The Food and Drug Administration (FDA) has issued a warning to patients about the risks of using smartwatches and smart rings that claim to measure blood sugar levels noninvasively, without piercing the skin. This caution comes in light of the discovery that numerous wearables, produced by a variety of companies and sold under many brand names, are being marketed with these claims, despite none having received FDA authorization for noninvasive blood glucose monitoring. The agency has expressed concern over the potential for inaccurate readings from these devices, which could lead to serious mismanagement of diabetes, including incorrect medication dosing that may result in severe health consequences like mental confusion, coma, or even death.
This development is notable against the backdrop of major tech companies like Samsung, Apple, and Google’s life sciences division, Verily, exploring noninvasive glucose monitoring technologies, with varying degrees of success. For instance, Verily’s project to develop a glucose-measuring contact lens was halted in 2018 due to inconsistent results. Despite these challenges faced by industry giants, lesser-known brands have been found selling purported glucose-monitoring wearables for under $50, raising concerns over their legitimacy and safety.
The FDA has not only advised consumers against purchasing these unverified products but also emphasized the absence of any safety and effectiveness review. Healthcare providers are encouraged to discuss the risks associated with these unauthorized devices with their patients, and the FDA urges reporting of any adverse events or inaccurate blood sugar readings linked to these wearables. Furthermore, the agency is taking steps to prevent the illegal marketing of these products, underscoring its commitment to patient safety and the regulation of medical devices.