2024-08-09
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On February 21, 2024, the FDA issued a safety communication warning consumers, patients, caregivers, and healthcare providers about the risks of using smart watches or smart rings that claim to measure blood sugar without piercing the skin. The FDA has not authorized, approved, or cleared any smart watches or smart rings that are designed to measure or estimate blood sugar levels on their own.
"I was fooled." Wu Qian tied the smart watch she just bought, which claims to be able to measure blood sugar non-invasively, to a plastic tube. The surface showed that the blood sugar value of the plastic tube was 9.6mmol/L. She took a photo, sent it to the merchant, and clicked to return the product. Wu Qian told the reporter of The Paper: "I feel my IQ has been insulted."
In recent years, promotions such as "non-invasive blood sugar monitoring" and "blood sugar measurement without needles" have often appeared on the Internet. On e-commerce platforms, merchants have begun to mark smart watches with the keyword "non-invasive blood sugar measurement". If you search for blood sugar monitoring devices on e-commerce platforms, you can usually find them, with prices ranging from tens of yuan to several thousand yuan. Consumers bought them with the mentality of trying new technology, but soon found that they had paid the "IQ tax".
Non-invasive blood glucose monitoring technology is a technology that many scientists and technology companies hope to break through. According to a review article published in the journal Sensors in 2020, non-invasive blood glucose monitoring technology can generally be divided into optical, microwave and electrochemical methods. These technologies estimate blood glucose levels indirectly rather than directly, so the correlation between the measured blood glucose level and the actual blood glucose level is not high.
On February 21, 2024, the U.S. Food and Drug Administration (FDA) warned that any smart watches and bracelets for medical purposes that claim to measure blood sugar levels without piercing the skin are dangerous and should be avoided, regardless of the brand.
Wu Qian is in her forties and works in the IT industry. Her mother is a type 2 diabetic. She usually uses a fingertip blood glucose meter to monitor her blood sugar regularly. She pricks her finger almost every day. When her blood sugar is unstable, she has to test it five or six times a day. Wu Qian once heard about a dynamic blood sugar monitoring device that fixes a tiny needle on the skin and allows you to see the blood sugar level at all times. But she heard that this device is very expensive. She thought it would be great if there was a wearable device that could be fixed on the hand without piercing the skin.
Unexpectedly, she found a lot of watches that matched her imagination. She saw on Pinduoduo that many merchants not related to Huawei claimed that the watches they sold were Huawei watches, and the transaction volume was very high, generally tens of thousands of pieces, and some even showed more than one million pieces. Based on her previous online shopping experience, she felt that "non-invasive blood glucose monitoring technology is probably very mature. Although this store is not a Huawei flagship store, it should be authorized by Huawei. If the technology is mature, it can be authorized for everyone to use, and the hardware can be produced by each."
Wu Qian once bought a Huawei sports watch, which can accurately measure the swimming distance and even the swimming style, so she trusts the Huawei brand. So she bought the watch at a store called "Hongmeng R&D Health Technology" for only more than 50 yuan, which is "cheap and affordable."
According to the Beijing News, on May 18, 2023, Huawei officially released the Huawei WATCH 4 series of watches at the summer full-scenario new product launch conference. Huawei said that this is the industry's first smartwatch that supports hyperglycemia risk assessment research. Its hyperglycemia risk assessment research was jointly initiated by Nanjing Drum Tower Hospital, Peking Union Medical College Hospital, and China Medical Health International Exchange Promotion Association. Huawei specifically marked the introduction page of WATCH 4 on its official website as "Assessing hyperglycemia risk (non-blood sugar output value)".
After getting the watch, Wu Qian calibrated it according to the prompts, that is, she entered the fasting and postprandial blood sugar values that her mother had previously measured with a fingertip blood glucose meter. Then she clicked the button and the screen would give the blood sugar value. She guessed that maybe there was a sensor on the side of the watch close to the skin, which could scan the changes in skin color and ultimately measure the blood sugar value. But she accidentally put the watch on the table and found that the watch could measure the value without touching the skin. So she tied the watch to a wooden chair and a kitten's neck and found that it could measure blood sugar values. She realized that this was fake high-tech.
Although the watch was very cheap and the return was smooth, she was still afraid: if she bought it directly online for her mother, her mother might think it was very useful, which might mislead her diet and treatment and cause serious consequences.
Measuring blood sugar without pricking your finger is an irresistible temptation for diabetic patients.
