JP4853207B2 - Blood glucose measuring device - Google Patents

Description

  The present invention relates to a blood glucose measurement device.

  In the treatment of diabetes, when hyperglycemia continues even after dietary therapy or exercise therapy, drug treatment in which drugs such as oral hypoglycemic agents and insulin preparations are administered may be performed. For example, Patent Document 1 discloses a system in which blood glucose level is continuously monitored or intermittently measured non-invasively, the amount of insulin is optimized quantitatively according to the value, and insulin is automatically injected into the body.

  However, human blood glucose levels are constantly changing according to daily life such as the amount of meal, the interval between meals, the amount of exercise, and the amount of work. Along with this, the amount of insulin secreted from the pancreas is also adjusted according to the blood glucose at that time. That is, it is difficult to determine an appropriate dose of a drug such as insulin by simply measuring the blood glucose level of the subject.

  Patent Document 2 discloses a blood glucose management system that uses a mounting system including a blood glucose level measurement unit, a control unit, an insulin pump, and an exercise amount measurement unit having a short-range wireless communication function. That is, not only the blood glucose level is measured by the blood glucose level measurement unit, but also the exercise amount of the measurement subject is measured by the exercise amount measurement unit. And it is a blood glucose management system which determines the amount of insulin to administer by referring these results. However, even with the blood sugar management system disclosed in Patent Document 2, it is difficult to monitor the amount of meal, the interval between meals, and the like.

  Based on the above, the secretion of drugs such as insulin by drugs administered to diabetic patients, the action of drugs such as insulin, and the effects of drugs such as injected insulin, in response to subtle fluctuations in blood glucose in daily life, There are technical limits to adapting to adaptation. Therefore, in a blood glucose measurement device having a function of administering a drug such as insulin as in Patent Document 1 or Patent Document 2, a large amount of drug such as insulin to be administered may be set erroneously. As the amount of the drug to be administered increases, the effect becomes stronger, so that the blood sugar level may be lowered more than expected and hypoglycemia may occur.

  Hypoglycemia refers to a state in which blood sugar is too low due to the effect of drugs used in drug treatment being too effective. Symptoms include hunger, dullness, fluffiness, cold sweat, hand tremor, palpitation, anxiety, and headaches (also called autonomic symptoms and warning symptoms). If the blood glucose level further decreases, symptoms such as drowsiness, weakness, dizziness, poor concentration, confusion, misplacement, disappointment, irritation, awkward movements, unusual speech and speech disorders, etc. (central nervous system symptoms) . If the blood glucose level further decreases, symptoms such as disturbance of consciousness, seizures, and coma appear (cerebral dysfunction symptoms).

  Above all, the most frightening part of hypoglycemia is that the symptoms may not be noticed. This is called unconscious hypoglycemia. Unconscious hypoglycemia suddenly causes cerebral hypofunction symptoms such as consciousness disturbance, seizures, and coma. For this reason, for example, when a cerebral hypofunction due to unconscious hypoglycemia appears during driving, it is very dangerous. It is also very dangerous if cerebral dysfunction due to unconscious hypoglycemia appears in a place where there is no helping person nearby.

JP 09-192218 A JP 2004-024699 A

  An object of the present invention is to provide a pre-prevention function before symptom of hypocerebral function due to unconscious hypoglycemia.

The present invention
[1] A non-invasive and continuous measurement device for blood glucose level,
A measurement unit that continuously and non-invasively measures blood glucose levels;
A history of blood glucose levels of the subject to be measured, measured by the measurement unit, and a storage unit for storing a caution blood glucose change value;
Whether the measurement subject has a hypoglycemic tendency by referring to the blood glucose level measured by the measurement unit, the history of the blood glucose level for a predetermined period of time stored in the storage unit, and the caution blood glucose change value A determination unit for determining whether or not,
When the determination unit determines that the measurement subject has a hypoglycemic tendency, the notification unit notifies the measurement subject that the measurement subject has a hypoglycemia tendency,
When the difference between the maximum value and the measured blood glucose level in the blood glucose level history for the past certain time of the measured person referred from the storage unit is equal to or greater than the caution blood glucose change value, the determining unit blood sugar measuring device and judging that the trend,
And [2] further comprising transmission means for transmitting information that the measured person is at the second danger level when the determined unit determines that the measured person is in a dangerous state.
The determination unit is a case where the subject is determined to be in the hypoglycemia trend, characterized in that the measured person when said measured blood glucose level is below critical level blood glucose is determined to be dangerous state The present invention relates to the blood glucose measurement device according to [1].

