Dexcom’s over-the-counter continuing glucose monitor (CGM) has been approved by the Food and Drug Administration (FDA), the company announced Tuesday afternoon.

The CGM, dubbed Stelo, consists of a small wearable sensor that’s placed on a person’s upper arm. The sensor is linked to an app on the patient’s smartphone, where it directly sends glucose updates every 15 minutes — and it’s meant for patients with type 2 diabetes who aren’t taking insulin. 

In a press release, Dexcom noted that since the device will be available OTC, people won’t need a prescription to buy Stelo — providing an option for those who do not have insurance coverage for it.

“Based on our experience serving people with type 2 diabetes not using insulin, we have developed Stelo with their unique needs in mind,” stated Jake Leach, EVP and chief operating officer at Dexcom.

In particular, Stelo may be helpful for people with diabetes who are taking oral medications — or even people who don’t have diabetes, who simply want to better monitor how their diet and exercise affects their blood sugar, the FDA noted in a statement.

The agency said its decision was based on a clinical study that showed Stelo performed as effectively as other iCGMs, with adverse events reported including local infection, skin irritation and discomfort.

“CGMs can be a powerful tool to help monitor blood glucose,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement. “Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a healthcare provider.”

While Dexcom has largely dominated the CGM space — with TikTok diabetes influencers crediting the brand by name regularly in their videos — it wasn’t the first manufacturer to the market. 

In 2017, the FDA approved the first glucose monitoring system developed by Abbott, and since then the CGM market has grown to be worth around $5 billion.

Apple has also reportedly been in works to develop a CGM feature for the Apple Watch.

William Blair analyst Margaret Kaczor wrote in a research note that the FDA greenlight will have a broader impact on the industry and “meaningfully ease” the barriers to accessing CGM technologies.

“This is important not only for non-insulin users, where demand has been strong despite limited access, but it opens up the non-diabetic market for CGM technologies altogether,” Kaczor wrote.

Last year, Dexcom launched several campaigns focused on its CGM products, including its name, image, likeness (NIL) program for college athletes with diabetes. In November, the company also rolled out its #SeeDiabetes campaign which featured several of its patient ambassadors known as Dexcom Warriors having their photos taken in a series that depicts how diabetes impacts their lives.