CN102841117A - Portable blood glucometer subsection statistical averaging and measuring method capable of improving detection accuracy - Google Patents
Portable blood glucometer subsection statistical averaging and measuring method capable of improving detection accuracy Download PDFInfo
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Abstract
The invention relates to a 'portable blood glucometer subsection statistical averaging and measuring method capable of improving detection accuracy', belonging to the technical field of accurate measuring methods for a portable blood glucometer in medical measurement devices. Under the premise that regulations of national standards are met, on the basis of guaranteeing the current blood glucometer measurement process, an algorithm is further refined, for blood glucose values in different intervals, a large number of results are obtained by virtue of a development and test stage of the blood glucometer, a curve function reflecting corresponding blood glucose values and current magnitudes is obtained, a tapping coefficient of the curve function is adjusted, corresponding accuracy which accords with the national and international standards is obtained, and the effect that an error rate distinguished by key blood glucose values is reduced to below five per mill can be guaranteed, thus the method disclosed by the invention is completed.
Description
Technical field
The accurate measurement method of medical treatment measuring element → portable glucose meter.
Background technology
According to investigation in 2010, China had diabetic 9,200 ten thousand people at present, prediabetes patient 1.48 hundred million people, and diabetes become and have a strong impact on one of sanitarian subject matter of China.And in the monitoring field of blood sugar, China only has 1.5% diabetic that oneself blood sugar monitoring instrument is arranged, and the diabetic of American-European countries more than 90% has the portable blood sugar monitor of oneself.China's blood glucose meter produce market is mainly captured by foreign brand names such as U.S. Johnson & Johnson, German Luo Shi at present; Domestic brand is only occupied the market share less than about 10%, and all there are matching problem in varying degrees in the blood glucose meter of most of domestic brands and corresponding supporting test paper plug-in unit.
The appearance and the popularization of the portable medical electronics product of China, the rise, consumer that comes from domestic medicine nursing is to the increase of self health concerns degree, and the individual consumer is to the demand of health care with simple diagnostic products.On the one hand, the key that China's aging population aggravation, people's living standard improve and factor such as demand for medical service increase is impelled the change of traditional medical mode, portability and intelligent management to become to influence the medical electronics industrial market and necessary.On the other hand, calculate in fast processing, under the drive of high precision analogue conversion and the scientific and technological progresses such as medical electronic measuring method of constantly bringing forth new ideas, that the medical electronics product moves towards gradually is portable, miniaturization and precision.Improving easy and simple to handleization and intelligentized while such as portable small-sized blood glucose meter, more requiring to obtain accurate blood glucose value measurement result through high-precision algorithm measurement.
The accurate blood glucose measurement instrument of hospital's employing at present is the blood sugar biochemical instruments; Method is to obtain blood plasma through the back that phlebotomizes with the hydro-extractor separating blood; Blood plasma through with glucose oxidase enzyme reaction oxidizing glucose after produce hydrogen peroxide; Through measuring what of hydrogen peroxide, thereby draw blood-sugar content.The advantage of biochemical instruments mainly is to measure very accurately, and shortcoming is that Measuring Time is slow, just can obtain the result in common second day; Blood using amount is many, wants 3000~5000 microlitres usually; Complicated operation could be operated by the people of professional training only; Machine costs an arm and a leg, and has only part hospitals that outfit is just arranged.
Invent pocket portable rapid blood sugar appearance since the seventies, can with one bleed measure blood sugar since, patient's blood sugar of can according to circumstances testing oneself, and obtaining a result fast, thereby think a milestone on the treating diabetes history.The rapid blood sugar appearance is because can be by patient from advantages such as line operates; So diabetes associations not only recommends to use the blood sugar rapid blood sugar appearance of testing oneself to carry usefulness as patient's household; And the usefulness that is decided to be the inspection of inpatient's bedside, especially more suitable in emergency ward, operating room, intensive care unit etc.Present case is, stresses to promote the rapid blood sugar appearance blood sugar of testing oneself, and uses the venous plasma of biochemical instruments to measure to measure mainly as diagnosis, proofreaies and correct pocket blood glucose meter, scientific research and subsidiary mensuration when doing other biochemical analysis.At present the main measuring metering method of each big medicine equipment manufacturer such as Johnson & Johnson, Luo Shi portable glucose meter of producing is the glucose oxidase electrode mensuration.