  Since the blood glucose measurement device of the present invention has a pre-prevention function before symptom of hypocerebral dysfunction due to unconscious hypoglycemia appears, the measurement subject can preliminarily observe symptom of hypocerebral dysfunction due to unconscious hypoglycemia by ingesting glucose. Prevention can be done. Moreover, even if there is a possibility that the advance prevention may be delayed, for example, the relative of the measurement subject and / or the doctor in charge can be notified, which is safe.

  The present invention will be described below with reference to the drawings.

  FIG. 1 is a functional block diagram of the blood measuring apparatus of the present invention. The blood measurement device of the present invention refers to a device that continuously or intermittently measures the blood glucose level of a measurement subject. The configuration stores a measurement unit 1 that continuously measures blood glucose levels non-invasively, a history of blood glucose levels for a predetermined period of time measured by the measurement unit 1, and a caution blood glucose change value. By referring to the storage unit 2, the blood glucose level measured by the measurement unit 1, the history of blood glucose levels for a predetermined period of time stored in the storage unit, and the caution blood glucose change value, A determination unit 3 for determining whether or not the blood glucose tendency is present, and a notification means 4 for notifying the subject to be in a hypoglycemic tendency when the determination unit determines that the blood glucose tendency is low. . The person to be measured in the present invention refers to a person to be measured by the blood glucose measurement device of the present invention, and mainly includes diabetic patients.

  The blood measurement apparatus of the present invention includes a measurement unit 1 that continuously or intermittently measures a blood glucose level of a measurement subject. The measuring unit 1 in the present invention, although the concept is variable depending on the measurement system employed, includes at least means for performing measurement and means for converting the measured result into a blood glucose level. For example, when the blood glucose level is optically measured, the means for irradiating the measurement target with light, the means for receiving the light transmitted or reflected through the measurement target, and the change in the irradiated light and the received light are the blood glucose level. Including means for converting to

  Most preferably, the measurement is continuously performed from the viewpoint of always managing the blood glucose level of the measurement subject. However, it is not always necessary to measure continuously, and intermittent measurement is sufficient if the measurement time interval is short. The measurement time interval is, for example, within 5 minutes, preferably within 3 minutes. This is because if the measurement time interval is longer than 5 minutes, the determination in the determination unit 3 to be described later and the operation of the notification means 4 that operates according to the result determined by the determination unit 3 are delayed. These measurements are performed fully automatically.

  Further, in order to measure continuously or intermittently, the person to be measured must always carry the blood glucose measuring device of the present invention. And the measurement part 1 contains the structure which contacts a to-be-measured person's skin etc., in order to measure a to-be-measured person's blood glucose level. For example, structures such as a wristband type, a headgear type, a wristwatch type, a necklace type, a ring type, an earring type, and an adhesive film type are exemplified, but the present invention is not limited to these structures.

  Further, the measurement can be performed invasively or non-invasively, but preferably non-invasively. Measurements are basically targeted for the amount or concentration of glucose in the blood, but for biological fluids that can be collected non-invasively other than blood, such as sweat, urine and / or saliva, and indirectly in the blood. It is also possible to convert to glucose amount or concentration. In particular, sweat is preferable from the viewpoint of easy collection.

  As an example of the above measurement system, for example, Japanese Patent Laid-Open No. 2006-000659 discloses a system that irradiates a measurement subject with a millimeter wave and measures a glucose concentration from a reflection coefficient or the like. Japanese Patent Application Laid-Open No. 09-068523 discloses a system that collects saliva and indirectly converts it into a blood sugar level from its viscosity. Furthermore, Japanese National Publication No. 09-503924 discloses a system that irradiates perspired sweat with near infrared rays and indirectly converts it to a blood glucose level from the measurement result. Among these systems, it is preferable to use a system that measures the glucose concentration by irradiating the subject with millimeter waves from the viewpoint of directly measuring the blood glucose level, but the present invention is not limited thereto. It is not something.

