On March 5, 2024, the Food and Drug Administration approved the Dexcom Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitor (CGM) available in the US. Let’s discuss why this is a significant and exciting development.
CGMs are critical tools for managing both Type 1 and Type 2 diabetes, providing real-time updates when attached to the body. Stelo goes beyond standard CGMs. However, the Stelo system elevates this standard. Unlike regular CGMs that require prescriptions, Stelo offers an alternative route. It can be purchased and used without involving a doctor, potentially enhancing accessibility for individuals managing diabetes without insulin. The Dexcom Stelo Biosensor has a 15-day lifespan, compared to 10 days for the Dexcom G7 Sensor, but the underlying technology is the same. The key difference is Stelo is available without a prescription.
At the Raymond James Institutional Investors Conference on Tuesday March 5, Sean Christensen, Dexcom's vice president of investor relations, said, "We need to give doctors the ability to take advantage of their preferred prescription or their preferred methodology to treat these patients, most of whom do not have reimbursed access for the CGM today."
The Stelo System is Dexcom's provided solution. The Stelo's software is designed to meet the needs of people with Type 2 diabetes who are not using insulin. According to Christensen "These are people who have different needs. These are people who do more self-management of diabetes care as opposed to being managed directly by their clinician. We can give them greater data and greater ability to engage with their health with this product."
This milestone significantly impacts diabetes management. The Stelo system provides real-time glucose monitoring without the need for finger stick tests, offering a constant stream of data. This empowers users to make informed decisions about their diet and exercise, ultimately leading to better glycemic control and improved overall health.
While the Stelo system is a major breakthrough, users should not take medical action based solely on the device output without consulting a qualified healthcare professional.
Can Everyone Use the Stelo System?
The simple answer is NO. The Stelo Glucose Biosensor System is intended for individuals aged 18 years and above who are NOT on insulin.
It helps detect normal (euglycemic) as well as low or high (dysglycemic) glucose levels. Additionally, the Stelo system is NOT intended for people with a history of severe hypoglycemia (low blood sugar).
The Stelo Biosensor Might Cover Broader Population other than Diabetics
While Dexcom sought to offer the new Stelo device to people with Type 2 diabetes who don't take insulin, the Food and Drug Administration (FDA) expanded on that, opening the CGM to most adults who don't take insulin, this includes people with prediabetes, potentially helping them to be more aware of their glucose (sugar) levels.
This broad indication clears a pathway for Dexcom to grow its CGM business. The Dexcom Chief Operating Officer, Jake Leach, said, "The indication for use is broad...That covers this population that Stelo was designed for, but it also covers a broader population too. We feel that over time, the opportunity for CGMs to provide benefits to people goes far beyond diabetes."
The FDA's decision has set a high bar for competitors like Abbott who is working to bring its CGM technology Lingo, to a broader audience. Abbott's Lingo is a CGM technology which only measures blood glucose, launched last year for general wellness purposes, but is not intended for people with diabetes.
When Will The Dexcom Stelo System be Available?
Dexcom anticipates launching Stelo in summer 2024. it is important to remember that Stelo is a monitoring tool, not a replacement for professional medical advice.
While it can provide valuable insights, users should always consult their healthcare provider for interpreting data and making treatment decisions.
Dexcom has stated that Stelo will be available to purchase online when it initially launches. But what it hasn't yet said is yet is whether it will be sold at pharmacies or other in-person retailers or how much it will cost. On the price of Stelo, however, a company spokesperson declined to provide pricing estimates but said the biosensor would be competitive. J.P. Morgan and William Blair analysts expect the Biosensor to be competitively priced with the Abbott's Freestyle Libre CGMs, which are about $80 per month.
As many people look forward to gaining access to this groundbreaking technology, we can expect to see profound improvements in glycemic control, reduced risk of complications, and greater overall well-being for individuals with diabetes around the world.
Stay tuned for further updates on the official launch date and pricing details.
Need a CGM Solution Now?
While you wait for the Dexcom Stelo to launch, the Dexcom G7 Sensor is a great option for managing your diabetes. It offers real-time glucose readings and trend data.
You can find the Dexcom G7 Sensor for retail price at www.prestigemedicalsupply.net (Prestige Medical Supply) and get up to 20% discount by subscribing to their mailing list.
Risks Associated with Stelo
The Stelo device is not meant as an option for those who use insulin because it lacks a warning system for hypoglycemia; hence, users are expected not to use provided data for key health decisions without consulting a medical professional.
According to the Food and Drug Administration (FDA) "Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs. Adverse events reported in the study included local infection, skin irritation and pain or discomfort."
Pouya Shafipour, MD, a family and obesity medicine physician at Providence Saint John’s Health Center, said the product is a promising development, but he expressed concerns about its accuracy and how patients might react to near real-time data.
Neither of these potential risks however underestimates the usefulness of the powerful Stelo Glucose Biosenseor System.
What Experts Are Saying About The New Dexcom Stelo Biosensor
The introduction of the Dexcom Stelo Biosensor has sparked a wave of anticipation and interest among experts in the diabetes management community. With its innovative design and advanced features, health professionals are eager to explore the benefits and here's what some of them have to say.
Pouya Shafipour, MD, a family and obesity medicine physician at Providence Saint John’s Health Center:
“I think they’re great devices,” Shafipour said. “They can provide a lot of information in terms of activities, different types of foods that can influence [blood sugar levels], and there’s a lot of doctors who have great podcasts that are advocating for these devices for people to take control of their health and diet.”
Tamara Oser, MD, Family Physician.
“Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values,”...“For people newly diagnosed with Type 2 diabetes or not taking insulin, these devices are often not covered by insurance and Stelo presents an opportunity to provide valuable information that can impact their diabetes management.”
Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
“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,”...“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 US patients.”
I look forward to this as lately I have been forgetting to test and when I do the timing of when I should test is off.. I do feel that this product will be too expensive for me to use which is sad because I could really benefit from real time numbers. As a senior, it will just be another expense where I would have to sacrifice something in order to get it.