The fundamental measurement principle of portable rapid blood sugar appearance product glucose oxidase electrode mensuration is: the magnitude of current through glucose in the measurement blood and the glucose oxidase enzyme reaction in the test paper produce is measured blood sugar.Be specially: bleeding back 5-10 in second; Glucose and the glucose oxidase in the test paper in the blood can produce reaction; In the process of reaction; Generally get the single any time point (time point that each producer obtains differs) in 5 seconds to 10 seconds; The kinetic current that actual measurement is corresponding obtains this kinetic current through the portable glucose meter current sensor, and the voltage amplifier circuit of the embedded system through portable glucose meter obtains real-time amplified voltage value; Through the analog to digital conversion of embedded scm (8051 series, ARM series or DSP series) and the measured value of function conversion acquisition blood glucose value, and on portable glucose meter, realize showing fast or voice suggestion.
The chemical method of obvious above-mentioned glucose oxidase electrode mensuration comparison biochemical instruments possesses measurement faster (generally being no more than 20 seconds), and blood using amount is the advantage of (5 microlitre) still less.Its shortcoming mainly contains two aspects; The one, because airborne oxygen content is more much higher than hydrogen richness; Test paper is influenced by air easily, will within 5 minutes, need finish using after general test paper takes out from container, and test paper makes moist and to measure inaccurate possibility very big; There is inherent error in the electron device of adding embedded electric measuring equipment, causes measuring accuracy and descends.The 2nd, blood glucose meter Measurement Algorithm and supporting test paper course of reaction existing problems; Specifically be that current interior reaction content of drug size and the quality good or not of supporting test paper exists deviation; Even also have this type problem with a collection of test paper; Cause on single Measuring Time point, there is reference error in the momentary current value that the patient blood reaction that test paper medicine and siphon suck produces with the current value of actual blood glucose response generation, cause analog to digital conversion after; There is gap in the inaccurate biochemical blood-sugar detecting instrument understable and that part hospitals is used of the measurement of blood glucose value on degree of stability and accuracy.
Patent of the present invention " a kind of portable blood glucose meter segmentation statistical average measuring method that improves accuracy of detection "; Under the prerequisite of standard GB/T 19634-2005 [test oneself and the use the blood glucose monitoring system general technical specifications] regulation that satisfies the issue of State Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (PRC); Guarantee portable " the measuring fish " 2 of our company's independent research be with 3 be serial blood glucose meter have easy to carry, ease in use; Possess and to carry out on the basis of characteristics such as data communication with computing machine and smart mobile phone; Improved corresponding Measurement Algorithm emphatically; The innovative point of this patent is mainly: 1) improve and be different from the result that one-shot measurement in the traditional measurement algorithm-glucose oxidase electrode mensuration of main flow blood glucose meter on the market obtains single blood glucose measurement; In our company independent research portable " measure fish " 2 be with 3 be serial blood glucose meter on; Through in measuring section effective time (generally being that the generation of blood and test paper plug-in unit is reacted within 5 seconds-10 seconds), divide the time interval to obtain the corresponding instant value of electric current, use elder generation to sue for peace and calculate the method for obtaining the arithmetic mean value again; Obtain more accurately more stable user real time blood glucose value, the measurement numerical value deviation of avoiding burst error to cause.2) on the basis of above-mentioned improved Measurement Algorithm; Carry out further algorithm refinement; To different interval blood glucose values,, obtain the curvilinear function of corresponding blood glucose value and kinetic current size through a large amount of measurement results that the blood glucose meter development& testing stage obtains; Adjust the tap coefficient that corresponding embedded scm is embedded in curvilinear function in the formula program; To guarantee in different blood glucose value intervals, obtain to meet accordingly the accuracy of country and international standard, guarantee that the more interval error rate of distinguishing of crucial blood sugar is reduced to below 5/1000ths.
