The San Diego-based company made Stelo available for purchase — without prescription — at Stelo.com. Dexcom became the first company to receive FDA clearance for an OTC CGM when the FDA cleared Stelo in March. Abbott followed in June with FDA clearance for its over-the-counter Libre Rio.
Dexcom designed Stelo, a small, wearable sensor, specifically for people with type 2 diabetes who do not use insulin. Worn on the back of the arm, the sensor provides insights directly to a user’s smartphone. Stelo features a 15-day wear based on the G7 platform. It offers a software experience tailored specifically for non-insulin users. The company said it makes it easier for the target population to access CGM and offers an option for those who don’t have insurance coverage for CGM.
(CEO Kevin Sayer spoke to Drug Delivery Business News about the next steps for Stelo at ADA 2024 — read about it here.)
“Dexcom has been at the forefront of glucose biosensing for 25 years. With the launch of Stelo, we’re defining a brand-new category and once again setting the gold standard for people to easily take control of their health,” said Jake Leach, Dexcom EVP and COO. “Now, millions more have access to 24/7, easy-to-understand glucose insights that can inform their daily lifestyle choices and support behavior modification.”
More about the Dexcom Stelo sensor
Key features of Stelo include no need for fingersticks. It offers the longest biosensor wear time and highest waterproof rating on the market, Dexcom says. The sensor also provides daily, weekly and session summary insights to help form healthier habits, plus spike and pattern detection.
Dexcom offers Stelo with multiple purchase options. Customers can pay $99 for a single pack of two sensors in a pay-as-you-go scheme. They can also pay $89 a month for an ongoing subscription, with two sensors delivered every 30 days.
“Dexcom glucose biosensors are an essential and proven tool for diabetes management – driving strong clinical outcomes regardless of medication use and even potentially slowing the progression of diabetes,” said Dr. Thomas Grace, head of clinical advocacy and outcomes at Dexcom. “In a world where GLP-1 use is becoming increasingly more common, glucose biosensors like Stelo can help make those medications more effective.”
Dexcom featured on our list of the nine largest diabetes technology companies in the world. Read here.
The analysts’ view
BTIG analysts Marie Thibault and Sam Eiber say Dexcom plans to target 125 million Americans with type 2 diabetes and prediabetes with its Stelo device.
The analysts said the pricing model fell in line with their previous projection of $100 per month. They made a one-time purchase, expected to arrive with shipping in three business days. The analysts called the ordering process “simple and smooth.”
According to Thibault and Eiber, Dexcom expects a 1% revenue contribution from Stelo in 2024, with sales weighted toward the fourth quarter. They maintained their “Buy” rating for Dexcom.
“We continue to see a significant market opportunity for CGMs further down the acuity curve and believe this will represent the next phase of growth in the space,” the analysts said.
Dexcom’s rival in the CGM space has a competitive offering
Abbott’s Libre Rio will combat the Stelo device as another OTC CGM offering, while the company also told Drug Delivery Business News via email that its FreeStyle Libre 2 Plus and FreeStyle Libre 3 Plus have a wear time of 15 days as well. While those devices are compatible with automated insulin delivery systems, the company says people with type 2 diabetes not using insulin can also use those CGMs.
Lisa Earnhardt, EVP and group president of Abbott’s medical devices business, said in a statement:
“At Abbott, our product development is centered on truly understanding the diverse needs of those we serve. Glucose monitoring is not one-size-fits-all, so we’ve developed distinct products to meet different needs. We’ve developed two over-the-counter glucose monitors based on the world-leading FreeStyle Libre technology: Libre Rio will offer essential features for adults managing their Type 2 diabetes without insulin. And Lingo is designed for the general consumer who wants to improve their overall health and wellness by delivering personal coaching insights based on their body’s reaction to nutrition, exercise and life’s daily stressors.”
