CN114137218B - Blood sugar detection device capable of correcting measured value according to blood volume ratio - Google Patents
Blood sugar detection device capable of correcting measured value according to blood volume ratio Download PDFInfo
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- CN114137218B CN114137218B CN202110766238.5A CN202110766238A CN114137218B CN 114137218 B CN114137218 B CN 114137218B CN 202110766238 A CN202110766238 A CN 202110766238A CN 114137218 B CN114137218 B CN 114137218B
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- 210000004369 blood Anatomy 0.000 title claims abstract description 187
- 239000008280 blood Substances 0.000 title claims abstract description 187
- 238000001514 detection method Methods 0.000 title claims abstract description 28
- 238000012360 testing method Methods 0.000 claims abstract description 103
- 239000003153 chemical reaction reagent Substances 0.000 claims abstract description 31
- 238000013500 data storage Methods 0.000 claims abstract description 7
- 238000006243 chemical reaction Methods 0.000 claims abstract description 6
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 102
- 239000008103 glucose Substances 0.000 claims description 102
- 238000012937 correction Methods 0.000 claims description 19
- 230000005484 gravity Effects 0.000 claims description 8
- 238000005259 measurement Methods 0.000 claims description 8
- 238000006073 displacement reaction Methods 0.000 claims description 3
- 238000002474 experimental method Methods 0.000 claims 1
- 229940079593 drug Drugs 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 238000005534 hematocrit Methods 0.000 description 3
- 238000010586 diagram Methods 0.000 description 2
- 238000009792 diffusion process Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 238000009825 accumulation Methods 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 208000007502 anemia Diseases 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 235000021152 breakfast Nutrition 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 238000012417 linear regression Methods 0.000 description 1
- 238000007726 management method Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000004962 physiological condition Effects 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
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- Investigating Or Analysing Biological Materials (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
The invention discloses a blood sugar detection device capable of correcting measured values according to blood volume values. The blood sugar test device comprises: a test strip receiving unit for receiving a plurality of first test strips, respectively, each of the first test strips having a first reagent and a second reagent; a detecting unit for generating a first electric signal and a second electric signal according to the chemical reaction of each first detecting strip and the blood sample; the operation control unit obtains a blood volume value from the first electric signal and obtains a blood sugar value from the second electric signal; and a data storage unit for storing a plurality of blood volume values obtained from the plurality of first test strips; wherein the operation control unit generates a blood volume ratio reference value according to the plurality of blood volume ratio values.
Description
Technical Field
The invention relates to a blood sugar detection device capable of correcting blood sugar value errors caused by blood volume value variation.
Background
For diabetics, it is important to monitor blood glucose from time to time. The primary goal of diabetes management is to maintain normal blood glucose levels, which would be effective in preventing the occurrence of such complications if the patient were able to take care of blood glucose control on a daily basis. Currently, most of blood glucose meters commercially available at home are used for whole blood glucose test, for example, blood concentration determination is performed electrochemically or photochemically after blood of a patient is obtained by using a lancet and a test paper.
However, the accuracy of the glucose meter test can be affected by factors such as: improper manual operation, variation of different test pieces, physiological factors of the subject, and the like. Red blood cells are one of the important factors affecting blood glucose level in the physiological condition of a subject, namely, an obstacle is formed that electrons move to electrodes in the chemical reaction of glucose on a test piece, so that the diffusion of electrons released by the glucose is generally slowed down when the hematocrit ratio (abbreviated as hematocrit ratio) is higher, and the read value of blood glucose measurement is lower; conversely, a lower hematocrit ratio generally accelerates the diffusion of electrons released by glucose, resulting in a higher reading of the blood glucose measurement. Dehydration can result in a higher blood volume ratio, resulting in a reduced rate of reaction, resulting in a lower reading of blood glucose values. Conversely, a lower blood volume ratio in the case of water accumulation or anemia will result in a higher blood glucose reading. The blood volume ratio of normal people also varies from person to person, and the influence on the accuracy of blood glucose level is also important.
