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The US Food and Drug Administration warned on Wednesday that smartwatches and rings claiming to measure blood sugar levels for medical purposes without piercing the skin could be dangerous and should be avoided.
This caution applies to any watch or ring, regardless of brand, that claims to measure blood sugar levels in a non-invasive manner, the agency said. The FDA said it has not authorized any such devices.
The agency’s notice does not apply to smartwatch apps attached to sensors, such as continuous glucose monitoring systems that directly measure blood sugar.
About 37 million Americans have diabetes. People suffering from this disease are not able to control their blood sugar effectively because their bodies either do not produce enough of the hormone insulin or they become resistant to insulin.
To manage the condition, they should regularly check their blood sugar levels with a finger prick blood test or a sensor that inserts a needle just under the skin to continuously monitor glucose levels.
Dr. Robert Gabay of the American Diabetes Association said the use of unapproved smartwatch and smart ring devices could lead to inaccurate blood sugar measurements, which could have “potentially devastating” consequences. Due to this, patients can take the wrong dose of the medicine, which can make the situation dangerous. blood sugar levels and possibly mental confusion, coma or even death.
Dr. David Klonoff, who has researched diabetes technology for 25 years, said several companies are working on non-invasive devices to measure blood sugar, but none have a product accurate and safe enough to get FDA approval. has made.
The technology that allows smartwatches and rings to measure metrics like heart rate and blood oxygen isn’t accurate enough to measure blood sugar, said Klonoff, of Sutter Health Mills-Peninsula Medical Center in San Mateo, California. Efforts to measure blood sugar in body fluids like tears, sweat and saliva also aren’t ready for prime time.
“It is challenging, and I believe there will be at least one scientist or engineer to solve it at some point,” Klonoff said.
In the meantime, consumers who want to accurately measure their blood sugar can purchase an FDA-approved 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 has not been approved by the FDA, the risk is often much larger.”
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This story is published from a wire agency feed without any modifications to the text. Only the headline has been changed.
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Published: Feb 22, 2024, 08:19 am IST
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