The agency is warning that no devices have been approved that can accurately measure a user’s blood glucose without piercing the skin
Federal regulators are hitting the pause button on digital health advancements for diabetes care management.
The U.S. Food and Drug Administration (FDA) has issued a safety alert indicating that smartwatches or smart rings that claim to measure a user’s blood glucose levels without piercing the skin should are not reliable and should not be trusted.
“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 agency said.
Some 38.4 million Americans live with diabetes, according to a 2021 report from the American Diabetes Association (ADA), and experts say that population is the fastest growing chronic care population in the nation. Care management includes monitoring blood glucose levels throughout the day and taking immediate action (such as injecting insulin) when those levels are out of particular range. A trending high or low blood glucose level could lead to serious health issues, including coma and death.
[See also: Future Samsung smartwatches might keep tabs on glucose levels without any needles.]
Digital health advances have greatly improved care management for diabetes over the past two decades, including wearable sensors that can track blood glucose and administer doses of insulin when needed and AI-enhanced tools that can identify trending blood glucose levels before they become dangerous or are even noticed.
While the industry has been working on wearables that can accurately measure blood glucose without pricking the skin, that technology hasn’t yet been perfected.
“The FDA routinely monitors the medical device market and became aware of unauthorized products being marketed to consumers,” the agency said in its alert. “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels. Additionally, the FDA is alerting consumers about this issue and making the public aware that smartwatches and smart rings should not be used to measure blood glucose levels.”
Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, and Pharma for HealthLeaders.
KEY TAKEAWAYS
Some 38.4 million Americans live with diabetes and measure their blood glucose levels every day.
While digital health companies have made care management easier, they haven’t yet developed a device that can accurately measure blood glucose without piercing the skin.
The FDA is warning that some devices on the market may be making that claim, which puts users in danger of serious health issues, including death, if they rely on those readings.