KR102392948B1 - Blood Glucose Index Calculation Method of Non-invasive Type and Non-invasive Blood Glucose Index Measurement System Thereof - Google Patents

Abstract

Disclosed are a non-blood drawing type blood glucose level calculating method and a non-blood drawing blood glucose measuring system, which are to enable an examinee shown with metabolic abnormality due to hyperglycemia to calculate a blood glucose without an invasive process as necessary. According to the present invention, to this end, a blood glucose can be simply calculated without an additional blood drawing process after securing an average calculation ratio obtained by using a blood glucose level obtained by blood drawing and skin local resistance and variable-reflected resistance measured by a simple method. Also, blood glucose calculation can be performed by the number of times as needed at a required time, an optimization measure can be performed in response to a blood glucose level due to high reliability on a calculated blood glucose value, and high convenience of blood glucose management can be provided.

Description

Blood Glucose Index Calculation Method of Non-invasive Type and Non-invasive Blood Glucose Index Measurement System Thereof

In particular, the present invention relates to a blood glucose level calculation method and a blood glucose measurement system in a bloodless manner so that an examinee with metabolic abnormalities due to hyperglycemia can easily obtain a blood glucose level whenever necessary for blood glucose management in a bloodless manner.

The International Diabetes Federation (IDF), established in 1950 and affiliated with 230 diabetes associations in 170 countries around the world, published new figures in the 9th IDF Diabetes Atlas, according to which: As of 2019, out of 7.71 billion people worldwide, 463 million adults have diabetes, and it is expected that the number will increase to 700 million by 2045.

For these diabetic patients, it is most important to control blood sugar in order to lower the incidence of complications such as decreased visual acuity due to diabetes rather than diabetes itself, so doctors point out that it is absolutely necessary to measure blood sugar 4 to 8 times a day.

However, in the process of measuring blood glucose by putting blood collected from the fingertip on a sensor strip for such blood glucose measurement, and putting it in a glucose meter operated by photometric or electrochemical measurement, at least 4 to 8 times a day at the fingertip The invasive process of stabbing with a needle and the process of collecting or squeezing blood from the fingertips resulted in severe pain and psychological anxiety in diabetic examinees, so most examinees only measure their blood sugar twice a day on average.

In addition to this, even if diabetes is measured by collecting blood 4 times a day or more faithfully according to the doctor's instructions, shock due to blood sugar rise or blood sugar drop during sleep is unavoidable. Therefore, in response to an urgent request for a diabetic examinee to be able to measure a diabetic level without the burden of blood sampling, various types of blood glucose measurement devices without blood sampling have been recently proposed.

When such a blood glucose measurement apparatus is classified according to its type, it can be divided into an optical method and an electrical method.

First, looking at the technology using the optical method, there are those using infrared spectroscopy, Raman spectroscopy, Optical coherence tomography, OCT, Polarization, Fluorescence, and occlusion. A blood glucose measurement method using occlusion spectroscopy and photoacoustic spectroscopy is also known.

Among these, infrared spectroscopy is a typical example of the fact that when infrared rays reach blood or tissue containing sugar, the reflected light emits specific energy, and changes in blood sugar concentration affect the scattering and absorption of light. it was conceived

That is, when the amount of sugar inside the skin is small, as shown in Fig. 1, the reflection angle is small with respect to the vertical line, and when there is a lot of sugar, on the contrary, as shown in Fig. 2, the reflection angle is large, so that the scattering value is large and the absorption rate is increased. This principle is illustrated in FIG. 1 for reference.

More specifically, when the wavelength of light is 600 ~ 1300 nm, it is known that the least absorption occurs when penetrating the skin, and the less absorption, the better it can reach the tissue. Therefore, this wavelength band is called the "optical window" of the skin, and in most cases, near-infrared rays with a wavelength of 750 to 2000 nm can penetrate deeply into the tissue, so it has been the subject of research in the field of medical imaging and blood glucose measurement.

On the other hand, in the infrared spectroscopy method, the layers constituting the skin itself cause light reflection and refraction, and the roughness of the skin can also affect the light path. And it is a problem that not only sugar but also various substances exist together in the tissue. In fact, albumin, cholesterol, urea, etc. also become variables that affect light scattering and absorption, and thus may interfere with calculating the blood glucose concentration.

Another variable is that the scattering and absorption of light are affected by blood pressure, body temperature, arterial pulsation, and blood vessel dilation, which further lowers the reliability of the calculated value.

Looking at the commercialized example by applying this infrared spectroscopy method, although sales approval was not obtained in the United States due to errors, etc., Diasensor 1000 (https://www.meddeviceonline) of Biocontrol Technology ( www.bico.com ) approved in 15 European Union countries. (see .com/doc/fda-orders-diasensor-1000-from-biocontrol-tec-0001), sold for $9000 in Europe, but has now disappeared from the market.

In addition, there are a reverse iontophoresis method, an impedance spectroscopy method, and an electromagnetic sensing method as a device to which an electrical method for measuring blood glucose without blood is applied. A representative example of a device to which such an electrical method is applied is a reverse iontophoresis method, and a representative example is disclosed in Korean Patent Laid-Open No. 10-2009-0118314 (Title of the Invention: Device and method for measuring blood glucose without blood sampling using electrophoresis; hereafter referred to as 'cited invention').

The cited invention relates to an apparatus and method for measuring blood glucose without blood using an electrophoresis phenomenon, which enables blood glucose to be measured by extracting glucose present in the subcutaneous tissue through the epidermis using the electrophoresis phenomenon.

According to this cited invention, in the apparatus for measuring blood glucose without blood using electrophoresis, two different extraction electrodes, an extraction electrode engaging unit applying a constant current to the extraction electrode, and selecting an extraction electrode to which the constant current is applied It is characterized in that it includes a microcontrol unit for generating a control signal for and calculating blood glucose data based on the extracted glucose.

This cited invention can prevent the shortening of the lifespan due to the continuous oxidation or reduction reaction of the extraction electrode, and can acquire accurate blood glucose data compared to the prior art by considering the changes according to the skin local resistance and the skin temperature.

Looking at this in more detail, as shown in FIG. 3 , the first extraction electrode 120 or the second extraction electrode 125 transmits the constant current supplied from the extraction electrode engaging unit 115 to each other through the current path formed in the subcutaneous tissue. Output to the corresponding extraction electrodes (120, 125). The first extraction electrode 120 and/or the second extraction electrode 125 may be an electrode made of platinum, platinum/carbon, or silver/silver chloride, around which the working electrode 135 and a counter electrode (not shown) and A reference electrode may be positioned.

In the cited invention, the ion delivery medium 130 is a medium for accommodating glucose derived/extracted from body fluid, and may be composed of a water-soluble material, hydrogel. In particular, the ion delivery medium 130 may include a glucose oxidase that generates hydrogen peroxide when it reacts with glucose extracted from the skin, and the ion delivery medium 130 is in direct contact with the skin and diffuses the hydrogen peroxide generated from glucose. In this way, it is transferred to the working electrode 135 .

In addition, the working electrode 135 in the cited invention is located on the inner peripheral surface of the first extraction electrode 120 or/and the second extraction electrode 125, and the hydrogen peroxide delivered from the ion transfer medium 130 is oxidized to generate a current. is a place to A relative voltage of a certain magnitude is applied to the working electrode 135 . This relative voltage is preferably 0.4V or less to ensure the accuracy of the analysis.

In addition, the working electrode 135 in the cited invention may be an electrode made of platinum or platinum/carbon.

In addition, the microcontrol unit 140 in the cited invention performs overall control of all modules and calculates blood sugar for the examinee based on the generated current input from the working electrode 135 .