Lu Bi is 28 years old and was diagnosed with type 1 diabetes in November 2022. She was devastated because she had always thought that diabetes was a disease that only the elderly would get, and she was not yet 30 years old. When she searched for necessities such as fingertip blood glucose meters online, big data pushed a watch that can measure blood sugar non-invasively to her. She felt that such a watch would perfectly solve the series of troubles she would face: "I have to prick my fingers myself every day, which is troublesome and painful. When I saw a watch that can measure blood sugar non-invasively, to be honest, I really wanted to buy it."
Lu Bi saw that many watches with non-invasive blood sugar measurement functions on e-commerce platforms would be marked with the word "Huawei" on the product recommendation page, but they were actually not related to Huawei. The dido brand did not make such promotions. At the end of November 2022, she bought a dido watch on Taobao for more than 700 yuan. At that time, she did not know much about blood sugar monitoring and related technologies. Looking back now, she feels that she was a bit "desperate to try all kinds of treatments."
After receiving the watch, Lu Bi followed the customer service's request to fit the electrode on the back of the watch tightly to her wrist. As a result, the blood sugar value displayed on the watch shocked her: when the fingertip blood glucose meter measured hypoglycemia, the blood sugar value displayed on the watch was more than 6mmol/L (approximately normal blood sugar value). After eating, the watch showed that her blood sugar value was more than 3mmol/L (hypoglycemia). [Note: According to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)", the normal range of fasting blood sugar is 3.9-6.1 mmol/L, and the normal range of blood sugar 2 hours after a meal is below 7.8 mmol/L. ] She felt that she had paid the "IQ tax" and asked the customer service for a refund. The customer service suggested that she wear it for another week to let the instrument correct itself, but she insisted on returning it.
Yuan Dong is 37 years old. He was diagnosed with type 2 diabetes in May 2024. During his hospitalization, he had to prick his fingers to measure his blood sugar 6-8 times a day. "My fingers were covered with small blood spots, which was very painful." After being discharged from the hospital, he had to continue pricking his fingers to monitor his blood sugar and observe what foods he could eat. In the hospital, the old man in the next bed bought a watch that can measure blood sugar. Yuan Dong asked him how effective it was, and the old man said it was okay. So he also started searching online, "It's better than pricking your fingers all the time."
Yuan Dong said that long-term use of fingertip blood glucose meters actually costs a lot of money for consumables. Needles, blood glucose test strips and alcohol cotton are all disposable. The Paper found that sets of these three necessities can be purchased on e-commerce platforms, 50 sets for about 40 yuan, can be used for a week, and the consumables for a month cost about 200 yuan. Yuan Dong said that including the cost of medication, he spends 1,000-1,500 yuan a month on diabetes, which is a certain burden for him. If you can use a watch to monitor blood sugar, it is equivalent to investing a sum of money in the early stage, but saving a lot of money in the later stage.
Yuan Dong searched online and found a blood glucose watch from Dalexing. Among many brands, this watch had the best publicity, had a patent, had been on CCTV, and was more expensive. In Yuan Dong's opinion, the high price indicated good quality to a certain extent. He saw that the comments on this watch were all "all positive" on Taobao and JD.com, but the price of 5,000-6,000 yuan was a bit beyond his expectations. In the end, he spent 2,499 yuan on Xianyu to buy a Dalexing D2plus watch, which the seller said was "absolutely new, authentic, and unopened."
After receiving the watch, Yuan Dong wore it at a distance of one finger from his wrist as required, and then entered the blood sugar value measured by the fingertip blood glucose meter during the corresponding time period, and the modeling was completed. But he found that the blood sugar value measured by the watch was extremely inaccurate. 30 minutes after breakfast one day, the blood sugar value he measured with the fingertip blood glucose meter was 9.3mmol/L, but the watch showed 7.1mmol/L. "The difference in blood sugar values is more than 2mmol/L, which is very scary." Yuan Dong told the reporter of The Paper.
He immediately went to ask the seller, who asked him to send her the comparison records of the blood glucose values after three meals with those of the fingertip blood glucose meter, and reminded him to scan the QR code on the packaging box and add the WeChat of Dai Lexing customer service. As a result, he got into a "ball war" with the Xianyu seller and Dai Lexing customer service.
