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FDA warns physicians, patients about false claims of devices that can lead to inaccurate data about blood glucose.
Your patient’s smart device may have the latest technology, but it’s not smart enough to detect blood sugar without piercing the skin.
The U.S. Food and Drug Administration (FDA) this month warned physicians, other clinicians and patients that smartwatches and rings wrongly may claim to measure blood glucose levels by reacting to the skin’s surface. Those devices are different from smartwatch applications that display data from continuous glucose monitors (CGMs) that are approved by the FDA and that go more than skin deep.
Currently the suspect devices are made by dozens of companies selling them under multiple brand names, according to FDA. The administration said its safety warning applies to all of them.
“Sellers of these smartwatches and smart rings claim their devices measure blood glucose levels without requiring people to prick their finger or pierce the skin,” the FDA safety warning said. “They claim to use noninvasive techniques. These smartwatches and smart rings do not directly test blood glucose levels.”
This slideshow includes recommendations for physicians and other clinicians, along with consumers, patients, and their caregivers.
FDA also makes available its MedWatch medical product safety reporting program. That website is available here.