TWI755050B - Blood glucose detecting apparatus capable of correcting measured values according to hematocrit values - Google Patents

Abstract

The invention discloses a blood glucose detecting apparatus capable of correcting measured values according to hematocrit values. The apparatus comprises a test strip accepting unit, a detecting unit, an operating and controlling unit, and a data storage unit. The test strip accepting unit is capable of respectively accepting each of a plurality of first test strips, and each of the first test strip has a first reagent and s second reagent. The detecting unit generates a first electrical signal and a second electrical signal based on the chemical reactions between each of the first test strips and a blood sample. The operating and controlling unit derives a hematocrit value from the first electrical signal and derives a blood glucose value from the second electrical signal. The data storage unit stores hematocrit values measured from the first test strips. The operating and controlling unit generates a hematocrit reference value based on the hematocrit values.

Description

Blood sugar detection device capable of correcting measured value according to blood volume ratio

The present invention relates to a blood sugar detection device capable of correcting the blood sugar value error caused by the variation of blood volume value.

For people with diabetes, regular monitoring of blood sugar is very important. The primary goal of managing diabetes is to maintain normal blood sugar levels. If patients can pay close attention to blood sugar control on weekdays, the above-mentioned complications can be effectively prevented. At present, most of the blood glucose meters for home use in the market are whole blood blood glucose tests. For example, after using blood collection needles and test strips to obtain the patient's blood, the blood glucose concentration is determined by electrochemical or photochemical methods.

However, the accuracy of blood glucose meter detection will be affected by many factors, such as improper human operation, variation of different test pieces, and physiological factors of the subjects. Red blood cells are one of the important factors affecting the blood sugar level in the physiological condition of the subject, that is, it will form an obstacle to the movement of electrons to the electrodes in the chemical reaction of glucose on the test piece. Therefore, a high hematocrit (hematocrit for short) usually causes The diffusion of electrons that slow down the release of glucose results in low readings in blood glucose measurements; conversely, a low hematocrit usually accelerates the diffusion of electrons released from glucose causing high readings in blood glucose measurements. Dehydration can lead to a high blood volume ratio, which reduces the reaction rate and causes low blood glucose readings. Conversely, hematocrit in the presence of hydrops or anemia If it is too low, it will cause the blood sugar reading to be too high. The blood volume ratio of a normal person will also vary from person to person, and the impact on the accuracy of the blood sugar level is also very important.

U.S. Patent No. US20150268228 discloses a method and a blood glucose meter for blood volume ratio correction. The reference value of the blood volume ratio used is measured by an external reference instrument in the laboratory, and external software is used to convert the determined blood volume through an interface. The ratio reference value is transferred to the memory of the blood glucose meter (see paragraph [0037] of the description). This kind of blood glucose meter needs to be measured by an external reference instrument, and an external software must be used to input the blood volume ratio reference value to the blood glucose meter for the correction of the blood glucose value. The prior art not only requires a variety of devices, but also is difficult for the subject to operate, and it is difficult to spread to general users.

In order to ensure the correctness of blood glucose measurement, the present invention provides an easy-to-operate blood glucose detection device, which can automatically correct blood glucose value errors caused by differences in blood volume ratios of different subjects to realize the purpose of personalizing the blood glucose detection device.

The present application provides a blood sugar detection device capable of correcting the measured value according to the blood volume ratio, which is convenient for users in ordinary households to operate, and can automatically correct the blood sugar value error caused by the difference of the blood volume ratio of different subjects.

Therefore, the present application provides a blood glucose detection device capable of correcting the measured value according to the blood volume ratio, comprising: a detection strip receiving unit, which respectively accepts a plurality of first detection strips, each of the first detection strips has a first detection strip. a reagent and a second reagent; a detection unit for generating a first electrical signal and a second electrical signal according to the respective chemical reactions between the test strips and the blood sample; an arithmetic control unit for obtaining from the first electrical signal a blood volume ratio, and a blood glucose value obtained from the second electrical signal; and a data storage unit, storing a plurality of blood volume ratios obtained from the plurality of first detection strips; wherein, in a first operation mode , the arithmetic control unit obtains each of the plurality of blood volume ratio values to generate a blood volume ratio reference value as the basis for calibrating the measured value.

