FDA approves first direct-to-consumer glucose monitor | Cromos Pharma

Revolutionizing Diabetes Management: FDA Approves First Direct-to-Consumer Glucose Monitor

The FDA has given the green light to the Dexcom Stelo Glucose Biosensor System, the first of its kind continuous glucose monitor (CGM) that will be available directly to consumers. Slated for release in summer 2024, this innovative device offers adults over 18 who do not rely on insulin a novel way to monitor their blood sugar levels. Importantly, the Dexcom Stelo is not recommended for those at risk of severe hypoglycemia as it does not include low blood sugar alerts.

In an effort to democratize health monitoring, the Dexcom Stelo aims to fill the void in the current market for CGMs, which typically require a prescription. This advancement is particularly significant for the estimated 25 million Americans with Type 2 diabetes who do not use insulin. By making CGM devices available over the counter, the FDA is taking a significant step towards reducing health disparities, ensuring more people have access to crucial health data.

The Dexcom Stelo utilizes a sensor that pairs with a smartphone app, enabling continuous tracking and analysis of glucose. Designed for people with Type 2 diabetes not on insulin and those without severe hypoglycemia, the sensor updates glucose data every 15 minutes and can be used for up to 15 days. Despite this, the manufacturers caution against using the app’s data for medical decisions without consulting a healthcare professional.

Clinical trials have shown the Dexcom Stelo’s performance to be in line with other CGMs, noting minor side effects like skin irritation and local infections.

The integration of biosensors, such as the Dexcom Stelo, into wellness practices represents a transformative approach to health monitoring. Their success and widespread use depend on affordability and insurance support. As biosensor technology becomes more common, it highlights its capability to improve metabolic health and prevent chronic diseases, promising broader access and enabling proactive health management for many.



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