As described above, in the cited invention, in particular, the ion delivery medium is made of hydrogel, and it must include a glucose oxidase to generate hydrogen peroxide when it comes into contact with the skin and reacts with a very small amount of glucose extracted from the skin, and the first By supplying a constant current to the extraction electrode 120 or / and the second extraction electrode 125, hydrogen peroxide is generated from a very small amount of glucose extracted from the skin by the electrophoretic effect to the first extraction electrode 120 or / and the second extraction A precise voltage is supplied to the working electrode 135 made of platinum or platinum/carbon installed on the inner circumferential surface of the electrode 125, and blood glucose is calculated by the microcontrol unit 140 from a current signal generated therefrom.

Therefore, the structure and blood sugar calculation method are complicated, and the manufacturing cost is high, such as the need to precisely process expensive materials, and the amount of hydrogen peroxide generated is irregular depending on the constitution or body temperature, so the reliability of the blood sugar measurement result cannot be guaranteed. problem was discovered, and the reliability was lowered, and as a result, the dissemination is not activated.

As a result, the applicant of the cited invention (KMH Co., Ltd.) developed by applying the cited invention and has undergone the only clinical test, GluCall, which has the function of measuring blood glucose without blood sampling in the reverse ion osmosis method, is also the same as described above. Due to circumstances, it has not been commercialized until now in 2021.

(Refer to http://www.monews.co.kr/news/articleView.html?idxno=20736 "MEDICAL OBSERVER 2008. 2. 4.")

Korean Patent Laid-Open Patent No. 10-2009-0118314 (Title of the Invention: Device and method for measuring blood glucose without blood sampling using electrophoresis)

MED DEVICE ONLINE NEWS 1999. 2. 9. Issued (https://www.meddeviceonline.com/doc/fda-orders-diasensor-1000-from-biocontrol-tec-0001 )

It is an object of the present invention to calculate a basic local skin resistance value in order to calculate a reliable blood glucose value despite the vital signs and surrounding environment changes that continuously change at every moment, which are common problems of the cited inventions by the optical or electrical method. In addition, the variable-reflected resistance ratio, which is the ratio of the variable-reflected skin resistance to the basic local skin resistance value, is calculated by using the variable-reflected skin resistance value that reflects vital signs and the surrounding environment as an approximation, and the blood glucose value by blood sampling is reflected as the variable The average calculation ratio is obtained by averaging a plurality of calculation ratios obtained by repeating the process of dividing by resistance ratio multiple times, and after obtaining the average calculation ratio, various variables are reflected by measuring the calculation variable-reflected resistance ratio and multiplying it by the average calculation ratio It is to provide a blood glucose level calculation method and a blood glucose measurement system with no blood method that can provide an unrestricted, highly reliable calculated blood glucose value that minimizes errors caused by various factors by making it possible to obtain a blood glucose value .

In order to achieve this object, the present invention reflects variables that change according to vital signs (Vital Signs, V/S) including blood pressure, pulse, respiration, and body temperature of the examinee in contrast to the skin local resistance value correlated with the blood sugar value. The process of obtaining the skin local resistance value, obtaining the variable-reflected resistance ratio based on these ratio values, and obtaining the calculated ratio by dividing the blood glucose value obtained by the blood sampling method by the variable-reflected resistance ratio by the blood sampling method is repeated multiple times to obtain the average value Provided is a blood-less blood glucose level calculation method in which a calculated blood sugar value is obtained by obtaining a calculated ratio, then multiplying a measured variable-reflected resistance ratio by an average calculated ratio, and then displaying the calculated blood sugar value on a display of a wearable device.

In addition, in the blood-less blood glucose measurement system in which the blood-less blood glucose level calculation method is implemented, the present invention provides a skin local resistance electrode for measuring a skin local resistance value between two epidermal points, and an electricity reflecting vital signs between the inside of the dermal layer of the skin A variable-reflecting skin local resistance electrode equipped with a means for minimizing epidermal contact resistance having a cavity for accommodating a conductive skin penetrating solvent that detects a change in resistance and reduces the contact resistance of the terminal is connected to the input/output port of the microcontrol unit, respectively, , by providing a blood glucose measurement system without blood having a solvent supply hole capable of supplying a conductive skin penetrating solvent to the skin-contacting part of the variable-reflecting skin local resistance electrode.

In this way, the present invention obtains a number of frequently changing vital signs of the human body and variable values according to the surrounding environment in a relatively simple way, and corresponds to the skin local resistance value to calculate a reliable and accurate blood sugar value. It is possible to measure blood glucose without blood sampling as often as necessary at a time, so it is possible to obtain an accurate blood glucose level easily.

Accordingly, the present invention can not only obtain a blood sugar level at a necessary time without the burden of blood sampling, so that it is possible to fully manage blood sugar, but also greatly reduce the pain of the examinee due to frequent blood collection. Since the blood glucose measurement system does not require an expensive sensor or material, it has a useful effect such as greatly reducing the cost burden of the examinee and allowing it to be widely distributed.

1 is an explanatory diagram showing a measurement principle using a conventional infrared spectroscopy method, showing a state in which the reflection angle is small when the amount of sugar in the skin is small.
2 is an explanatory diagram showing a measurement principle using a conventional infrared spectroscopy method, showing a state in which the reflection angle is large when there is a lot of sugar in the skin.
3 is an explanatory diagram showing the electrical configuration of a blood glucose measurement apparatus using a known electrophoresis phenomenon.
4 is a conceptual diagram showing the operating principle of the present invention.
5 is a schematic diagram showing the electrical configuration of a blood glucose measurement system to which the present invention is applied.
6 is a flowchart showing a method of providing an average calculation ratio of low-level blood sugar testers for calculating blood sugar levels in a bloodless method to which the present invention is applied;
7 is a flow chart illustrating a method for displaying a blood glucose calculation value of a low-level blood glucose examinee, which relates to a blood glucose level calculation method according to the present invention to which the present invention is applied.
8 is a flowchart illustrating a method of providing an average calculation ratio of high-level blood glucose examinees for calculating blood glucose levels in a bloodless method to which the present invention is applied.
9 is a flow chart showing a method for displaying a blood glucose calculation value of a high blood glucose examinee, which relates to a blood glucose level calculation method according to the present invention.
10 is a perspective view showing an external appearance of a wearable device incorporating a blood glucose measurement system to which the present invention is applied;
11 is a bottom perspective view of a wearable device showing a common terminal and first and second terminals for measuring a skin local resistance value and a variable-reflected skin local resistance value in the present invention;
12 is an exploded perspective view showing a state in which the second terminal shown in FIG. 11 of the present invention is removed;
13 is a table summarizing the results of Examples 1 to 4;
Fig. 14 is a table summarizing the results of Examples 5 to 17;
15 is a table comparing and summarizing the results of Comparative Examples and Examples 5 to 17;
16 is a structural diagram showing an example of a micropump that can be utilized by being embedded in the second terminal in the present invention.
17 is a perspective view showing a state in which a common terminal and a first terminal are separated and mounted according to another embodiment of the present invention;
18 is a longitudinal cross-sectional view showing the structures of the common terminal and the first terminal according to another embodiment of the present invention according to FIG.

The present invention applies a skin local resistance measurement method to calculate blood sugar in a bloodless method. As described above, since the blood sugar content is proportional to the dermal sugar content of the skin, a method for calculating the blood sugar content by measuring the dermal sugar content is known. That is, since the sugar content of the dermis is proportional to the blood sugar content, infrared spectroscopy for calculating the sugar level by using the change in the scattering angle of infrared rays according to the sugar content of the dermis is a representative example.

In addition, optical coherence imaging (OCT), which calculates the sugar level by using the output of the light scattering degree of the superluminescent diode that changes according to the increase in the amount of sugar in the dermis of the human body, is also used, and the wavelength of the visible light region is used. (400-700 nm (4,000-7,000 Å)) When irradiating the dermal layer with light with wavelengths of 340 nm, 380 nm, and 400 nm, the fluorescence method is also used to calculate the sugar level as the fluorescence intensity changes according to the sugar concentration.

