The FDA cautions against the use of smartwatches and rings that purport to detect blood sugar levels without the need for needles.
The U.S. Food and Drug Administration cautioned on Wednesday against the use of smartwatches and rings that claim to track blood sugar levels for medical purposes without penetrating the skin, as they may pose potential risks. It is advised to refrain from using such devices.
The warning pertains to all watches and rings, regardless of brand, that claim to measure blood sugar levels without the need for invasive methods, according to the agency. The FDA stated that it has not approved any devices of this kind.
The notification from the agency does not cover smartwatch apps that are connected to sensors, such as continuous glucose monitoring systems that directly measure blood sugar.
Approximately 37 million individuals in the United States suffer from diabetes. Those with the condition struggle to properly manage their blood sugar levels due to a lack of the hormone insulin or a resistance to it within their bodies.
In order to handle the condition, individuals must routinely monitor their blood sugar levels through either a finger prick test or a sensor that inserts needles just beneath the skin to constantly track glucose levels.
Dr. Robert Gabbay from the American Diabetes Association warned that utilizing unapproved smartwatches and smart rings may lead to incorrect blood sugar readings, which could have serious consequences. This could potentially result in patients taking incorrect doses of medication, leading to high or low blood sugar levels and potentially severe outcomes such as confusion, coma, or even death.
Dr. David Klonoff, a diabetes technology researcher for 25 years, has stated that various companies are developing noninvasive tools for measuring blood sugar. However, so far, no product has met the accuracy and security standards required for FDA approval.
According to Klonoff, a researcher at Sutter Health Mills-Peninsula Medical Center in San Mateo, California, the current technology used in smartwatches and rings is not precise enough to measure blood sugar levels. Additionally, attempts to measure blood sugar through bodily fluids like tears, sweat, and saliva are not yet reliable for widespread use.
According to Klonoff, the task is difficult and he anticipates that eventually a scientist or engineer will be able to resolve it.
In the interim, individuals looking to accurately measure their blood sugar levels can purchase an FDA-approved blood glucose monitor at a local pharmacy.
The determining factor is the level of risk. According to him, if the FDA gives its approval, the risk is minimal. However, if you opt for a product that has not been cleared by the FDA, the risk is usually significant.
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