Stelo Will Be First Continuous Glucose Monitor (CGM) Available Without a Prescription
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This story also appears on Everyday Health’s network site Diabetes Daily.
Dexcom, the maker of the G6 and G7 continuous glucose monitor (CGM) systems, has been granted approval to sell America’s first over-the-counter CGM. For the first time, people with (and without) diabetes will be able to track their blood sugar levels around the clock without a doctor’s prescription.
CGM technology, which provides constantly updated blood glucose measurements, was initially developed to treat type 1 diabetes, a condition that requires the administration of insulin and carries a constant risk of dangerously low and high blood sugar levels. In recent years, however, doctors and insurers alike have been more supportive of CGM use in people with type 2 diabetes. Now people with diabetes who do not use insulin — a patient group with little need for alarms and safety features — will have easy access to a CGM made just for them.
The Stelo CGM
The full name of the new device is the Dexcom Stelo Glucose Biosensor System. Last summer, Dexcom’s executive vice president and chief operating officer, Jake Leach, previewed the product for Diabetes Daily.
The Stelo sensor will be the same physical device as the sensor for the Dexcom G7 system, a leading CGM that is available only with a prescription. Like the G7, the Stelo sensor attaches to the body (typically the upper arm) with an adhesive and continuously updates the user’s smartphone app with new blood sugar measurements. The Stelo sensor works by penetrating the skin with a thin, flexible needle, which samples glucose levels in the interstitial fluid between the skin and blood. Insertion is relatively painless, and the sensor can remain on the body for 15 days before it must be replaced. The Stelo is expected to be as accurate as the G7.
A Redesigned App
The device may be familiar, but the Stelo will come with a redesigned app that should result in a substantially different user experience.
The Stelo will be streamlined, according to Teri Lawver, Dexcom’s chief commercial officer: “There are a lot of features [on the G7 app] that are not needed for the population not using insulin.” Such users, for example, have relatively little risk of hypoglycemia (low blood sugar), a potentially dangerous side effect of insulin usage. The Stelo will strip away the system of alerts and alarms that warn insulin users of dropping blood sugar levels. Because it lacks these alerts, the Stelo should not be used by individuals who use insulin or who have a history of hypoglycemia.
Instead, the Stelo aims to provide “all the insights without the interruption,” Lawver says. Like all CGMs, it will deliver a huge amount of valuable diabetes management data, particularly rapid feedback on how diet and exercise choices affect blood sugar levels. Some studies have suggested that CGM usage can greatly improve blood sugar control in people with diabetes who do not use insulin, resulting in impressive improvements to A1C.
The Stelo app will also be much more engaging than the G7 platform, providing feedback “in a gentle, encouraging way,” says Lawver.
“For the vast, vast majority of this population, they’ve never seen an endocrinologist,” says Lawver. “They’re seeing a primary care physician who has very limited time, and sometimes they don’t have access to diabetes education and glucose education. We are endeavoring to provide that to them.”
The app will “offer encouragement, pointing out when things are going well, helping the user to understand what combinations of food and activity, for example, are producing the outcomes that they want.”
“Telling people to eat less, lose weight, and exercise without giving them the right tools, it’s sort of like driving down a dark backcountry road with no headlights. You’re gonna bang into stuff. Using a CGM is like turning on the lights.”
Insurance Coverage Will Be Rare
When the Stelo goes on the market, few insurers will be ready to reimburse the cost.
Dexcom hopes that it will eventually be able to convince insurers to cover CGMs for people with type 2 diabetes who do not require insulin. Today, most insurance plans offer at least some coverage for people with type 1 or type 2 diabetes who use both rapid and basal insulin, and coverage is quickly expanding for those who use basal insulin exclusively. Lawver states that in these populations, a CGM can lower costs to insurers by as much as $450 per month, principally by reducing the number of emergency hospital visits due to critical low and high blood sugar events.
It may take some time and more study before Dexcom and other CGM manufacturers can make the case to insurers that CGMs will be a cost-effective preventive measure in people who do not use insulin.
A Cash Pay Option
In the meantime, Dexcom has announced a new cash pay option, which will allow customers to purchase over-the-counter Stelo sensors directly, without involving insurance at all.
Lawver states that “we are not sharing the price until launch” but promises that “it will be competitive with other cash pay options that are available.” The FreeStyle Libre 3 CGM, the Dexcom G7’s biggest competitor, doesn’t advertise a cash pay option, but pharmacies generally price a month’s supply at about $140 to $150 for customers without insurance.
Use by People Without Diabetes
As an over-the-counter device, the Dexcom Stelo will also be available for purchase by people without diabetes. CGMs have become popular in recent years among all sorts of people eager to track their blood sugar levels, including athletes hoping to optimize their performance and those with prediabetes or a family history of diabetes.
In its statement, the FDA made explicit reference to users without diabetes “who want to better understand how diet and exercise may impact blood sugar levels.”
Jeff Shuren, MD, the director of the FDA’s Center for Devices and Radiological Health, said, “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients.”
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