aは、血糖値による低血糖判断により否と判断し、血糖値以外のバイタルサインによる低血糖判断により否と判断した場合は、低血糖状態ではないと判別する。 Thus, the hypoglycemia level is determined according to the number of measured values determined to be hypoglycemia and the type thereof (blood glucose level, heart rate, sweat rate, hand tremor frequency). Note that the determination unit 44a determines that the hypoglycemia is determined based on the hypoglycemia based on the blood glucose level, and determines that the hypoglycemia state is not determined if the determination is based on the hypoglycemia determination based on vital signs other than the blood glucose level.
 このように、複数のバイタルサイン(血糖値、心拍数、発汗量、手の震えの振動数)の測定値に基づいて、被検者の低血糖状態を判別し、低血糖状態と判別した場合は、被検者に警告を行うので、被検者は、低血糖状態であることをより正確に認識することができる。つまり、血糖値以外の他のバイタルサインも測定するので、血糖値のみでは低血糖状態であると判別されない場合であっても、血糖値以外の他のバイタルサインの測定値から低血糖状態と判別することが可能となる。 As described above, when the hypoglycemic state of the subject is determined based on the measured values of a plurality of vital signs (blood glucose level, heart rate, sweat rate, hand tremor frequency), and the hypoglycemic state is determined. Warns the subject so that the subject can more accurately recognize that the subject is in a hypoglycemic state. In other words, since vital signs other than blood glucose level are also measured, even if it is not determined that the blood glucose level is a hypoglycemic state alone, it is determined from the measured values of vital signs other than the blood glucose level that the blood sugar level is low. It becomes possible to do.
 複数のバイタルサインを測定して得られた測定値に基づいて、バイタルサイン毎に低血糖であるか否かを判断し、低血糖であると判断されたバイタルサインの測定値の数及び種類に応じて低血糖レベルを判別し、該判別した低血糖レベルに応じて警報レベルを変更して警告を行うので、被検者は、低血糖状態のレベルを認識することができる。 Based on the measurement values obtained by measuring multiple vital signs, it is determined whether or not there is hypoglycemia for each vital sign, and the number and types of vital sign measurements determined to be hypoglycemia Accordingly, the hypoglycemia level is discriminated, and the alarm level is changed according to the discriminated hypoglycemia level to give a warning, so that the subject can recognize the level of the hypoglycemia state.
 また、低血糖レベルに応じた音量で警告音を出力するので、直感的に簡単に低血糖レベルを認識することができる。 Also, since the warning sound is output at a volume corresponding to the low blood sugar level, the low blood sugar level can be easily and intuitively recognized.
 複数のバイタルサイン毎に閾値が設定されており、測定値と閾値とを比較することで、バイタルサイン毎に低血糖か否かを判断するので、各測定値による低血糖か否かの判断を簡単に且つ精度よく行うことができる。 A threshold is set for each vital sign, and by comparing the measured value with the threshold, it is determined whether the blood glucose is hypoglycemic for each vital sign. It can be performed easily and accurately.
 バイタルサインは、血糖を含み、血糖値又は血糖値の変化量と閾値とを比較し、血糖値又は血糖値の変化量が閾値以下の場合は、低血糖であると判断するので、血糖値による低血糖判断を精度よく行うことができる。 Vital signs include blood sugar, compare blood sugar level or amount of change of blood sugar with a threshold value, and if blood sugar level or amount of change of blood sugar level is less than or equal to threshold value, it is determined that the blood sugar level is low. Hypoglycemia can be determined with high accuracy.
 血糖値に基づいて低血糖と判断した場合は、血糖値に基づいて低血糖と判断しなかった場合より低血糖レベルを高くするので、低血糖か否かをダイレクトに示す血糖値に重点をおいて、低血糖レベルを判断することができ、正確に低血糖レベルを判別することができる。 If the hypoglycemia is determined based on the blood glucose level, the hypoglycemia level is set higher than if the hypoglycemia is not determined based on the blood glucose level, so focus on the blood glucose level that directly indicates whether or not the hypoglycemia is present. Thus, the hypoglycemia level can be determined, and the hypoglycemia level can be accurately determined.
 バイタルサインは、被検者の拍動、発汗、又は手の震えを含み、測定値である心拍数、発汗量、又は手の震えの振動数と閾値とを比較し、心拍数、発汗量、又は、振動数が閾値以上の場合は、低血糖であると判断するので、精度よく血糖値以外のバイタルサインでも低血糖であるか否かを判断することができる。 Vital signs include the subject's pulsation, sweating, or hand tremor, comparing the measured heart rate, sweating amount, or hand tremor vibration frequency with a threshold value, heart rate, sweating amount, Alternatively, when the frequency is equal to or higher than the threshold value, it is determined that the blood glucose is low, so it is possible to accurately determine whether the blood glucose is low even with vital signs other than the blood glucose level.
