FDA Clears New OTC Stelo Continuous Glucose Monitor for Type 2 Diabetes
By Susannah Chen
The FDA has cleared Stelo by Dexcom, a new over-the-counter continuous glucose monitor (CGM) designed for people with diabetes who do not take insulin.
Stelo by Dexcom, a new continuous glucose monitor targeted to people with diabetes who are not on insulin, has been 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).
In its announcement, the FDA also revealed that the Stelo will be the first-ever continuous glucose monitor (CGM) available in the U.S. without a prescription.
“Today’s 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.
“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 diabetes who do not require insulin, which Dexcom estimates represents 70% of Americans with diabetes.
The device will feature 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.
When will Stelo by Dexcom be available for purchase?
The Stelo by Dexcom glucose biosensor system is expected to launch this summer now that it has received a green light from U.S. regulators.
What is the price of Stelo by Dexcom?
While Dexcom has not been specific about pricing, according to diaTribe’s sister publication Close Concerns, representatives have implied that the product would be competitive with Abbott’s cash-pay pricing for its Freestyle Libre systems.
The new glucose monitoring device will launch with a cash-pay model for anyone without insurance.
At the launch announcement, Dexcom CEO Kevin Sayer said 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 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.
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.
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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.
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Photo credit: Stelo by Dexcom
