The FDA has advised against using smartwatches and rings that claim to test blood sugar without needles. The Indian government has not approved any noninvasive blood sugar monitoring watch or ring, and the caution applies.
The FDA warned Wednesday that smartwatches and rings that claim to test blood sugar levels for medicinal purposes without piercing the skin are unsafe.
The EPA warned against any watch or ring that claims to test blood glucose noninvasively. The FDA denied approval of such devices.
Not covered by the agency’s notice are smartwatch apps linked to sensors like continuous glucose monitoring systems that detect blood sugar directly.
About 37 million Americans have diabetes. People with the condition can’t regulate their blood sugar because they don’t make enough insulin or are insulin-resistant.
They must regularly check their blood sugar levels using a finger prick blood test or a sensor that puts needles under the skin to detect glucose levels to control the condition.
Dr. Robert Gabbay of the American Diabetes Association warned that the unapproved smartwatch and smart ring gadgets could mismeasure blood sugar, with “potentially devastating” implications. That could cause patients to take the improper medicine amounts, causing severe blood sugar levels, mental confusion, coma, or death.
Dr. David Klonoff, a 25-year diabetes technology researcher, said several companies are developing noninvasive blood sugar measurement devices, but none have achieved FDA approval.
Klonoff of Sutter Health Mills-Peninsula Medical Center in San Mateo, California, said smartwatches and rings cannot accurately detect blood sugar. Trying to measure blood sugar in tears, perspiration, and saliva is also unfinished.
“It’s challenging, and I believe at some point there will be at least one scientist or engineer to solve it,” Klonoff.
Any drugstore sells FDA-approved blood glucose monitors for precise blood sugar measurement.
“Risk is involved. He stated the danger is low if FDA authorizes it. “If you use a product that is not cleared by the FDA, very often the risk is very large.”
Conclusion
The FDA has advised against smartwatches and rings that detect blood sugar without piercing the skin. The FDA does not permit such gadgets or sensor-linked wristwatch apps. Checking blood sugar levels is essential for 37 million Americans with diabetes. Using unauthorized smartwatches and rings could lead to erroneous measures, high blood sugar levels, mental confusion, coma, or death. Despite multiple firms developing noninvasive devices, none have achieved FDA approval via accuracy.