 なお、判別部44aは、血糖値による低血糖判断により低血糖であると判断され、且つ、血糖値以外のバイタルサインによる低血糖判断に基づいて低血糖と判断された場合に、被検者が低血糖状態であると判別し、警告部44bは、警告音を出力するようにしてもよい。また、複数のバイタルサインによる低血糖判断に基づいて、低血糖であると判断されたバイタルサインの測定値の数(血糖値、心拍数、発汗量等の測定値の数)が一定数以上の場合に、被検者が低血糖状態であると判断してもよい。これにより、被検者が確実に低血糖であると判断できる時に、被検者が低血糖状態であると判別することができ、被検者は、低血糖状態にあることをより正確に認識することができる。また、低血糖であると判断されたバイタルサインの測定値の数が一定数以上であっても、低血糖であると判断されたバイタルサインの測定値の中に、血糖値が含まれていない場合は(血糖値による低血糖判断により低血糖と判断されなかった場合は)、被検者が低血糖状態であると判断しなくてもよい。 The determination unit 44a determines that the subject is hypoglycemic based on the hypoglycemia determination based on the blood glucose level, and determines that the subject is hypoglycemic based on the hypoglycemia determination based on the vital sign other than the blood glucose level. It may be determined that the blood glucose level is low, and the warning unit 44b may output a warning sound. In addition, the number of measured values of vital signs determined to be hypoglycemia (number of measured values of blood glucose level, heart rate, sweat rate, etc.) based on the hypoglycemia determination by a plurality of vital signs exceeds a certain number In this case, it may be determined that the subject is in a hypoglycemic state. As a result, when the subject can be surely determined to have hypoglycemia, the subject can be determined to be in a hypoglycemic state, and the subject can more accurately recognize that the subject is in a hypoglycemic state. can do. In addition, even if the number of vital sign measurements determined to be hypoglycemia is greater than a certain number, the vital sign measurement values determined to be hypoglycemia do not include blood sugar levels In such a case (when the hypoglycemia is not determined by the hypoglycemia determination based on the blood glucose level), it is not necessary to determine that the subject is in a hypoglycemic state.
 以上、本発明について好適な実施の形態を用いて説明したが、本発明の技術的範囲は上記実施の形態に記載の範囲には限定されない。上記実施の形態に、多様な変更又は改良を加えることが可能であることが当業者に明らかである。その様な変更又は改良を加えた形態も本発明の技術的範囲に含まれ得ることが、特許請求の範囲の記載から明らかである。 As mentioned above, although this invention was demonstrated using suitable embodiment, the technical scope of this invention is not limited to the range as described in the said embodiment. It will be apparent to those skilled in the art that various modifications or improvements can be added to the above embodiment. It is apparent from the description of the scope of claims that embodiments with such changes or improvements can be included in the technical scope of the present invention.

Claims (8)

  1.  被検者の異なる複数のバイタルサインを測定する複数の測定装置(12、14)と、
     前記複数の測定装置(12、14)の測定結果である複数の測定値に基づいて、前記被検者の低血糖状態を判別する判別部(44a)と、
     前記判別部(44a)が低血糖状態と判別した場合は、前記被検者に警告を行う警告部(44b)と、
     を備えることを特徴とする測定システム(10)。
    A plurality of measuring devices (12, 14) for measuring a plurality of vital signs of different subjects;
    A determination unit (44a) for determining a hypoglycemia state of the subject based on a plurality of measurement values which are measurement results of the plurality of measurement devices (12, 14);
    When the discrimination unit (44a) discriminates a hypoglycemic state, a warning unit (44b) that warns the subject,
    A measurement system (10) comprising:
  2.  請求項1に記載の測定システム(10)であって、
     前記低血糖状態は、複数の低血糖レベルを含み、
     前記判別部(44a)は、前記複数の測定装置(12、14)の測定結果である前記複数の測定値に基づいて、前記バイタルサイン毎に低血糖か否かをそれぞれ判断し、低血糖であると判断された前記バイタルサインの前記測定値の数及び種類に応じて、前記被検者の低血糖レベルを判別し、
     前記警告部(44b)は、前記判別部(44a)が判別した低血糖レベルに応じて、警報レベルを変更して警告を行う
     ことを特徴とする測定システム(10)。
    A measurement system (10) according to claim 1, comprising:
    The hypoglycemic state comprises a plurality of hypoglycemic levels;
    The determination unit (44a) determines whether or not the blood glucose level is low for each vital sign based on the plurality of measurement values that are measurement results of the plurality of measurement devices (12, 14). According to the number and type of the measured value of the vital sign determined to be, determine the hypoglycemia level of the subject,
    The measurement unit (10), wherein the warning unit (44b) changes the alarm level according to the hypoglycemia level determined by the determination unit (44a).
