2024-02-22 08:01:00
(CNN) — The US Food and Drug Administration (FDA) warned this Wednesday about the risks of using smart watches and rings that claim to measure blood glucose levels without piercing the skin.
The FDA notes that it has not cleared or approved any smartwatch or smart ring that is intended to measure blood glucose levels on its own. Use of these devices can lead to inaccurate measurements of blood glucose, also known as blood sugar, and errors in diabetes management that can be fatal, the agency warned.
“If your healthcare depends on accurate blood glucose measurements, talk to your healthcare provider about an appropriate FDA-cleared device for your needs,” the FDA said in a statement.
These unauthorized devices are different from smartwatch apps that display data from FDA-approved continuous glucose monitoring devices that pierce the skin.
The FDA did not name specific brands, but said sellers of these unauthorized smart watches and rings advertise the use of “non-invasive techniques” to measure blood glucose without requiring people to prick their fingers or pierce their skin. However, these devices do not directly test blood glucose levels, the agency said, urging consumers to avoid purchasing them for that purpose.
The FDA also advised healthcare providers to discuss the risk of using unauthorized devices to measure blood glucose with their patients and to help them select an approved device appropriate for their needs.
“The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smart watches or smart rings that claim to measure blood glucose levels,” the FDA said in the statement.
Consumers can report any adverse events or problems with inaccurate blood glucose measurement when using unauthorized smart watches or smart rings through the FDA MedWatch Voluntary Reporting Form.
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