How a device for diabetics became a must-have wellness accessory

The device Sheree Clark taped to her upper arm was intended for diabetics, not relatively healthy patients like her, but it was a revelation nonetheless. A continuous glucose monitor, available only with a prescription, gave her a constant readout on foods that cause her blood sugar to spike — including things like organic crackers she thought were healthy.

“It’s one thing to know it intellectually,” said Clark, a 67-year-old resident of Des Moines, Iowa, who paid about $75 out of pocket for two sensors that lasted a month. “It’s another thing to see it, to watch in real time what you’re doing to yourself.”

Soon, a prescription won’t be necessary. In a groundbreaking expansion of technology previously aimed at diabetics who need to carefully control their blood sugar, Abbott Laboratories and Dexcom are poised to begin selling continuous glucose monitors over the counter, meaning they can be purchased by adults without first seeing a doctor.

The potential market is vast, analysts say, made up of millions of people with diabetes who do not depend on insulin as well as legions of health-conscious people who don’t have diabetes but are trying to get even healthier.

Dexcom and Abbott each won Food and Drug Administration clearance to market the devices this year. Dexcom has not disclosed specific pricing but said it expects to offer “subscriptions” for under $100 a month and initially sell them online, starting this month. Abbott has said it plans to launch its devices this summer but hasn’t disclosed details including pricing or how they can be purchased.

There are about 7.5 million diabetic patients who use insulin in the United States, according to Margaret Kaczor Andrew, an analyst at William Blair. The devices by Dexcom and Abbott will target the roughly 25 million diabetics who don’t, and their over-the-counter designation will open up the market to nearly 100 million people who are prediabetic, she said.

“Now both companies are targeting one of the arguably largest medical technology markets we have ever seen,” she wrote in a note to clients in June.

Abbott is explicitly marketing one of its two new sensors, Lingo, as a wellness tool. Beyond broadening the use of its devices among diabetes patients, the company wants to reach “what is probably the larger market, which is people that don’t have diabetes,” Robert Ford, the company’s CEO, said on an earnings call with analysts last month. He described Lingo as a potential multibillion-dollar product in the United States and Europe, where it was introduced in Britain earlier this year.

Some physicians see benefits for nondiabetics, saying the monitors can head off metabolic disease, reduce cardiovascular risks and encourage healthy eating and exercise. Already, several telehealth firms offer subscriptions to apps combined with continuous glucose monitors, working with physicians who prescribe the device to people regardless of whether they have diabetes.

While some research suggests that healthy people could benefit from continuously monitoring their glucose, there aren’t many rigorous studies demonstrating that the devices will benefit people who don’t have diabetes, according to experts in the field. Studies done on people without diabetes have tended to find their blood sugar stays in a healthy range most of the time. Though the monitors have little risk, some argue that there could be a downside — including the not-insignificant cost.

“Just because you can measure something doesn’t mean you should,” said Robert Shmerling, a doctor who reviewed the prospect of broad CGM use for Harvard Health Publishing. “If you’re focused on potentially normal fluctuations in blood sugar,” he said, “maybe that takes focus and energy away from things you could be looking at more closely.”

“If people are eating healthy food and exercising regularly and avoiding stress, they’re probably doing everything they can to avoid diabetes,” said David Klonoff, an endocrinologist and medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center.

Abbott said in a statement that research shows a connection between moderating glucose and preventing many diseases. That led the company to develop a product for “an audience that traditional health care companies don’t usually target — the healthy — to help them stay healthy.”

Continuous glucose monitors work by penetrating the skin with a sensor — a painless sensation, several users said in interviews — which scans the fluid between cells to estimate the amount of glucose in the blood. A transmitter ships the data wirelessly to a smartphone or watch, while an adhesive patch holds it in place. The FDA approved the first version 25 years ago.

Insurance coverage, however, remains spotty. The Centers for Medicare and Medicaid Services significantly expanded its coverage of the monitors in 2023 for Medicare beneficiaries, but it is still limited to patients using insulin or those who can demonstrate a history of problematic low blood sugar. Medicaid and commercial plans tend to follow Medicare. That leaves many diabetics who don’t use insulin unable to get reimbursed. The American Diabetes Association has found that people with lower incomes and older people of color in particular struggle to obtain the devices.

In clearing Dexcom’s Stelo in March for over-the-counter sales, an FDA official called it “an important step forward in advancing health equity for U.S. patients.” The American Diabetes Association said in a statement that the new nonprescription monitors have “the potential to greatly expand access to this technology for people living with diabetes,” noting that they’re intended for those who don’t use insulin.

But the prescription-free products are not expected to be covered by most insurance. An over-the-counter continuous monitor “will still be cost-prohibitive to many people, but it will be a tool for people that financially are able to cover a $100 a month investment in their health,” said Nicole Ehrhardt, an endocrinologist at UW Medicine in Seattle.

Kyra Pellant, an athlete in Los Angeles who’s training for an Ironman triathlon, was keenly aware of this dynamic when she wore her CGM at the gym.

“People would come up to me and ask, ‘Are you diabetic?’” said Pellant, 30, who doesn’t have diabetes. She said she paid about $80 for a CGM that lasted two weeks. “I know it’s such a privilege to be able to afford that,” she said.

One of the highest profile endorsers of continuous glucose monitors, longevity medicine doctor Peter Attia, was introduced to them on a flight several years ago when he happened to sit next to Kevin Sayer, Dexcom’s chief executive.

“He was sticking his finger like 12 times a day,” Sayer said in an interview. “We got him on a CGM and it was definitely life-changing for him.” He added, “I do think everybody can learn from a CGM. It’s absolutely true.”

Attia, who has a vast social media following, went on to consult for Dexcom and praised the benefits of CGMs at its annual meeting with Wall Street analysts in 2020.

“It’s going to give you insights that I can’t even give you,” Attia said he told his patients, listing the effects on glucose from food, exercise, stress and sleep, according to a transcript compiled by S&P Global Intelligence. A CGM can “become the most powerful behavioral tool you’ve ever encountered,” he added.

A representative for Attia said he was traveling and couldn’t be reached.

Clark said she lost five pounds wearing a glucose monitor and lowered her blood sugar, and she plans to wear one periodically. The continuous data she got gave her new insights into how her body processed food, and she now takes walks after eating a large, celebratory meal.

As for whole-grain crackers, she said, “It’s probably a better idea to put my cheese on a zucchini slice.”

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