  The blood glucose measurement device of the present invention includes a storage unit 2 that stores a history of blood glucose levels for a predetermined period of time measured by the measurement unit 1 and a caution blood glucose change value.

  The past fixed time refers to a time for storing a blood glucose level measured immediately after blood glucose measurement. FIG. 3 is a graph showing the history of blood glucose measured by the blood glucose measuring device of the present invention, and the past fixed time can be the maximum value on the horizontal axis of the graph.

  The past certain time must be sufficient to determine that the measurement subject has a tendency to hypoglycemia. If the past fixed time is a short time, malfunction may occur due to the contact state between the measurement unit 1 and the skin of the measurement subject 1 and the skin of the measurement subject, measurement error, or the like. . On the other hand, if the past fixed time is a long time, it is likely to be affected by an old history, and malfunction may occur. Considering these points, the above-mentioned past fixed time is 5 to 40 minutes, preferably 15 to 30 minutes.

  In addition, the caution blood glucose change value is a value that serves as a borderline as to whether or not the subject has a hypoglycemic tendency, and the difference between the maximum blood glucose level and the measured blood glucose level in the history of blood glucose levels for a certain period in the past. The value to be compared with. The blood glucose change value is determined by the past fixed time determined as described above, although there are individual differences among the persons to be measured. In general, when the subject has a hypoglycemic tendency, the change in blood glucose is 20 to 40 mg / dl per 30 minutes. That is, the caution blood glucose change value is determined with reference to the determined past certain time and the change in blood glucose in this hypoglycemic tendency. For example, when the past fixed time is 20 minutes, the caution blood glucose change value is set to a value obtained by multiplying the upper and lower limits of the numerical range by 2/3, that is, 13.3 to 26.7 mg / dl. Can do.

  The past fixed time and the caution blood glucose change value may be input from the input unit 6 installed in the blood glucose measurement device of the present invention, for example. The input past fixed time and the caution blood glucose change value are stored in the storage unit 2. For example, as shown in FIG. 1, the storage unit 2 stores the blood glucose level history storage memory 21 for the past fixed time for the past fixed time and the caution blood glucose change value storage memory 22 for the caution blood glucose change value. Further, the storage unit 2 may of course store the past certain time, the caution blood glucose change value, and the like in one memory.

  The blood glucose measurement device of the present invention includes a determination unit 3 that determines whether or not the measurement subject has a hypoglycemic tendency. The determination by the determination unit 3 is performed by referring to the blood glucose level measured by the measurement unit 1, the history of the blood glucose level for a predetermined period of time stored in the storage unit 2, and the caution blood glucose change value. The And when it determines with it not being a hypoglycemia tendency, the measurement state of an apparatus is maintained as it is. When it is determined that the measurement subject has a tendency to hypoglycemia, the determination unit 3 activates a notification unit 4 described later.

  In the present invention, the notification means 4 refers to means that operates when the determination unit 3 determines that the person to be measured has a hypoglycemic tendency. The mechanism mainly includes alarm, light emission, color development, electrical stimulation, and vibration. In particular, alarms and vibrations familiar to mobile phones and the like are preferable, but the present invention is not necessarily limited to these. When the notification means 4 is activated, the blood glucose level of the measurement subject is lower than the first risk level blood glucose level, so even if the measurement subject has unconscious hypoglycemia, glucose etc. By ingesting, it is possible to recover to a normal blood sugar level region. Examples of the intake of glucose and the like include foods containing 5 to 10 g of glucose or 10 to 20 g of sugar or a sugar corresponding thereto. In particular, when an α-glucosidase inhibitor is used in combination with another tendency to drop blood sugar, sugar is not effective, and glucose is preferable. In any case, an appropriate response may be made in accordance with the instructions of the doctor in charge.

  The above is the basic configuration of the blood glucose measurement device of the present invention. However, for example, even if it is determined by the determination unit 3 that the measured person is prone to hypoglycemia, if the mode of the notification means 4 is an alarm, the measured person is alarmed in a place where there is noise such as in the city. You may not notice. In addition, even when the mode of the notification unit 4 is vibration, there is a case where the vibration is not noticed if the person to be measured is walking. In such a case, the measurement subject may be delayed in taking glucose and the like. In particular, in the case of unconscious hypoglycemia, since the blood glucose level decreases rapidly, symptoms of reduced cerebral function may appear before the subject measures to take glucose or the like.

