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Apple Watch app aims to monitor glucose levels to help people with diabetes

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David Sims/Apple
The line between a medical device and a health-focused wearable is about to get much blurrier. Over the past year, Apple met with the Food and Drug Administration to ensure that its first wearable doesn’t face tough government regulation. Based on the FDA’s most recent guidelines for wearable regulation, it seems the company has succeeded. However, many health-focused companies are working on apps that are intended to help people with chronic health issues stay on top of their well-being.

The most recent Apple Watch app to come out of the woodwork isn’t from Uber or Tesla, it’s from a medical device maker named DexCom. DexCom has created a continuous glucose monitoring device that can be incorporated into the Apple Watch and linked up with an app on the device, reports the Wall Street Journal. DexCom’s monitor places a sensor that’s as wide as a human hair under the skin to measure glucose every five minutes. The company’s app then converts all the data collected by the Apple Watch and DexCom’s sensor into a simple graph that illustrates blood sugar levels, so the wearer knows that they are in the safe range.

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The app will be ready to go when the Apple Watch debuts in April, so long as it receives FDA approval. Luckily, getting a mobile app that registers data from a certified medical device through the FDA is relatively easy. The app simply needs to register with the FDA, and doesn’t need marketing approval ahead of time. DexCom’s glucose sensors are still Class III devices, but since those kinds of devices are the most heavily monitored by the FDA already, the company’s app will go through much less scrutiny before landing on the Apple Watch. The company already has iOS and Android apps that monitor glucose levels.

Seeing as 29 million Americans have diabetes, DexCom’s app could make the Apple Watch a must-have device for those with the most serious type of diabetes. If DexCom’s app is any indication, the Apple Watch may end having all the powers of a medical device, without having to jump through any of the hoops medical devices have to go through.

Malarie Gokey
Former Digital Trends Contributor
As DT's Mobile Editor, Malarie runs the Mobile and Wearables sections, which cover smartphones, tablets, smartwatches, and…
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Apple and Samsung — the two titans of the smartwatch industry — are chasing a new feature that would allow a smartwatch to measure the glucose levels in your blood. But the U.S. Food and Drug Administration (FDA)  is already concerned about misleading marketing tactics, even though the feature is yet to appear on a commercially available smartwatch from a well-known brand.
“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” says the regulatory agency. As such, the agency has asked users that they should refrain from buying or using smartwatches or rings that claim to measure the sugar levels in the bloodstream. 
Right now, there are medical-grade devices out there that can measure blood glucose levels, but most of them rely on an invasive method where a small puncture is required to draw out a blood sample and then analyze it. Noninvasive blood glucose monitoring has remained elusive so far, especially in a miniaturized form that is suitable for smartwatches.

In 2020, Samsung announced that it had developed a noninvasive method for blood glucose level measurement in partnership with the Massachusetts Institute of Technology (MIT). Samsung didn’t specify whether the tech would make its way to a smartwatch, but multiple reports claimed that Samsung is exploring the tech for its smartwatches. 
Apple, on the other hand, is also said to be working toward the same goal. Rumors suggest that noninvasive blood glucose level analysis could arrive as a marquee new addition for the t10th-generation Apple Watch slated to hit the shelves later this year. 
Assuming the tech eventually makes it to the market later this year, it would start a mad race where every player would want to advertise that health facility for their own product. And that would mean misleading marketing claims, which is already a worrisome reality. It seems the FDA has already braced for the onslaught and has, therefore, made it clear that it hasn’t certified any such tech -- from Apple or any other consumer electronics brand whatsoever. 

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I was pre-diabetic since my college years (it runs in both sides of my family), but then my doctor officially diagnosed me with Type 2 diabetes around early 2018. However, I was told that my case was more “mild” than others and that taking some medication — while also cutting out carbs and sweets, plus daily exercise — can help me keep it under control.

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