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| AP |
Smartwatches and rings claiming to measure blood sugar levels for medical purposes without piercing the skin could be dangerous and should be avoided, warned the U.S. Food and Drug Administration (FDA) on Wednesday.
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The warning applies to any watch or ring, regardless of the brand, claiming to measure blood glucose levels non-invasively, the agency said. The FDA noted that it has not authorized any such device.
The agency's notice does not include smartwatch applications linked to sensors, such as continuous glucose monitoring systems that directly measure blood sugar.
Approximately 37 million Americans suffer from diabetes. People with this condition are unable to effectively regulate their blood sugar because their bodies either do not produce enough insulin or have become resistant to it.
To manage the disease, they must periodically check their blood sugar levels with meters that require pricking the finger 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 unauthorized smartwatches and rings could lead to inaccurate blood sugar measurements, with potentially devastating consequences. This could cause patients to take incorrect doses of medication, resulting in dangerous blood sugar levels and possibly leading to mental confusion, coma, or even death.
Several companies are working on non-invasive devices to measure blood sugar, but none has created a product accurate and safe enough to obtain FDA approval, said Dr. David Klonoff, who has been researching diabetes technology for 25 years.
According to Klonoff, from 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. Methods for measuring blood sugar in bodily fluids like tears, sweat, and saliva are also not ready for commercial release.
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"It's a challenge, and I think at some point, there will be at least one scientist or engineer who will solve it," said Klonoff.
Meanwhile, consumers who want to accurately measure their blood sugar can purchase an FDA-approved glucose meter at any pharmacy.
"It all comes down to risk. If the FDA approves it, the risk is very small," he said. "If you use a product not authorized by the FDA, very often the risk is very large."