Check that relevant up-to-date announcements is technological, document and up-to-date blood glucose meter measure scientific and technological novelty assessment report; Documents 1 enzyme electrode method blood glucose meter is to adopt the curing technology of enzyme and the method for electro-detection to develop; Measure little current conversion that reaction produces on the electrode of enzyme and obtain blood glucose value, and not mentionedly how to improve concrete Measurement Algorithm to improve blood glucose measurement precision and degree of stability.Documents 2 has been mentioned the blood glucose meter measurement data has been delivered to the thought on the mobile phone; It is specific mobile phone dedicated that but used is; And data communication is to use existing telecom operators GPRS network to obtain at a distance and manage; Exist no small communication cost, do not mention with the relevant problem of accurate measurement method.Documents 3 provides the system and method for diabetes management, can be used to analyze a large amount of measurement of blood sugar concentration relevant with the patient with identification and other physiological parameter patterns through the mode of copying data, does not have the function of real-time measurement and data analysis.Documents 4 provides a kind of system and method for new diabetes management, can be used to analyze a large amount of measurement of blood sugar concentration relevant with the patient with identification and other physiological parameter patterns.Documents 5 has been reported a kind of hardware designs of portable glucose meter controller, comprises analog to digital converter, embedded scm, LCD, storer, timer manager, voltage monitor, level translator, voltage stabilizer etc.
Be different from the technological document and the technical patent of above-mentioned contrast portable glucose meter; By patent of the present invention " a kind of portable blood glucose meter segmentation statistical average measuring method that improves accuracy of detection "; Improved corresponding idea and method and Measurement Algorithm, the quick, intelligent portable glucose meter device of exploitation has the more stable characteristics more accurately of measurement.Innovative point and improved index are mainly:
1) improves and is different from the result that one-shot measurement in the traditional measurement algorithm-glucose oxidase electrode mensuration of main flow blood glucose meter on the market obtains single blood glucose measurement; In our company independent research portable " measure fish " 2 be with 3 be serial blood glucose meter on; Through in measuring section effective time; Divide the time interval to obtain the corresponding instant value of electric current, use summation earlier to calculate the method for obtaining the arithmetic mean value, the measurement numerical value deviation of avoiding burst error to cause again.Through corresponding supporting test; Accuracy after can being improved and stability indicator are superior to ISO of ISO (International Standards Organization) and domestic industry standard index greatly; Accuracy index after concrete the improvement is: when blood sugar solubility is lower than 4.2mmol/L, the testing result error is in the scope of positive and negative 0.2mmol/L; When blood sugar solubility greater than 4.2mmol/L, the testing result error is in positive and negative 5% scope.The degree of stability index is: the STDEV standard deviation is less than 0.1, and CV (%) is less than 2%.
2) on the basis of above-mentioned Measurement Algorithm; Carry out further algorithm refinement; To different interval blood glucose values,, obtain the curvilinear function of corresponding blood glucose value and kinetic current size through a large amount of measurement results that the blood glucose meter development& testing stage obtains; Adjust the tap coefficient that corresponding single-chip microcomputer is embedded in curvilinear function in the formula program; Further improving on the basis of user real time blood glucose value accuracy, guarantee that when the blood sugar interval of key was distinguished, hyperglycaemia/euglycemia/hypoglycemic error differentiating rate was reduced to below 0.5% (5/1000ths).
Documents
[1] the development Chinese journal of scientific instrument magazine of enzyme electrode method blood glucose meter is in 2003 24 phases of Yang Chun
[2] based on the master thesis Liu Jun of research Jilin University China of the blood glucose monitoring system of mobile phone 2005
[3] in diabetes management, be used for the patent of invention CN200810125865 of system and method Life Scanning Co., Ltd of pattern-recognition
[4] be used for the patent of invention CN200810125872 of computer system Life Scanning Co., Ltd of diabetes management
[5] the patent of invention CN03116986.4 of portable glucose meter controller Shanghai Communications University.
