Release date: 2009-03-12
——Li Yanbin, Director of Equipment Department, Jinan Fifth People’s Hospital
Editor's note:
At present, the number of diabetic patients in China is as high as 40 million, ranking first in the world. Dynamic monitoring of blood glucose is of great significance for the diagnosis and treatment of diabetes. In recent years, blood glucose testing technology has developed rapidly. There are many kinds of blood glucose detectors on the market, and the performance and price are very different, which brings certain difficulties to the purchase. The author comprehensively introduces the development of blood glucose detection technology, and emphasizes that the invasive, non-invasive and continuous detection technologies of blood glucose detection have their own advantages and disadvantages, and the invasive technology is mature. The non-invasive and continuous detection technology is simple and fast, but it must be corrected regularly. When purchasing blood glucose testing equipment, be sure to consult with medical institutions and instrument experts to purchase qualified blood glucose tester products that have been approved by the relevant authorities.
Since its invention by foreign researcher Tom Clemens in 1968, the blood glucose detector has undergone an invasive, non-invasive, continuous dynamic detection phase and is developing towards the integration of detection and treatment. With the continuous improvement of the performance of the blood glucose detector, its accuracy is greatly improved, and the continuous dynamic blood glucose detector can better guide the clinical medication, which will greatly improve the therapeutic effect of diabetes.
Invasive / minimally invasive blood glucose detector:
Mature technology, numerous brands
At present, common invasive/minimally invasive blood glucose detectors collect peripheral blood to measure blood glucose, which is mainly based on electrochemical sensor technology. This design began in 1962 with the basic principle of relying on a thin layer of glucose oxidase (GOx) attached to the oxygen electrode to detect the oxygen consumption in the enzyme-catalyzed reaction to calculate the blood glucose level. Later, the technology evolved to use one or more enzymes to convert electroactive materials into electrically active products, using two electrodes to eliminate interference, and using an ammeter to detect the amount of hydrogen peroxide released to obtain blood glucose values. Technology.
In the 1980s, a large amount of research focused on the development of catalyst-based second-generation glucose sensors and the use of replaceable electrodes to improve sensor performance; in the 1990s, the center of research and development focused on the establishment of glucose oxidase reaction centers, electrode surfaces The electrical connection and development of minimally invasive portable devices. The earliest marketed blood glucose-based sensor was introduced by YSI in 1975. The detector immobilizes glucose oxidase on a cellulose acetate film via covalent bonding, and has a platinum electrode capable of detecting hydrogen peroxide. It can be used to quickly detect glucose concentrations in a sample. However, the instrument is bulky and cannot be carried around. In 1988, MedSense introduced a home electrochemical blood glucose analyzer. The instrument prints the carbon paste on the polyvinyl chloride plate by screen printing to form a flat electrode, and then mixes the enzyme solution with other components and directly fixes it on the surface of the electrode to form an enzyme electrode. The detector is small in size and can be detected with only a small drop of blood from the tip of the fingertip. The detection time is within one minute and the operation is very convenient. It is worth noting that since then, foreign countries have developed a blood test instrument for collecting blood from multiple sites (upper arm, forearm, thigh, calf, palm, etc.). Among them, the FreeStyle blood glucose detector developed by TheraSense's patented Coulomb method has made a qualitative leap in quality. Using this instrument to collect blood, the patient has almost no pain, and the blood collection is extremely low (0.3 microliters). The instrument has more than 100 patented technologies.
At present, most home blood glucose detectors are also known as electrochemical enzyme sensor micro blood fast blood glucose testers, and most home blood glucose meters are invasive, from the blood collection methods are two: blood drop and bloodsucking. The blood-dropping blood glucose meter generally has a large amount of blood collection, and is mostly photoelectric type; the blood-sucking blood glucose meter is convenient to operate, and the blood drops can be used with the test paper, and all of them are electrode type. At present, there are many products and brands of home blood glucose detectors, including Johnson & Johnson, Roche, Kyoto, Abbott, Yicheng, Sannuo, Huihao, Reiter, Dr. Tang, Berenger, Bayer, Pulse, Shijiale, Taixin. , An Mi, Jin Yu, Wu Ding, Fuxin, Aikang, Houmei De, Kang Pei, Ted, Prestige and BD. The test film market is mainly occupied by large manufacturers such as Abbott, Roche and Bayer.
It should be noted that when purchasing a blood glucose tester, you should not be overly superstitious about imported products. Domestic research shows that the domestic and imported blood glucose testers based on the oxidase method detect 47 specimens from the same source, and the test results have no significant difference. The hospital can be purchased according to actual needs. Invasive/minimally invasive blood glucose meters detect blood sugar that is affected by many factors and is only suitable for routine testing, but not as a tool for accurate diagnosis of diabetes. In order to ensure the accuracy of the results, timely calibration and routine quality control should be carried out.
