In A First FDA Approves OTC Continuous Glucose Monitoring Device

This over-the-counter sensor is aimed at individuals aged 18 and older who are not on insulin and do not experience problematic hypoglycemia.

In a first, the US Food and Drug Administration (FDA) has granted marketing clearance for an over the counter (OTC) continuous glucose monitor (CGM) available on the market to the Dexcom Stelo Glucose Biosensor System.

The integrated CGM (iCGM) is intended for individuals aged 18 and older who do not use insulin. It also includes those managing diabetes with oral medications and individuals without diabetes seeking insight into the impact of diet and exercise on blood sugar levels.

The Stelo Glucose Biosensor System, however, is not intended for individuals with problematic hypoglycemia (low blood sugar) as it does not provide alerts for this potentially dangerous condition.

Stelo will be available for purchase online without a prescription in the US from 2024 summer.

Highlighting the significance of the clearance, Jeff Shuren, MD, JD & director, FDA’s Center for Devices and Radiological Health, said, "CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider."

He further emphasized the importance of providing valuable health information to individuals, regardless of their access to healthcare professionals or insurance coverage, as a step forward in advancing health equity for US patients.

How Does Dexcom Stelo Glucose Biosensor System Work?

The Stelo Glucose Biosensor System utilizes a wearable sensor paired with a smartphone application to continuously measure, record, analyze, and display glucose values in users.

This over-the-counter sensor is aimed at individuals aged 18 and older who are not on insulin and do not experience problematic hypoglycemia.

Each sensor can be worn for up to 15 days before replacement, with the device presenting blood glucose measurements and trends every 15 minutes in the accompanying app.

However, users are cautioned against making medical decisions based solely on the device's output and are advised to consult with their healthcare provider.

Clinical data provided to the FDA demonstrated that the device performed comparably to other iCGMs. Reported adverse events included local infection, skin irritation, and pain or discomfort.

As part of the FDA’s strategic priority to advance health equity, the Center for Devices and Radiological Health aims to support innovation that addresses health equity by promoting care and wellness in home settings.

According to Jake Leach, Dexcom’s executive VP & and COO, Dexcom was the pioneer in linking CGM to various insulin delivery devices, integrating CGM with smartphones, eliminating fingersticks‡ for treatment decisions, and is now innovating by introducing the first glucose biosensor cleared for over-the-counter use.

“Based on our experience serving people with Type 2 diabetes not using insulin, we have developed Stelo with their unique needs in mind,” he added.

How does Continuous Glucose Monitoring help?

Continuous Glucose Monitoring (CGM) is an important tool for people with diabetes, as it allows them to monitor their blood sugar levels continuously and make informed decisions about their diabetes management.

CGM systems provide real-time blood sugar tracking, enabling individuals to monitor their blood sugar levels continuously.

It also provides insights into blood sugar patterns, helping individuals understand how their blood sugar levels change throughout the day and in response to different activities.

Continuous Glucose Monitoring also is a better alternative to fingerstick testing, which can be painful and inconvenient for individuals with diabetes.

Depending on the region/country, there are several Over-the-counter available in the market including Ultrahuman M1, Freestyle Libre, Actofit CGM Contour Plus Blood Glucose Monitoring System, etc.

However, none of the Over the Counter CGM devices in the market are FDA-approved.

The FDA approval for Dexcom’s Stelo also opens the door for other OTC CGM devices to get FDA-approved stamps.