The U.S. Food and Drug Administration (FDA) has recently issued a safety communication regarding the use of smartwatches and smart rings that claim to measure blood glucose levels without piercing the skin. This warning, dated February 21, 2024, is a critical alert for consumers, patients, caregivers, and healthcare providers, emphasizing that no such devices have been authorized, cleared, or approved by the FDA.

The Risks of Unapproved Devices

The FDA's concern stems from the potential for inaccurate blood glucose measurements provided by these unauthorized devices. For individuals managing diabetes, precise glucose monitoring is crucial. Inaccurate readings can lead to serious errors in diabetes management, such as incorrect insulin dosing, which can result in dangerously low glucose levels, mental confusion, coma, or even death within a few hours.

Understanding the Fine Print

Interestingly, some advertisements for these devices may include fine print stating that they only display blood glucose readings from a continuous glucose monitor (CGM) that is already passing data to a smartphone. This distinction is vital as it implies that the smartwatch or ring itself is not measuring glucose levels but merely acting as a secondary display for data from an FDA-authorized device that does pierce the skin. This could potentially mislead consumers into believing the smartwatch or ring is independently monitoring glucose levels.

FDA Recommendations

The FDA advises against purchasing or using smartwatches or smart rings that claim to measure blood glucose levels on their own. Instead, consumers should consult with healthcare providers to select an appropriate FDA-authorized device. Healthcare providers are also encouraged to inform their patients about the risks associated with using unauthorized devices and to assist them in choosing a suitable FDA-authorized blood glucose measuring device.

Market Monitoring and Reporting

The FDA is actively monitoring the market to prevent the illegal marketing of these unauthorized products. They are also urging the public to report any problems with inaccurate blood glucose measurement or adverse events from using these devices through the MedWatch Voluntary Reporting Form.

Conclusion

The FDA's warning is a reminder of the importance of using medical devices that have undergone rigorous testing and approval processes. While the allure of non-invasive glucose monitoring is strong, the current state of technology has not yet produced a device that can safely and accurately perform this function without FDA approval. Consumers should remain vigilant and rely on approved methods for managing their diabetes to ensure their health and safety.