Smartwatches That Claim to Measure Blood Sugar Deemed Unsafe by FDA

FDA warns consumers to avoid smartwatches and rings claiming to measure blood sugar without piercing skin, saying they are unauthorized, risky, and inaccurate.

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That smartwatch tracking your blood sugar could end up doing more harm than good.

The U.S. Food and Drug Administration (FDA) issued a warning against using wearable devices that measure blood glucose without piercing the skin, saying they provide inaccurate readings that could lead to “potentially fatal errors” in diabetes management.

While these smartwatches and rings are indeed noninvasive, they have been not cleared or approved, making them risky for diabetics who depend on accurate monitoring, according to the FDA.

Serious Potential Consequences

These smartwatches and smart rings are manufactured and sold under various names by many companies. They claim their devices can accurately monitor blood sugar through sensors that scan glucose levels in blood vessels using the skin’s natural moisture.

However, the FDA says these noninvasive smart devices do not actually test blood glucose. Although the products claim to use noninvasive techniques, they provide inaccurate results.

For people with diabetes, faulty blood sugar measurements could lead to potentially fatal errors in managing their condition. This includes taking the wrong medication dose, like insulin or other drugs that lower blood glucose. Taking too much medication can rapidly induce low blood sugar, causing mental confusion, coma, or even death within hours.

What to Do if You Own One

Over 29 million American adults have been diagnosed with diabetes, representing more than 10 percent of the population. An additional 8.7 million are likely to have undiagnosed diabetes, according to the U.S. Centers for Disease Control and Prevention (CDC).

Precise blood glucose measurements enable patients to make informed decisions with their doctors to prevent diabetes complications like heart attack, stroke, kidney disease, blindness, and amputation.

The FDA urges anyone who owns an unauthorized smartwatch or ring that claims to measure blood glucose to report it via the MedWatch Voluntary Reporting Form. Prompt reporting can help the FDA identify risks associated with these unauthorized medical devices and better safeguard patient safety, the agency said.

Health care providers should ensure they equip diabetes patients with proper FDA-approved blood glucose monitors as needed, the FDA noted.

FDA-Approved Devices That Don’t Require Finger Prick

The FDA has approved some blood glucose monitors that don’t require finger prick. However, most of these noninvasive devices are implanted in or on the body.

For example, the FreeStyle Libre, approved in 2017, reads glucose levels from interstitial fluid underneath the skin. This monitor is worn on the upper arm, though it’s been known to cause skin irritation at the site of the sensor.

The Eversense CGM is another under-the-skin device that measures glucose in interstitial fluid.

The Guardian Connect System and Dexcom G6 CGM are two abdominal implants that transmit blood sugar data to a smart device. Both received FDA approval in 2018.