Health & Wellness
FDA’s Approval of Dexcom’s Stelo: A Leap Forward in Diabetes Management
The recent FDA approval of the first OTC Continuous Glucose Monitor, Dexcom’s Stelo Glucose Biosensor System, marks a significant milestone in diabetes care.
Diabetes is a global health concern that affects millions of people worldwide. Managing this condition requires constant monitoring of blood glucose levels, which has been challenging for many until now. However, the recent FDA approval of Dexcom’s Stelo Glucose Biosensor System, the first OTC Continuous Glucose Monitor, promises to revolutionize diabetes management.
Understanding Dexcom’s Stelo Glucose Biosensor System
Unlike Dexcom’s G6 and G7 CGM systems, the Stelo is designed for adults with or without diabetes who do not use insulin. The FDA emphasized in its statement on March 5, 2024, that this system is not intended for individuals with problematic hypoglycemia as it is not designed to alert the user to this potentially dangerous condition.
The Stelo system comprises a wearable sensor paired with an application installed on a smartphone or other reader device. It continuously measures, records, analyzes and displays glucose values every 15 minutes. Each sensor can be worn for up to 15 days before it must be replaced. It is not intended to be used to make medical decisions without first checking with a healthcare provider.
How Does This Approval Help in the Reduction of Diabetes Complications?
The FDA's approval of the Stelo system is a significant step in diabetes management. Continuous glucose monitoring allows individuals to monitor their glucose levels closely, enabling them to take timely action to prevent potential complications.
Moreover, the convenience of an over-the-counter device eliminates the need for frequent doctor visits for prescription refills, making diabetes management more accessible and less burdensome for patients.
Conclusion
The FDA’s approval of Dexcom’s Stelo Glucose Biosensor System is a game-changer in diabetes management. By making continuous glucose monitoring more accessible, it empowers individuals to take control of their health and reduce the risk of diabetes complications. As we move forward, we can expect to see more innovations like this that will continue improving the lives of those with diabetes.
Please note: This article is intended for informational purposes only. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your healthcare provider with any questions you may have regarding a medical condition.