Non-invasive blood glucose detector:
High R&D heat, few mature products
The non-invasive blood glucose detecting method measures the blood sugar concentration without damaging the human skin, and has the advantages of convenience and continuous measurement. However, such percutaneous detectors are affected by many factors, and their data reproducibility, sensitivity, selectivity, and adaptability to individuals are not as good as minimally invasive instruments.
Non-invasive blood glucose testing is divided into in vitro collection of tissue fluid detection and direct detection in body tissues. Body tissue testing is the mainstream of non-invasive testing. The detection site includes a fingertip, a fingertip, a forehead, an arm, an earlobe, an eyeball, and the like. The test medium includes blood, tissue fluid, aqueous humor, sweat, and the like. Although the technique for analyzing human body fluids (such as saliva, urine, sweat, and tears) is mature, however, the glucose content in the body fluid lacks a strict correspondence with the blood glucose content, so that the test results sometimes fail to accurately reflect the pathological changes.
From the principle of detection, non-invasive blood glucose detection is mainly divided into two categories: spectral analysis, non-spectral analysis. Among them, the spectral analysis includes: infrared method, that is, spectral analysis by near-infrared, mid-infrared or far-infrared to obtain blood sugar values. However, because infrared measurement of blood glucose needs to be corrected frequently, and various body factors (such as moisture, fat, skin, muscle, bone, drugs, hemoglobin concentration, body temperature and nutritional status) affect the absorption of light waves, therefore, different components of the human body are treated. The error interference caused by it becomes the main factor limiting the accuracy of this blood glucose detector; the polarization type, which uses the optical rotation characteristics of glucose for blood glucose detection, the instrument based on this principle generally reverses the blood glucose by measuring the glucose concentration of the aqueous humor of the eye. Concentration, but because the position of the polarized instrument is sensitive to the eyeball, and there is a time lag between the blood glucose concentration and the glucose concentration of the aqueous humor in the eye, there is no mature product available yet; RF impedance type, the principle of this type of instrument When electromagnetic waves with longer wavelengths than infrared rays radiate to the human body, non-ionic soluble substances such as blood sugar absorb certain electromagnetic waves. Therefore, by extracting the absorption characteristic value, theoretically, blood sugar levels can be obtained, but there are other fluids in the body fluid. Non-ionic soluble substances can also absorb electromagnetic waves, so how Non-spectral analysis techniques include: subcutaneous interstitial fluid assay, the biggest problem with this method is the delay; saliva detection method, which can avoid bacterial infection caused by poor disinfection.
At present, the research and development of non-invasive blood glucose detectors is progressing rapidly, but most instruments have not yet been approved for marketing. Non-invasive blood glucose detectors that are on the market or under research include bedside detectors, portable personal detectors, and diabetes treatment detectors. The main new developments are:
1. Biosensor Technology's Diasensor 1000: Using near-infrared light to reflect the skin, calculate the blood glucose level from the change in reflected light intensity. The US FDA has not yet approved, but Europe has approved the listing.
2. Cygnus GlucoWatch Biographer: The blood glucose level is calculated by analyzing the exuded body fluid using reverse ion electrophoresis. The instrument can read one data every 10 minutes and can record 13 hours, or 78 blood glucose levels. The FDA has approved prescriptions for adult and child sales, and Europe has approved listings.
3.Medtronic's Continuous Glucose Monitoring System: It records one data every 5 minutes and can store data within 3 days, ie 864 data. However, data can only be uploaded to a doctor's computer for review by a doctor or patient. The device must be calibrated with a conventional invasive blood glucose meter and calibrated 3 to 5 times a day.
4. Samsung Fine Chemicals' Glucontrol GC 300: a near-infrared portable detector with battery power. When testing, the patient simply places his finger on the infrared sensor for a few minutes to get the result.
5. CME Telemetrix's GlucoNIR: is a near-infrared portable detector, liquid crystal display, battery-powered, with a communication port, can download test data to the host.
6. NIMOS's noninvasive monitoring system: a subcutaneous interstitial blood glucose meter, the test sample is drawn from the skin through a micro suction cup. The suction cup is equipped with a blood glucose sensor and has a cable connected to the main unit.
7. Inverness Medical Technology's L collection is not used for the usual fingering, but by arm collection. After placing the device on the arm, it takes 4 to 5 minutes to collect enough body fluid (1 μL). According to the manufacturer, the measurement error is no more than 10% compared with the conventional invasive method.
8. L light, then analyze and calculate the reflected signals of different wavelengths to obtain the blood sugar level. The designer believes that the tympanic membrane microcirculation system has more blood glucose characteristics, so the signal collected from the tympanic membrane can more accurately reflect the blood sugar level. Currently, the device is in clinical trials.
