FDA warns about smartwatches that claim to measure blood sugar without needles

The 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 (FDA) has warned.

The warning applies to any watch or ring, regardless of brand, that claims to measure blood glucose levels non-invasively, the agency said. The FDA noted that it has not authorized any such device.


The agency’s advisory does not include smartwatch apps linked to sensors, such as continuous glucose monitoring systems that directly measure blood sugar.

About 37 million Americans have diabetes. The people that suffer from this disease They are not able to effectively regulate their blood glucose because their body does not produce enough insulin or has become resistant to it.


To control the disease, they should periodically check their blood sugar levels with meters that require drawing blood through a finger prick or with a sensor that places needles just under the skin to continuously monitor glucose levels.

According to Dr. Robert Gabbay of the American Diabetes Association, the use of non-approved smart watches and rings could lead to inaccurate blood glucose measurements, with “potentially devastating” consequences. That could cause patients to take the wrong doses of medication, leading to dangerous blood sugar levels and possibly mental confusion, coma or even death.


Several companies are working on non-invasive devices to measure blood glucose, but none have created a product accurate and safe enough to win FDA approval, said Dr. David Klonoff, who has been researching diabetes technology for 25 years.

According to Klonoff, of Sutter Health Mills-Peninsula Medical Center in San Mateo, California, the technology that allows smartwatches and rings to measure parameters such as heart rate and blood oxygen is not accurate enough to measure blood sugar. the blood. Methods to measure blood glucose in body fluids such as tears, sweat and saliva are also not ready for commercial launch.


“It’s a challenge, and I think 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 glucose accurately can purchase an FDA-cleared blood glucose meter at any pharmacy.

“It all comes down to risk. If the FDA approves it, the risk is very small,” she said. “If you use a product not authorized by the FDA, very often the risk is very great.”


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