Updated February 22nd, 2024 at 10:29 IST

FDA warns users to avoid smartwatches claiming to measure blood glucose

No smartwatch or smart ring designed to measure or estimate blood glucose values non-invasively has received FDA authorisation.

Reported by: Business Desk
Representative | Image:Unsplash
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FDA’s Smartwatch warning: The United States Food and Drug Administration (FDA) has issued a warning advising consumers against the use of smart watches or smart rings claiming to measure blood glucose levels through non-invasive methods. The FDA highlights that these devices, which purportedly monitor blood sugar without the need for skin pricks, can lead to inaccuracies in diabetes management, potentially resulting in incorrect medication dosages.

No smartwatch or smart ring designed to measure or estimate blood glucose values non-invasively has received FDA authorisation, clearance, or approval. While continuous glucose monitoring devices (CGMs) exist, which transmit data through smartwatch apps, the FDA has not sanctioned any non-invasive blood glucose monitoring devices.

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Although there are reports of Apple exploring the development of an Apple Watch capable of non-invasively measuring blood glucose levels, such a device is still in the conceptual stage and not expected to launch for several years. Other companies are also researching similar technologies, but no proven and FDA-approved method for non-invasive blood sugar monitoring is currently available on the market.

The FDA's warning extends to numerous low-cost smart watches and smart rings that claim to monitor glucose levels without requiring skin pricks or integration with CGM devices. Patients are advised to steer clear of these unauthorised devices, while healthcare professionals should caution patients about the risks associated with their use.

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Various companies manufacture these smartwatches and smart rings, selling them under multiple brand names. The FDA underscores that its communication applies to all smart watches or smart rings making claims of blood glucose monitoring without skin penetration, regardless of the manufacturer or brand.

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Published February 22nd, 2024 at 10:29 IST