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The US agency said smartwatches and smart rings that claim to measure blood glucose without piercing the skin are not FDA approved and could cause people with diabetes to mismanage their condition.
Wearables such as smartwatches are commonly associated with health monitoring, but the US Food and Drug Administration (FDA) has issued a warning about a particular feature being advertised by some devices.
The FDA warned against using smartwatches or smart rings that claim to measure blood glucose levels – or blood sugar – without piercing the skin.
Regularly monitoring blood sugar levels is important for people with diabetes to manage the condition. The World Health Organization estimates that more than 422m people live with diabetes globally.
Smartwatches have been able to monitor blood glucose for some time, but the FDA said these usually display data from FDA-authorised measuring devices that pierce the skin, such as continuous glucose monitoring devices.
“The FDA has not authorised, cleared or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the organisation said.
As the devices have not been reviewed by the US agency, it warned that these devices could create inaccurate measurements of blood sugar levels. The organisation said this could cause people with diabetes to take the wrong dose of insulin, sulfonylureas or “other medications that can rapidly lower blood glucose”.
“Taking too much of these medications can quickly lead to dangerously low glucose, leading to mental confusion, coma or death within hours of the error,” the FDA said.
Despite the lack of FDA approval, the organisation claimed that “dozens of companies” who make smartwatches and smart rings claim to measure blood glucose “non-invasively”.
“The agency is working to ensure that manufacturers, distributors and sellers do not illegally market unauthorised smartwatches or smart rings that claim to measure blood glucose levels,” the FDA said.
“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.”
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