In addition, when laser is irradiated to the sugar component contained in the dermis layer, the sugar component absorbs energy and emits kinetic energy, and this kinetic energy emits an acoustic pressure waveform to calculate the sugar level based on this. As in the example, the sugar content in the dermal layer also changes according to the blood sugar content of the examinee.

As exemplified above, the applicant of the present invention paid attention to the fact that the sugar content of the dermal layer is in a proportional relationship with the blood sugar content.

That is, the fact that the blood sugar content of the human body and the dermis sugar content of the skin local resistance, including the dermis measured via the epidermis, is in a substantially proportional relationship with the dermal sugar content of the skin is shown in <Table 3-1> to <Table 3-9 below. > It is confirmed by the same process as shown. In other words, the thickness of the epidermis covering the dermis of the human body is about 0.6 mm on the soles of the feet, but only 0.08 mm on thin places such as the wrists. It is possible to measure the local skin resistance corresponding to blood sugar in a thin area (hereinafter referred to as 'localized skin'), and using this, it is possible to calculate the blood sugar level.

In particular, focusing on the positive correlation between the sugar content and the electrical resistance of the epidermis, it was noted that a simple basis for calculating the sugar level could be secured by measuring the epidermal local resistance.

As described above, the electrical resistance between the content of glucose (glucose) in the blood and the local location of the user's skin has a positive correlation as follows. This changing result was confirmed by the measured <Table 1-1> experiment.

<Table 1-1>

●Resistance unit: [㏀]

As can be seen in <Table 1-1>, when only the water contained in the container was 100%, the electrode of the electrical resistance meter was immersed in the water of the container and repeated measurements over 10 times, and the average was 900.1 [㏀],

After that, the weight of water is decreased by 5%, the weight of sugar is increased by 5%, and the electrode of the electrical resistance meter is immersed in the water of the container 10 times at each step, and the result of repeated measurements is 1065.2 [㏀], 1172.7 [㏀] , became 1246.8 [㏀] and 1376.8 [㏀].

These results confirmed that as the weight of water is reduced and the weight of sugar is increased, the electrical resistance measured value increases as shown in <Table 2-1> below. It could be estimated that there was also a positive correlation with the resistance value between the

<Table 2-1>

As described above, the present applicant paid attention to the increase in electrical resistance when the amount of sugar added to water increases, and conducted an experiment to investigate the correlation with the glycemic index determined according to the amount of glucose contained in the blood of the human body. tried

To this end, the applicant first measures the user's blood glucose level by supplying the blood sampled blood to HemoScan (manufactured by Dasan Medical Instruments, model name GM901B; hereinafter referred to as 'glucometer') and the company's test strip, which is a general blood glucose meter. The blood glucose was measured by blood sampling and at the same time, the resistance measuring device (Dongwha Electronics Co., Ltd.: model name: DM-300A) was connected to the user's local area of the skin to measure the skin local resistance value, and the blood glucose value measured with this blood glucose meter (A) The results were as shown in <Table 3-1> to <Table 3-9>. In <Table 3-1> to <Table 3-9>, the unit of blood sugar on the vertical axis is [mg/dL], the skin local resistance value (measured resistance value) (R0) is [㏀], and the horizontal axis is time.

<Table 3-1>

It can be seen that in the section from 06:30 to 14:30 in <Table 3-1>, the blood glucose value (BS) and the skin local resistance value (R0) are rising together. On the other hand, at 18:30, although the blood glucose value (BS) is decreasing, the skin local resistance value (R0) is rather rising, and it can be seen that before 22:30 it is rising again.

<Table 3-2>

In addition, if you look at <Table 3-2>, from 03:00 to 06:00, both the blood glucose value and the skin local resistance value are changing in almost the same state.

At 07:30, the blood glucose value for blood sampling is rising, but the skin local resistance value does not change.

<Table 3-3>

Also, looking at <Table 3-3>, at 04:00, there is no significant difference between the blood glucose value and the local skin resistance value, but at 20:30 there is a large difference between the blood glucose value and the skin local resistance value, 23: From 00 to 24:00, the blood glucose value and the skin local resistance value tend to decrease at the same rate,

Next, looking at <Table 3-4>, it is shown that the blood glucose value and the skin local resistance value fluctuate at about the same rate.

<Table 3-4>

In addition, looking at <Table 3-5>, it is observed that the blood glucose value and the skin local resistance value change at about the same rate from 03:30 to 10:00, but the blood glucose value from 10:00 to 11:00 While this decreases, the skin local resistance value shows an increasing pattern, and it can be seen that it changes at about the same rate from 11:00 to 13:00.

<Table 3-5>

In addition, looking at <Table 3-6>, in this case, the increase/decrease in the blood glucose value and the skin local resistance value from 03:00 to 17:00 are opposite, and they show the same tendency at 22:00.

<Table 3-6>

And, looking at <Table 3-7>, it can be observed that from 03:15 to 09:30, the blood glucose value and the skin local resistance value change at almost the same rate, but from 09:30 to 12:00, the increase/decrease is reversed. From 12:00 to 14:30, the increasing trend is the same, but the rate of increase is different, and from 14:30 to 19:00, the skin local resistance value increases compared to the decrease in the blood glucose value. , from 19:00 to 22:00, the increase in blood glucose value and the skin local resistance value almost coincide.

<Table 3-7>

Next, looking at <Table 3-8>, this shows that the rate of change of blood glucose value and skin local resistance value from 03:00 to 07:00 is almost identical, but there is a difference in the rate of change from 07:00 to 09:30 In the section from 09:30 to 11:30, the blood glucose value decreased while the skin local resistance value increased.

<Table 3-8>

Lastly, looking at Table <3-9>, this shows that the blood glucose value and the skin local resistance value increase and decrease from 04:00 to 21:00, but the rate of increase and decrease is different for each section, and the blood glucose value after 21:00 In contrast to the decrease, the skin local resistance value rather increases.

<Table 3-9>

If we examine this series of phenomena closely, it can be estimated that there is a generally positive correlation between the blood glucose value and the skin local resistance value, but the increase or decrease is frequently partially reversed, and the increase rate is the same, but then changes differently. It can be arranged to be

The present applicant found that although there is a clear correlation between the blood glucose level and the skin local resistance value in the above-described experimental process, this positive correlation is sometimes distorted by certain factors, and as a result, the skin local resistance By multiplying the value by a certain calculation ratio, the actual blood-collecting method blood glucose value can be approached, but it has been concluded that a reliable calculated blood glucose value cannot be obtained only from this.

Therefore, the present applicant identified the factors that distort the correlation between the blood glucose value and the skin local resistance value, and made efforts to find a solution over a long period of time. Two factors were identified that distorted the correlation between blood glucose levels and skin local resistance values.

First: Changes in biometric indices due to vital signs such as sweat, pulse, respiration, blood pressure, and body temperature

Second: Variation of unstable contact resistance between the skin and the electrode of the terminal for measuring the skin local resistance value

In consideration of the factors that distort the correlation between the blood sampling glucose value and the skin local resistance value, the present applicant calculated the skin local resistance value (R0) as the biometric signal value obtained through the pulse rate measuring means and the skin moisture ratio measuring means. want to correct

On the other hand, as a representative value, the correction value based on the pulse and skin moisture ratio measurement values was obtained and these correction values were reflected in the measured resistance value to implement the blood sugar calculation. As a result, the fluctuation of the biometric index did not compensate for the complex interaction, making it difficult to accurately calculate blood glucose values.

Accordingly, the present applicant judged that it is impossible to avoid the distortion of the calculation result even when an attempt to reflect the aforementioned multiple biometric indices one by one is not realistic and reflects the pulse and skin moisture ratio measurement values as representative values.

Accordingly, the present applicant stated that the method of indirectly calculating blood sugar by reflecting the fluctuations of biometric indices one by one not only makes the process complicated and complex, but also interacts with each other, so that the above-mentioned multiple biometric indices interact with each other. Rather, it came to the conclusion that the reflection attempt has no choice but to lower the reliability of the blood glucose calculation value.