  Therefore, the blood glucose measuring device of the present invention has sufficient time for the subject to be able to cope with the blood glucose level at the time when the subject is determined to be hypoglycemic by the determination unit 3. It is desirable to determine whether or not. Whether or not there is sufficient time for the person to be measured to cope with the subject is determined by determining whether the person to be measured has a hypoglycemic tendency in the determination unit 3, the blood sugar level is equal to or less than the risk level blood sugar level It is determined by whether or not.

  If the subject is not unconscious hypoglycemia, one of the symptom groups consisting of feelings of hunger, dullness, flirting, cold sweat, hand tremor, palpitation, anxiety and headache, That is, the blood glucose level at which autonomic symptoms (warning symptoms) begin to appear. That is, if the hypoglycemic tendency continues as it is, it means a blood sugar level that is likely to cause a cerebral hypofunction. Therefore, the dangerous level blood sugar level is lower than the normal range (daily fluctuation range) of the blood sugar level of the measurement subject. Of course, in the case of unconscious hypoglycemia, these symptoms do not appear. The risk level blood glucose level varies from individual to individual depending on the dietary life, exercise amount, constitution, etc. of the subject, but is usually about 50-70.

  When the blood glucose level at the time when the determination unit 3 determines that the measured person has a hypoglycemic tendency is less than or equal to the dangerous level blood glucose level, the measured person is likely to develop symptoms of reduced cerebral function. It is in. That is, there is not enough time for the person to be measured to deal with it. Hereinafter, in the present invention, such a state of the measurement subject is referred to as a dangerous state. Therefore, when the measurement subject is in a dangerous state, the determination unit 3 according to the present invention states that the measurement subject is in a dangerous state, not the notifying unit 4 but the relative of the measurement subject and / or the doctor in charge. It is preferable that the transmission means 5 for transmitting information is operated. That is, the blood glucose measurement device of the present invention preferably includes the transmission means 5.

  In the present invention, the transmission means 5 refers to means that operates when the determination unit 3 determines that the person to be measured is in a dangerous state. The mechanism mainly includes a telephone line, a LAN line, the Internet, and optical broadband. In particular, a telephone line capable of directly talking with a destination person is preferable, but the present invention is not necessarily limited thereto. When the transmission means 5 is activated, the blood glucose level of the person being measured is lower than the dangerous level blood glucose level, so that there is a high possibility that a cerebral function symptom will eventually appear. At this time, even if there is no person who rescues the person to be measured around the person to be measured, the person can be rescued based on the information transmitted from the transmission means 5. Further, it goes without saying that even if there is a person who rescues the subject around the subject, the role can be supplementarily played. At this time, from the viewpoint of accurately grasping the current position of the person to be measured, the blood glucose measurement device of the present invention preferably further includes a GPS function.

  Also, in general, when the subject has cerebral dysfunction due to unconscious hypoglycemia, and there is a person who rescues the subject around the subject, the person who rescues the subject is The patient is rescued by ingesting glucose or the like according to the document written on the patient card carried by the patient. However, since there are people who have no knowledge about hypoglycemia among those who rescue the subject, there are many cases where the subject does not even realize that the subject is carrying a patient card.

  Therefore, it is preferable that the blood glucose measurement device of the present invention is equipped with a conversation function that enables direct conversation with relatives by the transmission means 5. With the conversation function, the person who rescues can rescue according to the instructions of the relatives.

  Further, in addition to the above-described mode of installing the conversation function, the blood glucose measurement device of the present invention may be equipped with a voice notification function for notifying a person who rescues the person being measured by voice. The rescuer can rescue the subject in accordance with the instructions of the voice notification function.

  In addition, the voice notification function notifies the rescuer of the position of the parts including the display unit 7 of the blood glucose measurement device of the present invention, and then instructs to view the display unit 7 displaying the same description as the patient card. It may be a function to do. Thereby, since the information notified by the voice notification function is shortened, the reproduction time is also shortened, and the rescuer can rescue quickly.

