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Your Position: Home - - No, smartwatches and smart rings can't measure blood ...

No, smartwatches and smart rings can't measure blood ...

Author: Evelyn

May. 06, 2024

No, smartwatches and smart rings can't measure blood ...

If you see a smartwatch or smart ring for sale that claims to noninvasively measure your blood glucose levels, don’t believe it. Today, the Food and Drug Administration has issued a safety communication that warns consumers, patients, and healthcare professionals that the agency has “not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.”

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To be crystal clear, no major wearable maker has a smartwatch or smart ring that’s currently capable of this. The most any Apple Watch, Fitbit, Samsung watch, or Oura Ring can do is support integrations with an FDA-authorized continuous glucose monitor (CGM), which are wearable devices that use needles to read blood sugar levels. These integrations allow users to monitor data gathered from connected CGMs that have companion smartphone apps. The Dexcom G7 is one such device.

Instead of those well-known wearables, the FDA’s warning seems to target scammy devices making unsubstantiated claims.

Unfortunately, you can find unscrupulous companies at trade shows like CES hawking smart rings and smartwatches that claim to take noninvasive blood glucose measurements. These companies then sell these devices directly on their websites, through crowdfunded campaigns, or on online marketplaces like Alibaba. If you do see companies selling such devices, the FDA urges consumers to report the issue through its MedWatch Voluntary Reporting Form.

The timing of the FDA’s safety communication makes sense, given the increased coverage surrounding this tech. Apple purportedly has a secret team that’s been working on this for close to a decade. Samsung also has researchers exploring blood glucose monitoring tech. Occasionally, you’ll find misleading headlines that make it seem like otherwise reputable wearable brands can already measure blood glucose. That does not change the fact that the FDA has never granted authorization to any smartwatch or smart ring for this purpose. While there has been some promising progress in the wearable space, we are still several years away from a device that would be ready for healthcare settings, let alone consumers.

It bears repeating that you should be skeptical of any wearable claiming to have FDA approval. In general, smartwatches and smart rings can have FDA-cleared features (i.e., EKGs and atrial fibrillation detection), but they are not considered medical devices and shouldn’t be treated as such.

FDA warns against smartwatches, rings that claim to ...

Smartwatches and rings that claim to measure blood sugar levels for medical purposes without piercing the skin could be dangerous and should be avoided, the U.S. Food and Drug Administration warned Wednesday.

The caution applies to any watch or ring, regardless of brand, that claims to measure blood glucose levels in a noninvasive way, the agency said. The FDA said it has not authorized any such device.

The agency's notice doesn't apply to smartwatch apps linked to sensors, such as continuous glucose monitoring systems that measure blood sugar directly.

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Roughly 37 million Americans have diabetes. People with the disease aren't able to effectively regulate their blood sugar because their bodies either don't make enough of the hormone insulin or they have become resistant to insulin.

To manage the condition, they must regularly check their blood sugar levels with a finger prick blood test or with a sensor that places needles just under the skin to monitor glucose levels continuously.

Using the unapproved smartwatch and smart ring devices could result in inaccurate blood sugar measurements, with "potentially devastating" consequences, said Dr. Robert Gabbay, of the American Diabetes Association. That could cause patients to take the wrong doses of medication, leading to dangerous levels of blood sugar and possibly mental confusion, coma or even death.

Several companies are working on noninvasive devices to measure blood sugar, but none has created a product accurate and secure enough to get FDA approval, said Dr. David Klonoff, who has researched diabetes technology for 25 years.

The technology that allows smartwatches and rings to measure metrics like heart rate and blood oxygen is not accurate enough to measure blood sugar, said Klonoff, of the Sutter Health Mills-Peninsula Medical Center in San Mateo, California. Efforts to measure blood sugar in body fluids such as tears, sweat and saliva are not ready for prime time, either.

"It's challenging, and I believe at some point there will be at least one scientist or engineer to solve it," Klonoff said.

In the meantime, consumers who want to measure their blood sugar accurately can buy an FDA-cleared blood glucose monitor at any pharmacy.

"It comes down to risk. If the FDA approves it, the risk is very small," he said. "If you use a product that is not cleared by the FDA, very often the risk is very large."

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