FDA clears first over-the-counter continuous glucose monitor (fda.gov)

Article summary

The FDA has cleared the first over-the-counter continuous glucose monitor, the Dexcom Stelo Glucose Biosensor System, for people 18 years and older who do not use insulin. This system allows users to monitor their blood glucose levels without the need for a healthcare provider. The device uses a wearable sensor and a smartphone app to track glucose levels every 15 minutes. The clearance aims to expand access to glucose monitoring devices and promote health equity.

Main themes

• FDA clearance
• continuous glucose monitoring
• diabetes management
• medical device waste
• health equity
• cost and accessibility

What commenters say

• Some commenters question the availability of similar devices on online marketplaces, suggesting that they may be unauthorized or fraudulent.
• The high cost and plastic waste associated with continuous glucose monitors are major drawbacks for some users.
• Others argue that the benefits of continuous glucose monitoring, including improved blood sugar control and reduced risk of complications, outweigh the costs and environmental impact.
• The reliability and accuracy of different continuous glucose monitoring systems are debated, with some users reporting positive experiences and others experiencing failures or inaccuracies.
• Some users appreciate the convenience and improved quality of life offered by continuous glucose monitoring, particularly when combined with other diabetes management tools like insulin pumps.
• The environmental impact of medical device packaging is a concern, with some commenters suggesting that companies could reduce waste without compromising safety and sterility.
• The cost of continuous glucose monitoring systems can be a significant burden, especially for those without insurance coverage or with high out-of-pocket expenses.