US20150268228 discloses a method for blood volume ratio correction and a blood glucose meter, which is to measure a blood volume ratio reference value used by an external reference instrument in a laboratory and to transmit the determined blood volume ratio reference value to a memory of the blood glucose meter via an interface using external software (see paragraph [0037 ]). Such a glucose meter needs to be measured by an external reference instrument, and external software is also used to input a reference value of the blood volume ratio to the glucose meter so as to correct the blood glucose value. The prior art not only needs a plurality of devices, but also is not easy to operate for a testee, and is difficult to popularize to a common user.
In order to ensure the accuracy of blood glucose measurement, the invention provides an easy-to-operate blood glucose detection device which can automatically correct blood glucose value errors caused by the difference of blood volume ratios of different testees so as to realize the purpose of a personalized blood glucose detection device.
Disclosure of Invention
The application provides a blood sugar detection device capable of correcting measured values according to blood volume values, which is convenient for a user to operate in a common family, and can automatically correct blood sugar value errors caused by the difference of blood volume ratios of different testees.
In order to achieve the above object, the present application provides a blood glucose measuring device capable of correcting a measured value based on a blood volume value, comprising: a strip receiving unit for receiving a plurality of first strips, each of the first strips having a first reagent and a second reagent; a detecting unit for generating a first electric signal and a second electric signal according to the chemical reaction of each detecting strip and the blood sample; the operation control unit obtains a blood volume value from the first electric signal and obtains a blood sugar value from the second electric signal; and a data storage unit for storing a plurality of blood volume values obtained from the plurality of first test strips; in the first operation mode, the operation control unit obtains the plurality of blood volume ratio values respectively to generate a blood volume ratio reference value as a basis for correcting the measured value.
In another embodiment, in a second mode of operation, the blood volume ratio reference value is used to correct a subsequent blood glucose level measured by a second test strip having a third reagent that is the same as the second reagent.
In another embodiment, the operation control unit automatically switches to the first operation mode according to the first test strip received by the test strip receiving unit, or switches to the second operation mode according to the second test strip received by the test strip receiving unit.
In another embodiment, the detecting strip receiving unit includes at least two pairs of detecting electrodes, and the operation control unit automatically switches the first operation mode or the second operation mode according to the resistance value or the current value obtained by the at least two pairs of detecting electrodes respectively.
In another embodiment, when the operation mode is set to the first operation mode, the operation control unit obtains the blood volume value of each first test strip to generate the reference blood volume value, and further obtains a correction value to correct the blood glucose value measured by the second test strip in the second operation mode.
In another embodiment, the arithmetic control unit reads and averages the plurality of blood volume values to generate the blood volume ratio reference value.
In another embodiment, the number of the plurality of test strips is between 5 and 10.
In another embodiment, the plurality of blood volume values are obtained during at least a specified period of time per day.
In another embodiment, the plurality of blood volume values are obtained in two specified time periods each day, and the two specified time periods respectively read the plurality of blood volume values, so as to correspondingly calculate two average values, and the correction value is generated according to the two average values.
In another embodiment, the blood glucose level measured by the second test strip is calculated by the following formula to obtain a corrected blood glucose level:
GL C ＝GL O +m×HCT i +n
wherein GL is C Is the corrected blood glucose value; GL (GL) O Is the blood glucose level before correction; HCT is the blood volume ratio reference value; the coefficients m and i are experimentally or empirically derived correction parameters such as: depending on glucose concentration and temperature; n is a constant, where m×HCT i +n is a correction value.
In another embodiment, the blood glucose detecting apparatus further comprises a gravity sensor and a timer, wherein when the timer accumulates a specific time and the gravity sensor has no displacement signal, the blood glucose detecting apparatus provides beeps or shakes to remind the testee of the movement.
Drawings
Fig. 1 is a schematic perspective view of an embodiment of a blood glucose testing device according to the present invention.
Fig. 2 is a schematic perspective view of a first test strip of the blood glucose test device of the present invention.
Fig. 3 is a schematic perspective view of a second test strip of the blood glucose test device of the present invention.
FIG. 4 is a block diagram of a blood glucose testing device according to an embodiment of the present invention.
Fig. 5 is a flowchart of the measurement value of the blood glucose measuring device of the present invention.
