FDA Warns Against Using Smartwatches or Rings to Measure Blood Glucose Levels

The United States Food and Drug Administration (FDA) is warning consumers against purchasing and using smartwatches and smart rings that claim to measure a user’s blood glucose levels via non-invasive measures.

In a safety warning today FDA officials told consumers to avoid taking measurements with smart devices that claim to check blood glucose levels without piercing the skin, as they can lead to errors in diabetes management, resulting in taking too little or too much medication.

The FDA warns that it has not authorized, cleared, or approved any smartwatch or smart ring that is designed to measure or estimate blood glucose values on its own. It should be noted that non-invasive devices like these are different from continuous glucose monitoring devices (CGMs) that display data via a smartwatch app.

While we’ve seen frequent reports that Apple is working on a way for the Apple Watch to use a non-invasive way to measure blood glucose level, the release of such a device is said to be several years away.

According to some reports, Apple began working on non-invasive blood glucose monitoring back in 2010 while Steve Jobs was still running things. Under Jobs, Apple purchased RareLight, a startup company that had been working on non-invasive blood glucose monitoring. However, Apple’s work remains stuck at the proof-of-concept stage.

While Apple’s non-invasive blood glucose monitoring isn’t yet ready for prime time, that hasn’t stopped several manufacturers of low-cost smartwatches and smart rings from claiming that their wearables can monitor blood glucose level without a skin prick or connecting to a CGM device.

The FDA advises consumers to avoid these devices and it tells doctors to warn patients about using such devices.

Sellers of these smartwatches and smart rings claim their devices measure blood glucose levels without requiring people to prick their finger or pierce the skin. They claim to use non-invasive techniques. These smartwatches and smart rings do not directly test blood glucose levels.

These smartwatches and smart rings are manufactured by dozens of companies and sold under multiple brand names. This safety communication applies to any smartwatch or smart ring that claims to measure blood glucose without piercing the skin, regardless of manufacturer or brand.

The FDA says it routinely monitors the medical device market and discovered several such unauthorized devices being marketed to consumers as valid options for monitoring blood glucose.

The agency also says that it is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smart watches or smart rings that claim to measure blood glucose levels.

The agency says it will continue to keep the public informed if and when new information becomes available.

While companies like Apple and Samsung are working on non-invasive ways of measuring blood glucose levels using wearable smart devices, the companies will need to receive FDA approval before being allowed to sell the devices in the United States. However, there is no proven and approved way to non-invasively measure blood sugar available in stores or online at this time.