FDA Cautions Against Using Uncleared Devices to Measure Blood Glucose

FDA Safety Communication  

On February 21, 2024 the U.S. Food and Drug Administration (FDA) issued a safety communication regarding the use of smartwatches or smart rings that claim to measure blood glucose levels without the need for skin piercing.  

Its cautionary message is directed toward consumers, patients, caregivers, and healthcare providers, emphasizing the potential risks associated with relying on such devices for blood glucose monitoring. 

Key Points from the FDA Announcement 

Risk of Inaccurate Measurements 

The FDA warns against the use of smartwatches or smart rings that claim to measure blood glucose levels without skin piercing, highlighting the potential for inaccurate readings. Inaccurate blood glucose measurements can significantly impact diabetes management, potentially leading to serious errors in medication dosage and subsequent health complications. 

Unapproved Devices 

It’s important to note that the FDA has neither authorized nor approved any smartwatch or smart ring intended for standalone blood glucose measurement. These devices differ from applications that display data from FDA-authorized blood glucose measuring devices that do require skin piercing, such as continuous glucose monitoring (CGM) devices. 

Consumer Recommendations 

Consumers, patients, and caregivers are advised not to purchase or use smartwatches or smart rings claiming to measure blood glucose levels. The safety and effectiveness of these unapproved devices have not been evaluated by the FDA, posing a risk of inaccurate measurements and potential harm to individuals relying on them for diabetes management. 

Healthcare Provider Guidance 

Healthcare providers are urged to inform patients about the risks associated with using unauthorized blood glucose measuring devices. Additionally, they should assist patients in selecting appropriate FDA-authorized devices for accurate blood glucose monitoring, ensuring optimal diabetes management and patient safety. 

FDA Actions 

The FDA is actively monitoring the medical device market and is taking steps to prevent the illegal marketing of unauthorized smartwatches or smart rings for blood glucose measurement. Public awareness is being raised regarding the potential risks associated with relying on these devices for medical purposes. 

How to Report Problems 

Individuals who encounter inaccuracies or adverse events related to the use of unauthorized smartwatches or smart rings for blood glucose monitoring are encouraged to report such incidents through the FDA’s MedWatch Voluntary Reporting Form. Prompt reporting can aid the FDA in improving patient safety and understanding the risks associated with these devices. 

Conclusion 

The FDA’s warning serves as a vital reminder to exercise caution when considering the use of smartwatches or smart rings for blood glucose monitoring. For individuals managing diabetes, accuracy in blood glucose measurements is crucial for effective treatment and prevention of complications.  

By heeding the FDA’s guidance and utilizing FDA-authorized devices, individuals can ensure reliable blood glucose monitoring and safeguard their health. Stay informed, prioritize safety, and consult healthcare providers for guidance on suitable blood glucose monitoring solutions. 

Links 

Read the FDA Safety Communication here.