We know that blood glucose testing is a very important part of diabetes management. Although the blood glucose meter has undergone numerous improvements, the invasive invasive blood glucose meter still occupies the entire blood glucose testing market.
Due to the fear of pain and the resulting psychological fear, invasive measurement methods directly lead to a large part of diabetic patients giving up fixed blood glucose tests. Therefore, the invention of minimally invasive or even non-invasive blood glucose meters has become the peak of many scientists.
But this is really bad! In fact, glucose can be found in body fluids in many parts of the body. In addition to blood, there are interstitial fluids, tears, vitreous humor, urine and sweat. There are also many ways to measure the glucose concentration in these body fluids. Ideally, the concentration of blood glucose can be analyzed by measuring the concentration of these body fluid glucose at any time. However, due to a variety of constraints, looking back at more than 20 years of research progress, there are small surprises but no major breakthroughs, slightly sad. Today we will look at several minimally invasive/non-invasive blood glucose meters to see how difficult it is.
Current champion in the micro-creative world: Dexcom G4 PLATINUM
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Dexcom's Dexcom G4 PLATINUM is a minimally invasive continuous monitoring blood glucose meter. It consists of a sensor (embedded under the skin), a transducer (fixed on the sensor to transmit wireless signals) and a receiver (receiving and displaying blood sugar change information).
The underlying principle of this device is that there is a stable relationship between the glucose concentration of superficial skin tissue fluid and blood glucose concentration. The detection principle of Dexcom G4 PLATINUM is similar to that of blood glucose test strips. The micro-glucose oxidase electrode sensor implanted under the skin reacts with the glucose in the tissue fluid. This chemical signal is converted into a monitorable electrical signal through the electrode, and the electrical signal passes through a specific algorithm. After processing, it becomes the blood sugar level on the receiver.
This is like, you want to know how hard the water in a big river is, but don't want to take risks directly from the river. But you know that the hardness of the groundwater near the river is related to the hardness of the river. At this time, you can take a look at the river and calculate the hardness of the river by the hardness of the well water. Having said that, the problem with this type of blood glucose meter is obvious: although there is a stable relationship between well water and river water hardness, this relationship will also change with changes in external conditions.
Dexcom G4 PLATINUM has been approved by the FDA and CE. The blood glucose range that can be monitored is 2.22~22.2mmol/L. The applicable population is diabetic patients over 2 years old. The price is about 2,000 US dollars. The FDA states that the Dexcom G4 PLATINUM blood glucose meter should be checked at least once every 12 hours; when the Dexcom G4 PLATINUM warns that the blood sugar is too high or too low, the blood glucose meter must be used to detect the finger blood before it can be processed; Dexcom G4 PLATINUM cannot be used as a reference for insulin usage; the accuracy of Dexcom G4 PLATINUM is affected by diet and exercise.
Learning non-invasive blood glucose meter: TensorTip CoG
Israeli company CNOGA has launched a blood glucose meter TensorTip CoG between invasive and non-invasive. This blood glucose meter has a very contemporary positioning: a learning non-invasive blood glucose meter. Let's take a look at how this blood glucose meter is learned.
Segmen, CEO of CNOGA, is a technical expert in TV imaging technology. Color TVs are colorful in our eyes, but in Segmen's view, all the colors are just a mixture of red, green and blue. Therefore, he believes that the color of human body expression also has its own internal laws. As long as the law can be found, the blood sugar changes can be analyzed through large-scale data operations. TensorTip CoG was born in this context.
When the light from the diode in the TensorTip CoG passes through the fingertip, some of it is absorbed and the light signal changes. The sensor only receives light at wavelengths from 600 nm to 1150 nm. Next, there is a camera sensor similar to a professional digital camera that detects changes in optical signals in real time. The signal is passed to a processor that digitizes the signal into a combination of red, blue, and green. TensorTip CoG is unique in that it uses a proprietary algorithm and a large amount of data collected by the processor (more than 68 billion color combinations), combined with the correlation between the light signal "learned" by TensorTip CoG and blood glucose, and finally calculates The concentration of blood sugar.
The TensorTip CoG has a "learning" phase that lasts for about a week before non-invasive blood glucose testing is enabled. This is because TensorTip CoG establishes the relationship between light signal and blood glucose, and needs to collect at least 130 invasive blood glucose data and 65 non-invasive optical signal data. Non-invasive blood glucose testing can only begin once this learning process is completed.
TensorTip CoG is currently only approved by CE. The detectable blood glucose range is 3.89~24.4 mmol/L. It can only be used for patients with type 2 diabetes over 18 years old. The price in Europe is about 2,000 US dollars. Keep your fingers clean and free of trauma when using TensorTip CoG; TensorTip CoG cannot be used alone as the sole indicator for the diagnosis and treatment of diabetes; there is a long, invasive “learning†phase before use.
