Biotech
Wednesday, March 6th, 2024 3:58 pm EDT
Key Points
- Dexcom’s new over-the-counter continuous glucose monitor, Stelo, has been FDA-cleared and will be available online this summer.
- Stelo is designed for Type 2 diabetes patients who do not use insulin, marking the first glucose biosensor not requiring a prescription.
- This clearance expands access to CGMs, allowing individuals to purchase without healthcare provider involvement, benefiting the more than 25 million Type 2 diabetes patients in the U.S. who do not use insulin.
Dexcom announced FDA clearance for its new over-the-counter continuous glucose monitor (CGM) called Stelo, set to be available for purchase online in the summer. CGMs are vital for diabetes management, monitoring glucose levels in real-time through sensors under the skin, sending data to smartphones to alert users and caregivers of emergencies. Stelo, the first glucose biosensor not requiring a prescription, targets Type 2 diabetes patients not using insulin, providing accessibility to those without insurance coverage for CGMs. With over 25 million Type 2 diabetes patients in the U.S. not using insulin, Dexcom’s existing G7 CGM requires a prescription, limiting accessibility. Dr. Jeff Shuren of the FDA stated that this clearance expands CGM access by allowing individuals to purchase without healthcare provider involvement. Dexcom revealed Stelo’s submission to the FDA in February, emphasizing its arm placement and 15-day lifespan before replacement. Jake Leach, Dexcom’s COO, highlighted Stelo’s tailored platform and branding for Type 2 patients, offering a simpler experience without complex alerts. Dexcom aims to demonstrate Stelo’s benefits for insurance coverage in the future but initially offers it at an “approachable” cash pay price to facilitate quick user access, recognizing the personal significance of CGM insights into one’s body.
For the full original article on CNBC, please click here: https://www.cnbc.com/2024/03/05/dexcom-announces-stelo-has-been-cleared-by-the-fda-.html
