Over-the-Counter CGM: A Turning Point in Diabetes Management?
Soon, in the U.S., folks will have access to an FDA-cleared over-the-counter (OTC) continuous glucose monitor (CGM). That means without a doctor's prescription and no worrying about whether health insurance will cover it. The cost is out of pocket—just go online and order it. Or maybe walk into the neighborhood pharmacy and pick one up.
Coming soon: Easier access to continuous glucose monitors
The FDA recently approved a fully functional CGM based on an approved medical device sensor. The difference in the OTC CGM option is in the software that comes with it. As a result, this OTC CGM is meant to be used by a person with type 2 diabetes who doesn't use insulin or who doesn't have diabetes but wants to monitor their glucose levels.1
Over-the-counter CGM limitations
The accompanying application/software with the OTC CGM does not include any alarms for hypoglycemia. The sensor will still measure glucose levels, and the user can still see a low reading in the app. But the app won't automatically draw the user's attention to it with an alarm function.2
This is why the FDA limits its approval to people who don't use insulin. While people who don't use insulin can experience hypoglycemia, they tend to have fewer "hypos" than insulin users.1
At any rate, seeing a current glucose reading on your phone is still helpful in confirming any hypoglycemia or hyperglycemia symptoms. It's certainly quicker than checking blood sugar with a glucometer and finger stick.1
Data-sharing methods
Users can share their data with this approved OTC CGM, but the details aren't clear yet. But I wonder how many healthcare providers will take the time or be interested in seeing it.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 asked me to see the data from my fitness tracker.
How will users learn to use CGM data effectively?
Data from a continuous glucose monitor differs from readings gathered using a glucometer. This 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 one thing, much more data is available with CGMs. With a continuous glucose monitor, readings are taken every few minutes around the clock. Instead of having a handful of readings, the user can have a hundred or more daily. Readings are available in real-time. All the user needs to do is look at the app to see their current glucose reading. There's a risk of becoming obsessive about checking or getting overwhelmed by the sheer amount of data presented.
Understanding the data
CGM data is presented differently. Instead of a list of numbers or a scattergram of discrete readings, the user will likely see a squiggly line graph highlighting every high and low point throughout the day. The challenge is in understanding which part of that line is most valuable:
- Which readings call for an active response?
- What is the bigger context when highs or lows happen?
- How do meals, exercise, or sleep impact these readings?
- Is this a mystery spike that happened all on its own?
Motivation for type 2 diabetes management
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.
After a while, the fitness tracker became little more than a wristwatch. I lost all motivation to use it. While I'm curious to try this OTC CGM, I wonder if it will suffer the same fate as my fitness tracker.
Are you curious to try this OTC CGM? If you already use a CGM to help manage your diabetes, what words of advice do you have for people considering it?
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