Accordingly, the present applicant has endeavored to obtain a measurement value that is reflected by the complex action of the fluctuation of the biometric index due to the vital signs. We focused on a measurement method that utilizes the ratio of resistance values caused by the current flowing through the dermal layer of the skin.

That is, the measurement method in the present invention basically measures the local skin resistance value of the human body such as the wrist, where the thickness of the epidermis is thin about 0.08 mm, but at the same time and under two different conditions, the skin local resistance value (R0) is measured. do.

That is, the two terminals measure the skin local resistance value between two points of the epidermis, and the contact resistance between the terminal and the epidermis so that the vital signs as described above inside the dermal layer are reflected and detected as a change in electrical resistance. This is to measure the variable-reflecting skin local resistance value (R1) using two terminals with a cavity for accommodating the conductive skin penetration solvent applied to the pad of a general low-frequency treatment device to minimize the

In principle, this measurement process uses two terminals to detect different values of skin local resistance, but in this case, it can be measured only with four terminals.

On the other hand, wearable devices and the like need to be compact by minimizing the number of terminals, so in the embodiment of the present invention, there are three common terminals (C0), a first terminal (C1), and a second terminal (C2). Since a method of detecting two local skin resistance values using a terminal will be exemplified and described, an embodiment of a method of measuring two skin local resistance values with two terminals will be omitted.

In the present invention, the terminal (localized skin resistance electrode) for measuring the skin local resistance (R0) between the two points of the epidermis is a common terminal (C0) and the first terminal (C1),

The terminal (variable-reflecting skin local resistance electrode) for measuring the variable-reflecting skin local resistance value (R1), which is detected as a change in electrical resistance by reflecting vital signs, is a common terminal (C0) and a second terminal (C2).

In addition, the common terminal (C0) and the second terminal (C2) are provided with a solvent supply hole 500 capable of supplying a conductive skin penetrating solvent applied to the pad of the general low-frequency treatment device to the area in contact with the epidermis so that the epidermis is provided. It should function as a means of minimizing contact resistance.

A series of embodiments implemented by the common terminal C0, the first terminal C1, and the second terminal C2 according to the present invention as described above is a blood glucose calculation method as shown in FIGS. 6 to 9. To this end, a bloodless blood glucose measurement system manufactured in the form of a wrist watch-type wearable device (hereinafter referred to as 'device') with the electrical components shown in FIG. 5 as shown in FIG. As applicable, the specific action will be described with reference to the accompanying drawings as follows.

The present invention first varies the method of calculating the glucose level according to the examinee's blood sugar. For example, if the examinee's blood sugar is 220 [mg/dL] or less, it is classified as a low-level (mild) examinee, and exceeds 220 [mg/dL] In the case of , it is classified as a high-level (severe) examinee.

First, if the examinee's blood sugar is 220 [mg/dL] or less, it is judged as a low-level examinee, and the microcontrol unit of the blood glucose measurement system without blood draws the first terminal (C1) and the common terminal ( Step 1 of measuring the skin local resistance value (R0) between C0) and storing the measured value is performed.

In particular, in the present invention, the blood sugar component (reference symbol G in Fig. 4) moves to the dermal layer even though it is not ionized, and the sugar component moved to the dermal layer (SKIN) due to this electro-osmosis phenomenon occurs. Since the non-ionized component prevents the flow of electrons for resistance measurement, the current is reduced, thereby increasing the resistance value.

In this way, the resistance value between the first terminal (C1) and the common terminal (C0) is measured, and the principle of this operation is Electrochemical Sensors for Clinic Analysis as shown in FIG. It can be confirmed by The extraction of glucose by reverse iontophoresis of Sensors published Aug. 2008, page 2052).

In addition, the variable reflection skin area between the second terminal (C2) and the common terminal (C0) provided with a means for minimizing the skin contact resistance by accommodating a conductive skin penetrating solvent capable of minimizing the contact resistance between the electrode and the epidermis of the terminal Step 2 of measuring the resistance R1 and storing the measured value is performed.

In the present invention, the conductive skin penetration solvent supplied from the second terminal (C2) and the common terminal (C0) reaches the dermis through the epidermis. Between (C2), the electrical resistance between the inner layers of the dermis can be measured. In particular, when the pulse rate or respiration rate increases or the body temperature rises by the solvent penetrating into the inner layer of the dermis provided from the second terminal (C2). , when the blood flow and blood flow rate increase, the electrical resistance of the inner layer of the dermis decreases. .

This result is presumed because the increase in blood flow increases the flow path of the current, and the increase in the flow path of the current becomes the same as the parallel connection of resistors, leading to a decrease in the overall combined resistance.

In the present invention, the electrical configuration illustrated in FIG. 5 may be utilized to perform each step for calculating blood glucose illustrated in FIGS. 6 to 9 .

That is, in the blood-less blood glucose measurement system illustrated in FIG. 5 for this purpose, a predetermined constant voltage is applied between the common terminal C0 and the first terminal C1 by a program in which the microcontrol unit 100 is built-in, and the high voltage flowing at this time is applied. After allowing current to flow through the resistor, A/D-convert the voltage value of the high-resistance, read the A/D-converted data, convert it into a resistance value, and store it in internal/external memory.

According to this bloodless blood glucose measurement system, when a constant voltage is applied to the epidermis of the skin in order to measure the skin local resistance value (R0) between the first terminal (C1) and the common terminal (C0), a current is passed through the thin epidermis to the dermis layer. flows and this current causes current flow by ionization of sodium chloride present in the blood between the tissues of the inner layer of the dermis.

In the present invention, as shown in FIG. 5, first, the skin local resistance value (R0) is measured by the common terminal (C0) and the first terminal (C1), and the skin local resistance reflecting a variable corresponding to the change in vital signs of the living body The value R1 is stored as an electrical resistance measurement value measured by the common terminal C0 and the second terminal C2. Next, the present invention reflects the variable between the common terminal (C0) and the second terminal (C2) to the skin local resistance value (R0) between the common terminal (C0) and the first terminal (C1) reflected the local resistance value of the skin Step 3 of calculating and storing the variable-reflected resistance ratio by multiplying the ratio of (R1) by 100 is performed.

For convenience, this variable-reflected resistance ratio is referred to as AN, and the calculated ratio (KN) is obtained by dividing the blood glucose value (BS) by the blood sampling method provided together at the time of performing steps 1 and 2 by the variable-reflecting resistance ratio (AN). Step 4 of storing this is carried out, and a plurality of calculation ratios are obtained by measuring and calculating this process at intervals of several hours or more.

For example, after the calculation ratio is obtained N times or more, the average calculation ratio (KAVR) is obtained by adding up all calculation ratios and dividing by N. Step 5 is performed in which the average calculation ratio (KAVR) obtained in this way is stored in the internal and external memory of the microcontrol unit 100, and the average calculation ratio (KAVR) acquisition process is performed through steps 1 to 5. it can be

In addition, the blood glucose value obtained by blood sampling in the present invention is first inserted into the measuring device of the strip, and then the glucose oxidase of the strip oxidizes the blood glucose by blood sampling and blood dripping by conventional invasiveness to generate hydrogen peroxide (H ₂ O ₂ ) Since electrons are generated in the process of converting oxygen into oxygen, the higher the glucose level, the more electrons are generated and the current increases.

Although this method of blood sampling (BS) involves pain due to invasion, it is internationally recognized as being able to measure glucose levels more accurately than any other method with current technology.

The examinee's current blood glucose value (BS) obtained in this way is operated by combining a plurality of function buttons (S1, S2, S3) of the device to which the present invention is applied to input a 2-digit or 3-digit blood glucose value (BS). In addition, as will be described later, it is possible to receive input wirelessly by a known method such as installing the Bluetooth module 200 .

