The US Food and Drug Administration (FDA) does not want consumers to buy or use smartwatches or smart rings that claim to measure blood glucose levels using non-invasive methods. In a safety warning issued this week, the FDA said smart devices that claim to check blood sugar levels without pricking the skin can lead to errors in diabetes treatment, including taking too much or too little medication.
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No smart watch or ring type devices designed to non-invasively measure or estimate blood glucose values have been approved or cleared by the FDA. These non-invasive devices differ from continuous glucose monitoring (CGM) devices, which transmit data through a smartwatch app.
Company Apple reportedly working on a watch version Apple Watch, which will be able to non-invasively measure blood glucose levels, but the launch of such a device is still several years away. Company Apple is investigating optical absorption spectroscopy, which uses a laser to shine under the skin to detect blood glucose levels, but as of 2023, the company's work remains Apple in the proof-of-concept phase.
There are several inexpensive smartwatches and smart rings on the market today that claim to be able to monitor glucose levels without needing a skin prick or integration with a CGM device. According to the FDA, patients should avoid such devices and physicians should warn patients about the risks of using unauthorized blood glucose monitoring products.
“Vendors of these smart watches and smart rings claim that their devices measure blood glucose levels without people having to prick their finger or pierce their skin. They claim to use non-invasive techniques. These smartwatches and smart rings do not directly test blood glucose levels.
These smartwatches and smart rings are manufactured by dozens of companies and sold under different brands. This safety notice applies to all smart watches or smart rings that claim to measure blood glucose levels without piercing the skin, regardless of manufacturer or brand.”
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The FDA says it is working to ensure that manufacturers, distributors and retailers do not sell unauthorized smartwatches or smart rings that claim to measure blood glucose levels.
So if the company Apple sononec will release the watch Apple Watch, which will include a sensor for non-invasive blood glucose monitoring, will need to get FDA approval before they can be sold in the US. Other companies, such as Samsung, are working on similar technology, but there is currently no proven and approved method of non-invasive blood sugar monitoring on the market. It is therefore a big question how to Apple Watch The FDA has built
