FDA warns smart watches and rings that claim to measure blood sugar levels without needles

The U.S. Food and Drug Administration also says that rings that claim to measure blood sugar levels for medical purposes without puncturing the skin can be dangerous and should be avoided. warning on wednesday.

The warning applies to watches and rings that claim to measure blood sugar levels in a non-invasive way, regardless of brand, the agency said. The FDA said it has not approved such a device.

The agency’s notice does not apply to smartwatch apps linked to sensors such as continuous glucose monitoring systems that directly measure blood sugar levels.

Approximately 37 million Americans Diabetes. People with this disease are unable to effectively regulate blood sugar levels because their bodies do not produce enough hormones. Or you’ve become insulin resistant.

To manage this condition, you need to regularly check your blood sugar levels using a finger prick blood test or a sensor that sticks a needle just under your skin and continuously monitors your blood sugar levels. .

Dr. Robert Gabay of the American Diabetes Association says that using unapproved smartwatches or smart ring devices can result in inaccurate blood sugar readings, “with potentially devastating effects.” Stated. As a result, patients may take the wrong dose of the drug, causing dangerous levels of blood sugar levels and, in some cases, leading to mental confusion, coma, and even death.

Dr. David Klonoff, who has researched diabetes technology for 25 years, says multiple companies are working on developing non-invasive devices to measure blood sugar levels, but no product is accurate or safe enough to receive FDA approval. No company has yet developed one.

Klonoff, of Sutter Health Mills Peninsula Medical Center in San Mateo, Calif., said the technology that allows smartwatches and rings to measure metrics such as heart rate and blood oxygen is not as accurate as measuring blood sugar levels. He said no. Efforts to measure blood sugar levels in body fluids such as tears, sweat and saliva have not yet reached their peak.

“This is a difficult problem, but I believe that one day at least one scientist or engineer will be able to solve this problem,” Klonoff said.

In the meantime, consumers who want to accurately measure their blood sugar levels can purchase FDA-approved blood sugar monitors at any pharmacy.

“It comes down to risk. If the FDA approves it, the risk is very small,” he said. “The risks of using products that are not FDA-approved are often significant.”

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