What to Know About the New Over-the-Counter Continuous Glucose Monitor

Soon, folks in the U.S. will have access to an FDA-cleared, over-the-counter (OTC) continuous glucose monitor (CGM). This means you can obtain a glucose monitor without a doctor’s prescription and without worrying about health insurance coverage.

Because the cost is entirely out-of-pocket, you can simply go online to order it. Alternatively, you might just walk into your neighborhood pharmacy and pick one up.

How will easier access to continuous glucose monitors change things?

The FDA recently approved a fully functional CGM based on an existing, approved medical device sensor. The primary difference with this over-the-counter glucose monitor lies in its accompanying software. As a result, this OTC glucose monitor is designed for people with type 2 diabetes who do not use insulin. It is also intended for individuals without diabetes who simply want to track their blood sugar readings and analyze their glucose data.¹

What are the limitations of an over-the-counter glucose monitor?

The software paired with this over-the-counter CGM does not include built-in alerts for hypoglycemia. The sensor will still measure glucose levels, and the user can still see a low reading in the app. However, the app won't automatically sound an alarm to draw your attention to it.²

Because of this missing feature, the FDA limits its approval to individuals who do not use insulin. While non-insulin users can still experience hypoglycemia, they generally face fewer "hypos" than those who take insulin.¹

Even without alarms, viewing real-time glucose data on your phone is highly valuable for identifying symptoms of high or low blood sugar. It's certainly much faster and less painful than checking blood sugar with a traditional glucometer and finger stick.¹

How will data sharing work with an OTC glucose monitor?

While users can share their glucose data through this newly approved OTC CGM, the exact mechanics remain unclear. Furthermore, it raises a critical question: How many healthcare providers will actually take the time, or even have the interest, to review this information?²

A while back, I got a fitness tracker at a discount through my health insurance plan. To get the discount, I had to agree to share my data. However, my doctor never once asked to look at the data from my tracker.

How can users learn to use CGM data effectively?

Data from a continuous glucose monitor is vastly different rom isolated blood sugar readings gathered via a standard glucometer. This distinction brings me to my biggest question about using an OTC CGM to help people manage type 2 diabetes: How will the user learn to use CGM data effectively?

More readings in real-time

For starters, much more data is available with CGMs. With a continuous glucose monitor, readings are tracked automatically every few minutes around the clock. Instead of relying on a handful of daily finger sticks, a user receives over a hundred updates a day. Because these blood sugar readings are available in real-time, all you have to do is check the app to see your current levels. However, this convenience introduces a psychological risk: users might become obsessive about constantly checking or simply feel overwhelmed by the sheer mountain of glucose data presented.

Understanding the data

An over-the-counter glucose monitor also visualizes information quite differently. Instead of a simple list of numbers or a scattergram of discrete readings, the user will likely see a continuous, fluctuating trend line highlighting every high and low point throughout the day.

The real challenge lies in understanding which parts of that line are actually meaningful, requiring users to figure out:

• Which specific glucose data points call for an active response?
• What is the broader context when highs or lows happen?
• How exactly do meals, exercise, or sleep habits impact these blood sugar readings?
• Is a sudden spike an isolated mystery, or part of a larger pattern?

Will an OTC glucose monitor help maintain long-term motivation?

Returning to my experience with the fitness tracker, I realized it kept track of my steps. While I knew that more steps in a day were better, I could never get to a deeper understanding. I was only ever able to connect my step counts with my diabetes management in the most general way.

Eventually, the fitness tracker became little more than a wristwatch, and I completely lost the motivation to use it. While I am genuinely curious to try a new over-the-counter glucose monitor, I worry whether it might ultimately suffer the same fate.

Are you curious to try an over-the-counter glucose monitor yourself? If you already use a continuous glucose monitor to help manage your diabetes, what words of advice do you have for people considering it?