The US Food and Drug Administration (FDA) has cautioned against the use of smartwatches and rings claiming to measure blood sugar levels without skin piercing, emphasizing the potential dangers of inaccurate readings.
The US Food and Drug Administration (FDA) has issued a warning against the use of smartwatches and rings that claim to measure blood sugar levels for medical purposes without piercing the skin, citing potential dangers associated with inaccurate measurements.
According to the FDA, any device, irrespective of brand, that purports to measure blood glucose levels in a noninvasive manner should be avoided as it has not been authorized by the agency. This caution extends to all such devices currently available in the market.
The FDA clarification underscores the critical importance of accurate blood sugar monitoring, particularly for individuals with diabetes who rely on precise readings to manage their condition effectively. Traditional methods involve finger prick tests or continuous glucose monitoring systems with sensors placed under the skin.
Dr Robert Gabbay, representing the American Diabetes Association, emphasized the potential risks of relying on unapproved devices, citing the possibility of inaccurate measurements leading to incorrect medication dosages. This, in turn, could result in dangerous fluctuations in blood sugar levels, posing severe health risks including mental confusion, coma, or even death.
While several companies are actively developing noninvasive blood sugar measurement devices, none have yet met the rigorous standards required for FDA approval. Dr David Klonoff, a veteran researcher in diabetes technology, noted the technical challenges involved in achieving accurate measurements through wearable devices, indicating that current technologies are not yet capable of reliably measuring blood sugar levels without invasive methods.
In light of these concerns, consumers seeking accurate blood sugar monitoring are advised to use FDA-cleared blood glucose monitors available at pharmacies. Dr. Klonoff emphasized the importance of FDA approval in ensuring product safety and reliability, underscoring the potential risks associated with using unapproved devices.
As efforts continue to advance noninvasive blood sugar monitoring technology, the FDA's warning serves as a reminder of the critical need for accuracy and reliability in medical device development and regulation.