The U.S. Food and Drug Administration (FDA) wants to caution everyone, including consumers, patients, caregivers, and healthcare providers, about the risks involved in using smartwatches or smart rings that claim to measure blood glucose levels without the need for skin piercing.
The FDA emphasizes that inaccurate readings could lead to errors in diabetes management, which could have severe consequences.
It’s crucial to note that the FDA has not approved any smartwatch or smart ring that independently measures or estimates blood glucose values without skin piercing, regardless of the manufacturer or brand.
These devices are different from smartwatch apps that display data from FDA-authorized blood glucose measuring devices that do require skin piercing, such as the continuous glucose monitoring device.
Therefore, consumers, patients, and caregivers are advised not to purchase or use smartwatches or smart rings that claim to measure blood glucose levels, as they are not reliable and could pose risks to their health.
For individuals who require accurate blood glucose measurements for medical care, it’s highly recommended to consult a healthcare provider for a suitable FDA-approved device. Healthcare providers are also encouraged to address the risks of using unauthorized blood glucose measuring devices with their patients and help them choose an FDA-approved device if needed.
Furthermore, in case of any problems related to inaccurate blood glucose measurements or adverse events from unauthorized smartwatches or smart rings, customers are urged to report them via the MedWatch Voluntary Reporting Form to improve patient safety.
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