FDA Warning: Avoid Non-Invasive Blood Sugar Monitoring Devices

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FDA Warning: Avoid Non-Invasive Blood Sugar Monitoring Devices

FDA Warning: Avoid Non-Invasive Blood Sugar Monitoring Devices

FDA warns consumers not to use smartwatches or rings claiming to measure blood sugar levels.

The U.S. Food and Drug Administration (FDA) is advising consumers against buying or using smartwatches or smart rings that claim to measure blood sugar levels using non-invasive methods.

In a safety alert issued on February 21, the FDA stated that smart devices claiming to detect blood sugar without puncturing the skin could lead to errors in diabetes management, including taking too much or too little medication.

Currently, there are no smartwatches or smart rings authorized, cleared, or approved by the FDA for measuring or estimating non-invasive blood sugar values. These non-invasive devices are distinct from continuous glucose monitoring (CGM) devices that transmit data through smartwatch applications.

Apple is reportedly developing an Apple Watch version that can measure blood sugar non-invasively, but the launch of such a device is still several years away. Apple has been exploring the use of laser light to measure blood sugar levels subcutaneously, but as of 2023, Apple’s work remains in the concept verification stage.

Several low-cost smartwatches and smart rings claim to monitor blood sugar levels without puncturing the skin or integrating with CGM devices. The FDA advises patients to avoid using such devices, and doctors should also warn patients about the risks of using unauthorized blood sugar measurement products.

The sellers of these smartwatches and smart rings claim that their devices can measure blood sugar levels without people having to puncture their fingers or pierce their skin. They claim to use non-invasive technology. These smartwatches and smart rings do not directly test blood sugar levels.

These smartwatches and smart rings are manufactured by dozens of companies and sold under multiple brand names. This safety alert applies to any smartwatch or smart ring claiming to measure blood sugar without puncturing the skin, regardless of the manufacturer or brand.

The FDA states that it is working to ensure that manufacturers, distributors, and sellers do not illegally sell unauthorized smartwatches or smart rings that claim to measure blood sugar levels.

If Apple’s eventual release of the Apple Watch includes a non-invasive blood sugar monitoring sensor, Apple would need to obtain FDA approval to sell the product in the United States. Other companies such as Samsung are also developing similar technology, but there are currently no mature and approved non-invasive blood sugar monitoring methods on the market.