FDA approves the first OTC continuous glucose monitor

On March 5, 2024,  the U.S. Food and Drug Administration (FDA) approved the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is for adults who don’t use insulin. The device can be used by people who take medications to help them manage their blood sugar levels—and by people without diabetes who want to monitor how factors such as diet and exercise affect their blood sugar levels. 

What is Stelo?

Like other CGMs, the Stelo Glucose Biosensor System eliminates the need for regular fingerstick tests to measure glucose levels. Instead, a small wearable sensor on the back of your upper arm takes glucose readings every 15 minutes and transmits the data to a smartphone app. It helps detect normal readings, high glucose levels, or low glucose levels. The sensor can be worn for up to 15 days before it needs to be replaced. 

Produced by DexCom, Inc., Stelo is meant to provide personalized insights about glucose health—but it is not meant to be a substitute for medical advice from a healthcare provider. Especially for people who are managing diabetes, the Stelo GCM should be used in communication with a healthcare team.

The Stelo Glucose Biosensor System should not be used by people with problematic hypoglycemia—i.e., people with Type 1 diabetes who have had two or more episodes of severe hypoglycemia a year. The system is not designed to send alerts about this condition, which can lead to confusion, disorientation, fainting, seizures, or even death when untreated.

When will Stelo be available?

According to DexCom, the Stelo glucose biosensor will be available for purchase online in the summer of 2024. Because it will be an OTC product, consumers will not need a prescription.

How much does Stelo cost?

Information about the cost of the new Stelo system is not yet available. 

“By bringing Stelo to the market without a prescription needed, at a competitive price and shipping it directly to your door, we’re expanding access to life-changing glucose biosensing technology and addressing an unmet need for many of the 25 million people with Type 2 diabetes who don’t use insulin,” Thomas Grace, MD, head of Clinical Advocacy and Outcomes at Dexcom said in a statement to SingleCare.

Why this approval matters

The first continuous glucose monitor was approved 25 years ago. Since then, CGM technology has improved, becoming increasingly reliable and helping to improve care for the nearly 40 million people with diabetes in the U.S. 

Making CGMs available over the counter will help to eliminate barriers to diabetes management so that more people can achieve better long-term health outcomes. Additionally, this OTC approval can help people:

• Improve their A1Cs 
• Increase the amount of time spent in individual target glucose range
• Learn about their body’s response to diet and exercise 
• Identify early warning signs of diabetes (a CGM can detect signs of prediabetes, which is often a precursor to Type 2 diabetes)

“Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a healthcare provider,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”