Dexcom Releases the First Over-the-Counter Continuous Glucose Monitor (CGM)

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The Stelo continuous glucose monitor (CGM) is now for sale; it is the first over-the-counter CGM available in the United States. Made by Dexcom, Stelo aims to provide an affordable and accessible option for people with prediabetes and type 2 diabetes who don’t use insulin.

Like other CGMs, the Stelo attaches to the skin and samples blood sugar levels around the clock, automatically sending the data to a smartphone. It can provide an unmatched opportunity to understand how lifestyle decisions like food and exercise immediately impact blood sugar concentrations.

Here’s a closer look at the Stelo, with insights from Jake Leach, Chief Operating Officer at Dexcom.

The Value of CGM Data

Today, most insurance companies are reluctant to reimburse the cost of a CGM for people who do not use insulin. But CGM data for those with prediabetes or type 2 diabetes can still be truly valuable.

“We already have the evidence on the benefits of CGM in type 1 diabetes,” explained Leach. “We know it improves time-in-range and reduces A1C levels. We know it can do the same for people with prediabetes and type 2 who aren’t using insulin.”

CGM data in type 2 diabetes has demonstrated the same benefits plus reduced overall medical costs — fewer trips to the emergency room, fewer overall dependence on the hospital system, and more motivation to take medications as prescribed.

Research also showed significant improvements in A1C levels when people with type 2 diabetes use a CGM with non-insulin diabetes medications compared to medications alone.

Leach explains these positive results in a way that most people with diabetes should be able to understand: When a person can see the impact of their medications and lifestyle habits, it can change their behaviors.

A person with prediabetes, for example, will inevitably be more motivated to make changes in what they eat or drink if they can watch their blood sugar spike after drinking a bottle of soda every day with lunch. And someone with type 2 diabetes is considerably more likely to continue taking their glucose-lowering medications if they can see the real-time impact it has on their blood sugar levels.

There are nearly 140 million people across the country with diabetes or prediabetes. “The Stelo is a wonderful tool to help them understand their lifestyle habits and where they can make changes. We’ve all been told what you should do, but when you actually see your own data, it really shows you what’s happening,” said Leach.

The data can offer priceless motivation.

“We’ve seen that 100 percent of users make changes to their diet because of CGM data,” said Leach. “It’s personalized, real-time data that connects the dots between what you eat and how it impacts your blood sugar. It reinforces healthy habits.”

Meet the Stelo CGM

Here are the quick facts you need to know about the Stelo CGM — and why it’s probably not ideal for people who take insulin.

Basic Details:

Is about the size of three stacked quarters — same as the Dexcom G7
Attaches to the skin of the upper arm
Delivers real-time blood glucose data via Bluetooth to the app on your smartphone
Measures glucose levels every 15 minutes
Is wearable for up to 15 days
Can be inserted easily at home without any training
Is waterproof

Stelo is available over-the-counter, no prescription necessary. Anyone with or without diabetes can buy one. As of this writing, it costs $99 for a pack of two (one month’s worth) when purchased online directly from Dexcom. A subscription plan offers two Stelo sensors for $89.

Stelo Differs from Previous Dexcom Models

The biggest difference between Stelo and the Dexcom G7 is that Stelo does not sound alarms for high or low blood sugar values. People who do not use insulin (or certain glucose-lowering drugs, such as sulfonylureas) only rarely encounter a danger of critically high or low blood sugar levels, so this feature is largely unnecessary for Stelo’s intended customers.

This difference also makes Stelo inappropriate for people with diabetes who do use insulin. If you take insulin, your blood sugar can fluctuate more often, easily, and dramatically.

Instead, Stelo offers a new “spike detection” feature. This CGM learns what times of day your blood sugar tends to significantly spike. The app will ask you what you ate or drank before that spike.

“This feature is unique to the Stelo,” explained Leach. “It’s really trying to engage the person in the impact of their decisions around what they eat or drink, helping them understand what caused the spike,” explained Leach.

Understanding the cause creates an opportunity to make different choices. Stelo has the potential to empower simple but impactful changes in what a person eats or drinks thanks to the inside look at blood glucose levels.

Another Over-the-Counter Option is Coming Soon

Stelo may be the first over-the-counter CGM available in the United States, but Dexcom’s biggest competitor, Abbott Laboratories, is close on their heels. Abbott recently received FDA clearance to sell two over-the-counter CGMs, the Libre Lingo and Libre Rio — with the official launch planned for this month, September 2024.

That’s good news for people with diabetes. With rapidly rising rates of obesity, prediabetes, and diabetes, more options mean more access to this potentially life-changing technology.

“We hope to see that the Stelo has made an impact on the increasing rates of obesity and type 2 diabetes,” says Leach. “Hopefully Stelo can curb those numbers and change the curve.”

 

Ilham S, et al. Cost-Effectiveness of Dexcom Real-Time Continuous Glucose Monitoring vs Self-Monitoring of Blood Glucose in Patients With Type 2 Diabetes on Intensive Insulin Therapy in Estonia. Abstract presented at EASD 2024. 2024.

Layne J et al. Long-Term Improvement in Time in Range and Time in Tight Range With Dexcom CGM Use in Adults With Type 2 Diabetes Not Treated With Insulin: Real-World Data. Abstract presented at EASD 2024. 2024.

Nemlekar P et al. The Combined Effect of CGM With Anti-diabetes Medications and the Association With Improved HbA1C in People With Type 2 Diabetes Not on Insulin. Abstract presented at EASD 2024. 2024.