Feb. 22, 2024 -- The FDA is warning against the use of smartwatches and rings that claim to measure a person’s glucose levels without piercing the skin.
The warning doesn’t apply to authorized smartwatch applications that display levels from an FDA-approved continuous glucose monitor with a sensor implanted under the skin.
Rather, the warning pertains to watches or rings sold through online marketplaces or directly from sellers who claim that the devices measure blood sugar without requiring the wearer to prick their finger or pierce their skin. These products are manufactured by dozens of companies and sold under many different brand names. The FDA’s warning applies to all of them, although the agency did not provide specific companies or brand names to watch out for.
These devices have not been evaluated by the FDA for safety and effectiveness, and their use by people with diabetes could result in false blood glucose measurements, with potentially serious consequences if relied upon for medication dosing.
“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency said in a statement issued Wednesday.
They add, “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”
People who experience any problems with inaccurate blood glucose measurement or experience any adverse events from using an unauthorized smartwatch or smart ring are urged to report it to the FDA through its MedWatch program.
