FDA: Don’t Use Smartwatches, Smart Rings for Blood Glucose Measurements

Patients should not use smartwatches or smart rings alone to measure blood glucose levels, the FDA warned on Wednesday.

Noninvasive devices that do not rely on finger-pricks or pierce the skin are not authorized, cleared, or approved for measuring blood sugar levels, the agency detailed in a new safety communication. As a result, these devices do not directly test blood glucose levels and can give inaccurate measurements.

“For people with diabetes, inaccurate blood glucose measurements can lead to errors in diabetes management, including taking the wrong dose of insulin, sulfonylureas, or other medications that can rapidly lower blood glucose,” the FDA stated. “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 warning pertains to any device that doesn’t pierce the skin regardless of manufacturer or brand. Such devices may be sold through online marketplaces or directly from the seller.

Of note, the warning does not pertain to smartwatch applications that display blood glucose pulled from compatible, authorized devices that do pierce the skin, like continuous glucose monitoring devices.

Healthcare providers should instruct patients to only rely on FDA-authorized devices for managing diabetes. They should also discuss the risks of using unauthorized blood glucose measuring devices with their patients.

The FDA said it will keep the public informed if and when new information is available. People who have experienced problems with inaccurate blood glucose measurements or who had adverse events from unauthorized smartwatches or smart rings should report their experience to the FDA’s MedWatch Voluntary Reporting Form.

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