FDA: Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels

[Eddy Edson]

Smartwatches, Rings Claiming to Measure Glucose are not FDA-Authorized

Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose

www.fda.gov

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• Do not buy or use smartwatches or smart rings that claim to measure blood glucose levels. These devices may be sold through online marketplaces or directly from the seller.
• Be aware that the safety and effectiveness of these devices have not been reviewed by FDA, and the use of these devices could result in inaccurate measurements of blood glucose levels.

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Device Description​

Sellers of these smartwatches and smart rings claim their devices measure blood glucose levels without requiring people to prick their finger or pierce the 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 multiple brand names. This safety communication applies to any smartwatch or smart ring that claims to measure blood glucose without piercing the skin, regardless of manufacturer or brand.

FDA Actions​

The FDA routinely monitors the medical device market and became aware of unauthorized products being marketed to consumers. The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels. Additionally, the FDA is alerting consumers about this issue and making the public aware that smartwatches and smart rings should not be used to measure blood glucose levels.

The FDA will keep the public informed if significant new information becomes available.

 

[everydayupsanddowns]

There was a spate of advertising on the UK recently, which led to a Diabetes UK statement very much along the same lines, and drawing distinctions between approved and regulated CGM (glucose data from some of which can be viewed on smartwatches), and these unregulated devices.

Diabetes UK put this response together after a number of enquiries:

• There is currently no regulation for this technology to be tested for accuracy in the same way that glucose sensors (CGM and Flash) are.
• Where accuracy data is available and from customer reviews, this technology does not currently provide accurate enough data (especially for anyone living with type 1 diabetes)
• People should continue to use the blood glucose monitoring equipment supplied by their diabetes teams.
• If an individual with type 2 diabetes is considering purchasing one as a guide, they should discuss this with their diabetes healthcare professional. We should also make them aware of this GOV.UK webpage - Know what you're buying! which has information to help people buy medicines and medical devices online safely. Please note – this is not an endorsement of buying medicines/medical devices online – it is information on what people should look out for and check when looking at these products online
• We would not recommend purchasing as a gift for a friend with diabetes