Dexcom launches Stelo, its first over-the-counter continuous glucose monitor

Dexcom on Monday announced its latest over-the-counter continuous glucose monitor Stelo is officially available for purchase within the U.S.

Glucose is a variety of sugar people receive from food, and it is the body’s predominant source of energy. Continuous glucose monitors, or CGMs, are small sensors that poke through the skin to measure glucose levels in real time. They’re typically prescribed to patients with diabetes since they might help alert users, their family members and their doctors to emergencies.

Stelo is primarily intended for patients with prediabetes or Type 2 diabetes who don’t use insulin, though individuals without either condition also can purchase it. Users should purchase a one-month supply online for $99, or join for an ongoing subscription at $89 a month. 

Dexcom said patients even have the choice to make use of their flexible spending accounts and health savings accounts to pay for Stelo, in line with an announcement.

The corporate already offers continuous glucose monitors for Type 1 and Type 2 diabetes patients, but Stelo is Dexcom’s first product that doesn’t require a prescription. While most Type 1 patients can already get insurance coverage for the sensors, Stelo is now accessible to hundreds of thousands of Type 2 patients who’ve been unable to get prescriptions or coverage. It also marks the corporate’s official foray right into a latest and potentially lucrative prediabetes market. 

Dexcom said there are greater than 125 million Americans with prediabetes or Type 2 diabetes not using insulin, in line with an announcement. The corporate designed Stelo to assist teach this patient population learn how to keep their glucose levels inside a healthy range.   

“The thought is to assist people, over time, find out about eating regimen decisions and habits, and the way those are impacting glucose,” Jake Leach, chief operating officer at Dexcom, told CNBC in an interview. “It’s about uncovering stuff you have not seen before after which using that to create healthier habits.”

How it really works

The U.S. Food and Drug Administration approved Stelo in March. It was the primary over-the-counter continuous glucose monitor to be cleared to be used, though Dexcom’s competitor, Abbott, received clearance for 2 similar devices in June. 

Leach said Dexcom is working with Amazon to satisfy Stelo deliveries. Users with a subscription can decide to skip or adjust their delivery date, but it’s going to typically be scheduled on the 30-day interval from their initial sign-up. 

Stelo is worn on the upper arm and lasts for 15 days before it needs to get replaced. It’s gray, concerning the size of 1 / 4 and around half an inch thick. 

The sensor wirelessly transmits data to a smartphone app. When users are getting arrange, they’ll select whether or not they have Type 2 diabetes, prediabetes or not one of the above. This helps establish their “Goal Range,” which is where Dexcom wants users to attempt to keep their glucose levels. The goal range relies on established medical standards, and most of the people fall between 70 and 180 milligrams per deciliter, in line with the American Diabetes Association.

After they open the Stelo homepage, they’ll see their latest reading, which is updated every quarter-hour. They’ll also see a graph of their readings every day, which incorporates a shaded green area to point the goal range. In the event that they scroll down, they’ll see a summary of the time spent within the goal range over time.

Everyone’s glucose levels are variable, but Stelo will send users a notification once they are experiencing a considerable spike. Glucose spikes occur when the quantity of sugar present within the bloodstream rapidly increases after which decreases. This often happens after eating. 

Within the short term, spikes could cause feelings of fatigue, but high glucose levels can result in more serious health problems like diabetes, heart disease and kidney disease over time, in line with the Centers for Disease Control and Prevention. This is the reason Dexcom wants users to attempt to keep their levels inside Stelo’s goal range. 

The tab next to the house page is the “Events” page, which is where Stelo users can log meals, activity, fingersticks or other notes. Leach said it’s most vital for users to log an entry once they’re experiencing a giant spike in order that they will reflect on what is likely to be causing it. 

Stelo notifies users about noteworthy spikes, so that they won’t necessarily get alerted each time their levels rise. Leach said that is an intentional design selection that is meant to call attention to the larger swings that patients experience. 

“Even for somebody who has normal glucose and the occasional spike, it’ll search for essentially the most impactful spikes after which try to have interaction the user around, ‘OK, what happened there?'” he said. 

And for users who need to dig deeper into their glucose and understand what causes spikes, there is a trove of educational materials within the app’s “Learn” tab. The articles are transient, sometimes only a couple of sentences, they usually’re broken down into categories like “Stelo Basics,” “Glucose Deep Dive,” “Nutrition,” “Exercise,” “Sleep” and “Stress.”

CNBC Tests Stelo

I have been testing Stelo since early August. On the entire, I feel it has been easy and helpful to make use of. 

When my monitors arrived within the mail, the primary order of business was applying the sensor to my arm and pairing it with the Stelo app. I discovered this process very straightforward – the app walked me through what to do with clear, step-by-step instructions.   

I cleaned the back of my right arm, placed Dexcom’s applicator there, pressed the button and popped the CGM right on. It happens fast and doesn’t hurt in any respect. 

The monitor connects to the Stelo app via Bluetooth, after which it takes a couple of half hour to warm up. 

That is where I initially encountered some problems. Once my device had warmed up, I got an error message that said “Temporary Sensor Issue.” The message told me to not take off the CGM, and that the difficulty was temporary. I left it on for the day, but by evening, I noticed some light bleeding. I made a decision to take that sensor off. 

I applied one other CGM to my other arm, and that one warmed up and worked accurately. I have been wearing it ever since and have not had any trouble with bleeding. Leach said if users have problems with the product, they will message the chat interface on Stelo’s website to get a alternative or answer their questions there. 

Once I used to be all up and running with my second sensor, it was smooth sailing. 

I’ve found the Stelo app easy and simple to make use of. I never felt like I used to be being overloaded with an excessive amount of data or too many notifications, and logging meals and exercise may be very straightforward. Users also can decide to import their sleep and activity data from the Apple Health app or Android’s Health Connect app, which I feel is a pleasant touch. 

If it is your first time using a CGM, I definitely recommend reading through the articles within the “Learn” tab. I feel Dexcom does an excellent job using plain language to elucidate what glucose is, what affects it and why it matters. 

The longer I wear the sensor, the more I can tell that the algorithm is tuning to me and my habits. I do not get notifications every time my glucose spikes, but it surely does alert me once I’m experiencing a very substantial jump. The app can be starting to select up on my patterns. As an illustration, it recently told me that my glucose tends to spike between 5 p.m. and seven p.m., which will likely be around once I eat dinner. 

More often than not, I forget I’m even wearing a sensor. It’s waterproof, so I didn’t must worry about it within the shower. And I didn’t notice it once I was sleeping. I’d advise somewhat caution when pulling on long sleeves, because the sensor can snag a bit, but it surely’s easy to wear every kind of garments and jackets over it. 

Within the short time I have been using Stelo, I’ve learned rather a lot about how my body responds to certain foods. Even small adjustments (eating carbs last, as an example) helped me reduce spikes. It is easy to see how CGMs can function a priceless window into the body. If you happen to’re in search of an easy, approachable entry to understanding your glucose data, I feel Stelo is a solid option.