FDA safety warning: do not use smartwatches or smart rings to measure blood glucose

FDA safety warning: do not use smartwatches or smart rings to measure blood glucose

Yesterday the FDA issued a safety communication warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin. These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs). 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.

“For people with diabetes, inaccurate blood glucose measurements can lead to errors in diabetes management, including taking the wrong dose of insulin, sulfonylureas, or other medications that can rapidly lower blood glucose. Taking too much of these medications can quickly lead to dangerously low glucose, leading to mental confusion, coma, or death within hours of the error,” the FDA wrote in a safety communication on its website.

The agency stated that the smartwatches and smart rings are made by dozens of companies and sold under multiple brand names. FDA’s safety communication applies to any smartwatch or smart ring that claims to measure blood glucose without piercing the skin, regardless of manufacturer or brand. 

Read the full patient safety communication on FDA’s website.