February 22, 2024 – The FDA warns against the usage of smartwatches and rings that claim to have the opportunity to measure an individual's glucose levels without piercing the skin.
The warning doesn’t apply to authorized smartwatch applications that display values from an FDA-cleared continuous glucose monitor with a sensor implanted under the skin.
Rather, the warning applies to watches or rings sold through online marketplaces or directly from sellers who claim the devices measure blood sugar without the wearer having to prick their finger or prick their skin. These products are manufactured by dozens of firms and sold under many alternative brand names. The FDA's warning applies to everyone, although the agency hasn't named any specific firms or brand names to observe out for.
These devices haven’t been evaluated by the FDA for safety and effectiveness, and their use in diabetics could lead to false blood glucose readings, with potentially serious consequences when used for medication dosing.
“The FDA has not approved, approved, or approved any smartwatch or smart ring designed to self-measure or estimate blood glucose levels,” the agency said in an announcement released Wednesday.
They add: “The agency is working to ensure that manufacturers, distributors and sellers do not market illegal smartwatches or smart rings that claim to measure blood sugar levels.”
Anyone who experiences problems with inaccurate blood glucose measurement or experiences adversarial events while using an unauthorized smart watch or smart ring is urged to report it to the FDA MedWatch program.