The agency has warned that no device has been approved that can accurately measure a user’s blood sugar levels without puncturing the skin.
Federal regulators are pressing the pause button on digital medical advances for diabetes care management.
The U.S. Food and Drug Administration (FDA) has issued a safety warning stating that smart watches and smart rings that claim to measure a user’s blood sugar levels without puncturing the skin are unreliable and should not be trusted.
“FDA has not cleared, authorized, or approved any smart watch or smart ring that is intended to independently measure or estimate blood glucose levels,” the agency said.
Approximately 38.4 million Americans live with diabetes, according to a 2021 report from the American Diabetes Association (ADA), and experts believe the population is the nation’s fastest-growing chronic care population. It states that. Care management includes monitoring blood sugar levels throughout the day and taking immediate action (such as insulin injections) if blood sugar levels exceed a certain range. High or low blood sugar levels can lead to serious health problems, including coma and death.
[See also: Future Samsung smartwatches might keep tabs on glucose levels without any needles.]
Advances in digital health have significantly improved diabetes care management over the past two decades. This includes wearable sensors that can track blood sugar levels and administer insulin when needed, as well as AI-enhanced tools that can identify trends before blood sugar levels become dangerous or rise. . Noticed.
The industry has been working to develop wearables that can accurately measure blood sugar levels without puncturing the skin, but the technology is not yet complete.
“FDA regularly monitors the medical device market and has become aware that unauthorized products are being sold to consumers,” the agency said in the alert. “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally sell unapproved smart watches and smart rings that purport to measure blood sugar levels. Additionally, the FDA is warning consumers about this issue. , we are reminding the public that smart watches and smart rings should not be used to measure blood sugar levels.”
Eric Wicklund is an associate content manager and senior editor for Innovation, Technology, and Pharma for HealthLeaders.