Thereafter, as shown in FIG. 7 , the microcontrol unit 100 of the blood glucose measurement system without blood draws the skin local resistance (R0), which is the resistance value of the common terminal (C0) and the first terminal (C1) to calculate the current blood glucose. Step 6 of measuring and storing

Step 7 of measuring and storing the variable-reflecting skin local resistance value (R1), which is the resistance value of the common terminal (C0) and the second terminal (C2);

Step 8 of multiplying the ratio of the local variable skin resistance value (R1) to the skin local resistance value (R0) by 100 to calculate the current blood sugar and storing the result value as the variable reflection resistance ratio (A) for calculation;

The blood glucose calculation step including step 9 of multiplying the calculated variable-reflected resistance ratio (A) and the average calculation ratio (KAVR) obtained in step 5 to obtain a calculated blood glucose value is performed, and the display 300 of the device as shown in FIG. ) to output and display the calculated blood glucose value. After doing this, when the examinee presses the operation end button, the series of operations is terminated.

The present invention as described above will be described in detail according to the attached embodiments as follows.

Example 1

In this embodiment, the process of dividing the blood glucose value (BS) obtained by the blood sampling method by the calculation ratio (KN) is repeated several times to obtain a plurality of calculation ratios (KN), and by averaging the plurality of calculation ratios (KN), the average calculation ratio ( KAVR) is obtained.

Multiplying this average calculated ratio (KAVR) by the variable-reflected resistance ratio (A) obtained from the common terminal (C0) and the first and second terminals (C1, C2) gives the calculated blood glucose value. The program for performing the process shown in Figs. 6 to 9 is executed by the microcontrol unit 100 shown in Fig. 5 .

To this end, the microcontrol unit 100 is to measure the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), at this time, the skin local resistance value measured by the microcontrol unit 100 (R0) became 70 [㏀].

The skin local resistance value (R0) is converted into digital data and stored in the internal and external memory according to the program in which the microcontrol unit 100 is built, of course.

Then, the conductive skin penetration solvent embedded in the common terminal C0 and the second terminal C2 is discharged to the solvent supply hole 500 and reaches the dermis through the epidermis. It was measured as 48 [㏀] as a result of measuring the variable-reflecting skin local resistance value (R1), which is the electrical resistance between the inner layer of the dermis that exists between the common terminal (C0) and the second terminal (C2) as current flows by applying a . In this way, the microcontrol unit 100 performs the following calculations.

로 연산되어 변수반영저항비로 68.57이 저장된다. where AN is the variable-reflected resistance ratio, and the result of substituting the measured resistance value in the above formula

, and 68.57 is stored as the variable-reflected resistance ratio.

Then, in the present invention, if the average calculation ratio (KAVR) obtained by the process described later is used and divided by 68.57, which is the variable reflection resistance ratio (AN), the calculation ratio (KN) is 2.26 calculated and stored in internal and external memory .

In addition, since this calculation ratio (KN) is a value calculated at a certain point in time, by dividing by the number (N) of the calculation ratio (KN) after obtaining and summing multiple calculation ratios (KN) due to the nature of the human body, which causes various changes every moment An average calculation ratio (KAVR) capable of increasing reliability was obtained, and was calculated as 2.4 in the example shown in <Table 1>.

Therefore, it is a value obtained by multiplying the ratio of the variable-reflected skin local resistance (R1) by 100 to the local skin resistance (R0), which is a measurement of the average calculation ratio (KAVR), which will be described later separately from the calculation ratio of the current stage stored in the internal and external memory. The calculated blood glucose is 164.57 [mg/dL] by multiplying the variable-reflected resistance ratio of 68.57 by the mean output ratio (KAVR) of 2.4.

Example 2

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 60 [kΩ].

로 연산하여 변수반영저항비로 51.67이 저장된다.Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured to be 31 [㏀]. In this way, the microcontrol unit 100

, and 51.67 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 110 [mg/dL].

으로 계산되어 산출비 2.13을 얻게 되며, 이 역시 내, 외장 메모리에 저장한다.

calculated as , yielding a yield of 2.13, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 2 is 51.67, the calculated blood glucose is 124.00 [mg/dL] by multiplying this by the average calculated ratio (KAVR) 2.4, which will be described later.

Example 3

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 100 [kΩ].

로 연산하여 변수반영저항비로 78이 저장된다. Then, the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured as 78 [㏀]. In this way, the microcontrol unit 100

, and 78 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 211 [mg/dL].

으로 계산되어 산출비 2.71을 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

calculated as , yielding a yield ratio of 2.71, which is also stored in internal and external memory.

On the other hand, since the variable-reflected resistance ratio in Example 3 is 78, the calculated blood glucose is 187.20 [mg/dL] by multiplying this by the average calculated ratio (KAVR) 2.4, which will be described later.

Example 4

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 100 [kΩ].

로 연산하여 변수반영저항비로 39가 저장된다. Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured as 39 [㏀]. In this way, the microcontrol unit 100

, and 39 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 97 [mg/dL].

로 계산되어 산출비 2.49를 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

calculated as , yielding a yield ratio of 2.49, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 3 is 39, the calculated blood sugar is 93.60 [mg/dL] by multiplying this by the average calculated ratio (KAVR) 2.4, which will be described later.

In Examples 1 to 4, the calculation ratios are 2.26, 2.13, 2.71, and 2.49, respectively, and when these are added and divided by 4, the average calculation ratio (KAVR) is 2.4. In order to increase the reliability of the calculated blood glucose, for example The calculation ratio is obtained according to Examples 1 to 4, and the average calculation ratio (KAVR) is obtained thereafter, and thereafter, the common terminal (C0) measured by the micron control unit 100 without a painful blood sampling process due to a separate invasion. The calculated blood sugar can be easily displayed without limiting the number of times by calculating the variable-reflected resistance ratio only with the resistance values from the first and second terminals (C1, C2), multiplying the average calculated ratio (KAVR), and displaying it on the display 300 of the device. there will be

In addition, the Korea Food & Drug Ministration's (Korea Food & Drug Ministration) blood glucose meter performance evaluation guideline 2 (published on Nov. 2007) specifies the range of ±20% of the reference value as the minimum allowable performance condition, but it is ±15% Even if it is limited to , when it is seen in the table shown in FIG. 13 that the calculated blood glucose values are all within the range of the allowable lower limit and the allowable upper limit, the calculated blood glucose value has more than the allowable minimum performance condition, and the average error is +1.029%. It is confirmed that a high level of reliability is secured.

In addition, in the present invention, when the examinee's blood sugar is higher than 220 [mg/dL], the method of calculating the glucose level is changed in the form shown in FIG. 8 by branching as shown in the flowchart shown in FIG. is classified as a high-level examinee and the sugar level is calculated as follows.

First, when the examinee's blood sugar is more than 220 [mg/dL], it is determined that the blood sugar is high, and the microcontrol unit of the blood glucose measurement system without blood draws a first terminal (C1) and a common terminal (C0) as illustrated in FIG. 5 . Step 1 of measuring the skin local resistance (R0) between ) and storing the measured value;

Variable reflection skin local resistance ( Step 2 of measuring R1) and storing the measured value is performed. For this purpose, the apparatus illustrated in FIG. 5 may be used in the same manner as in the case of Examples 1 to 4.

However, in the case of severe examinees, in order to obtain the variable reflection resistance ratio, as in the case of mild examinees, the ratio of the variable reflection skin resistance (R1) to the skin local resistance (R0) is multiplied by 100 to obtain the variable reflection ratio, not Multiplying the ratio of the square of the variable-reflected skin resistance (R1) to the square of the skin resistance by 100 to obtain the variable-reflection ratio.

That is, in the case of a severe examinee, the blood glucose content is high by the mild examinee, and it is confirmed in Example 5 below that the blood glucose level that cannot be ionized is proportional to the square, not proportional to the resistance value increase rate. can be

Accordingly, the microcontrol unit 100 is programmed to perform the following operations.

