The U.S. Food and Drug Administration (FDA) issued a cautionary statement on Wednesday regarding smartwatches and rings that claim to measure blood sugar levels without the need for skin piercing. The agency emphasized that such devices, regardless of brand, could pose serious risks and should be avoided as they have not been authorized by the FDA.
The warning specifically applies to any watch or ring that purports to measure blood glucose levels in a noninvasive manner. Notably, the FDA clarified that its notice does not encompass smartwatch apps connected to sensors, such as continuous glucose monitoring systems, which directly measure blood sugar.
Approximately 37 million Americans live with diabetes, a condition that requires diligent blood sugar monitoring to manage effectively. Traditionally, individuals with diabetes rely on finger prick blood tests or continuous glucose monitoring systems with sensors placed just beneath the skin for accurate readings.
Dr. Robert Gabbay, representing the American Diabetes Association, cautioned against the use of unapproved smartwatch and smart ring devices, warning of potentially inaccurate blood sugar measurements. Such inaccuracies could lead to incorrect medication dosages, resulting in dangerously high or low blood sugar levels and severe complications, including coma or death.
While several companies are developing noninvasive blood sugar measurement devices, none have met the stringent criteria for FDA approval, according to Dr. David Klonoff, a diabetes technology expert with 25 years of experience. Current technology, including that used in smartwatches and rings for measuring heart rate and blood oxygen, is not sufficiently accurate for blood sugar measurement. Additionally, attempts to measure blood sugar in bodily fluids like tears, sweat, and saliva are still in the experimental stages.
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Klonoff acknowledged the challenges but expressed optimism that a breakthrough may occur in the future. In the interim, consumers seeking accurate blood sugar measurement are advised to use FDA-cleared blood glucose monitors available at pharmacies. Klonoff stressed the importance of FDA approval in mitigating risks associated with medical devices, emphasizing that using non-FDA-cleared products can pose significant dangers to health and well-being.