The seller told him that the value of the blood glucose watch needs a period of time to be calibrated. The calibration time varies from person to person. Everyone has a different definition of "accurate". Some people can accept a difference of 2mmol/L, while others cannot even accept a difference of 0.2mmol/L. The value measured by the watch and the value of the biochemical blood are allowed to have an error of less than 20%.
Yuan Dong did several calibrations and sent the data to the seller at regular intervals. When the seller helped him analyze the cause, he mentioned that the Yuyue fingertip blood glucose meter he was using might not be accurate. Yuan Dong initiated a refund, but the seller said that product after-sales issues should be addressed to Dai Lexing customer service and rejected his refund application.
Yuan Dong then contacted the customer service of the watch and asked several times why the measured post-meal blood sugar value was about 2mmol/L different from that of the fingertip blood sugar meter. The customer service did not directly answer his question, but introduced the working principle of the watch to him: "It is mainly based on dynamic metabolic heat and near-infrared spectrum absorption technology. It continuously monitors the changes in human metabolic heat and infrared spectrum reflection, and cooperates with multiple sensors to continuously collect other relevant physiological parameters of the human body. It combines original signal processing and AI data large model fusion algorithm to achieve real-time monitoring of blood sugar levels."
The customer service said that its technical principles have been included and reported in Nature magazine, and it can enable diabetics to truly achieve "0 trauma, 0 pain, 0 infection, and 0 consumables" in the process of blood sugar management, eliminate the risk of hypoglycemia in time, and adjust their diet, daily routine, exercise, and medication according to blood sugar fluctuations.
Yuan Dong told the customer service that the "non-invasive blood sugar monitoring" and "real-time monitoring" mentioned in the Dalexing advertisements were not real values at all and were false propaganda. The customer service said that if he was not satisfied with the product, both Tmall and JD flagship stores supported a 30-day free trial and he could contact the store customer service. After kicking the ball around, Yuan Dong said, "I can't return it."
The U.S. Food and Drug Administration (FDA) has noticed the chaos in the consumer market. On February 21, 2024, local time, the FDA issued a safety communication warning consumers, patients, caregivers and healthcare providers that there are risks in using smart watches or smart rings that claim to measure blood sugar without piercing the skin.The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood sugar levels on its own. For people with diabetes, inaccurate blood sugar measurements can lead to errors in diabetes management, including taking the wrong dose of insulin, sulfonylureas, or other medications that quickly lower blood sugar. An overdose of these medications can quickly lead to a dangerously low blood sugar state, which can lead to confusion, coma, or even death within hours.
In fact, many scientists and companies have hoped to make breakthroughs in non-invasive blood glucose monitoring technology in the past. Many well-known big-name manufacturers have joined the ranks of developing non-invasive blood glucose monitoring devices, such as Huawei, Apple, and Samsung, which develop smart devices, technology companies Google, Microsoft, and Philips, and medical and health companies Johnson & Johnson, Abbott, and Roche, but there is no truly non-invasive device that can accurately measure blood glucose.
In December 2020, a research team from the Materials Science and Optoelectronics Technology Research Center of the University of Chinese Academy of Sciences and the Department of Biomedical Engineering of Yishou University in Taiwan jointly wrote a review on the progress of non-invasive blood glucose monitoring technology in the journal Sensors, stating that non-invasive blood glucose monitoring technology has become an international research topic. According to them, frequent and regular blood glucose testing is crucial for diabetic patients. The new non-invasive blood glucose monitoring technology can provide continuous real-time blood glucose monitoring, which can solve the limitation of traditional invasive blood glucose meters that require repeated fingertip blood sampling, allowing diabetic patients to conveniently monitor and manage their blood glucose levels, and has broad market application prospects.
Yuan Dong told the reporter of The Paper that non-invasive blood sugar monitoring is the dream of every diabetic patient. The large number of diabetic patients means that there is a huge market demand for it. According to the "Guidelines for Exercise Treatment of Type 2 Diabetes in China (2024 Edition)", the number of people with diabetes in China has exceeded 140 million, ranking first in the world.
The above review introduces that, at present, non-invasive blood glucose monitoring methods are generally divided into three categories: optical method, microwave method and electrochemical method. Optical methods include near-infrared reflectance spectroscopy (NIRS), polarization rotation, Raman spectroscopy, fluorescence, optical coherence tomography (OCT), etc. In addition to glucose in human blood, a considerable amount of glucose is also present in other biological fluids such as saliva, tears, sweat and interstitial fluid (ISF) in the human body. The electrochemical method uses the coherent correlation between biological fluids and blood glucose values to measure the glucose content in body fluids and indirectly obtain blood glucose values after calibration of the algorithm or data model.