In another embodiment, in a second operation mode, the blood volume ratio reference value is used to correct the blood sugar value subsequently measured by a second test strip, the second test strip has a and the second reagent. The same third reagent.

In another embodiment, the operation control unit automatically switches to the first operation mode according to the first detection strip accepted by the detection strip accepting unit, or switches to the second operation mode after accepting the second detection strip .

In another embodiment, the detection strip receiving unit includes at least two pairs of detection electrodes, and the arithmetic control unit automatically switches the first operation mode or the second mode of operation.

In another embodiment, when the first operation mode is set, the arithmetic control unit obtains the blood volume ratio value of each of the first detection strips respectively to generate the blood volume ratio reference value, and then obtains a calibration value to The blood glucose value subsequently measured by the second test strip is corrected in the second operating mode.

In another embodiment, the arithmetic control unit reads and averages the plurality of blood volume ratio values to generate the blood volume ratio reference value.

In another embodiment, the number of the plurality of detection bars is between 5 and 10.

In another embodiment, the plurality of hematocrit values are obtained during at least a specified period of time each day.

In another embodiment, the plurality of blood volume ratios are obtained in two designated time periods each day, and the two designated time periods are respectively read the plurality of blood volume ratios, thereby correspondingly calculating two average values, And the correction value is generated according to the two average values.

In another embodiment, the blood glucose value measured by the second test strip is calculated by the following formula to obtain a corrected blood glucose value: GL _C =GL _O +m×HCT ⁱ +n

Among them, GL _C is the blood glucose value after the correction; GL _O is the blood glucose value before the correction; HCT is the reference value of the blood volume ratio; the coefficient m and the index i are the correction parameters obtained by experiments or experience, such as: the glucose concentration and temperature; n is a constant, where m×HCT ⁱ +n is a correction value.

In another embodiment, the blood glucose detection device further includes a gravity sensor and a timer. When the timer accumulates a specific time and the gravity sensor has no displacement signal, the blood glucose detection device will provide a beep or a beep. Vibrate to remind subjects that they need to exercise.

10: Blood sugar detection device

11: Shell

13: Display screen

14: Test strip receiving unit

15: Data input and output ports

20: First test strip

20': Second test strip

21: The first reagent

22: Second reagent

40: Blood sugar detection device

41: Test strip receiving unit

42: Detection unit

43: Operation control unit

44: Data storage unit

45: Display screen

46: Touch keys

47: Data input and output port

48: Timer

49: Gravity Sensor

121, 122, 123, 124: touch buttons

411: The first pair of detection electrodes

412: The second pair of detection electrodes

51~56: Steps

FIG. 1 is a three-dimensional schematic diagram illustrating a blood glucose detection device according to an embodiment of the present application.

FIG. 2 is a three-dimensional schematic diagram illustrating a first detection strip used in an embodiment of the present application.

FIG. 3 is a three-dimensional schematic diagram illustrating a second detection strip used in an embodiment of the present application.

FIG. 4 is a circuit block diagram of a blood glucose detection device according to an embodiment of the present application.

FIG. 5 is a flowchart illustrating a flow chart for calibrating the measurement value of the blood glucose detection device according to an embodiment of the present application.

Hereinafter, various embodiments for carrying out the present invention will be described. Please refer to the accompanying drawings and refer to their corresponding descriptions. In addition, in this specification and drawings, substantially the same or the same structure is given the same code|symbol, and the repeated description is abbreviate|omitted.

FIG. 1 is a schematic diagram illustrating a blood glucose detection device according to an embodiment of the present application. The blood sugar detection device 10 includes a casing 11 , a plurality of touch buttons ( 121 , 122 , 123 and 124 ), a display screen 13 , a detection strip receiving unit 14 and a data input and output port 15 . The subject can use the touch buttons 121, 122, 123 and 124 complete the input and setting of personal data (such as gender, age, weight, exercise, medication, emergency contact information, etc.) and detection conditions, or through data input and output port 15 or wireless transmission (such as WiFi, Bluetooth, etc.) etc.) import the personal file into the blood glucose detection device 10 . The display screen 13 is used to display measurement results, user name, setting parameters or detection status (for example: waiting for blood samples, analyzing blood samples, inactivity time, etc.), and can also change the screen color, beep sound or Vibrate to warn that the measured blood sugar level is out of the normal range. For example, a green screen indicates that the measured blood glucose value is within the normal range, and a red screen indicates that the measured blood glucose value is out of the normal range.

