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The Dexcom Stelo represents a significant milestone in expanding access to continuous glucose monitoring technology for people with type 2 diabetes who do not use insulin therapy. Continuous glucose monitors have traditionally been prescribed for those with type 1 diabetes or type 2 diabetes requiring insulin injections, as the real-time glucose data provides vital information for determining precise insulin dosing. However, the benefits of CGM extend far beyond just insulin management.
For the approximately 25 million Americans with type 2 diabetes not on insulin therapy, continuous glucose monitoring can provide invaluable insights into how dietary choices, physical activity, medications, and other factors impact their blood sugar levels throughout the day. This visibility into the dynamics of their glucose levels can empower better self-management through increased awareness and data-driven decision making. The clearance of the Stelo by the U.S. Food and Drug Administration (FDA) as the first over-the-counter CGM device is groundbreaking. By removing the prescription requirement, Dexcom has opened the door for this population to more easily access this technology, which could lead to improved outcomes and quality of life.
The Stelo is a compact, wearable sensor that is applied to the back of the upper arm to continuously monitor glucose levels. It wirelessly transmits the readings to a user's smartphone app, providing real-time glucose data 24/7 for up to 15 days before the sensor needs to be replaced.
While based on Dexcom's flagship G7 CGM platform, the Stelo has been specifically designed for the needs of type 2 diabetes patients not using insulin therapy. Unlike insulin-focused CGMs, the Stelo does not include features like low glucose alerts or insulin dosing calculators. Instead, the accompanying smartphone app is focused on delivering insights and trends about the user's glucose patterns in response to various lifestyle factors. The primary use case for the Stelo is to help users better understand how different foods, activities, and behaviors impact their blood sugar levels. By visualizing the real-time effects of these variables, users can make more informed choices to help manage their diabetes more effectively. For example, they may discover that certain meals or snacks cause significant glucose spikes, prompting them to adjust portion sizes or opt for alternatives with a lower glycemic impact.
A key driver behind the development of the Stelo was to address the accessibility and affordability barriers that have historically prevented many type 2 diabetes patients from benefiting from CGM technology. With the Stelo being an over-the-counter product, users will be able to purchase it directly without needing a prescription, eliminating a common obstacle to adoption.
Additionally, Dexcom has stated its intention to price the Stelo competitively for those who must pay out-of-pocket due to lack of insurance coverage for CGMs. While the exact pricing has not been disclosed, the company has acknowledged that traditional CGMs can cost upwards of $173 per month for individuals without insurance coverage, which can be prohibitively expensive for many. By offering the Stelo at a more affordable price point, Dexcom aims to make this technology accessible to a broader segment of the population, potentially improving health outcomes and reducing the long-term financial burden associated with poorly managed diabetes.
Numerous studies have demonstrated the clinical benefits of continuous glucose monitoring for people with type 2 diabetes, even those not requiring insulin therapy. Research has shown that the use of CGMs in this population is associated with improved time in target glucose range, better glycemic control (lower HbA1c levels), and enhanced quality of life.
For example, a study published in the Journal of Diabetes Science and Technology in 2021 found that participants with type 2 diabetes not on insulin who used a CGM experienced a significant reduction in their average blood glucose levels and spent more time in the target glucose range compared to those using traditional self-monitoring methods. Another study, published in the journal Diabetes Technology & Therapeutics in 2020, reported that CGM use in this population led to improved treatment satisfaction, increased engagement in self-management behaviors, and better psychological well-being.
By empowering individuals with real-time data and insights into their glucose patterns, CGMs like the Stelo have the potential to facilitate more informed decision-making, encourage healthier lifestyle choices, and ultimately improve long-term diabetes management and outcomes. This, in turn, could lead to a reduced risk of developing diabetes-related complications, such as heart disease, stroke, kidney disease, and vision loss, which can significantly impact quality of life and impose a substantial financial burden on individuals and healthcare systems.
While the introduction of the Stelo represents a significant step forward in expanding access to CGM technology, there are several challenges and considerations worth noting. First, the effectiveness of the Stelo will largely depend on user engagement and understanding of how to interpret and act upon the glucose data. Proper education and support will be crucial to ensure that users can effectively leverage the insights provided by the device to make meaningful lifestyle modifications. Additionally, the integration of CGM data into clinical workflows and the development of best practices for healthcare providers to incorporate this information into patient care will be an important consideration. Ensuring that providers are equipped to interpret and effectively utilize the data from devices like the Stelo will be essential for maximizing the potential benefits.
Furthermore, as with any new technology, there may be initial barriers to adoption, such as concerns about cost, usability, or privacy. Dexcom will need to address these potential concerns through effective marketing, user-friendly design, and robust data security measures to build trust and encourage widespread adoption. Finally, while the Stelo represents a promising solution for individuals not requiring insulin therapy, it is important to note that it is not a substitute for professional medical guidance and care. Users should still maintain regular consultations with their healthcare providers and follow prescribed treatment plans in conjunction with using the Stelo.
The FDA clearance of the Dexcom Stelo as the first over-the-counter continuous glucose monitoring system marks a significant milestone in expanding access to this valuable technology for a large underserved population. By removing the prescription requirement and offering a more affordable option, Dexcom has opened the door for millions of individuals with type 2 diabetes not on insulin therapy to benefit from the real-time insights and data provided by CGMs. Through increased awareness and understanding of how various lifestyle factors impact their glucose levels, users of the Stelo may be better equipped to make informed decisions and implement sustainable lifestyle modifications to improve their diabetes management. This, in turn, could lead to better glycemic control, reduced risk of complications, and improved overall health outcomes and quality of life.
While challenges remain, such as ensuring proper education, integration into clinical care, and addressing potential barriers to adoption, the introduction of the Stelo represents a significant step forward in leveraging technology to empower individuals and democratize access to tools that can support better self-management of chronic conditions like diabetes. As the landscape of digital health and wearable technologies continues to evolve, innovations like the Dexcom Stelo have the potential to reshape the way we approach chronic disease management, offering new opportunities for personalized, data-driven care and improved health outcomes for millions of individuals worldwide.