9.Megnetic Diagnotics' Multi-analyte Meter: The designer tried to analyze the molecules in the body fluid collected by fingers, arms or other parts using a device similar to the principle of magnetic resonance imaging, but using RF and magnetic fields to analyze the molecules. It is also currently in the laboratory research phase.
10. OptiScan Biomedical's Temperature Blood Glucose Detection Device: The researchers envisioned the use of sugar molecules to test blood sugar when the temperature changes. They are placed on the skin for detection using a small rapid cooling device. The current research is also in the experimental stage.
11. Pinin Products' Noninvasive Glucose Meter: This is a special membrane electrode that is non-invasive. When using it, stick it on your finger and insert the electrode plug into the tester. After 5 seconds, you can get the blood sugar level. According to the company, there are two prototypes, one is portable and can be self-tested by patients; the other is a desktop, which can be used by hospitals.
Dynamic blood glucose monitor:
High application value, technology to be improved
The dynamic blood glucose testing system is a device operated by medical personnel to monitor the patient's blood glucose changes for 3 days, so that the doctor can fully understand the type and trend of blood sugar fluctuations. A typical dynamic blood glucose detection system includes a probe, an information logger, an information extractor, and a software system. However, at present, this blood glucose detector is still immature in technology and still needs to be corrected by using a blood glucose meter. The main research and development progress of the dynamic blood glucose monitor is:
1. Watch-type blood glucose monitor developed by Cygnus, USA: Cygnus' new blood glucose watch (trade name GlucoWatch) is a continuous automatic blood glucose detecting device. It can automatically collect blood glucose data every 10 minutes to instantly display the blood sugar status. A layer of disposable gel is required between the sensor of the watch type blood glucose meter and the skin, and there are two electrodes on the gel. At work, the circuit is turned on, and the resulting microcurrent causes the glucose molecules to move into the gel through the patient's skin. The device can calculate the blood sugar level of the human body by measuring the degree of reaction between the glucose molecules in the gel and the enzyme. The device provides continuous 12-hour measurement, reads glucose values ​​3 times per hour, and alerts when blood glucose levels are particularly low or high. However, due to the accuracy of this device, the US FDA recommends using a standard blood glucose meter for calibration.
2. Medino's Leyland Dynamic Glucose Monitoring System: The core product of the company, the Rayland Dynamic Glucose Monitoring System, consists of a retrospective glucose monitoring system, a real-time display blood glucose monitoring system, a real-time blood glucose central monitoring system and a closed loop. The insulin pump system consists of four series and different types of products. Among them, the Rayland Dynamic Glucose Monitoring System (also called the subcutaneous tissue fluid glucose detection system) can collect the glucose changes of the wearer for 24 hours, and can download the data to the computer to form a glucose change map, and compare the wearer with the map. Daily life, medication, exercise and other daily life conditions, analysis of the wearer's daily blood sugar changes and blood sugar fluctuations. With a diameter of only 0.2 mm, the sensor is the smallest in the world, the only sensor that does not require the aid of an aid and painless intervention. The sensor is divided into short-term and long-term. Short-term sensors can work for 3 to 15 days; long-term sensors can work for 3 to 6 months. The Rayland Dynamic Real-Time Monitoring System (also known as the Subcutaneous Tissue Liquid Glucose Detection Real-Time Display System) is an instant-type blood glucose watch. The system consists of two parts: a sensor and a data display. The data display itself is capable of receiving, processing, storing, and displaying the patient's glucose concentration data. Its main technical feature is the real-time display of blood glucose levels and blood glucose concentration curves.
3. Medtronic's Dynamic Blood Glucose Monitor: In 2004, the company launched the Guardian, a dynamic blood glucose monitoring system with blood glucose alarm function; in 2005, the Guardian RT real-time dynamic blood glucose monitoring system was launched; its latest 5th generation dynamic blood glucose monitor The performance characteristics of the Guardian REAL-Time System are: a blood glucose change speed alarm, a comprehensive trend graph reflecting the overall condition of blood sugar, etc. The comprehensive trend graph can display the diet and exercise of the patient within 3, 6, 12, and 24 hours as time increases. Effects of changes in medications and lifestyles on blood glucose levels.
4. Abbott's Continuous Blood Glucose Monitoring Freestyle Navigator: Abbott has completed the acquisition of TheraSense. TheraSense recently applied to the FDA for an application called FreeStyle NavigatoR, a continuous blood glucose monitoring freestyle navigator. The system is capable of continuous blood glucose testing in real time, with high or low blood glucose alarms, and blood glucose trend analysis. The system uses a patented technology called Wired Enzyme, which obtains the corresponding blood glucose value by measuring the amount of interstitial liquid sugar in the human body and can be measured every minute. The instrument is also equipped with a wireless receiver. (China Medical News)
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