There is an opening on the top of the housing 11, through which the first test strip 20 can be inserted into the test strip receiving unit 14, and the blood sample sampled from the subject's finger is received through the opening (not shown) on the side of the first test strip 20 . The blood sample will flow to the two reagents on the first test strip 20, so that the blood and the two reagents react chemically to generate electrons. The internal circuit of the blood sugar detection device 10 measures the electrical signal (eg, current or voltage) formed by the electrons through the test electrode, and calculates the blood sugar level or the hemolysis ratio according to the electrical signal.

Referring to FIG. 2 , a first reagent 21 and a second reagent 22 are disposed in the first test strip 20 (which are disposed in the stack of the first test strip 20 ). The first reagent 21 and the second reagent 22 will chemically react with the blood sample respectively, and each generates a first electrical signal representing the blood volume ratio and a second electrical signal representing the blood glucose level. Relatively referring to FIG. 3 , only the second reagent 22 (or the third reagent identical to the second reagent 22 ) is set in the second test strip 20 ′, so only the second electrical signal representing the blood glucose level is generated. It should be noted here that the structure of the second test strip 20' is similar to that of the first test strip 20, and the only difference is that only the second reagent 22 is provided in the second test strip 20', so it is not repeated here.

FIG. 4 is a block diagram illustrating a blood glucose detection device according to an embodiment of the present application. The blood sugar detection device 40 includes a detection strip receiving unit 41 , a detection unit 42 , an arithmetic control unit 43 , a data storage unit 44 , a display screen 45 , a touch key 46 and a data input and output port 47 . The test strip receiving unit 41 can respectively accommodate each of the plurality of first test strips 20 at different times. The detection strip receiving unit 41 has a first pair of detection electrodes 411 and a second pair of detection electrodes 422 that can respectively contact the first detection strip 20 and the first reagent 21 and The second reagent 22 corresponds to two electrode pairs (not shown). The detection unit 42 generates a chemical reaction with a blood sample respectively according to the first reagent 21 and the second reagent 22 on the first detection strip 20, and correspondingly generates a first electrical signal representing the blood volume ratio and a second electrical signal representing the blood glucose value. No. In other embodiments, the blood glucose detection device 40 further includes a timer 48 and a gravity sensor 49. When the timer 48 accumulates a specific time, for example, the blood glucose detection device 40 is placed in the subject's pocket for 60 minutes, and the gravity sensor If the detector 49 does not sense a displacement signal, the blood glucose detection device 40 will provide beeps or vibrations to remind the subject to exercise, so as to optimize the blood glucose control of the subject.

The calculation control unit 43 obtains a blood volume ratio by calculating the first electrical signal, and obtains a blood glucose value by calculating the second electrical signal. The arithmetic control unit 43 can sequentially store the blood volume ratio values measured by each of the first detection strips 20 in the data storage unit 44, or store a plurality of blood glucose values together. The arithmetic control unit 44 can generate a blood volume ratio reference value according to the plurality of blood volume ratio values, and the blood volume ratio reference value is used to correct the blood sugar value measured by the second detection strip 20' subsequently. The number of the plurality of detection strips 20 is between 5 and 10, however, this case is not limited to this, and the number can be increased or decreased according to actual needs. In this embodiment, the plurality of blood volume ratios are obtained during at least a specified period of time every day, for example: before breakfast or from 6:00 to 7:00 in the morning, but this case is not limited to this, and can be based on actual needs. Change the time period.

The arithmetic control unit 43 can detect and receive the input signal from the touch key 46, and control the display screen 45 to display the measurement result, the user name, the setting parameter or the detection state. The input and setting of the subject's personal data (eg: gender, age, weight, medication, emergency contact information, etc.) and detection conditions (drug interference factors or environmental factors; temperature, humidity and altitude), or through data input and output The port 47 imports the aforementioned data into the blood glucose detection device 40 and stores it in the data storage unit 44 .

