x

Sciences

FDA Warns against Smartwatches and Rings that Claim to Measure Blood Sugar without Needles

February 21, 2024

SILVER SPRING, Md – 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.

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.”

RELATED

HONOLULU  — The Hawaii attorney general's office must pay attorney fees for using last year's Maui wildfire tragedy to file a petition in “bad faith” that blamed a state court judge for a lack of water for firefighting, Hawaii's Supreme Court ruled.

Top Stories

Columnists

A pregnant woman was driving in the HOV lane near Dallas.

General News

NEW YORK – Meropi Kyriacou, the new Principal of The Cathedral School in Manhattan, was honored as The National Herald’s Educator of the Year.

Video

9 Are Facing Charges in What Police in Canada Say is the Biggest Gold Theft in the Country’s History

TORONTO (AP) — Police said nine people are facing charges in what authorities are calling the biggest gold theft in Canadian history from Toronto’s Pearson International airport a year ago.

HONOLULU  — The Hawaii attorney general's office must pay attorney fees for using last year's Maui wildfire tragedy to file a petition in “bad faith” that blamed a state court judge for a lack of water for firefighting, Hawaii's Supreme Court ruled.

Allman Brothers Band co-founder and legendary guitarist Dickey Betts dies at 80 Dickey Betts, who died Thursday at age 80, really was born a ramblin’ man.

NEW YORK  — New York police removed a pro-Palestinian protest encampment at Columbia University on Thursday and arrested more than 100 demonstrators, including the daughter of a prominent Minnesota congresswoman.

ATHENS - The special 'Easter Basket,' which offers traditional Easter foods at lower or unchanged prices, will come into effect from April 24 to May 4.

Enter your email address to subscribe

Provide your email address to subscribe. For e.g. [email protected]

You may unsubscribe at any time using the link in our newsletter.