BLOG

CGMs will soon be available without a prescription and marketed to individuals without diabetes.

Introduction: The Changing Role of CGMs

Continuous glucose monitoring systems (CGMs) have become vital for those with diabetes in controlling blood sugar and lowering A1C scores. Now, they’re being marketed as a general wellness tool. Read on to learn more.

Suppose you’re among the more than 38 million Americans currently living with diabetes and are taking insulin to control your blood sugar. In that case, you may use a doctor-prescribed continuous glucose monitoring device to gain real-time blood sugar data and better control your disease.

CGMs have been proven to help those with both Type 1 and Type 2 diabetes, especially those who have had difficulty maintaining proper blood glucose levels, getting things back in line, and keeping blood glucose numbers within the target range.

But now, a whole new over-the-counter (OTC) CGM market is on the horizon, and it has little to do with managing diabetes and has a lot more to do with general health and wellness.

As with any new wellness path, there is some controversy as to whether this new way of applying CGM technology has any real value to users. Nevertheless, it is happening, with devices likely becoming available this summer (2024), so let’s dig into it.

 

Introducing the New Over-the-Counter CGMs: Dexcom Stelo and Abbott Lingo

The FDA has cleared two companies, Dexcom and Abbott Laboratories, to market CGM devices to adults 18 years of age or older without a doctor’s prescription.

The Dexcom Stelo and the Abbott Lingo are not exactly like the CGMs those living with diabetes are accustomed to using. In fact, they have not been cleared for anyone currently taking insulin to manage any form of diabetes or anyone at risk of hypoglycemia. Diabetics who do not rely on insulin to manage their conditions will be able to use the new devices.

These new CGMs work essentially the same way as others on the market. Transmitters are attached to the arm and send blood sugar data to a smartphone application, where the user can view it. However, these new systems do not monitor blood sugar in real time like most diabetes management devices.

For instance, Dexcom’s Stelo only updates blood glucose levels every 15 minutes and does not include alarms for spikes or dips in blood sugar. That is going to fall short when it comes to helping people who rely on insulin treatments to manage diabetes effectively. So, who are these CGMs for?

 

CGMs for Non-Diabetics: Benefits and Concerns

This is where the controversy thickens. A recent article in the August 5, 2024, online edition of The Washington Post points out that many physicians see tangible benefits of CGM devices for people without diabetes. Some argue that these devices could help prevent metabolic diseases, reduce cardiovascular risk, promote healthier eating habits, improve sleeping patterns, and help people achieve their exercise goals.

The argument is that when people see how sugary foods and sedentary living impact their blood sugar, even if it’s not to the point it would for someone with diabetes, then it might inspire them to make lifestyle adjustments that improve general health and lower the risk of serious medical conditions, such as cardiovascular disease and hypertension.

This reasoning, however, is certainly not shared across the board. In the same Washington Post article, Dr. Robert Shmerling, a physician who reviewed the possibilities of broad-based CGM use for Harvard Health Publishing, states, “Just because you can measure something doesn’t mean you should. If you’re focused on potentially normal fluctuations in blood sugar, maybe that takes focus and energy away from things you could be looking at more closely.”

A post on GoodRx Health points out that elite athletes have already started using CGM devices to optimize health, but it is not viable for the general public. The article calls into question the possibility that exposure to blood sugar data may cause perfectly healthy people to worry unnecessarily about normal fluctuations in blood sugar that occur after meals and following physical activity.

Dr Farah Khan, an endocrinologist cited in the article, says, “People who do not have diabetes don’t need to use a CGM. More information is not always a good thing.”

 

The Potential Impact on Prediabetes

The two CGM manufacturers say the new over-the-counter devices could benefit pre-diabetics, which the two CGM manufacturers say could benefit from them. The Centers for Disease Control and Prevention (CDC) estimates that about one out of every three American adults is prediabetic, which means they live with elevated blood sugar that has not yet reached the point where a diabetes diagnosis is warranted. That adds up to about 98 million people!

The frightening part is the vast majority of prediabetics are entirely unaware they have a problem because the condition rarely presents any symptoms until it’s too late and diabetes has already developed.

Therefore, it’s logical that an over-the-counter CGM could help individuals with prediabetes spot elevations in blood sugar. This might inspire them to make appropriate lifestyle changes to slow the progression of diabetes or even reverse blood sugar trends. It might also prompt a visit to a doctor’s office to address the elevated blood sugar.

The actual impact on the prediabetes market is uncertain, as many suffering from the condition are not part of the “health-conscious” group that seems to be driving this new CGM market. Prediabetes is most often associated with obesity and a high-sugar, high-fat diet. So, whether this group will trend toward a “wellness” device being marketed to health-conscious individuals and athletes remains to be seen.

 

Cost Considerations: Are OTC CGMs Affordable?

Insurance is not likely to cover this new family of CGM devices. While no actual costs have been provided yet, Dexcom says it expects to offer subscription plans for its Stelo device that will probably cost $100 per month in the ballpark. This is not a fortune regarding medical costs, but it is undoubtedly a heavy price burden for many on a fixed income.

 

Takeaways

New over-the-counter CGMs are a reality, and they will be on store shelves sooner than later. For those currently living with diabetes and using insulin to manage it, these new devices are essentially much ado about nothing. They will not work for you because they are not designed to be part of an insulin-reliant diabetes treatment plan.

There is hope that these OTC devices might help those living with prediabetes identify their conditions sooner, as well as some evidence that they might help those seeking to live healthier lives take proactive steps in the right direction.

We’ll just have to wait and see.

 

FAQs

What is a Continuous Glucose Monitoring Device (CGM)?

A continuous glucose monitoring device (CGM) consists of a sensor and transmitter worn on the arm or abdomen. The sensor measures blood glucose levels, while the transmitter sends this data to a smartphone app, allowing users to track their levels in real-time. CGMs have been widely used by individuals with diabetes to improve blood sugar control and lower A1C scores.

 

Will Over-the-Counter CGMs Help People with Diabetes?

Generally, no. These new OTC CGMs are not approved for individuals with diabetes who rely on insulin for blood sugar management. However, people with diabetes who do not use insulin may find some benefit in using these devices.

 

Why Would People Without Diabetes Use a CGM?

Some doctors believe CGMs can benefit non-diabetics by revealing how blood sugar levels change after meals or physical activity. Conversely, others caution that monitoring blood sugar may lead to unnecessary anxiety about normal fluctuations, potentially distracting from more important health indicators.

 

Can OTC CGMs Help Those with Prediabetes?

Yes, over-the-counter CGMs could assist millions of Americans in identifying prediabetes and encourage them to take proactive steps to prevent the progression to Type 2 diabetes. However, the cost—around $100 per month—may be a barrier for many individuals on tight budgets.

 

Do you have any thoughts about over-the-counter CGM devices? We hope you’ll share them with our readers in the comment section below. Thank you.

At Diabetic Warehouse, we’re committed to helping those with diabetes manage their blood sugar by offering a complete selection of testing and treatment supplies at up to 65% less than those found at most pharmacies and suppliers.