  3.  請求項2に記載の測定システム(10)であって、
     前記警告部(44b)は、前記判別部(44a)が判別した低血糖レベルに応じた音量で警告音を出力する
     ことを特徴とする測定システム(10)。
    A measurement system (10) according to claim 2, comprising:
    The measurement system (10), wherein the warning unit (44b) outputs a warning sound at a volume corresponding to the low blood glucose level determined by the determination unit (44a).
  4.  請求項2に記載の測定システム(10)であって、
     前記複数のバイタルサイン毎に閾値が設定されており、
     前記判別部(44a)は、前記測定装置(12、14)の測定結果である前記測定値と前記閾値とを比較することで、前記バイタルサイン毎に低血糖か否かをそれぞれ判断する
     ことを特徴とする測定システム(10)。
    A measurement system (10) according to claim 2, comprising:
    A threshold is set for each of the plurality of vital signs,
    The discriminating unit (44a) compares the measured value, which is the measurement result of the measuring device (12, 14), with the threshold value, thereby determining whether or not the blood glucose level is low for each vital sign. Characteristic measuring system (10).
  5.  請求項4に記載の測定システム(10)であって、
     前記複数のバイタルサインは、血糖を含み、
     前記判別部(44a)は、前記測定値である血糖値又は前記血糖値の変化量と前記閾値とを比較し、前記血糖値又は前記血糖値の変化量が前記閾値以下の場合は、低血糖であると判断する
     ことを特徴とする測定システム(10)。
    A measurement system (10) according to claim 4,
    The plurality of vital signs includes blood sugar,
    The determination unit (44a) compares the blood glucose level that is the measurement value or the amount of change in the blood glucose level with the threshold, and if the blood glucose level or the amount of change in the blood glucose level is less than or equal to the threshold, A measurement system (10) characterized by determining that
  6.  請求項5に記載の測定システム(10)であって、
     前記判別部(44a)は、前記血糖値に基づいて低血糖と判断した場合は、前記血糖値に基づいて低血糖と判断しなかった場合より低血糖レベルを高くする
     ことを特徴とする測定システム(10)。
    A measurement system (10) according to claim 5,
    The determination unit (44a) increases the low blood glucose level when it is determined that the blood glucose level is low, based on the blood glucose level, compared to when it is not determined that the blood glucose level is low. (10).
  7.  請求項4に記載の測定システム(10)であって、
     前記複数のバイタルサインは、前記被検者の拍動、発汗、又は、手の震えを含み、
     前記判別部(44a)は、前記測定値である心拍数、発汗量、又は、手の震えの振動数と前記閾値とを比較し、前記心拍数、前記発汗量、又は前記振動数が前記閾値以上の場合は、低血糖であると判断する
     ことを特徴とする測定システム(10)。
    A measurement system (10) according to claim 4,
    The plurality of vital signs include pulsation, sweating, or trembling of the subject,
    The determination unit (44a) compares the measured heart rate, the amount of sweating, or the vibration frequency of hand tremor with the threshold value, and the heart rate, the sweating amount, or the vibration frequency is the threshold value. In the above case, the measurement system (10) is characterized by determining that the blood glucose is low.
  8.  請求項1に記載の測定システム(10)であって、
     前記判別部(44a)は、前記複数の測定装置(12、14)の測定結果である前記複数の測定値に基づいて、前記バイタルサイン毎に低血糖か否かをそれぞれ判断し、低血糖であると判断された前記バイタルサインの前記測定値の数が一定数以上の場合は、前記被検者が低血糖状態であると判別する
     ことを特徴とする測定システム(10)。
    A measurement system (10) according to claim 1, comprising:
    The determination unit (44a) determines whether or not the blood glucose level is low for each vital sign based on the plurality of measurement values that are measurement results of the plurality of measurement devices (12, 14). The measurement system (10), wherein the subject is determined to be in a hypoglycemic state when the number of the measured values of the vital sign determined to be equal to or greater than a certain number.
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WO2022186359A1 (en) * 2021-03-05 2022-09-09 富士フイルム株式会社 Information processing device, information processing system, information processing method, and information processing program

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