DexCom, Inc., a leader in real-time continuous glucose monitoring (CGM) technology for diabetes management, has announced a significant breakthrough in diabetes care with the FDA clearance of Stelo by Dexcom. This marks the first glucose biosensor system cleared for over-the-counter (OTC) use, making it accessible without a prescription. Stelo is designed to cater to the needs of the approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin. This development is expected to simplify access to CGM technology for those who may not have insurance coverage for such devices, offering a new level of convenience and empowerment in diabetes management.
Stelo's clearance for OTC use is a milestone in Dexcom's history of innovation in the CGM market, including being the first to connect CGM to multiple insulin delivery devices, smartphones, and to replace fingersticks for treatment decisions. The device is intended for use by individuals aged 18 years and older, specifically targeting diabetics managing their condition with oral medications and non-diabetics interested in monitoring their blood glucose levels. However, it is not designed for individuals with problematic low blood sugar levels, as it does not alert users to this potentially dangerous condition. Stelo will be available online without a prescription starting this summer.
The introduction of Stelo by Dexcom represents a significant advancement in the management of Type 2 diabetes, offering a new tool for individuals to monitor their glucose levels more easily and effectively. This innovation aligns with the broader goal of improving diabetes care and empowering patients with the knowledge and tools needed to manage their condition more proactively.
Frequently Asked Questions
How accurate is Stelo compared to traditional glucose monitoring systems?
Since Stelo is built on the same technology as Dexcom's G7 system, it's expected to be just as accurate. These devices work by checking sugar levels in body fluid just under the skin and give updates in real time. While we don't have the exact numbers for Stelo, devices like the G7 are known for being very reliable. This means that Stelo should do a great job in helping people keep an eye on their sugar levels accurately, especially when sugar levels are within normal or high ranges.
What is the environmental impact of using Stelo, considering waste from sensors or other components?
The environmental impact of using Stelo involves the disposal of used sensors and potentially other components, which could contribute to electronic and medical waste. Dexcom, like many medical device manufacturers, is likely exploring ways to minimize waste and improve the sustainability of their products, though specific initiatives or recycling programs for Stelo have not been detailed.
Are there any special storage or handling requirements for Stelo sensors to maintain their efficacy?
Stelo sensors, like most medical devices, may require specific storage and handling conditions to maintain their efficacy, such as keeping them at a certain temperature range and away from moisture or direct sunlight. It's important to follow the manufacturer's guidelines closely to ensure the sensors perform as intended.
