Beware smartwatches that claim to monitor blood sugar without skin prick, FDA says

Smartwatches and "smart rings" are being marketed as being able to measure blood sugar without requiring a finger prick, but these devices are not authorized by the Food and Drug Administration (FDA) and should not be used, federal officials have warned.

People with diabetes must carefully monitor how their blood glucose levels fluctuate in response to medications, diet and exercise. Inaccurate measurements can lead people to take the wrong dose of insulin or other blood-sugar-lowering drugs, potentially leading to dangerous consequences, like seizures and coma.

Some smartwatch apps report blood sugar levels, but these apps are linked to FDA-authorized devices that do pierce the person's skin, such as continuous glucose monitors. Consumers should be wary of smartwatches that are marketed as monitoring blood sugar all on their own, the FDA cautioned in a statement released Feb. 21.

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"The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own," the statement reads. "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."

The FDA's warning applies to any smartwatch or smart ring that claims to measure blood sugar without piercing the skin. The agency's warning didn't list any specific products but noted that such devices are made by dozens of companies and are sold under multiple brand names. They're often sold through online marketplaces or directly from their makers, the agency noted.

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The FDA is now working to ensure that manufacturers, distributors and sellers don't illegally market these devices. In the meantime, the agency urges patients to discuss authorized blood sugar monitors with their medical providers.

"If your medical care depends on accurate blood glucose measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs," officials said in the statement.

Anyone who experiences a problem with inaccurate blood glucose measurement or who experiences any adverse events from using an unauthorized smartwatch or smart ring can report the problem through the FDA's MedWatch Voluntary Reporting Form.

This article is for informational purposes only and is not meant to offer medical advice.

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