Blood Glucose Meter for Medical Devices

      Development history and working principle of blood glucose meter
A blood glucose meter, also known as a blood glucose meter, is an electronic device that measures blood sugar levels in medical care. In 1968, (Tom Clemens) invented the first blood glucose meter. After decades of development, the blood glucose meter technology has gone through five stages of development, from the early light reflection technology to the current electrochemical method technology. Most blood glucose meters are fourth and fifth generation blood glucose meters that use electrochemical technology. At present, the mainstream blood glucose meter products all use electrochemical technology. The electrochemical method uses the principle of detecting the current signal generated in the reaction process to reflect the blood glucose level; the fourth generation blood glucose meter uses glucose oxidase as the oxidase, which is characterized by specificity. High, the technology is mature, but because the reaction process requires the participation of oxygen, the measurement results are easily affected by the blood oxygen content and cause deviations in the results; the fifth-generation blood glucose meter adopts the improved glucose dehydrogenase technology, which is no longer affected by blood. interference with other carbohydrates. Manufacturers with fifth-generation blood glucose meter technology have certain technical advantages, especially in the competition in the hospital market.
Product form and development trend of blood glucose meters
The technical iteration and product form process of blood glucose meters are mainly from the traditional invasive blood glucose to the minimally invasive blood glucose that is more common in the market now, and then to the non-invasive blood glucose that has a great opportunity to replace the existing product form in the future. Changes in testing convenience and technical principles are mostly changes in the entire industry chain, the entire blood sugar ecology, and the applicable population and application scenarios. The following lists several mainstream blood glucose product forms in the market for analysis.
1. Mobile blood glucose meter: “hardware + service” to create a closed loop of diabetes management
At present, the domestic mobile blood glucose meter should be represented by the “sugar nurse”, which monitors the patient’s diabetes data through the blood glucose meter as a monitoring terminal, and then responds to the
It is used to upload patient data to the company’s cloud, and finally provide medical services to patients through doctors in medical institutions to create sugar from monitoring to treatment to management.
Diabetes management vertical closed loop.
2. Continuous blood glucose monitoring (CGM)
At present, continuous glucose monitoring (CGM) is mainly used for continuous glucose monitoring. CGM products apply a new
Biomonitoring technology, which uses a sensor pierced under the skin to form an electrical signal when the patient’s interstitial fluid reacts with glucose in the body.
This is converted into a blood glucose reading, which is transmitted through the transmitter to a wireless receiver. Transmitters and receivers are durable devices, and sensors are disposable devices. In order to ensure measurement accuracy, current CGM products cannot be used independently and require blood readings to be corrected twice a day. CGM applications can warn patients of hypoglycemia events during the process of intensive blood sugar control, thereby reducing the incidence of hypoglycemia events. The mainstream brands in the market include Abbott’s Instantaneous Scanning Blood Glucose Meter, whose products were launched in China in 2017.
3. Non-invasive blood glucose monitoring
Non-invasive blood glucose monitoring technology has the advantages of no pain, no infection, simple measurement, and fast measurement speed, which can effectively meet the needs of diabetics to monitor blood glucose concentration in real time and frequently. According to the different monitoring objects, non-invasive blood glucose monitoring technology can be divided into near-infrared spectroscopy, microwave detection method, optical rotation method, energy metabolism conservation method, etc. These technologies are all indirect methods to measure human blood glucose concentration, which requires complex conversion. Formula to test the concentration of sugar in the blood, with a certain delay. We have noticed that non-invasive blood glucose monitoring, as a new generation of blood glucose monitoring technology, will have a subversive impact on traditional blood glucose meter manufacturers once it is commercialized. Non-invasive blood glucose monitoring can measure the blood glucose concentration of patients without test strips. In the future, breakthroughs in non-invasive blood glucose monitoring technology, enabling mass production and popularization, will have a strong impact on the traditional blood glucose meter industry chain. At present, there are dozens of brands of non-invasive blood glucose meters on the market, and few of them can get FDA and CFDA certification. The main reasons are as follows:
(1) Inaccurate test data
Non-invasive blood sugar testing is obviously non-invasive and does not collect blood, which means that this method cannot measure blood sugar by directly producing a chemical reaction with blood. The blood sugar content is calculated in an indirect way. The above process will inevitably affect blood sugar testing. Accuracy affects.
(2) high price
At present, there are very few non-invasive blood glucose detectors that have passed CE certification, let alone FDA and CFDA certification, and most of the CE certifications are Israel, the United States and other traditional powerhouses in this field, forming a monopoly in the market, and the price is also high. has been high.
(3) It is technically difficult
Non-invasive blood sugar cannot measure blood sugar through direct chemical reaction with blood. The blood sugar content is calculated by indirect methods such as optical detection. Therefore, the accuracy and stability of such products limit their development, and it is impossible to obtain high-precision non-invasive blood glucose detection products that meet the requirements of clinical diagnosis.
Prospects for blood glucose meters
The iterative upgrade cycle of technology is accelerated, and more intelligent blood glucose meters in product forms will appear
It has been less than 60 years since the birth of blood glucose meters. During this period, the detection technology of blood glucose meters has changed from optical reflection technology to electrochemical reaction technology, to body fluid detection and optical detection. While undergoing many iterations of technical principle upgrades, it is also accompanied by changes in product form, from traditional invasive testing to minimally invasive testing, and then transitioning to non-invasive testing that has not yet been used on a large scale. We can find that technology iterative upgrades faster. At the same time, the commercial application of 5G and the increasing maturity of AI technology will provide infinite possibilities for the intelligent upgrade of blood glucose meters.

Posted in Medical device knowledge.

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