Approval Given By FDA For First Over-The-Counter Continuous Glucose Monitor

Deposit Photos

Dexcom, the company behind the G6 and G7 continuous glucose monitor (CGM) systems, has received approval to sell the first over-the-counter CGM in the United States.

This means both individuals with and without diabetes can now monitor their blood sugar levels continuously without needing a prescription from a doctor. The U.S. Food and Drug Administration (FDA) announced the clearance of this new system, which is available for anyone over 18 years old does not use insulin.

The manufacturer has stated that the Stelo will be on the market in the summer of 2024, significantly expanding the pool of Americans who can purchase a CGM.

Initially developed to manage type 1 diabetes, which requires insulin and entails the constant risk of low and high blood sugar levels, CGM technology has gained acceptance for use in type 2 diabetes in recent years. This patient group, which typically does not require alarms and safety features, will now have easy access to a CGM specifically designed for their needs.


The Stelo CGM

The new device is called the Dexcom Stelo Glucose Biosensor System. Last summer, Dexcom’s executive vice president and chief operating officer, Jake Leach, provided a preview of the product to Diabetes Daily.

The Stelo sensor is identical in physical design to the sensor used in the Dexcom G7 system, a leading CGM available only by prescription. Like the G7, the Stelo sensor is applied to the body, typically the upper arm, using an adhesive, and continuously updates the user’s smartphone app with new blood sugar measurements.

The Stelo sensor operates by inserting a thin, flexible needle into the skin to sample glucose levels in the interstitial fluid between the skin and blood. Insertion is relatively painless, and the sensor can remain on the boy for 15 days before needing replacement. The Stelo is expected to provide accuracy similar to that of the G7.


The App, Redesigned

While the device itself may seem familiar, the Stelo will introduce a redesigned app, promising a significantly different user experience.

The Stelo will be streamlined, according to Teri Lawver, Dexcom’s chief commercial officer: “There are a lot of features [on the G7 app] that are not needed for the population not using insulin.”

For instance, individuals using the Stelo, who typically have a lower risk of hypoglycemia (low blood sugar) compared to insulin users, will not benefit from the system of alerts and alarms found in other CGM systems. Therefore, the Stelo is not suitable for insulin users or those with a history of hypoglycemia.

Lawver explains that instead, the Stelo aims to provide “all the insights without the interruption.” Similar to other CGMs, the Stelo will provide extensive diabetes management data, offering rapid feedback on the impact of diet and exercise on blood sugar levels. Studies indicates that CGM use can substantially enhance blood sugar control in individuals with diabetes who do not use insulin, leading to notable improvements in A1C levels.

Furthermore, the Stelo app will offer a more engaging experience compared to the G7 platform, providing feedback “in a gentle and encouraging manner,” according to Lawver.

“For the vast, vast majority of this population, they’ve never seen an endocrinologist. They’re seeing a primary care physician who has very limited time, and sometimes they don’t have access to diabetes education and glucose education. We are endeavoring to provide that to them,” says Lawver.

The app will “offer encouragement, pointing out when things are going well, helping the user to understand what combinations of food and activity, for example, are producing the outcomes that they want.”

“Telling people to eat less, lose weight, and exercise without giving them the right tools, it’s sort of like driving down a dark backcountry road with no headlights. You’re gonna bang into stuff. Using a CGM is like turning on the lights.”


Insurance Coverage Will Be Difficult

When the Stelo hits the market, only a few insurers will be prepared to cover the cost.

Dexcom aims to eventually persuade insurers to cover CGMs for individuals with type 2 diabetes who do not require insulin.

Currently, most insurance plans provide some coverage for individuals with type 1 or type 2 diabetes who use both rapid and basal insulin, and coverage is rapidly expanding for those who use basal insulin exclusively.

Lawver explains that in these groups, CGMs can save insurers up to $450 per month by reducing the number of emergency hospital visits resulting from critical low and high blood sugar events.

It may require additional time and research before Dexcom and other CGM manufacturers can demonstrate to insurers that CGMs are a cost-effective preventive measure for individuals who do not use insulin.


Option To Pay Cash

Meanwhile, Dexcom has introduced a new cash payment option, enabling customers to buy Stelo sensors directly over the counter, without the need for insurance.

Lawver states that “we are not sharing the price until launch” but promises that “it will be competitive with other cash pay options that are available.”

The FreeStyle Libre 3 CGM, Dexcom G7’s main competitor, doesn’t offer a cash payment option, but pharmacies typically chare around $140 to $150 for a month’s supply for uninsured customers.


Used By Those Without Diabetes Too

As an over-the-counter device, the Dexcom Stelo will be accessible for purchase by individuals without diabetes. CGMs have gained popularity in recent years among various groups of people interested in monitoring their blood sugar levels, including athletes aiming to optimize their performance and individuals with prediabetes or a family history of diabetes.

In response to this trend, various telehealth programs have emerged, offering online doctor consultations along with CGM sales and ongoing support.

Harvard Health notes that there is relatively little evidence supporting the medical benefits of CGMs for people without diabetes. However, eliminating barriers to CGM access could further fuel the growth of this trend.

In its statement, the FDA made explicit reference to users without diabetes “who want to better understand how diet and exercise may impact blood sugar levels.”

Jeff Shuren, MD, the director of the FDA’s Center for Devices and Radiological Health, said, “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.”