Consumers, patients, and healthcare professionals are being cautioned by the U.S. Food and Drug Administration (FDA) about the dangers of wearing smartwatches or smart rings that make the claim to be able to test blood glucose levels (blood sugar) without puncturing the skin. These are not to be confused with smartwatch apps that show information from FDA-approved skin-prick blood glucose meters, such as continuous glucose monitors (CGMs). It is not authorized, cleared, or allowed by the FDA for any wristwatch or smart ring to test or estimate blood glucose levels on its own.
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Smartwatch Glucose Apps: Risk of Fatal Errors
Inaccurate blood glucose readings can cause mistakes in diabetes care for those who have the condition, such as administering the incorrect dosage of insulin, sulfonylureas, or other drugs that can drop blood sugar levels quickly. Overdosing on these drugs can swiftly result in dangerously low blood sugar, which can cause coma, mental disorientation, or even death in a matter of hours. Smartwatch apps that are connected to sensors, such continuous glucose monitoring systems that take blood sugar readings directly, are exempt from the agency’s notice.
37 Million Americans Face Diabetes Challenges
About 37 million people in America suffer from diabetes. Because their bodies are either unable to produce enough insulin or have developed an insulin resistance, people with the condition are unable to control their blood sugar levels. They must periodically check their blood sugar levels with a finger prick blood test or a sensor that continually monitors glucose levels by inserting needles just beneath the skin in order to control the disease.
Unapproved Wearables Pose Blood Sugar Risks
According to Dr. Robert Gabbay of the American Diabetes Association, using the unapproved smartwatch and smart ring gadgets might lead to erroneous blood sugar levels, with “potentially devastating” implications. This may result in patients taking the incorrect amounts of their medications, which might induce severe blood sugar levels, mental disorientation, coma, or even death. Many businesses are developing noninvasive blood sugar monitoring devices, but according to Dr. David Klonoff, who has spent 25 years studying diabetes technology, none of them have produced a product that is secure and accurate enough to receive FDA clearance.
FDA Approved Glucose Monitors Recommend for Precise Monitoring
Blood sugar cannot be accurately measured by smartwatches or rings using the same technology that measures heart rate and blood oxygen levels, according to Klonoff of Sutter Health Mills-Peninsula Medical Centre in San Mateo, California. Additionally, attempts to monitor blood sugar in bodily fluids including saliva, perspiration, and tears are not yet ready for prime time. “It’s challenging, and I believe at some point there will be at least one scientist or engineer to solve it,” Klonoff said. In the meanwhile, customers may purchase an FDA-approved blood glucose monitor at any drugstore if they wish to measure their blood sugar precisely.
FDA Cracks Down on Illegal Smartwatch Claims for Blood Glucose Testing
The FDA became aware of illegal items being offered to consumers while conducting normal monitoring of the medical device industry. The organisation is attempting to guarantee that producers, suppliers, and merchants do not unlawfully advertise unapproved smartwatches or smart bands that make the claim to be able to test blood glucose levels. The FDA is also educating the public about this problem and warning people not to use smartwatches or smart rings to check their blood sugar levels.
If important new information comes to light, the FDA will notify the public. Individuals are encouraged to report issues with erroneous blood glucose measurement or adverse events resulting from the use of an unapproved wristwatch or smart ring to the FDA via the MedWatch programme.
