FDA Warns of Smartwatches That Claim to Monitor Blood Sugar

By: Lauren Fokas | Published: Mar 11, 2024

Smartwatches have become increasingly popular over recent years for their convenient features and even the ability to monitor one’s heart rate and sleep schedule. 

However, the FDA recently announced that those smartwatches and rings that claim to track glucose levels shouldn’t be used by diabetics as, without pricking the skin, they cannot accurately read the body’s blood sugar. 

Understanding the Importance of Tracking Blood Sugar Levels for Those With Diabetes

People with diabetes need to be extremely careful when tracking their blood sugar or glucose levels. 

Diabetic person injecting insulin into their abdomen

Source: Freepik

Getting an exact reading alerts diabetics as to what foods, exercise, or medicine makes their numbers increase or decrease, as well as how much or how little additional insulin they need at that moment.

What Happens to Diabetics When Their Blood Sugar Isn’t Stable?

High or low blood sugar levels can lead to mental confusion, nerve damage, slurred speech, blurred vision, and even seizures, coma, or in the worst possible case, death. 

Woman grabs her head in pain in a hospital bed

Source: Freepik

Therefore, the majority of diabetes use blood glucose meters to carefully track their glucose levels each and every day. 

How Do Blood Glucose Meters Work?

Blood glucose meters are small devices that use a mini needle to prick the skin, producing a small drop of blood, which is then placed on a small strip and analyzed by the electronic machine within seconds. The monitor then displays the glucose levels within the blood.

Person with diabetes using a glucose monitor to test their blood sugar

Source: Freepik

For the majority of those living with diabetes, these monitors are absolutely essential to their survival and they are never without them.

Smartwatches Are Now Offering the Same Medical Care

Now, some smartwatches and rings are reporting that, like the prescribed glucose monitors, they too can inform people of their exact blood sugar levels, but without piercing the skin. 

A close-up photograph of a smartwatch updating the wearer with their current blood glucose level

Source: @TypeOneTalks/YouTube

At first, this seemed like an incredibly exciting service for those living with diabetes as it meant they wouldn’t have to carry around a glucose monitor: they could just use their smartwatch.

Smartwatches Do Not Offer Accurate Blood Sugar Level Readings

But, unfortunately, it has become clear that without actually taking a blood sample, these devices cannot accurately read blood sugar levels specifically enough for diabetics to use them instead of a medical glucose monitor. 

Two people check their smartwatches after exercising

Source: Freepik

However, it became increasingly evident many people didn’t know that the smartwatches were inaccurate and, in fact, quite dangerous for diabetics.


What Does the FDA Have to Say About Smartwatches?

Because many people were unaware of the fact that smartwatches that claim they are reading glucose levels are in no way accurate enough to be used as a medical device, the Food and Drug Administration (FDA) decided they needed to make an announcement. 

Sign at the entrance of the FDA headquarters

Source: iStock

Within the statement, released on February 21, 2024, the FDA told Americans: “Do not buy or use smartwatches or smart rings that claim to measure blood glucose levels… the safety and effectiveness of these devices have not been reviewed by FDA.”


The FDA Is Working to Get Smartwatch Companies to Remove Glucose Monitoring from the List of Services

In addition to warning Americans with diabetes not to try to use these smartwatches to track their blood sugar levels, the FDA is also hard at work trying to get smartwatch companies to remove this service from the spec lists. 

Promotional photograph for a smartwatch showing the various services it provides

Source: Amazon

In the statement they wrote, “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”


It’s Hyper Important That Doctors Understand This Technological Shortcoming

The FDA also made it exceptionally clear that all physicians need to be aware that smartwatches and rings cannot accurately read glucose levels without pricking the skin. 

A doctor speaks with a patient during an appointment

Source: Freepik

The administration has asked doctors to: “Talk to [their] patients about the risk of using unauthorized blood glucose measuring devices,” and “Help [their] patients select an appropriate, FDA-authorized, blood glucose measuring device.”


Are There Any Smartwatches Safe for Diabetics?

It’s important to understand that no smartwatch that does not pierce the skin is safe for diabetics to use as a replacement for their glucose monitor. 

A woman uses a glucose monitor app to track her blood sugar levels

Source: National Institute for Diabetes

However, there are apps on some smart devices that can connect to doctor recommended monitors to keep track of blood sugar levels over time. While these apps can be helpful, they work in conjunction with the medical devices, and not as a replacement. 


Are Smartwatches Reliable for Medical Information?

While it’s impossible for a smartwatch to analyze one’s blood, technically, it can track a user’s heart rate and quality of sleep. 

Close up photograph of blood with several small bubbles in it

Source: Freepik

That being said, research has shown that these watches aren’t really that accurate. Users can enjoy knowing, more or less, where their heart rate sits after exercise or if they had a good night’s sleep, but they should never use this information in replace of actual medical tests.


Smartwatches Are Not Approved Medical Devices

What the FDA and doctors around the country want everyone, but specifically diabetics, to understand is that smartwatches and rings are in no way medical devices.

Person with diabetes using a doctor-prescribed glucose monitor

Source: Freepik

While they work toward forcing tech companies to take these specs off the list of offerings, it’s crucial that people keep themselves safe by only using FDA approved monitors to track their blood sugar, heart rate, and whatever other bodily concerns they may have.