  In the case where the blood glucose measurement device of the present invention is an aspect provided with the notification means 4 and the transmission means 5, the notification means 4 and the transmission means 5 are assumed to operate independently depending on the blood glucose state of the measurement subject, and are thus assumed. It is possible to respond to any situation of the subject. For example, when the notification means 4 is activated and the subject can respond by ingesting glucose or the like, the blood glucose level of the subject is restored to the normal range (daily fluctuation range). Since the blood glucose level of the person to be measured no longer reaches the dangerous level blood glucose level, the transmission means 5 does not operate. As a result, the frequency of communication of the person to be measured with the related person or the like is suppressed, and the frequency with which the action of the person to be measured is related is also reduced. Moreover, since the measurement subject does not fall into a psychological state that he / she is sorry for the relative of the measurement subject, the mental stress of the measurement subject is also reduced.

  In general, blood glucose measuring devices that measure non-invasively and continuously or intermittently are applied to a subject such as a wristband type, a headgear type, a watch type, a necklace type, a ring type, an earring type, and a patch membrane type. It has a structure that comes into contact with the skin of the measurer. Then, depending on the person to be measured, there is a person who dislikes the band of the structure that contacts the skin or the like. However, if it is a device with added value such as the blood glucose measurement device of the present invention, the person to be measured will be in a psychological state that he / she may share such a structure in contact with the skin or the like.

  Hereinafter, system control of the blood glucose measurement device of the present invention will be described with reference to the flowchart shown in FIG.

(Normal blood glucose measurement mode)
At the beginning of the measurement, the blood glucose measuring device of the present invention is in the normal measurement mode S01, assuming that the measurement subject is healthy. Then, the blood glucose level of the measurement subject is measured continuously or intermittently. The measured blood glucose level information is transmitted to the blood glucose level history storage memory for the past certain time in the storage unit 2 and the determination unit 3. The determination unit 3 determines whether or not the condition of the subject is a hypoglycemic tendency (S02 in FIG. 2). Whether or not the measurement subject by the determination unit 3 has a hypoglycemic tendency is determined based on the maximum value (arrow X _{MAX in} FIG. 3) in the history of the blood glucose level of the measurement subject for the past fixed time referred from the storage unit 2. It is determined whether or not the difference from the measured blood glucose level (arrow X in FIG. 3) is equal to or greater than the caution blood glucose change value.

  As long as the difference between the maximum value and the measured blood glucose level in the blood glucose level history for a certain period of time of the measurement subject is smaller than the caution blood glucose change value, the blood glucose measuring device of the present invention is under normal measurement mode S01 control.

  On the other hand, if it is determined that the difference between the maximum value in the blood glucose level history for the measured time in the past and the measured blood glucose level is greater than or equal to the caution blood glucose level, then the measured blood glucose level (arrow in FIG. 3) It is determined whether or not X) is equal to or less than the dangerous level blood sugar level (S03 in FIG. 2).

  Here, if the measured blood glucose level (arrow X in FIG. 3) is greater than the dangerous level blood glucose level, the determination unit 3 transmits a signal to activate the notification means 4 (S04 in FIG. 2). In other words, the determination unit 3 determines that the subject himself / herself is capable of handling the subject by giving a notification although the subject has a hypoglycemic tendency. Thereafter, the blood glucose measurement device of the present invention shifts to the standby mode S05.

  On the other hand, when the measured blood glucose level (arrow X in FIG. 3) is equal to or lower than the dangerous level blood glucose level, the determination unit 3 transmits a signal to activate the transmission means 5 (S07 in FIG. 2). That is, the determination unit 3 determines that the measurement subject is in a dangerous state. Thereafter, the blood glucose measurement device of the present invention shifts to the dangerous level blood glucose measurement mode S08.

(Standby mode)
In the standby mode S05, the transmission of the signal for operating the notification means 4 is stopped, and the standby mode S05 waits for a specified time (interval) (S06 in FIG. 2). This is because the notification means 4 is continuously operated so as not to give unpleasant feeling to the measurement subject who is trying to cope with ingestion of glucose or the like. In addition, there is an effect of suppressing unnecessary power consumption due to the operation of the high-frequency notification means 4. After the lapse of the specified time, the process proceeds to the normal blood glucose measurement mode S01 in order to determine the state of the subject again. The specified time is appropriately set on the assumption that the measurement subject can respond by ingesting glucose or the like. For example, it can be 1 to 10 minutes, preferably 2 to 8 minutes, but the present invention is not limited thereto.

