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Over-the-counter continuous glucose monitors empower diabetes patients and refine clinical insights | Viewpoint


This represents a new phase of data access, where hundreds of glucose reads per day per sensor provide greater insights into each patient’s disease management.

In an era shaped by the acceleration of healthcare technologies, the advent of over-the-counter (OTC) medical devices combines innovation with accessibility, symbolizing the availability of quality, equitable care.

Image: Rimidi

With the approval of over-the-counter continuous glucose monitors, consumer empowerment can rise to new heights, Lucienne Ide writes.

Most recently, Continuous Glucose Monitoring (CGM) is poised to undergo a monumental shift following the March announcement of FDA clearance for Dexcom's OTC Stelo Glucose Biosensor. More than just a regulatory milestone, this approval sends a message to the healthcare community about the growing opportunities for improvement in diabetes management.

Across the U.S. healthcare landscape, the approval of OTC CGM pushes consumer empowerment to new heights. The elimination of obstacles – such as insurance constraints and prescription dependencies – clears a path for people seeking more knowledge and control over their own health.

Today, there are more than 25 million Type 2 diabetes patients in the U.S. who don’t use insulin. Now those patients – as well as anyone interested in the relationship of diet and lifestyle with glucose regulation – have a valuable tool at their fingertips.

Improved CGM provides greater education and access to care

Previously, the narrative of diabetes management was shaped by intermittent glances into patients’ glucose levels. With routine fingersticks or occasional lab analyses serving as limited snapshots, the bigger picture of an individual’s diabetic experience remained obscure. OTC availability of CGMs signals a new phase of data access, where hundreds of glucose reads per day per sensor provide greater insights into each patient’s disease management.

The FDA’s CGM clearance may also have an especially beneficial impact on underserved communities, where access to innovative medical technologies and endocrinology care is often a challenge. There are just under 9,000 endocrinologists practicing in the U.S. and 38.4 million people with diabetes, so a reasonable ratio estimate is one endocrinologist for every 4,200 diabetic patients. Enhanced access to continuous glucose monitoring has the potential to reduce care disparities, paving the way for a more inclusive and equitable approach to healthcare for those with diabetes and those who are at risk from complications from this disease.

The relationship between healthcare providers and diabetes care is also on the verge of a significant transformation given this clearance. With the availability of over-the-counter CGM, physicians can play a crucial role in educating patients on newly available resources and can collaborate with patients to interpret the wealth of data generated by their devices. The insights gleaned from these CGMs are not just raw numbers; they're narratives waiting to be understood to drive action.

Provider guidance, paired with the enhanced attainability of a valuable tool, can help place individuals in the driver's seat of their health management journeys. Well-informed, engaged consumers have the power to drive change, which could improve accessibility to a wider range of tools and technologies for managing and treating various chronic conditions.

Education to encourage adoption will help overcome acceptance curve

With fewer barriers blocking the path to wider CGM adoption, the onus of realizing the potential of CGM monitoring is contingent on educational efforts. In healthcare settings and beyond, the potency of increased CGM usage lies in the hands of providers and advocates who can communicate its value. The FDA ruling was a necessary first step, but training programs and informational tools will be critical to shepherd patients to improvements during the ongoing evolution of diabetic care.

While many patients conduct their own research, most still expect their healthcare providers to serve as the experts on which treatments and tools will provide benefits. In fact, a Dexcom survey of diabetes patients who use insulin found that 68% of patients believe it is the responsibility of their healthcare provider to make them aware of new standards of care.

Individuals living with diabetes depend on healthcare professionals for education and guidance in selecting the most suitable resources, technologies, and medications to optimize their outcomes. Healthcare providers have an opportunity to advocate for the utilization of CGM among their patients, particularly those who may be unfamiliar with it or unaware of its potential benefits for their overall health.

The approval of over-the-counter CGMs is a reflection of consumer demands and a proactive approach to meeting them. Encouraging the adoption of practices that will provide widespread access to crucial health data – regardless of a patient's proximity to doctors or level of healthcare coverage – signifies a remarkable stride toward achieving national health equity.

Now the onus is on the healthcare system and technology infrastructure to be sure this data is easily shared from patients to their providers in a way that is convenient, efficient and actionable. At the end of the day, the goal of these devices is not just monitoring data but improving health management and outcomes.

Lucienne Marie Ide, M.D., is the founder and CEO of Rimidi, a company that supports healthcare providers with remote patient monitoring and chronic disease management.

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