FDA Issues Warning About This Smartwatch Feature

FDA Issues Warning About This Smartwatch Feature

Smartwatches and smart rings offer numerous health benefits, like monitoring heart rate, counting steps, and even providing an EKG of your heart rhythm. However, their ability to measure blood glucose (sugar) levels has recently been questioned, prompting a warning from the Food and Drug Administration.

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FDA's Warning

On February 21, 2024, the FDA issued a warning stating that any device claiming to measure blood glucose levels without piercing the skin has not been authorized, cleared, or approved by the FDA. The public is advised to refrain from using such devices to measure blood sugar levels.

This warning applies to well-known smartwatch brands as well as lesser-known imitators, including smart rings. These devices should not be trusted for blood glucose monitoring.

What’s the Big Deal?

For individuals with diabetes, monitoring blood sugar levels is a critical part of their daily routine. Blood sugar readings assist in making essential decisions about food intake, diabetes medication, and activity levels to manage blood sugar effectively. Incorrect readings can lead to severe consequences, such as coma or even death.

For instance, if a smartwatch indicates that your blood sugar is high and you adjust your diabetes medication accordingly, an inaccurate reading could have severe adverse effects, potentially leading to severe health consequences in just a few hours.

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Verified Methods for Blood Glucose Monitoring

According to the FDA, the only approved devices for measuring blood glucose levels are those that pierce the skin. This includes traditional finger stick monitors and Continuous Glucose Monitoring devices (CGMs).

A CGM is a small, FDA-approved disc worn on the body, often on the back of the arm, which uses a microneedle that slightly punctures the skin to monitor blood glucose. The device continuously sends readings to a smartphone, enabling real-time monitoring of blood sugar levels.

The Differentiation

It's crucial to distinguish between CGMs that communicate with your smartphone and smartwatches that claim to monitor blood sugar without skin puncture. Research has shown that these smartwatches and rings are inaccurate, leading to potential health risks due to erroneous readings.

In essence, the most reliable way to measure blood glucose levels is by directly accessing the blood.

The Bottom Line

If you're using a smartwatch or ring to monitor your blood sugar levels, it's best to stop immediately. Consult with your healthcare provider to obtain a finger-stick monitor or a CGM. While smartwatches and rings are excellent for tracking other health metrics such as steps and heart rate, they are not yet reliable for blood glucose monitoring.

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