The United States Food and Drug Administration (FDA) issued a warning this week about the potential dangers of smartwatches and rings that claim to measure blood sugar levels without piercing the skin. The agency clarified that it has not authorized any devices of this nature and advised against using them.
The FDA’s notice specifically excludes smartwatch applications that are linked to sensors, such as continuous glucose monitoring systems that directly measure blood sugar. This warning comes at a time when an estimated 37 million Americans suffer from diabetes and rely on accurate blood glucose measurements to manage their condition.
Dr. Robert Gabbay of the American Diabetes Association expressed concern that using non-approved smart watches and rings to measure blood glucose levels could lead to inaccurate readings and potentially devastating consequences. Incorrect dosing of medication and dangerous levels of blood sugar could result in mental confusion, coma, or even death.
While several companies are working on non-invasive devices to measure blood glucose, researcher David Klonoff explained that none have created a product accurate and safe enough to obtain FDA approval. The technology used in smartwatches and rings to measure other health parameters such as heart rate and blood oxygen is not yet accurate enough to measure sugar levels. Additionally, methods to measure blood glucose in body fluids like tears, perspiration, and saliva are not yet ready for commercial release.
Klonoff emphasized the importance of FDA approval in minimizing risks associated with medical devices, stating that using a product not authorized by the FDA generally poses a greater risk. However, he remains optimistic that scientific and engineering advancements will lead to the development of safe and accurate non-invasive blood glucose monitoring devices in the future.