Dexcom’s Stelo Glucose Biosensor Receives OTC Clearance for Kids With Type 2 Diabetes

On Friday, June 12, the Food and Drug Administration (FDA) approved the first over-the-counter, integrated continuous glucose monitoring (CGM) device for children, Dexcom’s Stelo. The Stelo has been approved for children ages 2 and older who do not use insulin and don’t require a prescription. 

The FDA previously approved the Stelo system over-the-counter for individuals 18 years and older in March 2024. 

The approval is intended for children without diabetes and those with diabetes who use oral medications to manage their condition. Over-the-counter approval will help children and youth understand the impact of diet and exercise on their blood sugar levels. It may also potentially help curb the rising tide of prediabetes and type 2 diabetes in the country.

Why is this approval important?

Approximately one in five children in the United States lives with obesity, and rates of both prediabetes and type 2 diabetes are on the rise in this age group. 

Access to over-the-counter CGMs, without the need for a prescription from a doctor, can play a pivotal role by providing real-time glucose data to build better glycemic awareness in more people.

“Children deserve access to the best tools available to manage their health,” Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said Friday in the news release. “Today’s clearance reflects the FDA’s commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn and play,” she added.

Families with children can track patterns in response to foods and exercise, and it can help families make more informed choices and adjustments to their routines to better support healthy lives. 

Learning blood sugar response to food is an important step in assessing how food affects not only insulin sensitivity and resistance, but also can help manage other factors associated with prediabetes and type 2 diabetes.

How does the Stelo work?

The Stelo system consists of a small sensor that’s inserted just under the skin, is wearable, and pairs with a smartphone app, either a child’s and/or their caregiver’s. It automatically measures glucose levels continuously, giving a new reading every 15 minutes, allowing users to view patterns and trends throughout the day.

Each biosensor can be worn for up to 15 days. The system is waterproof, working under eight feet of water for up to 24 hours. 

Who is the Stelo for?

The Stelo has been approved for children ages 2 and older who do not use insulin and don’t require a prescription. This device should only be used under the supervision of an adult caregiver. 

Notably, this system is not to be used for people at risk of severely low blood sugar (like those who are insulin-dependent) or who have hypo-unawareness, as it lacks the alerts and alarms that prescription CGMs provide. 

Parents of children with eating disorders or disordered eating should talk with their healthcare team before starting therapy with the Stelo.

What happens next?

The Stelo is available in pharmacies now. If you have questions about continuous glucose monitoring, you can speak with your healthcare team. There is no need for a prescription for the Stelo if you are interested in purchasing one for you or your child. 

If you want to learn more about the latest and greatest in diabetes tools and technology, check out our online resources here!