Pharma To Date

Dexcom, a leader in continuous glucose monitoring (CGM) technology, has expanded its product line with the launch of Stelo, its first over-the-counter (OTC) glucose biosensor. Approved by the FDA in March 2024, Stelo is now available for direct consumer purchase without a prescription. This development marks a significant shift in the accessibility of glucose monitoring technology, previously restricted largely to prescription-based systems.

Enhanced Accessibility and Market Impact

Stelo is designed for use by adults aged 18 and older who are not on insulin therapy—a demographic encompassing approximately 25 million people with Type 2 diabetes in the United States. It also caters to individuals with prediabetes and those without diabetes seeking to monitor their glucose levels to understand the impact of diet and exercise. This broad application aims to facilitate proactive health management and potentially slow diabetes progression.

By offering Stelo OTC, Dexcom addresses a crucial gap in the market. Before this, CGM systems were predominantly accessible through prescriptions and insurance coverage, largely benefiting individuals with Type 1 diabetes or those on insulin therapy. Stelo’s launch represents a significant advancement in democratizing access to glucose monitoring tools, aligning with growing trends in preventive healthcare and personal wellness.

Technical Specifications and Cost

Stelo is worn on the upper arm and provides continuous glucose readings for up to 15 days. It syncs with a smartphone app to deliver real-time glucose data without needing fingerstick measurements. The device offers insights into how various lifestyle factors, such as diet and sleep, influence glucose levels. Notably, it omits certain features necessary for Type 1 diabetes management, such as low blood sugar alerts, to focus on general health and wellness.

Priced at $99 for a two-sensor pack or $89 per month for a subscription with bi-monthly sensor replacements, Stelo is positioned as a cost-effective option for ongoing glucose monitoring. The device boasts the longest wear time and highest waterproof rating among similar products on the market.

Clinical and Educational Implications

The introduction of Stelo underscores the potential for CGM technology to enhance patient outcomes beyond traditional insulin-dependent diabetes management. By providing continuous glucose data and educational content, Stelo empowers users to make informed lifestyle changes, potentially improving their overall health and diabetes management strategies.

For healthcare professionals, Stelo offers an opportunity to recommend a tool that supports patient education and self-management. Its broad availability and affordability could lead to increased engagement in diabetes care and preventive health measures.

Conclusion

Dexcom’s Stelo represents a significant advancement in glucose monitoring technology, offering increased accessibility and educational support to a wider audience. Its introduction may reshape how patients and healthcare providers approach diabetes management and preventive care, highlighting a shift towards more inclusive and proactive health monitoring solutions.