“Smart” Devices to Measure Blood Sugar Can Pose Danger

The U.S. Food and Drug Administration (FDA) is 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. Such devices claim to use non-invasive techniques, but they in fact do not directly test blood glucose levels. They are manufactured by dozens of companies and sold under multiple brand names. These devices are different from 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. The FDA warns that 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’s recommendations: Buy only devices that have been reviewed and approved by the FDA. And talk to your health care provider about devices that can meet your needs.