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Bloomberg recently published an article that caused quite a stir in the medical technology industry. Citing insiders, Apple says it has reached a milestone in non-invasive blood glucose monitoring, which could revolutionize diabetes treatment as we know it. But while the technology is interesting, you won't see it on the Apple Watch — or any consumer-grade wearable device — for the next few years.
As with other emerging medical technologies, noninvasive blood glucose monitoring has technical and regulatory hurdles to overcome. But even if Big Tech and researchers come up with a workable solution tomorrow, the resulting technology probably won't replace finger pricking, experts say. As it turns out, this may not be the most practical or useful use of technology.
Pin punch test
Blood glucose monitoring is non-invasive. Measure your blood sugar without drawing blood, hurting your skin, or causing pain or injury. There are many reasons to follow this method, but the most important is the treatment of diabetes.
When you have diabetes, your body can't control blood sugar levels properly because it either doesn't produce enough insulin (type 1) or becomes resistant to insulin over time (type 2). To manage their condition, type 1 and type 2 patients must monitor their blood sugar with standard invasive procedures, such as a fingerprint or continuous glucose monitor (CGM). The finger prick test involves pricking the finger with a needle and placing a drop of blood on a test strip. A continuous glucose monitoring device (CGM) inserts a sensor under the skin, allowing patients to monitor blood sugar levels in real time 24 hours a day.
Few people enjoy annual acupuncture injections, let alone daily glucose checks. So you can understand the appeal of non-invasive monitoring. Patients don't need to donate blood or attach sensors to know when to take insulin or monitor the effectiveness of other medications. Doctors can monitor patients remotely, which increases access to patients living in rural areas. In addition to diabetes, this technology could be useful for endurance athletes who want to control their carbohydrate intake during long runs.
It's one of those win-win situations. The only problem is that research on non-invasive blood glucose monitoring began in 1975, and in 48 years no one has figured out how to do it safely.
Glucose signaling in biological grass cells
Currently, there are two main ways to measure glucose levels non-invasively. The first is to measure the amount of glucose in body fluids such as urine or tears. Google has been trying to develop smart contact lenses that can measure blood sugar before pulling the plug on the project in 2018. The second method involves spectroscopy. Basically, it illuminates an object using optical sensors and measures how the light is reflected to measure a certain balance.
If that sounds familiar, it's because the technology is already being used in smartwatches, fitness trackers and smart rings. This is how they measure heart rate, blood oxygen levels and many other parameters. The difference is that instead of green or red LEDs, this non-invasive glucose monitor uses infrared or near-infrared light. This light is directed to the interstitial fluid, which carries substances and nutrients and waste products in the spaces between the cells - or to other vascular tissue. Like heart rate and blood oxygen, the smartwatch theoretically uses a proprietary algorithm to determine glucose levels based on the amount of reflected light.
But although the method is the same, applying this method to blood sugar is more complicated.
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"The signal you get from glucose seems to be very weak, which is unfortunate," said David Klonoff, MD, medical director of the Diabetes Research Institute at Mills Peninsula Medical Center in San Mateo, California. Klonoff is also president of the Society for Diabetes Technology, Editor-in-Chief of Diabetes Science and Technology , and has pursued non-invasive glucose control technologies for the past 25 years.
When it comes to glucose, dosage is important. This weak signal causes glucose to be released from other similar chemicals in the body. This is frustrating for tool makers, who are as light as water and can stick everywhere.
John Mastrototaro, CEO of Movano, said: "Water interferes with optical measurement, the body is full of water . Even small changes in the amount of water can have a big impact on the measured signals." At CES, the first smart ring for women, however, the company developed a chip that can measure blood pressure and blood sugar levels using radio waves.
Klonof and Mastrototaro are not the only substances in the body that interfere with glucose signaling. External and environmental factors such as incorrect lighting, motion and poor skin contact with the transducer can also affect non-invasive measurements. Also, infrared light is basically a form of heat. It is invisible to the naked eye, but all objects, including people, emit some form of infrared heat. And sensors can't always tell if that heat is from your smartwatch or a sweltering summer day.
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For example, let's say we live in a future where smartwatches can non-invasively monitor your blood sugar. Climate change is making it hotter and your HVAC system is getting worse. The system is collapsing. The room heats up, you sweat, and your smartwatch sensor can easily mistake that extra heat for a spike in blood sugar.
An alternative solution is to collect more data using more wavelengths of light, for example by adding more sensors that emit different types of infrared light. More, it will be easier to understand what glucose is and what overlap there is. But implementing multiple sensors has its challenges. You need a more powerful algorithm to handle more numbers. And if you add too many wavelengths, you run the risk of making the device bigger.
There are less energy-efficient sensors to fit into smartwatches, but frequent, continuous measurement drains the battery. For example, many wearables that support overnight SpO2 monitoring will warn you that if you enable this feature, doing so will significantly reduce battery life.
Current CGMs take readings every five minutes, so a non-invasive display on a smartwatch should at least match those with batteries that last a full day. It should do this in addition to tracking, turning on the always-on display, measuring other health metrics, receiving messages and notifications, and sending data over cellular or Wi-Fi without draining a large battery. Therefore, the device can be comfortable to wear while sleeping.