Using the above blood volume ratio reference value, the blood glucose value measured by the second test strip is calculated by the following formula to obtain a corrected blood glucose value: GL _C =GL _O +m×HCT ⁱ +n where GL _C is The corrected blood glucose value; GL _O is the blood glucose value before correction; HCT is the measured blood glucose value; the coefficient m and the index i are the correction parameters obtained by experiment or experience, such as: determined by glucose concentration and temperature ; n is a constant. m×HCT ⁱ +n is the correction value for calibrating the blood glucose value measured subsequently, in which the constant n, the coefficient m and the index i can be obtained by statistical methods such as linear regression analysis. For the aforementioned equation, reference may be made to US20150268228. However, this case is not limited to this, and can be determined according to other blood glucose value correction formulas.

In other embodiments, the arithmetic control unit 43 may read a plurality of blood volume ratio values and calculate an average value to set as the blood volume ratio reference value, and generate a correction value (eg, m) according to the blood volume ratio reference value. ×HCT ⁱ +n). In another embodiment, the plurality of hematocrit ratios can be obtained respectively in two designated time periods, for example: six o'clock in the morning to eleven o'clock and twelve o'clock in the afternoon to seventeen o'clock, and the The plurality of hematocrit values are respectively read in two designated time periods, thereby correspondingly calculating two average values Avg1 and Avg2, and generating the correction value according to the two average values.

The correction value obtained by the above-mentioned various embodiments can be used to correct the blood glucose value measured by the second test strip 20' subsequently. Since only the second reagent 22 (or the same third reagent as the second reagent 22) is provided on the second test strip 20', the test cost of the second test strip 20' is lower than that of the first test strip 20. The user can use 5 to 10 test strips 20 for several consecutive days to obtain a plurality of blood volume ratios when the blood sugar detection device 10 is activated, and the blood sugar detection device 10 generates a blood volume ratio reference value according to the plurality of blood volume ratios. The blood volume ratio reference value is then used to obtain a correction value, which is used to correct the blood sugar value measured by the second test strip 20'. In this way, not only the accuracy of the blood glucose value is improved, but also the cost of the test strip is reduced.

In another embodiment, the operation control unit 43 identifies the first detection strip 20 or the second detection strip 20 ′ received by the detection strip acceptance unit 41 , and switches to a first operation mode or a second operation mode accordingly. operating mode. In this embodiment, the first operation mode is the setting mode, and the second operation mode is the general mode. During the setting mode, the user can set a personalized blood volume ratio reference value in the blood glucose monitoring device 10 through a plurality of first detection strips 20, and can use the second detection strip 20' during the normal mode Complete blood sugar testing quickly. Those skilled in the art should know that when another user operates the blood glucose detection device 40, it must go through the setting mode before the normal mode can be performed. The detection strip receiving unit includes a switch (for example: a micro switch) and at least two pairs of detection electrodes, the switch will sense whether the inserted detection strip has been correctly positioned at the tested position, and the arithmetic control unit will be based on the first The first operation mode or the second operation mode is automatically switched according to the resistance value or the current value obtained by the detection electrode 411 . When the resistance value obtained by the first pair of detection electrodes 411 is not infinite or the current value is not zero, when switching to the first operation mode, the arithmetic control unit 43 obtains the blood volume ratio of each of the first detection strips 20 to This in turn produces a hematocrit reference value. When the resistance value obtained by the first pair of detection electrodes 411 is infinite or the current value is zero, when switching to the second operation mode, the operation control unit 43 corrects the subsequent second detection strip 20 according to the blood volume ratio reference value. 'Measured blood sugar level.