Sugar is not a jealous: GlucoTrack
Integrity Applications' GlucoTrack non-invasive blood glucose meter received CE certification in 2014, and it also has a resounding Chinese name “sugarâ€. GlucoTrack consists of a main unit with a touch screen and a personal ear clip. When testing, simply clip the ear clip to the earlobe and wait for about 1 minute to know the blood sugar result. The principle of detection of this device is to calculate the blood glucose concentration by measuring changes in ultrasound, electromagnetic and heat.
To make it easier for you to understand the principles of GlucoTrack, I will give you a chestnut. You want to estimate the number of sparrows in your yard. In order to estimate more accurately, you decide to use several methods. So you put in a few foods that only a few birds, including sparrows, like to eat, record the sound of sparrows, count the sparrows of the sparrows, and observe their regularity. This way you get a set of data, and by combining the data, you get a more accurate estimate. GlucoTrack records changes in the transmission of ultrasound and electromagnetic waves in the earlobe, as well as changes in the heat of the earlobe. Then comprehensively analyze the three sets of data to estimate the blood sugar level.
GlucoTrack is also approved by CE. The detectable blood glucose range is 4.17~27.8mmol/L. It can only be used for diabetic patients over 18 years old. The price is about 2,000 USD. GlucoTrack is available for 3 people and is calibrated every 6 months. It is not the only basis for detecting and treating diabetes.
New hope for non-invasive blood glucose meters
Not long ago, the research team at the University of Leeds claimed that they also developed a non-invasive blood glucose testing device. This technology is currently licensed to Glucosense. The testing equipment is currently not named, and the R&D team has not released technical details and clinical data. According to the official website of Glucosense, this non-invasive blood glucose meter uses a new type of laser sensor. The sensor is the result of many years of research by Professor Jose Leeds University.
When the user's skin is in contact with the sensor glass, the change in the laser-reflected light caused by the finger reflects the concentration of blood glucose in the blood, and the entire measurement process takes only 30 seconds. From the official prototype, the device is currently in the portable device category. However, Glucosense said it is developing wearable blood glucose monitors to meet the real-time monitoring needs of critically ill patients. It is reported that this blood glucose testing technology was shortlisted for the 2012 UK Medipex NHS Award. This product is still in the experimental stage.
Of course, the most eye-catching thing in the industry is the number of Google contact lenses. The Google Black Technology was developed by the joint pharmaceutical giant Novartis. In addition to knowing that the blood sugar content is calculated by measuring the glucose content of the tears, no other details have been reported so far. However, according to current research, there is no clear relationship between the concentration of glucose in saliva, sweat, tears and urine, and blood glucose concentration. This is also the reason why blood glucose meters have not been detected for many years. Of course, it does not rule out that Google will bring us unexpected surprises.
Non-invasive blood glucose meter may still have a light year away from us
Under normal circumstances, the fasting blood glucose concentration of healthy people is 3.61~6.11mmol/L. People with type 1 diabetes may have very low glucose levels, even below 2mmol/L, while patients with type 1 diabetes have faster fluctuations in blood glucose. The table below shows the data published by the first three blood glucose meters mentioned above.
According to the previous introduction, it is not difficult to see that Dexcom G4 is a minimally invasive blood glucose meter; TensorTip CoG is invasive in the early stage and non-invasive in the later stage; GlucoTrack is a non-invasive blood glucose meter. From invasive to non-invasive, it is a process that gradually moves away from the blood. The detection methods are more and more complicated, and the detection accuracy is getting lower and lower. As can be seen from the above table, TensorTip CoG and GlucoTrack have little significance for detecting hypoglycemia.
For diabetics, the biggest risk is the dramatic fluctuations in blood glucose levels. The speed and magnitude of fluctuations are big problems for minimally invasive and non-invasive blood glucose meters. Because minimally invasive and non-invasive blood glucose meters, indirectly calculate blood sugar, the results they detect have a certain lag, some blood glucose meters lag 5 minutes, and some even lag 20 minutes. Therefore, such blood glucose meters do not reflect the concentration of blood sugar in time. For the Dexcom G4, which is closest to blood, when the fluctuation of blood glucose reaches 0.11~0.16 mmol/L per minute, the test result is not accurate.
There are many reasons why minimally invasive and non-invasive blood glucose meters are difficult to be precise, such as signal-to-noise ratio (ratio of glucose signal to other substance signals), sensor sensitivity, continuous monitoring, signal processing, and data analysis. However, the fundamental reason is that the concentration of blood sugar itself is relatively low, and there is no single trait that only glucose has. Therefore, the current main research directions are still focused on: improving sensor sensitivity, eliminating the influence of background signals, and multi-factor joint detection.
From the current comparison devices, they can only be used as an early warning device for abnormal blood sugar. In fact, we still have a certain distance from non-invasive blood sugar. Therefore, for the majority of diabetic patients, when buying a non-invasive / minimally invasive blood glucose meter, the home must be prepared an invasive blood glucose meter.
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