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The FDA has issued a new safety alert for smartwatch enthusiasts relying on their devices to monitor their health and potentially detect common conditions, including diabetes.
The government agency warns consumers that they should steer clear of wearable smart devices that claim to detect blood glucose levels without actually penetrating a user’s skin — potentially misleading tech that could have serious health consequences for those relying on consistent monitoring.
“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 wrote. “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. They claim to use non-invasive techniques. These smartwatches and smart rings do not directly test blood glucose levels.”
According to the agency, unmonitored use of such devices could carry more risk for those with serious conditions. “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.”
Currently, there is no smart device on market that offers noninvasive blood glucose monitoring, but many tech companies are rumored to be exploring the possibility.
Last year, insiders reported that Apple was on the path to launching a series of innovative new health features for its line of Apple Watches, including new blood glucose monitoring tech that utilizes a noninvasive light that shines through a wearer’s skin to detect glucose levels. The feature is reportedly advertised as a non-treatment, non-diagnostic tool for those who are not already diabetic.
In January, Samsung announced plans to explore a similar non-invasive blood glucose monitoring for its line of wearables, including Galaxy Watches. In an interview with Bloomberg, Samsung’s mobile digital health chief, Hon Pak, explained that its part of a competitive industry push: “We can do continuous blood pressure and glucose, we’re in a whole different ballgame. I think that’s where everyone is trying to get to. We’re putting significant investment toward that.”
The FDA still approves of individuals using smart devices in conjunction with tested tech that does pierce the skin, including continuous glucose monitoring devices (CGMs), and urges health care providers to inform patients on the risks of using unauthorized blood glucose measuring devices.
The FDA asks consumers to report any inaccurate blood glucose measuring, adverse affects, or unauthorized devices using the agency’s MedWatch Voluntary Reporting Form.
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The FDA issued new guidance for consumers interested in using smartwatches to monitor their blood glucose levels, warning that devices that don’t pierce your skin are ineffective.
