The FDA says smartwatches and rings that don’t pierce the skin or prick a finder aren’t authorized for measure blood glucose levels and shouldn’t be trusted to provide accurate measurements. File Photo by peejhunt/Pixabay
Smartwatches and rings that don’t pierce the skin are unreliable when it comes to reporting blood glucose levels, the U.S. Food and Drug Administration announced Wednesday.
An FDA news release warns consumers and caregivers that smartwatches and rings that don’t pierce the skin might cause errors in managing diabetes and taking the correct dosages for various medications.
Only FDA-authorized smartwatches and rings that use measuring devices that pierce the skin to provide continuous glucose monitoring provide accurate measurement data that is reliable, according to the FDA.
“If your medical care depends on accurate blood glucose measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs,” the FDA said.
Relying on the data provided by non-authorized smartwatches and rings might lead to taking an incorrect dose of insulin, sulfonylureas or other medications designed to quickly lower blood glucose. Taking too much of the medications might cause dangerously low glucose levels in diabetics, which could cause mental confusion, a coma or death within hours, the FDA warned.
“Sellers of these smartwatches and smart rings claim their devices measure blood glucose levels without requiring people to prick their finger or pierce the skin,” the FDA said. “They claim to use non-invasive techniques,” but they “do not directly test blood glucose levels.”
Dozens of companies manufacture the devices that are sold using a variety of brand names, but none of those that don’t pierce the skin can be trusted, the FDA added.
Those who suspect they received inaccurate readings or had an adverse reaction due to bad information from an unauthorized smartwatch or ring can report the problem to the FDA by completing a MedWatch Voluntary Reporting Form online.
The reports help identify and better determine the risks associated with using the non-conforming smartwatches and rings, according to the FDA.