The US Food and Drug Administration (FDA) has issued a warning urging people not to rely on smart watches and rings to measure blood sugar levels for medical purposes without piercing the user’s skin. The FDA says that doing so could be dangerous and should be avoided, despite manufacturers’ claims.
The warning applies to any watch or ring that is promoted as having the ability to measure blood glucose levels non-invasively, without piercing the patient’s skin. The FDA emphasized that it has not authorized any device of this type and is warning consumers to avoid purchasing them for that purpose.
Approximately 37 million Americans suffer from diabetes, a condition that makes it necessary for them to periodically monitor their blood sugar levels. Using unapproved smartwatch and smart ring devices could lead to inaccurate blood sugar measurements, with potentially devastating consequences.
Dr. Robert Gabbay of the American Diabetes Association told The Associated Press that using unapproved devices could cause patients to take incorrect doses of medications, leading to dangerous blood sugar levels and possibly mental confusion, coma or even death.
While several companies are working on non-invasive devices to measure blood sugar, none have created a product that is accurate and safe enough to win FDA approval. Dr. David Klonoff, who has researched the technology, stated that the technology that allows smart watches and rings to measure metrics such as heart rate and blood oxygen is not accurate enough to measure blood sugar.
In the meantime, consumers who want to measure their blood sugar accurately can purchase an FDA-approved blood glucose monitor at any drugstore. The FDA notice does not include smartwatch applications linked to sensors, such as continuous glucose monitoring systems that measure blood sugar directly.
The FDA is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels. They emphasized that if the FDA approves a product, the risk is very small, whereas if it is not approved, the risk can be very great.