The Stelo Glucose Biosensor System, developed by Dexcom, has been granted approval by the US Food and Drug Administration (USFDA) as an Over-the-Counter (OTC) Continuous Glucose Monitoring (CGM) device. This innovative device is designed for individuals who are 18 years and older and do not use insulin. It offers a convenient and accurate way to monitor glucose levels throughout the day.
The Stelo Glucose Biosensor System consists of a small, wearable sensor that is inserted just below the skin. The sensor continuously measures glucose levels in the interstitial fluid and sends the data to a receiver or compatible smart device. Users can access real-time glucose readings and trends on their smartphone or other devices, providing them with valuable insights to manage their diabetes more effectively.
This OTC CGM makes it easier for individuals to monitor their glucose levels without the need for frequent fingerstick tests. It provides continuous monitoring and alerts users of high or low glucose levels in real-time. By tracking glucose trends, users can make informed decisions regarding food choices, exercise, and insulin management.
The Stelo Glucose Biosensor System is intended for individuals who manage their diabetes without insulin therapy. It is not suitable for those who use insulin, require frequent glucose calibrations, or have certain medical conditions. The device should be used as an adjunct to regular blood glucose monitoring and not solely for treatment decisions.
The approval of the Stelo Glucose Biosensor System by the USFDA is a significant development in the field of diabetes management. It provides individuals with a user-friendly and convenient option for continuous glucose monitoring. With this OTC device, more people will have access to valuable data about their glucose levels, helping them better understand their diabetes and make informed decisions to improve their health.
In conclusion, the USFDA’s approval of the Stelo Glucose Biosensor System as an OTC CGM device marks a milestone in diabetes care. This innovative device offers a convenient and easy way for individuals aged 18 and above to monitor their glucose levels. It empowers users to make informed decisions and take control of their diabetes management. Dexcom’s Stelo Glucose Biosensor System is set to revolutionize the way individuals manage their diabetes and improve their overall health and well-being.
