In the warning, the agency outlined the risks related to using smartwatches or smart rings for this purpose. Such devices may claim to measure blood glucose levels without piercing the skin. These devices are different from smartwatch applications that display data from FDA-authorized blood glucose measuring devices like CGMs.
The FDA says that, to date, it has not authorized, cleared or approved any smartwatch or smart ring intended to measure or estimate blood glucose values on its own. People with diabetes receiving inaccurate blood glucose measurements can experience errors in their diabetes management. That includes incorrect insulin dosing, sulfonylureas or other medications.
According to the FDA notice, consumers should not buy or use these devices that claim to measure blood glucose levels. Some may be sold through online marketplaces or directly from sellers. The agency wants to raise awareness that the FDA has yet to review the safety and effectiveness of these devices.
The FDA said it continues to alert consumers about the issue and raise public awareness. It plans to keep the public informed if new information becomes available.
While no device has FDA authorization, non-invasive glucose monitoring has become a target. Large tech companies like Samsung and Apple reportedly aim to offer glucose monitoring through their smart devices. Other, more diabetes-focused companies like Know Labs and Nemaura Medical, also have devices under development for this purpose. Neither have FDA authorization yet, though.
