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

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Your watch might be smart, but it’s not smart enough to measure your blood glucose levels.

FDA issued a statement confirming that it has not cleared any smartwatch or smart ring device to measure blood glucose levels.¹ While there are some smartwatches that have apps that can be used in conjunction with other devices to properly take these measurements, there is no approved device on the market that can do so on its own.

There are smart devices on the market that claim to be able to make these measurements. However, none of the watch or ring devices actually pierce the skin and therefore are unable to make an accurate reading. Instead, these devices make measurements based on data recorded from the skin and make an estimate. However, not all of these devices make it clear that this reading is not necessarily accurate.

FDA has not only not assessed the accuracy of these devices, it has not tested them for safety either. Since patients who require blood glucose measurements typically have severe conditions, FDA recommends that they discuss the use of any devices with their doctor or care provider first.

As previously stated, some smartwatches are able to use apps to provide measurement information. However, these apps are not actually taking the measurement themselves. Instead, they are paired with another device that draws blood, which is where the actual measurement is made. The apps are then able to display the information and potentially make some assessments. As is always the case, patients should still consult with their doctor prior to using these apps.

In its statement, FDA confirms that it is working with retailers, distributors, and manufacturers to curb the distribution of devices that make unauthorized claims about blood glucose monitoring.

Smartwatches and similar devices are becoming more common, and are able to provide the user with some information on their health. These devices are often able to track activity and can provide a general overview of the wearer’s health in certain regards. However, the accuracy of these devices is not perfect. While smartwatches might be an acceptable way to get a general idea of how many steps someone is taking during a day and what their general pulse is, they can only provide estimates. Anyone suffering from medical conditions that require measurements to be taken should consult with their doctor and ensure that the device they are using has been approved by FDA to take those measurements.

Anyone that encounters a smartwatch or smart ring product that makes to claims to be able to measure blood glucose levels should contact FDA and file a claim with a MedWatch Voluntary Reporting Form.

Source

Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication. FDA. February 21, 2024. Accessed February 23, 2024. https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication