CNN
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The U.S. Food and Drug Administration caveat Wednesday about the risks of using smart watches and smart rings that claim to measure blood sugar levels without puncturing the skin.
The FDA notes that it has not cleared or approved any smartwatch or smart ring intended to measure blood sugar levels alone. The use of these devices could lead to inaccurate measurements of blood sugar levels, also known as blood glucose levels, and potentially life-threatening diabetes management errors, authorities warned.
“If your medical care depends on accurate blood glucose measurements, talk with your health care provider about the appropriate FDA-cleared device for your needs,” the FDA said in a statement.
These unauthorized devices are different from FDA-approved smartwatch apps that display data from devices that puncture the skin and continuously monitor blood sugar levels.
The FDA did not mention specific brand names, but the sellers of these unlicensed smartwatches and smart rings are designed to help people measure their blood sugar levels without pricking their fingers or puncturing their skin. The company touted its use of “non-invasive technology.” However, these devices do not directly test blood sugar levels, authorities said, and urged consumers not to purchase the devices for that purpose.
The agency also advised health care providers to discuss with patients the risks of using unapproved blood glucose monitoring devices and help them select the appropriate approved device for their needs.
“The agency is working to prevent manufacturers, distributors, and sellers from illegally selling unlicensed smart watches and smart rings that purport to measure blood sugar levels,” the FDA said in a statement.
Consumers should be aware of any adverse events or problems caused by inaccurate blood sugar measurements due to the use of unapproved smart watches or smart rings. FDA MedWatch Voluntary Reporting Form.