FIG. 5 is a flowchart illustrating a flow chart for calibrating the measurement value of the blood glucose detection device according to an embodiment of the present application. As shown in step 51, a blood glucose detection device is provided. In actual use, the following steps must be performed when it is used by a subject for the first time. Next, in step 52, the subject uses a plurality of first detection strips according to a time plan to obtain a plurality of blood volume ratios and blood glucose values. In practical use, the plurality of first detection strips may be attached to the packaging of the new blood glucose detection device, and the number of the first detection strips is between 5 and 10. The blood sugar detection device obtains the blood volume ratio reference value according to the plurality of blood volume ratio values, as shown in step 53 . Those skilled in the art should know that the corrected blood glucose value can also be generated after step 53 . Afterwards, when the same subject is using, the blood sugar level can be measured by the second test strip, and the blood sugar testing device will use the aforementioned blood volume ratio reference value (such as step 53) to correct the measured blood sugar level, such as shown in steps 54~55. Finally, the blood glucose detection device displays the corrected blood glucose value on the display, as shown in step 56 . It should be noted here that if there are different subjects, steps 51 to 53 must be repeated again to automatically set the personalized blood volume ratio reference value.

The technical content and technical features of the present invention have been disclosed as above, but those skilled in the art may still make various replacements and modifications based on the teachings and disclosures of the present invention without departing from the spirit of the present invention. decoration. Therefore, the protection scope of the present invention should not be limited to those disclosed in the embodiments, but should include various replacements and modifications without departing from the present invention, and be covered by the following patent application scope.

20: First test strip

21: The first reagent

22: Second reagent

40: Blood sugar detection device

41: Test strip receiving unit

42: Detection unit

43: Operation control unit

44: Data storage unit

45: Display screen

46: Touch keys

47: Data input and output port

411, 412: detection electrodes

Claims (6)

A blood glucose detection device capable of correcting measured values according to blood volume ratio, comprising: a detection strip receiving unit, which respectively accepts a plurality of first detection strips, each of the first detection strips has a first reagent and a second reagent; a detection unit for generating a first electrical signal and a second electrical signal according to the chemical reaction between each of the first detection strips and the blood sample; an arithmetic control unit for obtaining a blood volume ratio from the first electrical signal, and from The second electrical signal obtains a blood glucose level; and a data storage unit stores a plurality of blood volume ratio values obtained from the plurality of first detection strips; wherein, in a first operation mode, the arithmetic control unit obtains respectively The blood volume ratio value of each of the first detection strips is used to generate a blood volume ratio reference value as the basis for calibrating the measurement value; wherein, in a second operation mode, the blood volume ratio reference value is used for calibrating a second For the blood glucose value measured by the test strip, the second test strip only has a third reagent that is the same as the second reagent; wherein, the arithmetic control unit will automatically determine the first test strip according to the first test strip accepted by the test strip accepting unit. Switch to the first operation mode, or automatically switch to the second operation mode by accepting the second detection strip; wherein, the detection strip acceptance unit includes a first pair of detection electrodes, and the arithmetic control unit The resistance value or the current value obtained by a pair of detection electrodes automatically switches the first operation mode or the second operation mode; and Wherein, when the first operation mode is set, the arithmetic control unit obtains the blood volume ratio value of each of the first detection strips respectively to generate the blood volume ratio reference value, and then obtains a correction value so as to be able to operate in the second operation mode. In the mode, the blood glucose value measured by the second test strip is corrected subsequently. The blood sugar detection device of claim 1, wherein the arithmetic control unit reads and averages the plurality of blood volume ratio values to generate the blood volume ratio reference value. The blood glucose detection device of claim 1, wherein the number of the plurality of first detection strips is between 5 and 10. The blood glucose detection device as claimed in claim 1, wherein the plurality of blood volume ratios are obtained within at least a specified period of time every day. The blood glucose detection device according to claim 1, wherein the blood glucose value measured by the second test strip is calculated by the following formula to obtain a corrected blood glucose value: GL _C =GL _O +m×HCT ⁱ +n Wherein GL _C is the blood glucose value after the correction; GL _O is the blood glucose value before the correction; HCT is the reference value of the blood volume ratio; the coefficient m and the index i are the correction parameters obtained according to experiments or experience; n is a constant; Where m×HCT ⁱ +n is the correction value. The blood glucose detection device according to claim 1 further comprises a gravity sensor and a timer. When the timer accumulates a specific time and the gravity sensor has no displacement signal, the blood glucose detection device will provide a beep or a timer. Vibrate to remind subjects that they need to exercise.

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