The FDA just approved an iPhone-powered blood glucose monitor as Apple Watch sugar-sensing plan continues

The Health App shown on an Apple iPad
(Image credit: Apple)

There have been ongoing rumors that Apple intends to add support for monitoring blood glucose levels with the release of a future Apple Watch but so far it's a feature that the company simply hasn't been able to make happen. Now, it seems that the closest thing that we're going to get is a third-party device that can offer the same functionality and connect to an iPhone via Bluetooth — and now it's here without the need for a prescription first.

A future Apple Watch feature?

Following an FDA assertion that any smartwatch that claims to be able to measure blood glucose levels is simply lying, the same outfit has now given the go-ahead for Dexcom's Stelo Glucose Biosensor System to be offered without the need for a prescription. The product connects to an iPhone via Bluetooth and while the FDA says that it isn't intended for use by people who have been diagnosed with low blood sugar or have been prescribed insulin, it's still likely to be of use for those who are non-insulin-dependent diabetics.

"The Stelo Glucose Biosensor System uses a wearable sensor, paired with an application installed on a user’s smartphone or other smart device, to continuously measure, record, analyze and display glucose values in people 18 years and older that are not on insulin and who do not have problematic hypoglycemia," the FDA explains. "Users can wear each sensor up to 15 days before replacing with a new sensor. The device presents blood glucose measurements and trends every 15 minutes in the accompanying app."

However, the FDA also notes that "users should not make medical decisions based on the device’s output without talking to their healthcare provider."

The device does appear to be accurate, which is a key factor for anything like this of course. "Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs," the FDA says. "Adverse events reported in the study included local infection, skin irritation, and pain or discomfort."

Of course, non-invasive blood sugar measurement devices are the main aim for companies right now and that's exactly what Apple wants to offer with a future Apple Watch product. There have been persistent rumors of such a thing being on Apple's roadmap but so far it has not been able to make the product work in a way that would be acceptable.

It's likely that we will one day see an Apple Watch capable of monitoring a wearer's blood glucose levels but it's something that seems to be years away from launch. That means that we're highly unlikely to see it arrive in 2024 alongside the release of the so-called Apple Watch X.

The FDA previously made a lot of noise about how unreliable smartwatches are in terms of measuring blood glucose as Reuters reported last month. The health regulator warned that it was "working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized gadgets that claim to measure blood glucose levels."

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Oliver Haslam
Contributor

Oliver Haslam has written about Apple and the wider technology business for more than a decade with bylines on How-To Geek, PC Mag, iDownloadBlog, and many more. He has also been published in print for Macworld, including cover stories. At iMore, Oliver is involved in daily news coverage and, not being short of opinions, has been known to 'explain' those thoughts in more detail, too.

Having grown up using PCs and spending far too much money on graphics card and flashy RAM, Oliver switched to the Mac with a G5 iMac and hasn't looked back. Since then he's seen the growth of the smartphone world, backed by iPhone, and new product categories come and go. Current expertise includes iOS, macOS, streaming services, and pretty much anything that has a battery or plugs into a wall. Oliver also covers mobile gaming for iMore, with Apple Arcade a particular focus. He's been gaming since the Atari 2600 days and still struggles to comprehend the fact he can play console quality titles on his pocket computer.