Stelo by Dexcom CGM: Overview, Features, and News

Key takeaways:

• Stelo by Dexcom, an over-the-counter biosensor and continuous glucose monitor (CGM) designed for people with prediabetes or people with type 2 diabetes who do not take insulin, is now available in the U.S. 
• The device has a 15-day wear time, is waterproof, and is available for purchase on Stelo.com.
• Stelo by Dexcom costs $99 for two sensors, a 30-day supply; those who enroll in a monthly subscription will receive a 10% discount.

Stelo by Dexcom, a new continuous glucose monitor targeted to people with diabetes who are not on insulin, is now available for purchase at Stelo.com. This makes Stelo the first ever continuous glucose monitor (CGM) available in America without a prescription. 

The device was cleared by the FDA for use in people 18 years and older who are not on insulin therapy and who do not have problematic hypoglycemia (low blood sugar). 

“FDA clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement at the time. 

“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.”

What is Stelo by Dexcom?

Stelo by Dexcom is tailored to people with prediabetes as well as people with diabetes who do not require insulin, which Dexcom estimates represents 70% of Americans with diabetes.

The device features software that, while built on the Dexcom G7 platform, will record blood glucose data for 15 days rather than 10, will exclude many of the alerts and alarms geared toward insulin users, and consequently will also require a shorter warmup time period. (With a continuous glucose monitor, warmup time refers to the amount of time it takes for the device to calibrate after it is placed under the skin and for data to begin to be transmitted; the only way to check blood glucose during this time is with a fingerstick blood test.) The Stelo by Dexcom is designed to present blood glucose measurements and trends every 15 minutes in an accompanying app. It has also been given the highest waterproof rating on the market.

The Stelo by Dexcom is designed to present blood glucose measurements and trends every 15 minutes in an accompanying app.

What is the price of Stelo by Dexcom?

The new FSA- and HSA-eligible glucose monitoring device will launch with a cash-pay model for anyone, including those without insurance. A two-pack (30-day supply) of sensors is available on Stelo.com for $99, or $89 per month for an ongoing subscription, with two sensors delivered every 30 days.

Will Stelo by Dexcom be covered by insurance?

Stelo is not currently covered by insurance, but at the announcement of the product’s launch, Dexcom CEO Kevin Sayer stated that he anticipates the product will eventually receive insurance reimbursement, alluding to the probability that CGM access is expanding to people with type 2 who have not reached advanced stages of diabetes.

“This would be of great help to people with type 2 diabetes who want to avoid both hyperglycemia as well as hypoglycemia and who aren't yet on insulin,” Sayer said.

Who is Stelo by Dexcom designed for?

Stelo by Dexcom is designed for people with prediabetes and those with type 2 diabetes who are not on insulin. This is one piece of Dexcom’s growing mission to help as many individuals as possible delay the progression of diabetes. According to Sayer, the company even hopes to eventually tap into the potential to prevent the onset of disease.

“There is so much that people who don’t use insulin can learn by receiving continuous glucose data and seeing first-hand how diet, exercise, sleep, stress, and other factors affect their overall health,” he said.

The product is also designed with those taking GLP-1s and other incretins in mind.

“Dexcom glucose biosensors are an essential and proven tool for diabetes management – driving strong clinical outcomes regardless of medication use9 and even potentially slowing the progression of diabetes,” Dr. Thomas Grace, head of clinical advocacy and outcomes at Dexcom, said in a statement, adding: “In a world where GLP-1 use is becoming increasingly more common, glucose biosensors like Stelo can help make those medications more effective.”

Stelo: Created with a broader customer base in mind

The launch of Stelo reflects a growing trend toward expanding access to diabetes technologies such as CGMs and automated insulin delivery systems, both to more people with diabetes and pre-diabetes as well as to a broader customer base.

In 2023, Medicare expanded CGM coverage for people with type 2 diabetes; UnitedHealthCare, the biggest private insurer in the U.S., followed suit several months later. Last year, the FDA also cleared Omnipod GO, a wearable basal insulin delivery device designed specifically for adults with type 2 diabetes.

Read next:

• FDA Clears Two New Abbott Over-the-Counter CGMs
• New AID Integrations Abound for Tandem, Dexcom G7, Freestyle Libre, and iLet
• Simplera CGM Approved in Europe
• Medicare Covers Freestyle Libre 3 CGM

Photo credit: Stelo by Dexcom