The FDA Approves The First Over-The-Counter Glucose Monitor

The U.S. Food and Drug Administration (FDA) approved the first over-the-counter continuous glucose monitor (CGM). 

The product, which is called the Stelo Glucose Biosensor System and is manufactured by Dexcom, is scheduled to hit the market this summer. According to a statement from the agency: 

“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider. 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.”

We’ll explore the potential implications of this approval in this article.

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What is a Continuous Glucose Monitor? 

Continuous glucose monitors use sensors placed under the skin to measure glucose levels 24 hours a day.

Typically used by people with Type 1 and Type 2 diabetes to track their insulin, most CGM devices send glucose data directly to a patient’s phone and can alert them to potentially dangerous blood sugar levels.

CGMs are increasingly being used by people without diabetes to understand the effects of exercise, food, and sleep on their blood sugar levels — allowing them to make lifestyle changes based on their data. 

Dexcom’s over-the-counter product appears to be targeted mainly at these individuals, as well as anyone who isn’t on insulin and doesn't have problematic hypoglycemia.

Unlike other CGMss, Stelo Glucose Biosensor System isn’t designed to warn users about potentially dangerous conditions. Instead, the system utilizes a wearable sensor, paired with an application installed on a user’s smartphone or other smart device, to continuously measure, record, analyze, and display glucose values. 

The Implications of This News

Introducing an over-the-counter version of a CGM makes this tool accessible to more people since it no longer requires a prescription. This, in turn, allows consumers to collect, analyze, and take action on their health data. 

These more accessible CGM devices could also enable early detection of prediabetes, which currently affects 1 in 3 Americans, allowing more people to proactively make lifestyle changes to prevent the onset of Type 2 diabetes.

Key Takeaways:

• The FDA approved the first over-the-counter continuous glucose monitor (CGM).
• CGMs are increasingly being used by people without diabetes to understand the effects of exercise, food, and sleep on their blood sugar levels.
• This decision empowers more consumers to collect and take action on their health data.