The industry believes that the difficulty of non-invasive blood glucose monitoring is comparable to that of landing on the moon. According to the above review, the measurement values of optical and microwave methods may not be highly correlated with the actual blood glucose values, and subsequent algorithm correction is required. Individual differences such as age, skin color, and skin condition can cause large errors in measurement results. In addition, there are problems such as complex detection methods, rough detection sites, cumbersome detection processes, high requirements for detection equipment, and large background signal interference. Electrochemical methods have defects such as low sensitivity, delayed measurement results, the need for calibration, poor comfort, and easy damage to the skin.
Su Yingwei, deputy chief physician of the Endocrinology Department of Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, said that directly measuring various indicators in the blood is the simplest method, while monitoring through the skin by various means will definitely be subject to various interferences. Just like applying coupling agent on the skin surface during physical examination and ultrasound, it is to avoid air or moisture between the skin and the probe, which will interfere with the detection.
Su Yingwei told The Paper that the rational use of existing and mature blood sugar monitoring methods can already assist blood sugar management. According to him, the standard blood sugar test method is to draw blood from the vein and use the glucose oxidase method to determine the blood sugar value, which represents the average glucose content in the body at a certain moment. The commonly used method now is fingertip blood sugar testing, which measures capillary blood sugar. Its stability is not as good as venous blood sugar testing, but it is more convenient and can be tested at home, especially helpful for excluding hypoglycemia. Clinically, drugs and basal insulin are also adjusted according to fasting blood sugar. The third method is glycated hemoglobin testing, which represents the average blood sugar level for three months and is an important indicator for testing whether blood sugar control is good. Another method is continuous glucose monitoring (CGM), which is divided into minimally invasive and non-invasive. Minimally invasive continuous blood sugar monitoring technology is already relatively mature, and the relevant equipment is usually very small. There is a thin and soft probe inserted under the skin, which can draw a blood sugar fluctuation map over a period of time, reflecting the fluctuation of blood sugar. But its accuracy is not as high as fingertip blood sugar, so the latter can be used to calibrate its value.
Su Yingwei said,The non-invasive continuous dynamic blood glucose monitoring system is the most interesting thing in the intersection of medicine and engineering. Many companies, institutions, and research teams are seriously developing this technology. Ruijin Hospital has also conducted relevant clinical research, but its reliability is still questioned. Therefore, the values measured using the so-called non-invasive blood glucose monitoring watch cannot be used to adjust insulin treatment plans. In fact, most of the watches on the market that claim to support non-invasive blood glucose monitoring will state on the details page that the product is not a medical device and cannot be used for diagnosis and treatment.
Su Yingwei told The Paper that the several blood glucose monitoring methods that are currently mature have their own usage scenarios and goals, and cannot replace each other, nor is it necessary to require their accuracy to be exactly the same. Usually, he will give different blood glucose monitoring recommendations based on the severity of the patient's diabetes. If the patient takes insulin four times a day (usually patients with very poor pancreatic islet function or type 1 diabetes), dynamic blood glucose monitoring is recommended as the main method, while for patients who only need to take insulin once a day, dynamic blood glucose monitoring is of limited significance.
Su Yingwei and Nie Zedong both believe that non-invasive blood glucose monitoring will be an important direction in the future. Su Yingwei said,More advanced blood glucose monitoring technologies will emerge in the future, but their development may cause blood glucose anxiety to a certain extent and ultimately increase the cost of drug treatment.This has been reflected in the use of dynamic blood glucose monitors. For example, if a type 2 diabetic can control glycated hemoglobin and fasting blood sugar very well by taking metformin, there is no need to use dynamic blood glucose monitoring. Because his/her purpose is probably to see the blood sugar value, so as long as the value is slightly higher, he/she will be very nervous. The purpose of doctors looking at dynamic monitoring values is to understand blood sugar changes, so as to adjust the treatment method to keep it within a safe range.
(Wu Qian, Yuan Dong, and Lu Bi are pseudonyms in this article)
References:
1.https://www.mdpi.com/1424-8220/20/23/6925
2.https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication
3.https://baijiahao.baidu.com/s?id=1766245166612142104&wfr=spider&for=pc
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