The U.S. Food and Drug Administration (FDA) Warns consumers not to purchase or use products that claim to use non-invasive methods to measure blood glucose levelssmartwatchOr a smart ring.
Smart devices that claim to check blood sugar without pricking the skin may lead to poor diabetes management, such as taking too much or too little medication, the FDA said in a safety warning issued today.
No smartwatch or smart ring claiming to non-invasively measure or estimate blood glucose has been authorized, approved or licensed by the FDA.Available. These non-invasive devices are different from continuous glucose monitoring (CGM) devices that deliver data through a smartwatch app.
Apple is rumored to be working on a version of the Apple Watch that can non-invasively measure blood sugar, but it will still be years before the device is available. Apple has been exploring optical absorption spectroscopy technology that uses a laser to illuminate the subcutaneous area to determine blood glucose levels, but as of 2023, the program is still in the proof-of-concept stage.
Inexpensive smartwatches and smart rings claiming to monitor blood glucose levels without the need for a fingertip blood prick or integration with a CGM device are currently available on the market.FDA urges patients to avoid the use of such devices and advises physicians to inform their patients of the risks of using unauthorized glucose-measuring products.FDA also recommends that patients be informed of the risks of using unauthorized glucose-measuring products.
Sellers of these smartwatches and smart rings claim that their devices measure blood sugar levels without people having to prick their fingers or pierce their skin, and they claim to use non-invasive technology. But in reality, these smartwatches and smart rings do not directly detect blood sugar levels.
These smartwatches and smart rings are manufactured by dozens of companies and sold under a variety of brand names. This safety notice applies to any smartwatch or smart ring that claims to measure blood glucose without piercing the skin, regardless of the manufacturer or brand.
The FDA says they are 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 eventually releases an Apple Watch with a non-invasive glucose-monitoring sensor, it would need to get FDA approval before the product could be marketed in the United States. Other companies, such as Samsung, are working on similar technologies, but there are currently no proven and approved non-invasive methods of blood glucose monitoring on the market.