FDA Warns Glucose Smart Watch Feature for Diabetics Not Approved

If you have diabetes the U.S. Food and Drug Administration (FDA) has a warning for you about using smart watches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin.

These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs).

This week, the FDA issued a statement that it has not authorized, cleared, or approved any smart watch or smart ring that is intended to measure or estimate blood glucose values on its own and the results could be inaccurate.

For people with diabetes, inaccurate blood glucose measurements could be dangerous leading to errors in diabetes management, including taking the wrong dose of insulin, sulfonylureas, or other medications that can rapidly lower blood glucose.

Conversley, taking too much of a medicine for diabetes based on the wrong data could quickly lead to dangerously low glucose, leading to mental confusion, coma, or death within hours of the error.

The FDA recommends people with diabetes not buy or use smartwatches or smart rings that claim to measure blood glucose levels.

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.