SaMD Diabetes Software Experts

Glucose Monitoring Smartwatches: 2021 May Finally be the Year

Two companies are currently working on the long-awaited glucose-monitoring smartwatch. Both promise release dates in late 2021. In this article, we look at what it will take to launch these products and the expected impact they’ll have on the diabetes technology market.

If you’ve been paying attention to the world of high-tech diabetes care, you’ve probably heard the rumors about smartwatches capable of monitoring blood sugars. Without pin pricks. Without inserting sensors.

These rumors first surfaced back in 2018, when news broke that Apple had a secret team of biomedical engineers working to create optics capable of detecting blood glucose levels. The team implicated in the report had already been hard at work on the project for five years before this news got out.

In 2021, we may finally see the long-anticipated product. 

Two of them, in fact.

Korean news outlets reported last month that Samsung would be unveiling its new smartwatch (tentatively called Galaxy Watch 4) in the second half of 2021. Among the host of new features? Blood glucose monitoring capability.

Multiple outlets, including TechRadar, are also predicting a 2021 second-half rollout for the Apple Watch 7. And rumor has it, this iteration will include the long-awaited glucose monitoring functionality as well.

The Long Road to Launch

Certainly, one of the biggest hurdles to deploying this widely anticipated tech is creating it. But likely just as difficult, will be the process of getting the glucose monitor cleared by the FDA and similar international regulating bodies.

As of now, neither the Samsung nor the Apple watch has been cleared by the FDA or others for use as a glucose monitor. Since the process of receiving clearance can take months, we would hope that both companies have already begun this process.

Getting FDA clearance for any medical device is tricky, and it can be even more difficult to request a “De Novo” classification — which will likely be required of these watches. These devices will be unlike any other product on the market, which means they cannot piggyback on clearances awarded to previous devices.

In 2018, Apple was able to move through the FDA hurdles needed to release its Apple Watch Series 4. 

This watch included two innovative medical functions: electrocardiogram (EKG) monitoring and an irregular heart rhythm alarm. The EKG function, specifically, received De Novo clearance because no other wearable EKG device has ever been available direct to the consumer in this way.

The clearance for both of these functions stipulated that they were only for use in adults over the age of 22 and not intended for those already diagnosed with certain heart conditions. They also included a special note dictating that the functions are not intended to be used to “replace traditional methods of diagnosis or treatment.”

This verbiage is notable given the potential implications similar restrictions could have on glucose monitoring smartwatches.

Even if FDA clearance is granted for the new Apple or Samsung watches, they are unlikely to be the diabetes-miracle devices the diabetic community is hoping for.

How They’ll Work

As the development of both of these products has been tightly guarded, we can only speculate on how they will work.

The most likely method would be some form of optical functionality.

Quantum Operation, a Japanese startup, recently revealed its smartwatch prototype, which is able to measure blood glucose levels using a small optical spectrometer.

Similarly, Samsung has, in the past, released research findings focused on Raman spectroscopy.

This method of identifying molecules relies on wavelengths reflected by the vibrations of molecules in the presence of a laser light. It appears plausible that this technique could be used to measure blood glucose levels using a monochromatic light and a sensor capable of interpreting the feedback.

A spectrometer of one type or another is the most likely method to be utilized by both these watches, given the broad customer base being targeted. But there are other possibilities, including a sticky skin tag powered and read by the watch that senses interstitial glucose levels.

Who They’ll Work For

Regardless of how these ingenious watches will work, we must return to the restrictions likely to be imposed by regulating bodies in order to keep our expectations in check.

Despite many claims to the contrary, these smartwatches are unlikely to replace current continuous glucose monitors and finger sticks anytime soon. (Even if they do come out when expected.)

As with the Apple Watch EKG and irregular heart rhythm monitor, it is unlikely that these glucose readers will be cleared for use in treating those who have already been diagnosed with diabetes.

Certainly, those living with diabetes could take advantage of the ease of use of these products, especially those who cannot afford true continuous glucose monitors. But it remains to be seen how accurate the products themselves will be. And given that these watches do not go through the same rigorous trials as true medical devices, we are unlikely to have a clear picture of their accuracy without trying them out ourselves.

It is much more likely that these products will be useful as a background monitoring device for non-diabetics at risk of developing type 2. When used in this way, the accuracy of each reading would not be as important as the overall glucose trends reported.

Hoping for the Future

While it is unlikely these glucose monitoring smartwatches will do much to relieve the diabetes management burden felt by the hundreds of millions of people living with this condition worldwide, it is still a step in the right direction.

The technologies developed by these tech-gadget businesses provide a roadmap for true diabetes technology companies to follow. 

While we are hopeful to see at least one glucose monitoring smartwatch released in 2021, we are much more excited about the slew of advanced, highly accurate, burden-reducing medical glucose monitoring devices that will inevitably follow.

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