Accordingly, step 3 of storing the result obtained by multiplying the squared ratio of the local variable skin resistance (R1) with respect to the square of the skin local resistance (R0) by 100 as the variable reflected resistance ratio (BN);

Step 4 of dividing the blood glucose value (BS) by the blood sampling method provided together at the time of execution of steps 1 and 2 by the variable-reflected resistance ratio (BN) to obtain a calculated ratio (KN) and storing it;

Steps 1 to 4 are repeated N times at different times,

The average output ratio (KAVR) acquisition process is performed, which consists of step 5 of summing the N calculation ratios (KN) obtained through N repetitions and storing the value divided by N as the average output ratio (KAVR);

Step 6, wherein the microcontrol unit of the blood glucose measurement system without blood measures the skin local resistance (R0) between the common terminal (C0) and the first terminal (C1) to calculate the current blood glucose and stores the measured value;

Step 7 of measuring the variable anti-perfect resistance (R1) between the common terminal (C0) and the second terminal (C2) and storing the measured value;

Storing the result of multiplying the ratio of the square of the local variable skin resistance (R1) to the square of the skin local resistance (R0) by 100 for the calculation of the current blood glucose as the variable-reflected resistance ratio (B) for calculation Lesson 8,

A blood glucose calculation step comprising step 9 of multiplying the calculated variable-reflected resistance ratio (B) and the average calculation ratio (KAVR) obtained in step 5 to obtain a calculated blood glucose value is performed.

The blood glucose calculation process by the method shown in FIGS. 8 and 9 in consideration of the electrophysiological characteristics of such severe autopsy will be described below in Example 5 below.

Example 5

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 100 [kΩ].

로 연산하여 변수반영저항비로 40.96이 저장된다. Then, the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured as 64 [㏀]. In this way, the microcontrol unit 100

40.96 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 167 [mg/dL].

으로 계산되어 산출비 4.08을 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

, and a yield ratio of 4.08 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable-reflected resistance ratio in Example 5 is 40.96, the calculated blood glucose is 172.00 [mg/dL] by multiplying this by an average calculated ratio (KAVR) of 4.2, which will be described later.

Example 6

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 60 [kΩ].

로 연산하여 변수반영저항비로 46.69가 저장된다. Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured to be 41 [㏀]. In this way, the microcontrol unit 100

, and 46.69 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 171 [mg/dL], so

으로 계산되어 산출비 3.66을 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 3.66 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable-reflected resistance ratio in Example 6 is 46.69, the calculated blood glucose is 196 [mg/dL] by multiplying this by an average calculated ratio (KAVR) of 4.2, which will be described later.

Example 7

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 100 [kΩ].

로 연산하여 변수반영저항비로 56.25가 저장된다. Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured to be 75 [㏀]. In this way, the microcontrol unit 100

, and 56.25 is stored as the variable-reflected resistance ratio.

Subsequently, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 245 [mg/dL].

으로 계산되어 산출비 4.36을 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

, and a yield ratio of 4.36 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 7 is 56.25, the calculated blood glucose is 236.25 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 8

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 40 [㏀].

로 연산하여 변수반영저항비로 27.56이 저장된다. Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured as 21 [㏀]. In this way, the microcontrol unit 100

, and 27.56 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 123 [mg/dL].

으로 계산되어 산출비 4.46을 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 4.46 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 8 is 27.56, the calculated blood glucose is 115.76 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 9

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 100 [kΩ].

로 연산하여 변수반영저항비로 19.36이 저장된다. Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured as 44 [㏀]. In this way, the microcontrol unit 100

, and 19.36 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 83 [mg/dL].

로 계산되어 산출비 4.29를 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 4.29 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 9 is 19.36, the calculated blood glucose is 81.31 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 10

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 100 [kΩ].

로 연산하여 변수반영저항비로 56.25가 저장된다. Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured to be 75 [㏀]. In this way, the microcontrol unit 100

, and 56.25 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 250 [mg/dL].

로 계산되어 산출비 4.44를 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 4.44 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 10 is 56.25, the calculated blood glucose is 236.25 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 11

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 32 [kΩ].

으로 연산하여 변수반영저항비로 76.56이 저장된다. Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured as 28 [㏀]. In this way, the microcontrol unit 100

76.56 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 333 [mg/dL].

로 계산되어 산출비 4.35를 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 4.35 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 11 is 76.56, the calculated blood sugar is 321.56 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 12

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 75 [kΩ].

로 연산하여 변수반영저항비로 37.62가 저장된다. Then, the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured as 46 [㏀]. In this way, the microcontrol unit 100

, and 37.62 is stored as the variable-reflected resistance ratio.

Subsequently, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 155 [mg/dL].

로 계산되어 산출비 4.12를 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 4.12 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 12 is 37.62, the calculated blood glucose is 158 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 13

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 100 [kΩ].

로 연산하여 변수반영저항비로 22.09가 저장된다.Then, when measuring the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), it was measured as 47 [㏀]. In this way, the microcontrol unit 100

22.09 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 76 [mg/dL].

로 계산되어 산출비 3.44를 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 3.44 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 13 is 22.09, the calculated blood glucose is 92.78 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 14

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 91 [kΩ].

로 연산하여 변수반영저항비로 44.93이 저장된다. Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured to be 61 [㏀]. In this way, the microcontrol unit 100

, and 44.93 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 208 [mg/dL].

으로 계산되어 산출비 4.63을 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 4.63 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 14 is 44.93, the calculated blood glucose is 188.72 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 15

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 44 [kΩ].

으 로 연산하여 변수반영저항비로 78.56이 저장된다.Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured as 39 [㏀]. In this way, the microcontrol unit 100

, and 78.56 is stored as the variable-reflected resistance ratio.

Subsequently, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 328 [mg/dL].

로 계산되어 산출비 4.17을 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

Calculated as , yielding a ratio of 4.17 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 15 is 78.56, the calculated blood glucose is 329.97 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 16

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 100 [kΩ].

로 연산하여 변수반영저항비로 14.44가 저장된다.Then, when the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured, it was measured to be 38 [㏀]. In this way, the microcontrol unit 100

, and 14.44 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 58 [mg/dL].

로 계산되어 산출비 4.02를 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 4.02 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 15 is 14.44, the calculated blood sugar is 60.65 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

Example 17

Also in this embodiment, the microcontrol unit 100 measures the skin local resistance (R0) between the first terminal (C1) and the common terminal (C0), and at this time, the skin localization measured by the microcontrol unit 100 The resistance value R0 became 75 [kΩ].

으로 연산하여 변수반영저항비로 92.16이 저장된다.Subsequently, the variable-reflecting skin local resistance (R1), which is the electrical resistance between the inner layer of the dermis existing between the common terminal (C0) and the second terminal (C2), was measured as 72 [㏀]. In this way, the microcontrol unit 100

92.16 is stored as the variable-reflected resistance ratio.

Next, in the present invention, the blood glucose value obtained by the invasive method is input at the same time, and the value at this time is 419 [mg/dL].

로 계산되어 산출비 4.55를 얻게 되며, 이 역시 내,외장 메모리에 저장한다.

is calculated as , and a yield ratio of 4.55 is obtained, which is also stored in internal and external memory.

On the other hand, since the variable reflection resistance ratio in Example 17 is 92.16, the calculated blood glucose is 387.07 [mg/dL] by multiplying this by the average calculated ratio (KAVR) of 4.2, which will be described later.

