Dexcom, a leading provider of continuous glucose monitoring (CGM) systems, has recently made waves in the healthcare industry with the announcement of FDA approval for its newest over-the-counter CGM, Stelo.
The device is set to be accessible for online purchase starting this summer. Dexcom plans to launch Stelo as a cash-pay product, with users covering the cost out-of-pocket. Worn on the back of the upper arm, the sensor can deliver 24/7 glucose readings to a smartphone app for up to 15 days.

Why it’s notable:

• FDA clearance for Stelo by Dexcom marks a pioneering moment as the first prescription-free glucose biosensor for continuous glucose monitoring. This advancement extends glucose monitoring access to individuals with Type 2 diabetes who do not require insulin and to adults interested in nonmedical blood sugar tracking. 

• Stelo addresses a vital need for those with Type 2 diabetes not covered by insurance for CGM devices. By offering an over-the-counter solution, Dexcom aims to overcome insurance barriers, ensuring a broader population can leverage glucose monitoring for improved diabetes management.

• Dexcom’s Stelo not only stands as a breakthrough in accessibility but also contributes to Dexcom’s history of CGM innovation. This innovation is poised to empower individuals with Type 2 diabetes by providing valuable insights into the impact of diet and activity on glucose values, potentially revolutionising T2D management strategies.

• The FDA clearance also emphasises that Stelo is not intended for individuals with low blood sugar. It underscores the importance of consulting a doctor before making any healthcare decisions based on the information provided by the CGM and its accompanying app. This sets it apart from conventional CGMs used by those with Type 1 diabetes.

• Dexcom's move to offer prescription-free glucose monitoring is in line with a rising trend of consumers taking charge of their health. It empowers more people with essential health insights, irrespective of their access to medical professionals or health insurance. This is an important step forward in advancing health equity for US patients.

• The growing market for CGMs extends beyond diabetes, opening it up to adults who want to track their blood sugar for nonmedical purposes. Startups are working to make this technology accessible to consumers beyond diabetes, promising benefits from weight loss to enhanced performance.

• The expanded accessibility to a wider consumer base is reshaping the glucose monitoring industry. With the FDA opening doors for over-the-counter access, Dexcom stands to gain a first-mover advantage. Other competitors, such as Abbott, are likely to follow suit. Abbott is set to launch a prescription-free biosensor that tracks glucose levels, sometime this year.

• Incorporating glucose monitoring into daily health routines, even for non-diabetics, offers a unique window into metabolic health. This rising trend of glucose monitoring among wellness enthusiasts not only provides valuable insights but also has the power to uplift individuals' overall well-being and preemptively curb the onset of chronic diseases.