Summary of the invention
The technical matters that 1, will solve (promptly former " goal of the invention ")
Concrete goal of the invention mainly contains following two parts:
1) in the application's patent; Improve and be different from the result that one-shot measurement in the traditional measurement algorithm-glucose oxidase electrode mensuration of main flow blood glucose meter on the market obtains single blood glucose measurement; Portable " measuring fish " 2 of our company research and development be with 3 be serial blood glucose meter on, through in measuring section effective time, divide the time interval to obtain the electric current instant value; Use summation earlier to calculate the method for obtaining the arithmetic mean value again, avoid burst error to cause measuring the numerical value deviation.Concrete grammar is through 8051 or the programmable single chip computer of ARM series; Divide the time interval to obtain the corresponding instant value of electric current; Use summation earlier to calculate the method for obtaining the arithmetic mean value again, calculate and demonstrate more accurately stable user real time blood glucose value, the measurement numerical value deviation of avoiding burst error to cause.
2) in the application's patent; On the basis of the innovation of above-mentioned measuring method, further algorithm refinement is to different interval blood glucose values; A large amount of measurement results through the acquisition of blood glucose meter development& testing stage; Obtain the curvilinear function of blood glucose value and kinetic current size, and adjust the tap coefficient that corresponding single-chip microcomputer is embedded in curvilinear function in the formula program, further improving on the basis of user real time blood glucose value accuracy; Guarantee that when the blood sugar interval of key was distinguished, hyperglycaemia/euglycemia/hypoglycemic error differentiating rate was reduced to below 0.5% (5/1000ths).
Based on the application's patent " a kind of portable blood glucose meter segmentation statistical average measuring method that improves accuracy of detection " research and development and " the measuring fish " 2 of producing be and 3 be blood glucose meter; Under the prerequisite that the standard GB/T 19634-2005 [test oneself and use the blood glucose monitoring system general technical specifications] that satisfies the issue of Chinese people State Administration of Quality Supervision, Inspection and Quarantine stipulates; The improvement of novelty concrete blood glucose measurement mode and algorithm, and can through devices such as blood glucose meter itself, desk-top computer or intelligent mobile terminal accomplish blood monitoring, show functions such as storage and analysis.Realized that portable glucose meter rises to the leap of the analysis of the accurate diabetes state of an illness from simple blood glucose measurement; Pass through human-computer interaction interface; Show the illness analysis curve; For the patient accurately understands the state of an illness, take treatment means that quantitative reference is provided targetedly, be indispensable during the diabetic lives " helper ".And used electron device is few, and cost is low, and volume is little, can make the size with common U, is easy to carry.The production and the popularization of the product of the application's patent correspondence are to be based on the growing health demand of the people thus; Be based on the new policy of medical reform; Be based on the new direction of the development in science and technology of intelligent portability, have tangible technological innovation property and product competition advantage.
2, technical scheme (method invention)
The application's patent " a kind of portable blood glucose meter segmentation statistical average measuring method that improves accuracy of detection "; Accompanying drawing 1 is always schemed for the technical design scheme of the application's patent; Square frame 1 is for having added the core single-chip microcomputer that improves this patent novelty blood glucose measurement algorithm of measuring accuracy among the figure; This patent 2 in company's independent research is in the portable intelligent blood glucose meter, and this single-chip microcomputer is C8051F330; This patent 3 is in the portable intelligent blood glucose meter, and this single-chip microcomputer is the ARM9 series monolithic.Square frame 2 is the measurement interface of this patent blood glucose meter and blood sugar test paper.Square frame 3 is the USB wired connection interface of this patent blood glucose meter and data terminal.Square frame 4 is the bluetooth or the GPRS wireless connections interface of this patent blood glucose meter and data terminal.The technical scheme that is adopted, in implementation procedure, concise and to the point three parts that are divided into are briefly described:
Part one) use segmentation statistical average measuring method and corresponding algorithm to improve measuring accuracy
According to the application's patent " a kind of portable blood glucose meter segmentation statistical average measuring method that improves accuracy of detection ", 2 of design is that the circuit outward appearance and the enclosure designs of novel blood glucose meter is accompanying drawing 2, and 3 of design is that the circuit outward appearance of novel blood glucose meter is an accompanying drawing 3.No matter be to use 51 series monolithics concise and to the point function 2 be blood glucose meter, also be to use the ARM series monolithic multiple function 3 be blood glucose meter, its core measuring method and corresponding algorithm all are " the segmentation statistical average measuring methods " that has improved measuring accuracy.