In Examples 5 to 17, the calculation ratios were 4.08, 3.66, 4.36, 4.46, 4.29, 4.44, 4.35, 4.12, 3.44, 4.63, 4.17, 4.02, and 4.55, respectively, and when these were summed and divided by 14, the average calculation ratio was (KAVR) will be 4.2. That is, in order to increase the reliability of the calculated blood sugar, for example, the calculation ratio is obtained according to Examples 5 to 17, and the average calculation ratio (KAVR) is obtained thereafter, without the need for a painful blood sampling process due to separate invasiveness. (100) to obtain the variable-reflected resistance ratio only with the resistance values of the common terminal (C0) and the first and second terminals (C1, C2) measured by (100), multiply this by the average calculation ratio (KAVR), and By displaying it, it is possible to easily display the calculated blood sugar without limiting the number of times.

In addition, the Korea Food & Drug Ministration's (Korea Food & Drug Ministration) blood glucose meter performance evaluation guideline 2 (published on Nov. 2007) specifies the range of ±20% of the reference value as the minimum allowable performance condition, but it is ±15% 14, except for the calculated blood sugar of Example 13, all other 11 calculated blood sugar values are within the range of the lower limit and upper limit of ±15%. It is confirmed that the blood glucose value has more than the minimum acceptable performance condition, and the average error is only +0.74%, ensuring a high level of reliability.

Comparative Example

In addition, in order to confirm the reliability of the calculated blood glucose value according to the present invention, the calculated blood glucose values shown in Examples 5 to 17 calculated at the same time as the standard blood glucose value obtained by blood sampling and the multinational measured for the same person at the same time 15 shows the results of comparison with ABBOTT's current health insurance benefit products for diabetic patients (abbreviated as 'A' products).

As a result, the calculated blood glucose value according to the present invention had an average error of only 0.74% when compared with the blood glucose value measured at the same time, but it was confirmed that the average error was -13.84% for product A measured at the same time Therefore, it is possible to confirm the high reliability of the calculated blood glucose according to the present invention.

In addition, in the present invention, the microcontrol unit 100 is loaded with a program for executing the operation stipulated in steps 1 to 9, and the blood glucose calculation result by the operation of the program is displayed on the wrist as shown in FIG. 10 or less. It may be implemented in the form of being output to the display 300 of the watch-type wearable device.

In this embodiment, the common terminal (C0) and the second terminal (C2) may have a cavity for accommodating the gel-like conductive skin penetrating solvent therein, communicate with the cavity, and be in contact with the skin. Although the solvent supply hole 500 capable of supplying the conductive skin penetration solvent may be provided, a known micropump as illustrated in FIG. 16 is operated whenever necessary by the microcontrol unit 100 to operate a small amount at a required time. Each time, the conductive skin penetration solvent may be pumped to penetrate into the epidermis.

As shown in FIG. 16, one-way valves are installed at the inlet and outlet of this micropump, and the conductive skin penetrating solvent accommodated in the cavity inside the second terminal C2 is obtained by vibrating the diaphragm by a piezo or a heater-operated bimetal. It can be applied as long as it can be extruded and supplied in small amounts.

In addition, the common terminal (C0) and the second terminal (C2) provided in the wristwatch-type wearable device in the present invention is a known fastening that can be removed and installed with a new one when the conductive skin penetrating solvent contained in the internal cavity is consumed. A detachable structure such as a combination of a protrusion and a groove may be provided, and this embodiment is shown in FIGS. 10 to 12 .

In addition, in the present invention, the common terminal (C0) and the first and second terminals (C1, C2) are in contact with the skin of the wrist with an appropriate pressure in order to measure the skin local resistance (R0) and the variable-reflecting skin local resistance (R1). Needs to be. Therefore, the elastic body inside the elastic band 400, each terminal (C0, C1, C2) for tightening the common terminal (C0) and the first and second terminals (C1, C2) to be in close contact with the skin at the same time with an appropriate pressure It is necessary to be provided with at least one or more tightening means, such as.

In addition, in the present invention, a plurality of buttons for controlling the operation of the microcontrol unit 100 and the common terminal (C0) and the first and second terminals (C1, C2), the display 300 and the microcontrol unit 100 Since it is manufactured as a wristwatch-type wearable device accommodated in this single package, it is possible to promote convenience in management such as portability, use, and storage.

In addition, in the present invention, in the preparation process for obtaining an accurate calculation ratio, it is necessary to obtain a blood glucose value by a blood sampling method blood glucose meter. These blood glucose values for blood sampling can be input by manipulating the function buttons (S1, S2, S3) of the device. By connecting each Bluetooth module so that the blood glucose value obtained by blood sampling of the examinee is wirelessly transmitted to the input/output port of the microcontrol unit 100, the blood glucose value is automatically input, thereby improving the convenience of use.

In the present invention, one step older, a Bluetooth module that can be directly or detachably connected to the input/output port of the microcontrol unit 100 by installing an application for blood sugar management on the examinee's terminal, such as a laptop, tablet PC, smart phone, etc. Paired with the examinee's terminal, the microcontrol unit 100 and the examinee's terminal share the operation control, status information, blood sugar value, measurement and calculation data of the microcontrol unit 100 through two-way wireless communication and installed in the examinee's terminal Through this application, time-series data detection and analysis can be performed to enable more efficient blood sugar management, making it more useful.

In addition, although the present invention has illustrated and described an embodiment applied to a wrist watch type wearable device as shown in the drawings, it may be implemented in various forms as necessary.

As a representative embodiment of another type as described above, the common terminal (C0) and the first and second terminals (C1, C2) are connected to the input/output ports of the microcontrol unit 100, and the microcontrol unit 100 is A program is loaded in the external memory to perform the operations specified in steps 1 to 9, but the microcontrol unit 100 and the common terminal (C0) and the first and second terminals (C1, C2) are one patch It is configured as a single package such as the back, and can be worn by attaching such a patch between the shoulder and the elbow, and can also be applied in a form that can be removed and replaced or stored when necessary, and by the operation of the program By allowing the blood glucose calculation result of the microcontrol unit 100 to be transmitted to the terminal of the examinee in which the application is installed by the Bluetooth module connected to the input/output port of the microcontrol unit 100, it can be implemented in the form of a patch rather than a wrist watch. , by making it possible to operate and control by the application, it is possible to promote convenience of use. In addition, the blood-less blood glucose level calculation method and the blood-free blood glucose measurement system according to the present invention can be put to practical use in various forms.

In addition, in the present invention, there are cases in which normal measurement becomes difficult due to excessive moisture due to sweat on the common terminal (C0) and the first terminal (C1) in summer, etc. Similarly, by providing the electrode exposed portion 600 and the dehumidifying layer 601 on the circumferential surface of the first terminal C1, the dehumidification layer is in line with the normal resistance measurement by the electrode exposed portion 600 made of a conductive metal. By removing the unnecessary excess moisture (601), the reliability of the measured value can be improved.

In addition, the dehumidification layer 601 in the present invention was confirmed by an experiment that it is practical to use a layered arrangement of silica gel particles.

In addition, in the present invention, the common terminal (C0) has a structure in which the conductive skin penetration solvent is accommodated in the same way as the second terminal (C2), and the solvent supply hole 500 may be provided on the surface. The common terminal (C0) has the same structure as the first terminal (C1), but the same level of calculated blood sugar can be obtained by applying arithmetic compensation for the change in the measured resistance value, and the common terminal (C0) and the second terminal (C0) The conductive skin penetrating solvent accommodated inside the second terminal (C2) is applicable if it is a general gel-type or liquid one used for applying to the pad of the low-frequency treatment device, so the presentation of specific components of the conductive skin penetrating solvent is omitted.

In addition, in the present invention, as shown in the figure, the local skin resistance value is measured between the skin epidermis by the common terminal and the first terminal, and the vital signs between the inside of the skin dermal layer are reflected by the common terminal and the second terminal. Although resistance measurement is made, if necessary, the measurement of the local resistance value between the skin epidermis and the measurement of the electrical resistance reflecting the vital signs between the inside of the skin dermis can be performed by means of two sets of terminals. In this case, since four terminals must be provided inevitably, it may be disadvantageous in terms of compactness as it is attached to the human body.