Description of main reference numerals:
10. blood sugar detection device
11. Shell body
13. Display screen
14. Test strip receiving unit
15. Data input/output port
20. First test strip
20' second test strip
21. 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 key
47. Data input/output port
48. Time-piece
49. Gravity sensor
121. 122, 123, 124 touch keys
411. First pair of detection electrodes
412. Second pair of detection electrodes
51 to 56 steps
Detailed Description
Hereinafter, various embodiments of the present invention will be described. Please refer to the accompanying drawings and to their corresponding description. In the present specification and drawings, substantially the same or identical structures will be denoted by the same reference numerals, and overlapping description thereof will be omitted.
Fig. 1 is a schematic view of an embodiment of a blood glucose testing device according to the present invention. The blood glucose detecting apparatus 10 includes a housing 11, a plurality of touch buttons (121, 122, 123 and 124), a display 13, a test strip receiving unit 14 and a data input/output port 15. The testee can use the touch buttons 121, 122, 123 and 124 to complete the input and setting of personal data (such as gender, age, weight, exercise amount, medication, emergency contact mode, etc.) and detection conditions, or can collect personal files into the blood glucose detecting device 10 via the data input/output port 15 or wireless transmission (such as Wi F i, bluetooth, etc.). The display 13 is used for displaying measurement results, user names, setting parameters or detection states (such as waiting for blood samples, analyzing blood samples, not moving time, etc.), and also can change the screen color, beep or vibration of the display 13 to warn that the measured blood glucose level is out of the normal range. For example, a green screen indicates that the measured blood glucose level is within a normal range, and a red screen alerts that the measured blood glucose level is outside the normal range.
An opening is provided in housing 11 to allow first test strip 20 to be inserted into test strip receiving unit 14 and to receive a blood sample from a subject's finger through a side opening (not shown) in first test strip 20. The blood sample will flow to both reagents on the first test strip 20 so that the blood and both reagents react chemically with the generation of electrons. The blood glucose test device 10 is internally configured to measure an electrical signal (e.g., current or voltage) generated by the electrons via the test electrode and to calculate a blood glucose or blood glucose level from the electrical signal.
Referring to fig. 2, a first reagent 21 and a second reagent 22 (disposed in a stack of the first test strip 20) are disposed within the first test strip 20. The first reagent 21 and the second reagent 22 react with the blood sample respectively to generate a first electrical signal representing the blood volume value and a second electrical signal representing the blood glucose value. In contrast, referring to FIG. 3, only the second reagent 22 (or the same third reagent as the second reagent 22) is disposed in the second test strip 20', so that only the second electrical signal representing the blood glucose level is generated. It should be noted that the second test strip 20 'is similar to the first test strip 20 in structure, except that only the second reagent 22 is disposed in the second test strip 20', and thus will not be described herein.
FIG. 4 is a block diagram of a blood glucose testing device according to an embodiment of the present invention. The blood glucose detecting apparatus 40 includes a detecting strip receiving unit 41, a detecting unit 42, an operation control unit 43, a data storage unit 44, a display screen 45, a touch button 46 and a data input/output port 47. The test strip receiving unit 41 can accommodate each of the plurality of first test strips 20 at different times, respectively. The test strip receiving unit 41 has a first pair of test electrodes 411 and a second pair of test electrodes 422 that are capable of contacting two electrode pairs (not shown) on the first test strip 20 corresponding to the first reagent 21 and the second reagent 22, respectively. The detecting unit 42 generates a first electrical signal representing the blood volume value and a second electrical signal representing the blood glucose value according to the chemical reaction between the first reagent 21 and the second reagent 22 on the first detecting strip 20 and a blood sample, respectively. In other embodiments, the blood glucose detecting apparatus 40 further comprises a timer 48 and a gravity sensor 49, when the timer 48 accumulates a specific time, for example, the blood glucose detecting apparatus 40 is placed in a pocket of the subject for 60 minutes, and the gravity sensor 49 does not sense the displacement signal, the blood glucose detecting apparatus 40 provides beeps or shakes to remind the subject to move so as to optimize the blood glucose control of the subject.