  When the process proceeds to the normal blood glucose measurement mode S01 again after passing through the standby mode S05, for example, if the person to be measured responds by ingesting glucose, for example, the patient's past certain amount of time The difference between the maximum value in the blood glucose history and the measured blood glucose level will not be more than the attention blood glucose change value.

  On the other hand, when the measurement subject is delayed in taking glucose or the like, the measured blood sugar level (arrow X in FIG. 3) is likely to be equal to or less than the dangerous level blood sugar level. That is, the determination unit 3 is highly likely to determine that the measurement subject is in a dangerous state (S07 in FIG. 2), and the blood glucose measurement device of the present invention will shift to the dangerous level blood glucose measurement mode S08.

(Danger level blood glucose measurement mode)
In the risk level blood glucose measurement mode S08, the determination unit 3 determines whether or not the state of the subject has returned to a normal state within a specific time (S09 in FIG. 2). The specific time is appropriately set in consideration of the time that the measurement subject is supposed to be able to deal with by ingesting glucose or the like, or the time that is assumed to be able to escape the dangerous state due to being rescued. For example, it may be 5 to 20 minutes, preferably 8 to 15 minutes, but the present invention is not limited to this.

  Whether or not it has returned to a healthy state is sufficient if at least the measured blood glucose level returns to a value greater than the dangerous level blood glucose level. Preferably, it is a return to the normal range (daily fluctuation range), but the present invention is not limited to these. In other words, the subject who is suspected of having a cerebral function dysfunction is regarded as having escaped the dangerous state by being rescued, for example. When the blood glucose measuring device of the present invention determines that the person to be measured has returned to the normal state, the blood glucose measuring device of the present invention shifts to the normal blood glucose measuring mode S01.

  On the other hand, the fact that the measured blood glucose level does not take a value greater than the dangerous level blood glucose level even after the elapse of a specific time can be said to be that the measurement subject is in a very dangerous state. Therefore, the determination unit 3 transmits a signal to operate the transmission unit 5 again (S10 in FIG. 2). The blood glucose measurement device of the present invention maintains the dangerous level blood glucose measurement mode S08.

  As described above, the blood glucose measurement device of the present invention operates corresponding mechanisms depending on whether or not the measurement subject can cope with it. For this reason, for example, information that the measurement subject is in a dangerous state is not inadvertently transmitted to the relative of the measurement subject. Therefore, the frequency at which the actions of the relatives of the measurement subject are restricted is reduced, and the mental stress that the measurement subject also annoys the surroundings is reduced.

It is a block diagram of the blood glucose measuring device of the present invention. It is a system flow figure of a blood glucose measuring device of the present invention. It is a figure which shows the example of a measurement chart of the blood glucose level measured with the blood glucose measuring device of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Measurement part 2 Memory | storage part 21 Blood glucose level log | history storage memory 22 Caution blood glucose change value storage memory 3 Judgment part 4 Notification means 5 Transmission means 6 Input part 7 Display part

Claims (2)

A non-invasive and continuous measurement device for blood glucose level,
A measurement unit that continuously and non-invasively measures blood glucose levels;
A history of blood glucose levels of the subject to be measured, measured by the measurement unit, and a storage unit for storing a caution blood glucose change value;
Whether the measurement subject has a hypoglycemic tendency by referring to the blood glucose level measured by the measurement unit, the history of the blood glucose level for a predetermined period of time stored in the storage unit, and the caution blood glucose change value A determination unit for determining whether or not,
When the determination unit determines that the measurement subject has a hypoglycemic tendency, the notification unit notifies the measurement subject that the measurement subject has a hypoglycemia tendency,
When the difference between the maximum value and the measured blood glucose level in the blood glucose level history for the past certain time of the measured person referred from the storage unit is equal to or greater than the caution blood glucose change value, the determining unit blood sugar measuring device and judging that the tendency. Furthermore, when the determination unit determines that the measurement subject is in a dangerous state, the transmission unit includes transmission means for transmitting information that the measurement subject is at the second danger level,
The determination unit is a case where the subject is determined to be in the hypoglycemia trend, characterized in that the measured person when said measured blood glucose level is below critical level blood glucose is determined to be dangerous state The blood glucose measurement device according to claim 1.

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