The mentality of designing of its inventive method is: through in measuring section effective time, divide the time interval to obtain the corresponding transient voltage value of kinetic current, use summation earlier to calculate the method for obtaining the arithmetic mean value again, avoid burst error to cause the deviation of measuring blood numerical value.
If the reaction valid period duration of test paper and blood is T (generally being to bleed between back 5 seconds to 10 seconds),
Precision segmentation subcycle duration according to the blood glucose meter measurement requirement does,
Then measure number of samples,
So 2 of design is and 3 be the circuit of blood glucose meter, can obtain circuit and amplify sampling voltage value,
Therefore, according to this patent algorithm, can export measuring blood and be worth pairing response voltage value and be:
2 is in the blood glucose meter, demonstration be the corresponding blood glucose value of response voltage value Y that obtains through above-mentioned algorithm computation.
In addition, in the actual measurement process, sampling voltage value that can be corresponding according to the experience blood glucose level data of measuring in the past before the summation arithmetic mean, is deleted some excessive or too small sampling voltage value, the blood sugar numerical value of avoiding the burst error influence to measure.
Part two) obtain blood glucose value and magnitude of voltage respective function, the function tap coefficient in adjustment is interval improves measuring accuracy
According to the application's patent " a kind of portable blood glucose meter segmentation statistical average measuring method that improves accuracy of detection "; On the basis of part one described measuring method and programmed algorithm; According to the numerical relation of measured voltage value and actual blood glucose value repeatedly in the different blood sugar interval; From amplifying sampling voltage value to (and having) to corresponding electrical circuits, the tap coefficient that each numerical characteristic according to the interval obtains corresponding function does at blood glucose value in acquisition.
Therefore can export the pairing response voltage value of adjusted blood glucose value according to this patent algorithm is:
3 is in the blood glucose meter, demonstration be the corresponding blood glucose value of response voltage value that obtains through above-mentioned algorithm computation.
In addition, in the actual measurement process, sampling voltage value that can be corresponding according to the experience blood glucose level data of measuring in the past before the summation arithmetic mean, is deleted some excessive or too small sampling voltage value, the blood sugar numerical value of avoiding the burst error influence to measure.
Part three) realizes the blood glucose value transmission and carry out control and management through communication interface modules through desk-top computer or smart mobile phone
In 2 of company research and development be and 3 be in the novel blood glucose meter; USB control chip PL2303 and corresponding USB interface have been increased; Circuit is seen accompanying drawing 4, can carry out hardware circuit change and embedded program design to novel blood glucose meter, links to each other with desk-top computer through the generic USB line.Accompanying drawing 5 is a communication interface Data Control software program flow chart, and this software can make control survey and the data management of desk-top computer to blood glucose meter.The usb communication interface communication baud rate of blood glucose meter and desk-top computer is 19200, and accompanying drawing 6 is this desk-top computer software master interface.The software copyright " blood glucose meter data exchange system V2.0 " that corresponding software control function has been authorized for company in detail, soft outstanding registration number 2011SR053424 sees accompanying drawing 7.
Accompanying drawing 8 is 2 to be the USB-OTG connection mode of blood glucose meter and smart mobile phone.The EXE file of accompanying drawing 9 smart mobile phone blood glucose meter softwares and cell phone software master interface.Accompanying drawing 10 is the principle of work of blood glucose meter bluetooth transceiver module.Accompanying drawing 11 is the synoptic diagram that blood glucose meter realizes blue teeth wireless data transmission and blood glucose measurement for smart mobile phone and 2.The software copyright " based on the blood glucose meter measurement data management system V1.0 of smart mobile phone " that accompanying drawing 12 has been authorized for company, soft outstanding application number 2011R11L125841.