The operation control unit 43 calculates a blood volume value from the first electrical signal, and calculates a blood glucose value from the second electrical signal. The arithmetic control unit 43 can sequentially store the blood volume value measured by each of the first test 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 for correcting the blood glucose level measured by the second test strip 20'. The number of the plurality of test strips 20 is between 5 and 10, but the present invention is not limited thereto, and the number can be increased or decreased according to practical needs. In this embodiment, the plurality of blood volume values are obtained during at least a specified period of time each day, for example: before breakfast or six to seven o' clock in the morning, however, the present invention is not limited thereto and the time period may be changed according to actual needs.
The operation 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 parameters or the detection status. The personal data (such as sex, age, weight, medication, emergency contact mode, etc.) and the detection conditions (medication interference factor or environmental factor; temperature, humidity and altitude) of the subject may be input and set, or the data may be input into the blood glucose detection device 40 via the data input/output port 47 and stored in the data storage unit 44.
The blood glucose level measured by the second test strip is calculated by the following formula to obtain a corrected blood glucose level:
GL C ＝GL O +m×HCT i +n
wherein GL is C Is the corrected blood glucose value; GL (GL) O Is the blood glucose level before correction; HCT is the measured blood glucose value; the coefficients m and i are experimentally or empirically derived correction parameters such as: depending on glucose concentration and temperature; n is a constant. m×hct i And +n is a correction value for correcting the blood glucose level measured later, wherein the constant n, the coefficient m and the index i can be obtained by a statistical method such as linear regression analysis. The above equation can be referred to in US20150268228, but the present invention is not limited thereto, and can be determined according to other blood glucose calibration formulas.
In other embodiments, the operation control unit 43 can read a plurality of blood volume values and calculate an average value to be set as the reference blood volume ratio value, and generate a correction value (e.g. mXHCT) according to the reference blood volume ratio value i +n). In another embodiment, the plurality of blood volume values may be obtained separately over two specified periods of time, for example: six to eleven am and twelve to seventeen pm, and the two specified periods of time respectively read the plurality of blood volume values, thereby correspondingly calculating two average values Avg1 and Avg2, and generating the correction value according to the two average values.
The correction values resulting from the various embodiments described above may be used to correct a subsequent blood glucose level measured by the second test strip 20'. 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 to obtain a plurality of blood volume values in a plurality of consecutive days when the blood glucose test device 10 is activated, and the blood glucose test device 10 generates a blood volume ratio reference value according to the plurality of blood volume values. The blood volume ratio reference value is then used to obtain a correction value that is used to correct the subsequent blood glucose level measured by the second test strip 20'. Thus, not only the accuracy of the blood glucose value is improved, but also the cost of the detection strip is reduced.
In another embodiment, the operation control unit 43 recognizes according to the first test strip 20 or the second test strip 20' received by the test strip receiving unit 41, and switches to the first operation mode or the second operation mode accordingly. In this embodiment, the first operation mode is a set mode, and the second operation mode is a normal mode. During the set mode, a user may set a personalized blood volume ratio reference value in the blood glucose test device 10 via the plurality of first test strips 20, and may quickly complete blood glucose testing via the second test strips 20' during the normal mode. It will be appreciated by those skilled in the art that when another user operates the present blood glucose testing device 40, the normal mode must be performed through the set mode. The test strip receiving unit includes a switch (e.g., a micro switch) and at least two pairs of test electrodes, the switch senses whether the inserted test strip has been correctly positioned at the receiving position, and the operation control unit automatically switches the first operation mode or the second operation mode according to the resistance value or the current value obtained by the first pair of test electrodes 411. When the resistance value obtained by the first pair of detection electrodes 411 is not infinite or the current value is not zero, the operation control unit 43 switches to the first operation mode, and the blood volume values of the first detection strips 20 are obtained respectively to generate the reference blood volume ratio value. When the resistance value obtained by the first pair of detection electrodes 411 is infinite or the current value is zero, the operation control unit 43 corrects the blood glucose level measured by the second detection strip 20' later according to the blood volume ratio reference value when switching to the second operation mode.
