Smartwatches and rings that claim to measure blood sugar levels for medical purposes without piercing the skin may very well be dangerous and needs to be avoided, the U.S. Food and Drug Administration warned Wednesday.
The caution applies to any watch or ring, regardless of brand name, 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, equivalent to continuous glucose monitoring systems that measure blood sugar directly.
Roughly 37 million Americans have diabetes. Individuals with the disease aren’t in a position to effectively regulate their blood sugar because their bodies either don’t make enough of the hormone insulin or they’ve turn into immune to insulin.
To administer the condition, they have to frequently check their blood sugar levels with a finger prick blood test or with a sensor that places needles just below the skin to watch glucose levels repeatedly.
Using the unapproved smartwatch and smart ring devices could end in inaccurate blood sugar measurements, with “potentially devastating” consequences, said Dr. Robert Gabbay, of the American Diabetes Association. That might cause patients to take the mistaken doses of medication, resulting in dangerous levels of blood sugar and possibly mental confusion, coma and even death.
Several firms 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 permits smartwatches and rings to measure metrics like heart rate and blood oxygen is just 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 equivalent to tears, sweat and saliva will not be ready for prime time, either.
“It’s difficult, and I think sooner or later there shall be at the very least one scientist or engineer to unravel it,” Klonoff said.
Within the meantime, consumers who wish to measure their blood sugar accurately can purchase an FDA-cleared blood glucose monitor at any pharmacy.
“It comes all the way down to risk. If the FDA approves it, the danger could be very small,” he said. “In case you use a product that is just not cleared by the FDA, fairly often the danger could be very large.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely accountable for all content.
Smartwatches and rings that claim to measure blood sugar levels for medical purposes without piercing the skin may very well be dangerous and needs to be avoided, the U.S. Food and Drug Administration warned Wednesday.
The caution applies to any watch or ring, regardless of brand name, 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, equivalent to continuous glucose monitoring systems that measure blood sugar directly.
Roughly 37 million Americans have diabetes. Individuals with the disease aren’t in a position to effectively regulate their blood sugar because their bodies either don’t make enough of the hormone insulin or they’ve turn into immune to insulin.
To administer the condition, they have to frequently check their blood sugar levels with a finger prick blood test or with a sensor that places needles just below the skin to watch glucose levels repeatedly.
Using the unapproved smartwatch and smart ring devices could end in inaccurate blood sugar measurements, with “potentially devastating” consequences, said Dr. Robert Gabbay, of the American Diabetes Association. That might cause patients to take the mistaken doses of medication, resulting in dangerous levels of blood sugar and possibly mental confusion, coma and even death.
Several firms 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 permits smartwatches and rings to measure metrics like heart rate and blood oxygen is just 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 equivalent to tears, sweat and saliva will not be ready for prime time, either.
“It’s difficult, and I think sooner or later there shall be at the very least one scientist or engineer to unravel it,” Klonoff said.
Within the meantime, consumers who wish to measure their blood sugar accurately can purchase an FDA-cleared blood glucose monitor at any pharmacy.
“It comes all the way down to risk. If the FDA approves it, the danger could be very small,” he said. “In case you use a product that is just not cleared by the FDA, fairly often the danger could be very large.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely accountable for all content.
