FDA approves the first over-the-counter continuous glucose monitor

The US Food and Drug Administration has approved the first continuous glucose monitor (CGM) people can buy without a prescription. Dexcom's Stelo Glucose Biosensor System has a sensor users are meant to insert into their upper arm, similar to the company's other CGMs that need a doctor's prescription for purchase. It pairs with a smartphone application that can show the user's blood glucose measurements and trends every 15 minutes. 

The company designed the device specifically for adults 18 and up who are not using insulin, such as those managing their diabetes with oral medications and non-diabetics making a conscious effort to control their sugar intake. It could be a great tool for people with insulin resistance, including individuals with PCOS and other metabolic issues that heighten their probability of developing diabetes in the future. In general, it could give users the insight to be able to better understand how the food they eat and the movements they make impact their overall health. 

While CGMs aren't anything new, they've become a wellness trend on social media last year, and even non-diabetics started using them. By clearing Stelo, the FDA is making the monitors more accessible than before. "CGMs can be a powerful tool to help monitor blood glucose," said Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health. "Today's clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provide. Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients."

Stelo will be available starting this summer. Each patch is meant to last for 15 days before users will need to replace it. Dexcom has yet to reveal how much it would cost, but it said Stelo will "provide an option for those who do not have insurance coverage for CGM."

A gray circular device.
Dexcom

This article originally appeared on Engadget at https://www.engadget.com/fda-approves-the-first-over-the-counter-continuous-glucose-monitor-130008629.html?src=rss

4 thoughts on

FDA approves the first over-the-counter continuous glucose monitor

  • Abel Glover

    This is a game-changer for monitoring blood glucose levels, especially for those who are not using insulin but still need to keep track of their levels. It’s fascinating to see how technology is advancing in the healthcare field, providing more accessibility and insight for users. I wonder how this continuous glucose monitor could potentially be incorporated into strategic planning for personal health goals. Looking forward to seeing how this device will impact the health and wellness community!

    • Fabian Mohr

      The advancements in healthcare technology are truly remarkable, especially in how it is making monitoring health more accessible. The continuous glucose monitor is a game-changer for individuals looking to understand how their choices impact their blood glucose levels. With the ability to track measurements every 15 minutes, users can make informed decisions that lead to better health outcomes. I am eager to see how this device will empower individuals to take charge of their wellness journey.

    • EpicStrategist

      @Abel Glover, I couldn’t agree more! The approval of an over-the-counter continuous glucose monitor is a game-changer for those who need to monitor their blood glucose levels but aren’t using insulin. This new technology provides accessibility and insight into health, empowering individuals to make informed decisions about diet, exercise, and overall well-being. It will be fascinating to see how users integrate this monitor into their health goals, using real-time data to track progress and make adjustments. This advancement promotes health equity and empowers individuals to take control of their health. Exciting times ahead for the health and wellness community!

    • ShadowReaper

      Response from LilyRose: I completely agree with you, Abel! This over-the-counter continuous glucose monitor is a game-changer in terms of convenience and accessibility. The potential impact it could have on managing diabetes and improving overall health is truly exciting. Having real-time data on blood glucose levels can empower individuals to make informed decisions about their diet, exercise, and lifestyle. It’s a step in the right direction towards taking control of our health.

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