Another potential problem: optical sensors may not be accurate for people with darker skin and tattoos. This is because dark colors do not reflect light in the way light colors do. Get a pulse oximeter, which uses red and infrared light to measure the amount of oxygen in your blood. Recently, an FDA panel called for more oversight of these devices because they may not be very accurate for people with dark skin. Since infrared light does a better job of removing melanin and pigment than visible light, non-invasive blood glucose monitors may not have much of a problem here. But despite that benefit, Mastrotaro says there is a problem with the wavelength currently used for non-invasive glucose monitoring.
Delegation of control means adjusting expectations.
Despite all these problems, the technology has advanced a lot and most of these problems can be solved. Artificial intelligence has become more powerful, so creating algorithms that can handle the complexities of non-invasive glucose monitoring is easier than ever. Chips and other components are becoming smaller and more powerful. Companies like Movano are actively looking for alternatives to optical sensors. But technology is only part of the equation.
There is also the Food and Drug Administration.
Health features such as real-time blood oxygen or heart rate monitoring are self-perceived and do not need to be evaluated by the FDA for safety or efficacy. But the risk of blood glucose levels is very high. A false reading or false alarm can cause a type 1 diabetic to take the wrong dose of insulin, with potentially life-threatening consequences. Therefore, any smartwatch that advertises blood glucose monitoring features must pass Food and Drug Administration review.
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The problem is getting FDA approval or approval, which is months and years away if you're lucky, a tedious process. Device manufacturers must undergo rigorous clinical trials and testing to ensure their accuracy, safety, and effectiveness. While frustrating for businesses, this level of strictness is good and protects us as consumers. But even if the company has the best idea, there is no guarantee that the process will be successful. And for many, the risk isn't worth it unless the benefits outweigh the risks.
That's why it's unlikely that consumer technology companies will try to replace established methods like finger tests or CGM, at least anytime soon. The blood glucose level in a smartwatch can be used as a fitness or health tracker, or even more popularly as a diabetes diagnosis tool.
In fact, this is the path followed by all electronic wearable manufacturers. When Apple introduced FDA-approved ECGs for the Apple Watch Series 4, the goal was to alert you to an irregular heartbeat and encourage you to see your doctor to assess your risk of atrial fibrillation. It was never meant to help you deal with illness or inform you about treatment. Other companies like Fitbit, Samsung and Garmin are doing the same with EKG and atrial fibrillation tracking capabilities.
These types of scanning capabilities may not seem revolutionary, but they create a win-win situation for researchers, businesses and consumers. In this case, the CDC reports that 96 million American adults have prediabetes, and 90 to 95 percent have type 2 diabetes. Interestingly, this population represents a large corporate client base for low risk. Additionally, any information gained from non-invasive monitoring can provide researchers and consumers with new insights.
"I think there will be subtle patterns that we don't know that are warning people about the space between normal and pre-diabetes. And I think there will be patterns that predict some types of pre-diabetes," he said. Klonoff
"It doesn't just know your glucose level. It knows everything about your health," Mastrotaro added. If successful with RF technology, Movano hopes to add glucose to the platform, along with other health parameters such as heart rate. example. and blood oxygen. He said this is more valuable because it creates a complete picture of a person's health. He worked on the team that created the first CGM approved by the FDA in 1999, a similar approach Mastrototaro took at Medtronic.
"Basically, CGM is able to track people's glucose trends over time, so you can get an idea of the big picture. That's where we started, and we haven't used it for real-time monitoring," Mastrotaro explained. Showing how type 1 diabetics can use CGM to determine how much insulin they need to take. Use it as a warning if you think your blood sugar is low. Your blood pressure is too high or too low, but you will need to confirm this later with a finger prick test and then treatment.
This is similar to smartwatches that detect irregular heartbeats before recommending users get an official checkup from a doctor.
Be prepared to wait
Big tech likes to screw things up and break things, but medicine doesn't. It took nearly two decades for the CGM to be used as the primary real-time glucose monitor to become accurate. It is reasonable to assume that even non-invasive procedures can take some time.
Klonoff and Mastrotaro didn't feel confident enough to predict when we were looking at non-invasive blood glucose monitoring in a smartwatch you can buy.
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In a milestone reported by Bloomberg, Apple will build an iPhone-sized prototype, drastically reducing the size of a device that previously had to sit on a desk. These are just speculations, but if true, Apple still has a lot of work to do. First, Apple needs to shrink this prototype to fit the Apple Watch. More data should be gathered from smaller prototypes, preferably before the results are published in a peer-reviewed journal. Everything must be reviewed by the Food and Drug Administration. And this is assuming that everything goes well, with no setbacks or mistakes that force the company to draw.
But perhaps Samantha Desai, Apple's VP of health care, is doing better. "These are all very interesting areas, but there's a lot of scientific research behind them," he said in a recent interview about the possibility of using blood glucose sensors on the Apple Watch in the future.
Good science cannot and should not be rushed. We've all seen what happens when companies rush to ship half-baked products. Personally, I'm willing to wait until someone fixes it.
