FDA Warns Smartwatch Users About Inaccurate Health Readings

The agency issued a warning for people who use these devices.

Smartwatches and smart rings have become go-to devices for millions of Americans looking to gain greater insight into their health. But for the more than 37 million in the U.S. living with diabetes, it turns out these devices might not be that helpful. 

The Food and Drug Administration announced a warning Feb. 21 about the "risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin," adding, "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."

Getting an accurate blood sugar reading is essential for people with diabetes, as it can lead to issues including taking too high or low of a dose of insulin or other medications used to lower blood glucose. Serious cases with extremely low blood sugar as a result of incorrect dosage can lead to "mental confusion, coma, or death within hours of the error." 

To avoid this potentially fatal mistake, the FDA is recommending patients avoid smartwatches and smart rings that claim to measure blood glucose levels but don't pierce the skin. None of these devices have been evaluated by the FDA so they could potentially lead to incorrect blood sugar level readings. "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," the agency advised. 

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The FDA is also keeping its eye on the medical device market for unauthorized products purporting to do things they actually can't. "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," the statement said. 

For now, it might be best to just use your smartwatch to track your steps.