In the above, the technical idea of the blood-less blood glucose level calculation method according to the present invention has been described along with the accompanying drawings. It is a clear fact that any person with ordinary skill in the art can change and imitate various changes and imitations of dimensions, shapes, and structures within the scope of the technical idea of the present invention. It is included in the scope of the technical idea.

R0: local skin resistance value (R0) R1: variable-reflecting skin local resistance value (R1)
AN: Variable-reflected resistance ratio (in case of low blood sugar testers)
BS : Blood glucose level KN : Calculation ratio KAVR : Average calculation ratio
A: Calculation variable-reflected resistance ratio (for low blood sugar testers)
BN: Variable-reflected resistance ratio (for subjects with high blood sugar levels)
B: Variable-reflected resistance ratio for calculation (in case of high blood sugar testers)
C0: common terminal C1: first terminal C2: second terminal
S1, S2, S3: Function button 100: Micro control unit
200: bluetooth module 300: display 400: band
500: solvent supply hole 600: electrode exposed part 601: dehumidifying layer

Claims (13)

If the examinee is classified as a low-level examinee,
Step 1, in which the microcontrol unit of the blood glucose measurement system measures the skin local resistance (R0) with the skin local resistance electrode in contact with two points of the epidermis and stores the measured value, to minimize the contact resistance between the electrode and the epidermis Step 2 of measuring the variable-reflecting skin local resistance (R1) with a variable-reflecting skin local resistance electrode equipped with means for minimizing epidermal contact resistance containing a conductive skin-penetrating solvent that can be applied and storing the measured value, the skin local resistance (R0) . Step 4 is performed to obtain a calculated ratio KN by dividing the value BS by the variable-reflected resistance ratio AN, and to store it. Steps 1 to 4 are repeated N times at different times, and the N times A process of obtaining an average output ratio (KAVR) consisting of step 5 of summing the N number of calculation ratios (KN) obtained through repetition and storing the value divided by N as the average output ratio (KAVR);
Step 6, in which the microcontrol unit of the blood-less blood glucose measurement system measures the skin local resistance (R0) with the skin local resistance electrode contacted to two points on the epidermis to calculate the current blood glucose and stores the measured value. A means for minimizing the epidermal contact resistance is provided Step 7, measuring the variable anti-reflection resistance (R1) with the applied variable-reflecting skin local resistance electrode and storing the measured value, the variable-reflecting skin local resistance (R1) for the current blood glucose calculation Step 8 is performed to store the result of multiplying the ratio by 100 as the variable reflected resistance ratio for calculation (A), and multiply the calculated variable reflected resistance ratio (A) by the average calculated ratio (KAVR) obtained in step 5 A blood glucose level calculation method without blood sampling, characterized in that a blood glucose calculation step comprising step 9 of obtaining a calculated blood glucose value is configured. If the examinee is classified as a high-level examinee,
Step 1 in which the microcontrol unit of the blood glucose measurement system measures the skin local resistance (R0) with the skin local resistance electrode in contact with two points on the epidermis and stores the measured value, to minimize the contact resistance between the electrode of the terminal and the epidermis Step 2 of measuring the variable-reflecting skin local resistance (R1) with a variable-reflecting skin local resistance electrode equipped with means for minimizing epidermal contact resistance containing a conductive skin-penetrating solvent that can be applied and storing the measured value, the skin local resistance (R0) ) of the square of the variable-reflected local resistance (R1) multiplied by 100, and the result value is stored as the variable-reflected resistance ratio (BN). Step 4 is performed to obtain a calculated ratio (KN) and store the calculated ratio (KN) by dividing the blood glucose value (BS) by A process of obtaining an average calculation ratio (KAVR) consisting of step 5 of summing the N calculation ratios (KN) obtained through the N repetitions and storing the value divided by N as an average calculation ratio (KAVR);
Step 6, in which the microcontrol unit of the blood-less blood glucose measurement system measures the skin local resistance (R0) with a variable-reflecting skin local resistance electrode contacted to two points on the epidermis to calculate the current blood glucose and stores the measured value, means for minimizing the epidermal contact resistance Step 7 of measuring the variable anti-reflection resistance (R1) and storing the measured value with the provided variable-reflecting skin local resistance electrode Step 8 of storing the result obtained by multiplying the ratio of the square of the resistance R1 by 100 as the calculated variable-reflected resistance ratio (B) is performed, and the calculated variable-reflected resistance ratio (B) and the average obtained in step 5 A blood glucose level calculation method without blood sampling, characterized in that the blood glucose calculation step includes step 9 of obtaining a calculated blood glucose value by multiplying the calculation ratio (KAVR). In the blood glucose measurement system in which the blood glucose level calculation method according to any one of claims 1 to 2 is implemented,
A common terminal and a first terminal constituting the skin local resistance electrode for measuring the skin local resistance value (R0) between the two points of the epidermis;
A variable-reflecting skin local resistance electrode equipped with an epidermal contact resistance minimization means containing a conductive skin penetrating solvent that detects a change in electrical resistance reflecting vital signs between the common terminal and the inside of the skin dermal layer and reduces the contact resistance of the terminal. A common terminal and a second terminal constituting the
The common terminal, the first terminal, and the second terminal are respectively connected to the input/output ports of the microcontrol unit, and a solvent supply hole capable of supplying a conductive skin penetration solvent to the area where the common terminal and the second terminal is in contact with the skin is provided. Blood glucose measurement system, characterized by a bloodless blood glucose measurement system. 4. The method of claim 3,
The microcontrol unit is loaded with a program for executing the operation stipulated in steps 1 to 9, and a blood glucose calculation result by the operation of the program is output to a display of a wristwatch type wearable device. blood glucose measurement system. 4. The method of claim 3,
The common terminal and the second terminal have a cavity for accommodating the gel-like conductive skin penetration solvent therein;
A blood glucose measurement system communicating with the cavity and having a micropump capable of supplying a conductive skin penetrating solvent to a portion in contact with the skin. 6. The method of claim 5,
and the common terminal and the second terminal have a detachable structure that can be removed and installed with a new one when the conductive skin penetrating solvent contained in the cavity is consumed. 5. The method of claim 4,
The wrist watch-type wearable device is characterized in that the common terminal, the first terminal, and the second terminal are all provided with one or more tightening means for bringing them into close contact with the skin of the wrist at the same time. 5. The method of claim 4,
The microcontrol unit and the common terminal, the first terminal, the second terminal, the display, and a plurality of buttons for controlling the operation of the microcontrol unit are accommodated in one package as a wristwatch-type wearable device, characterized in that it is manufactured as a non-blood glucose measuring system. 4. The method of claim 3,
A blood glucose measurement system without blood, characterized in that by connecting a Bluetooth module to the input/output port of the microcontrol unit and the blood glucose meter, the blood glucose value obtained by the examinee's blood collection is wirelessly transmitted to the microcontrol unit. 4. The method of claim 3,
A blood glucose measurement system without blood, characterized in that the Bluetooth module is connected to the input/output port of the microcontrol unit, and blood glucose related data is shared with the examinee's terminal after pairing with the examinee's terminal. 11. The method of claim 10,
and an application for controlling operation of the microcontrol unit and sharing data is mounted on the terminal of the examinee. 4. The method of claim 3,
The common terminal, the first terminal, and the second terminal are connected to the input/output port of the microcontrol unit through an interface means, and the microcontrol unit loads the program in the memory to perform the operations specified in steps 1 to 9. However, the microcontrol unit and the common terminal, the first terminal, and the second terminal are in one package and can be worn between the shoulder and the elbow, and the blood glucose calculation result of the microcontrol unit by the program is the output port of the microcontrol unit. Blood glucose measurement system, characterized in that it is transmitted to the terminal of the examinee by a Bluetooth module connected to the 4. The method of claim 3,
and an electrode exposed portion and a dehumidifying layer are provided on peripheral surfaces of the common terminal and the first terminal.

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