Tuesday, April 16, 2024

The FDA Advises Caution with Wearable Devices Claiming Needle-Free Blood Sugar Monitoring

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The U.S. Food and Drug Administration (FDA) issued a warning about the potential dangers of wearable devices, such as smartwatches and rings, that advertise the ability to monitor blood glucose levels without skin penetration. The agency emphasized that these claims might pose health risks and advised consumers to steer clear of wearable devices.

This advisory targets any wearable devices, regardless of the manufacturer, that offers noninvasive blood glucose monitoring, a feature for which the FDA has granted no approvals. The warning does not extend to smartphone applications connected to approved sensors, like those used in continuous glucose monitoring systems that require skin penetration for accurate readings.

Risks of Inaccurate Glucose Monitoring and Severe Health Consequences of Wearable Devices

An estimated 37 million people in the U.S. live with diabetes, a condition characterized by the body’s inability to properly manage blood sugar levels due to insufficient insulin production or resistance to insulin. Managing diabetes typically involves regular blood sugar checks through finger-prick blood tests or continuous monitoring devices that insert needles under the skin.

The use of unauthorized wearable technology for glucose monitoring could lead to dangerously inaccurate blood sugar readings. Dr. Robert Gabbay from the American Diabetes Association highlighted the serious risks of relying on such unvalidated devices, including the possibility of incorrect medication dosing, which could result in severe health complications like hypoglycemia or hyperglycemia, confusion, coma, or death.

Wearable Devices

Expert Highlights Gaps in Noninvasive Technology Reliability

Despite ongoing research into noninvasive glucose monitoring technologies, Dr. David Klonoff from the Sutter Health Mills-Peninsula Medical Center noted that no product has yet met the FDA’s stringent accuracy and safety criteria. He mentioned that current efforts to measure glucose in bodily fluids such as sweat, saliva, and tears are still not reliable for consumer use.

Klonoff remains hopeful that future innovations will overcome these challenges but advises that, for now, individuals should use FDA-approved glucose monitors available at pharmacies to ensure safety and accuracy. He stressed the importance of FDA approval in minimizing health risks associated with medical devices.

 

Resource: Quartz, February 21, 2024

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