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

Dexcom on Monday introduced its new over-the-counter steady glucose monitor Stelo is formally accessible for buy within the U.S.

Glucose is a kind of sugar folks obtain from meals, and it is the physique’s principal supply of power. Steady glucose displays, or CGMs, are small sensors that poke by way of the pores and skin to measure glucose ranges in actual time. They’re usually prescribed to sufferers with diabetes since they might help alert customers, their family members and their docs to emergencies.

Stelo is primarily meant for sufferers with prediabetes or Kind 2 diabetes who don’t use insulin, although people with out both situation also can buy it. Customers should purchase a one-month provide on-line for $99, or join an ongoing subscription at $89 a month. 

Dexcom mentioned sufferers even have the choice to make use of their versatile spending accounts and well being financial savings accounts to pay for Stelo, in accordance with an announcement.

The corporate already provides steady glucose displays for Kind 1 and Kind 2 diabetes sufferers, however Stelo is Dexcom’s first product that doesn’t require a prescription. Whereas most Kind 1 sufferers can already get insurance coverage protection for the sensors, Stelo is now accessible to tens of millions of Kind 2 sufferers who’ve been unable to get prescriptions or protection. It additionally marks the corporate’s official foray into a brand new and doubtlessly profitable prediabetes market. 

Dexcom mentioned there are greater than 125 million Individuals with prediabetes or Kind 2 diabetes not utilizing insulin, in accordance with an announcement. The corporate designed Stelo to assist train this affected person inhabitants easy methods to hold their glucose ranges inside a wholesome vary.   

“The thought is to assist folks, over time, study food regimen selections and habits, and the way these are impacting glucose,” Jake Leach, chief working officer at Dexcom, informed CNBC in an interview. “It is about uncovering issues you have not seen earlier than after which utilizing that to create more healthy habits.”

The way it works

The U.S. Meals and Drug Administration accredited Stelo in March. It was the primary over-the-counter steady glucose monitor to be cleared to be used, although Dexcom’s competitor, Abbott, acquired clearance for 2 comparable units in June. 

Leach mentioned Dexcom is working with Amazon to satisfy Stelo deliveries. Customers with a subscription can select to skip or modify their supply date, however it should usually be scheduled on the 30-day interval from their preliminary sign-up. 

Stelo is worn on the higher arm and lasts for 15 days earlier than it must be changed. It is grey, concerning the dimension of 1 / 4 and round half an inch thick. 

The sensor wirelessly transmits knowledge to a smartphone app. When customers are getting arrange, they’re going to choose whether or not they have Kind 2 diabetes, prediabetes or not one of the above. This helps set up their “Goal Vary,” which is the place Dexcom needs customers to attempt to hold their glucose ranges. The goal vary is predicated on established medical requirements, and most of the people fall between 70 and 180 milligrams per deciliter, in accordance with the American Diabetes Affiliation.

After they open the Stelo homepage, they’re going to see their newest studying, which is up to date each quarter-hour. They’re going to additionally see a graph of their readings every day, which features a shaded inexperienced space to point the goal vary. In the event that they scroll down, they’re going to see a abstract of the time spent within the goal vary over time.

Everybody’s glucose ranges are variable, however Stelo will ship customers a notification when they’re experiencing a considerable spike. Glucose spikes happen when the quantity of sugar current within the bloodstream quickly will increase after which decreases. This usually occurs after consuming. 

Within the brief time period, spikes may cause emotions of fatigue, however excessive glucose ranges can result in extra critical well being issues like diabetes, coronary heart illness and kidney illness over time, in accordance with the Facilities for Illness Management and Prevention. For this reason Dexcom needs customers to attempt to hold their ranges inside Stelo’s goal vary. 

The tab subsequent to the house web page is the “Occasions” web page, which is the place Stelo customers can log meals, exercise, fingersticks or different notes. Leach mentioned it is most necessary for customers to log an entry after they’re experiencing a giant spike in order that they’ll mirror on what could be inflicting it. 

Stelo notifies customers about noteworthy spikes, so they will not essentially get alerted each time their ranges rise. Leach mentioned that is an intentional design alternative that is meant to name consideration to the bigger swings that sufferers expertise. 

“Even for somebody who has regular glucose and the occasional spike, it will search for essentially the most impactful spikes after which attempt to interact the person round, ‘OK, what occurred there?'” he mentioned. 

And for customers who wish to dig deeper into their glucose and perceive what causes spikes, there is a trove of academic supplies within the app’s “Study” tab. The articles are transient, generally just a few sentences, they usually’re damaged down into classes like “Stelo Fundamentals,” “Glucose Deep Dive,” “Diet,” “Train,” “Sleep” and “Stress.”

CNBC Assessments Stelo

I have been testing Stelo since early August. On the entire, I believe it has been simple and useful to make use of. 

When my displays arrived within the mail, the primary order of enterprise was making use of the sensor to my arm and pairing it with the Stelo app. I discovered this course of very simple – the app walked me by way of what to do with clear, step-by-step directions.   

I cleaned the again of my proper arm, positioned Dexcom’s applicator there, pressed the button and popped the CGM proper on. It occurs quick and would not damage in any respect. 

The monitor connects to the Stelo app through Bluetooth, after which it takes a few half hour to heat up. 

That is the place I initially encountered some issues. As soon as my machine had warmed up, I obtained an error message that mentioned “Transient Sensor Challenge.” The message informed me to not take off the CGM, and that the difficulty was short-term. I left it on for the day, however by night, I observed some gentle bleeding. I made a decision to take that sensor off. 

I utilized one other CGM to my different arm, and that one warmed up and labored accurately. I have been carrying it ever since and have not had any bother with bleeding. Leach mentioned if customers have issues with the product, they’ll message the chat interface on Stelo’s web site to get a alternative or reply their questions there. 

As soon as I used to be all up and working with my second sensor, it was easy crusing. 

I’ve discovered the Stelo app easy and straightforward to make use of. I by no means felt like I used to be being overloaded with an excessive amount of knowledge or too many notifications, and logging meals and train may be very simple. Customers also can select to import their sleep and exercise knowledge from the Apple Well being app or Android’s Well being Join app, which I believe is a pleasant contact. 

If it is your first time utilizing a CGM, I undoubtedly suggest studying by way of the articles within the “Study” tab. I believe Dexcom does an excellent job utilizing plain language to elucidate what glucose is, what impacts it and why it issues. 

The longer I put on the sensor, the extra I can inform that the algorithm is tuning to me and my habits. I do not get notifications every time my glucose spikes, however it does alert me once I’m experiencing a very substantial soar. The app can also be starting to select up on my patterns. As an illustration, it just lately informed me that my glucose tends to spike between 5 p.m. and seven p.m., which is often round once I eat dinner. 

More often than not, I overlook I am even carrying a sensor. It is waterproof, so I did not want to fret about it within the bathe. And I did not discover it once I was sleeping. I might advise somewhat warning when pulling on lengthy sleeves, because the sensor can snag a bit, however it’s simple to put on all forms of garments and jackets over it. 

Within the brief time I have been utilizing Stelo, I’ve realized quite a bit about how my physique responds to sure meals. Even small changes (consuming carbs final, for example) helped me cut back spikes. It is simple to see how CGMs can function a priceless window into the physique. When you’re searching for a easy, approachable entry to understanding your glucose knowledge, I believe Stelo is a strong choice.