Buyer Beware: FDA Issues Warnings Against “Smart” Wearables that Claim to Measure Blood Sugar

By B.N. Frank

There is no doubt that diabetes has become an epidemic.  Additionally, decades of research have revealed that exposure to electromagnetic fields (EMF) from activity trackers and other wearables, cell phones, as well as other wireless sources – including Bluetooth and 5G – is biologically harmful.  There is even research that indicates it can affect blood sugar levels (see 1, 2).  In fact, manufacturers are required to provide consumers with warnings about radiation emissions from all wireless devices!  Nevertheless, wireless aka “smart” wearables continue to be created and promoted for a variety of purposes – including health and medical.  While the Food and Drug Administration (FDA) has a long history of NOT addressing wireless exposure risks, it has warned that wireless devices can affect pacemakers and other medical implants.  Recently it also started warning about wearables that promise to accurately measure blood sugar levels.


FDA warns against smartwatches and rings that claim to measure blood sugar without needles

by JONEL ALECCIA AP Health Writer

Smartwatches and rings that claim to measure blood sugar levels for medical purposes without piercing the skin could be dangerous and should be avoided, the U.S. Food and Drug Administration warned Wednesday.

The caution applies to any watch or ring, regardless of brand, that claims to measure blood glucose levels in a non-invasive way, the agency said. The FDA said it has not authorized any such device.

The agency’s notice doesn’t apply to smartwatch apps linked to sensors, such as continuous glucose monitoring systems that measure blood sugar directly.

Roughly 37 million Americans have diabetes. People with the disease aren’t able to effectively regulate their blood sugar because their bodies either don’t make enough of the hormone insulin or they have become resistant to insulin.

To manage the condition, they must regularly check their blood sugar levels with a finger prick blood test or with a sensor that places needles just under the skin to monitor glucose levels continuously.

Using the unapproved smartwatch and smart ring devices could result in inaccurate blood sugar measurements, with “potentially devastating” consequences, said Dr. Robert Gabbay, of the American Diabetes Association. That could cause patients to take the wrong doses of medication, leading to dangerous levels of blood sugar and possibly mental confusion, coma or even death.

Several companies are working on noninvasive devices to measure blood sugar, but none has created a product accurate and secure enough to get FDA approval, said Dr. David Klonoff, who has researched diabetes technology for 25 years.

The technology that allows smartwatches and rings to measure metrics like heart rate and blood oxygen is not accurate enough to measure blood sugar, said Klonoff, of the Sutter Health Mills-Peninsula Medical Center in San Mateo, California. Efforts to measure blood sugar in body fluids such as tears, sweat and saliva are not ready for prime time, either.

“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 meantime, consumers who want to measure their blood sugar accurately can buy an FDA-cleared blood glucose monitor at any pharmacy.

“It comes down to risk. If the FDA approves it, the risk is very small,” he said. “If you use a product that is not cleared by the FDA, very often the risk is very large.”

Activist Post reports regularly about wireless wearables and other privacy invasive and unsafe technologies.  For more information, visit our archives and the following websites:

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