3, beneficial effect
Based on the application's patent " a kind of portable blood glucose meter segmentation statistical average measuring method that improves accuracy of detection " research and development and " the measuring fish " 2 of producing be and 3 be blood glucose meter; Under the prerequisite that the standard GB/T 19634-2005 [test oneself and use the blood glucose monitoring system general technical specifications] that satisfies the issue of Chinese people State Administration of Quality Supervision, Inspection and Quarantine stipulates; The improvement of novelty concrete blood glucose measurement mode and algorithm, and can through devices such as blood glucose meter itself, desk-top computer or intelligent mobile terminal accomplish blood monitoring, show functions such as storage and analysis.Realized that portable glucose meter rises to the leap of the analysis of the accurate diabetes state of an illness from simple blood glucose measurement; Pass through human-computer interaction interface; Show the illness analysis curve; For the patient accurately understands the state of an illness, take treatment means that quantitative reference is provided targetedly, be indispensable during the diabetic lives " helper ".And used electron device is few, and cost is low, and volume is little, can make the size with common U, is easy to carry.The production and the popularization of the product of the application's patent correspondence are to be based on the growing health demand of the people thus; Be based on the new policy of medical reform; Be based on the new direction of the development in science and technology of intelligent portability, have tangible technological innovation property and product competition advantage.
Inventive method based on patent of the present invention; Obtain innovating 2 after the improvement and be and 3 be that the accuracy and the stability indicator of blood glucose meter is superior to ISO of ISO (International Standards Organization) and domestic industry standard index greatly, concrete beneficial effect can embody the improvement of following medical measurement index parameter:
When blood sugar solubility is lower than 4.2mmol/L, the testing result error is in the scope of positive and negative 0.2mmol/L;
When blood sugar solubility greater than 4.2mmol/L, the testing result error is in positive and negative 5% scope;
Medical measurement accuracy index is: the STDEV standard deviation is less than 0.1;
Medical measurement degree of stability degree index is: CV (%) is less than 2%.
Further improving on the basis of user real time blood glucose value accuracy, guarantee that when the blood sugar interval of key was distinguished, hyperglycaemia/euglycemia/hypoglycemic error differentiating rate was reduced to below 0.5% (5/1000ths).
Accompanying drawing and subordinate list explanation
The technical design scheme of Fig. 1 the application patent is always schemed
Fig. 22 is novel blood glucose meter circuit outward appearance and enclosure designs figure
Fig. 33 is novel blood glucose meter circuit outside drawing
Fig. 42 is and 3 be the partial circuit diagram and corresponding electronic chip and former device of blood glucose meter USB mouth
Fig. 5 communication interface Data Control program flow diagram
The software master interface of Fig. 6 desk-top computer
Fig. 7 software copyright " blood glucose meter data exchange system V2.0 "
Fig. 82 is that blood glucose meter is passed through USB mouth connection of intelligent mobile phone
The software EXE file of Fig. 9 smart mobile phone blood glucose meter and software master interface
The fundamental diagram of Figure 10 blood glucose meter bluetooth transceiver module
Figure 11 smart mobile phone and 2 is the synoptic diagram that novel blood glucose meter realizes blue teeth wireless data transmission and blood glucose measurement
Figure 12 software copyright " based on the blood glucose meter measurement data management system V1.0 of smart mobile phone "
Figure 13 smart mobile phone and 2 is the synoptic diagram that novel blood glucose meter realizes blue teeth wireless data transmission and blood glucose measurement
Figure 14 software copyright " based on the blood glucose meter measurement data management system V1.0 of smart mobile phone "
Embodiment
In the technical scheme and beneficial effect in third part invention or utility model content, specify.
Claims (2)
1. through in measuring section effective time; Divide the time interval to obtain the corresponding transient voltage value of kinetic current; Use summation earlier to calculate the method for obtaining the arithmetic mean value again, avoid burst error to cause the deviation of measuring blood numerical value, reach measuring accuracy through this invention mentality of designing.
2. on the basis of measuring method and programmed algorithm,, obtain blood glucose value and magnitude of voltage respective function, the function tap coefficient in adjustment is interval, raising measuring accuracy according to the numerical relation of measured voltage value and actual blood glucose value repeatedly in the different blood sugar interval.
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107576703A (en) * | 2017-10-12 | 2018-01-12 | 天津科技大学 | A kind of domestic glucometer based on fuzzy system |
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JPS5797431A (en) * | 1980-12-09 | 1982-06-17 | Fuji Electric Co Ltd | Calibrating method for analytical apparatus of blood sugar value |
CN1536353A (en) * | 2003-04-10 | 2004-10-13 | 力捷电脑股份有限公司 | Method for judging concentration of lood sugar |
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