FDA Warns Against Smartwatch that Monitors Blood Sugar
Key Takeaways
Unapproved smartwatches and smart rings claiming to measure blood sugar without drawing blood can be inaccurate and dangerous.
Rely on FDA-approved blood sugar monitoring devices for precise readings, especially if you need them for diabetes management.
Prioritize trustworthy data from approved devices for effective diabetes management.
Smartwatch That Monitors Blood Sugar Warning
The US Food and Drug Administration (FDA) issued a warning about the dangers of using certain smartwatches and smart rings that claim to measure blood sugar levels without drawing blood.
The agency emphasized the critical risk of inaccurate readings from these unauthorized devices, potentially leading to life-threatening errors in diabetes management.
But is there a smartwatch that monitors blood sugar accurately?
Focus on Accuracy, Not Convenience
The FDA has stated that it has not approved any smartwatch or smart ring designed to measure blood sugar on its own.
These unapproved tech devices often rely on "non-invasive techniques," according to the FDA, raising concerns about their ability to accurately assess blood glucose levels.
The agency stresses the importance of relying on FDA-approved devices instead of a blood sugar smartwatch, especially for people whose diabetes relies on accurate readings.
Not All Smartwatches Are Created Equal
It's important to distinguish between these unapproved devices and smartwatch apps that display data from FDA-approved glucose monitoring (CGM) systems.
CGMs use sensors that are inserted under the skin to provide continuous blood sugar readings, which can then be displayed on compatible smartwatches.
Taking Action Against Misleading Claims
While the FDA didn't name specific brands in their warning, they did condemn the marketing tactics used by sellers of these devices.
These sellers often make misleading claims about "non-invasive" and "finger-prick free" blood sugar monitoring, creating a false sense of total accuracy.
Recommendations for Consumers and Healthcare Providers
Among urging consumers to avoid purchasing wearable devices solely for the purpose of measuring blood sugar levels, the FDA also advises healthcare providers to discuss the risks associated with unapproved blood sugar monitoring devices with their patients.
Healthcare professionals are also encouraged to help patients find appropriate FDA-approved devices that suit their needs.
The agency is actively working to prevent the illegal marketing and sale of unauthorized smartwatches and smart rings that make claims about measuring blood sugar levels.
If you have experienced any adverse events or issues with inaccurate blood sugar readings due to an unauthorized smartwatch or smart ring, the FDA encourages you to report them through the FDA MedWatch Voluntary Reporting Form.