Fig. 5 is a flowchart of the measurement value of the blood glucose measuring device of the present invention. As shown in step 51, a blood glucose testing device is provided. In practical use, the following steps must be performed under conditions that are first used by a subject. Next, in step 52, the subject uses the plurality of first test strips according to the time schedule to obtain a plurality of blood volume values and blood glucose values. In actual use, the plurality of first test strips may be in a package attached to a new blood glucose testing device, the number of first test strips being between 5 and 10. The blood glucose test device obtains a blood volume ratio reference value according to the plurality of blood volume ratios, as shown in step 53. It will be appreciated by those skilled in the art that the corrected blood glucose level may also be generated after step 53. Then, when the same subject is in use, the blood glucose level can be measured by the second test strip, and the blood glucose measuring device corrects the measured blood glucose level by the blood volume ratio reference value (step 53), as shown in steps 54 to 55. Finally, the blood glucose measuring device displays the corrected blood glucose level on the display, as shown in step 56. It should be noted that if the subject is a different subject, the steps 51 to 53 must be repeated again to automatically set the personalized blood volume ratio reference value.
While the technical content and features of the present invention have been disclosed above, those skilled in the art may make various substitutions and modifications based on the teachings and disclosure of the present invention without departing from the spirit of the present invention. Therefore, the scope of the invention should not be limited to the embodiments disclosed, but should include various alternatives and modifications without departing from the invention, and be covered by the claims.
Claims (6)
1. A blood glucose testing device capable of correcting a measured value based on a blood volume ratio, comprising:
a test strip receiving unit for receiving a plurality of first test strips, wherein the test strip receiving unit comprises a first pair of test electrodes and a second pair of test electrodes respectively contacting a first reagent and a second reagent in each first test strip;
a detection unit for generating a first electric signal and a second electric signal according to the first reagent and the second reagent and the chemical reaction with the blood sample, and the resistance value or the current value obtained by the first pair of detection electrodes and the second pair of detection electrodes respectively;
the operation control unit obtains a blood volume value from the first electric signal and obtains a blood sugar value from the second electric signal; and
a data storage unit for storing a plurality of blood volume values obtained from the plurality of first test strips;
the operation control unit automatically switches to a first operation mode according to a resistance value or a current value obtained by the first pair of detection electrodes of the detection strip receiving unit contacting the first reagent, or automatically switches to a second operation mode;
in the first operation mode, the operation control unit obtains and averages the blood volume ratio value of each first detection strip to generate a blood volume ratio reference value as the basis of the correction measurement value;
in the second operation mode, a correction value is generated according to the reference blood volume ratio to correct the blood glucose level measured by the second test strip, and the second test strip only has the second reagent.
2. The blood glucose testing device of claim 1, wherein the computing control unit obtains the blood volume values of the first test strips to generate the blood volume ratio reference value when the blood glucose testing device is set in the first operation mode, and further obtains a correction value to correct the blood glucose value measured by the second test strips when the blood glucose testing device is set in the second operation mode.
3. The blood glucose testing device of claim 1, wherein the first plurality of test strips is between 5 and 10 in number.
4. The blood glucose testing device of claim 1, wherein the plurality of blood volume values are obtained during at least a predetermined time period per day.
5. The blood glucose testing device of claim 2, wherein the blood glucose level measured by the second test strip is a corrected blood glucose level calculated by the following equation:
GL C ＝GL O +m×HCT i +n
wherein GL is C Is the corrected blood glucose value; GL (GL) O Is a blood glucose level before correction; HCT is a blood volume ratio reference value; the coefficient m and the index i are correction parameters obtained according to experiments or experience; n is a constant; wherein m×HCT i And +n is the correction value.
6. The device of claim 1, further comprising a gravity sensor and a timer, wherein the gravity sensor is configured to provide beeps or vibrations to alert the subject to the movement when the timer accumulates for a predetermined time and the gravity sensor has no displacement signal.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TW109130330A TWI755050B (en) | 2020-09-04 | 2020-09-04 | Blood glucose detecting apparatus capable of correcting measured values according to hematocrit values |
| TW109130330 | 2020-09-04 |
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| CN114137218A CN114137218A (en) | 2022-03-04 |
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| CN112557663A (en) * | 2019-09-25 | 2021-03-26 | 百略医学科技股份有限公司 | Test strip and method for manufacturing test strip |
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| TW202210827A (en) | 2022-03-16 |
| TWI755050B (en) | 2022-02-11 |
| CN114137218A (en) | 2022-03-04 |
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