Glucose Monitors Revolutionized Diabetes Care. Now Digital Health Startups Want to Bring Them to the Masses

For the 1.6 million people in America living with type 1 diabetes, a continuous glucose monitor can be a lifesaver.

Since the first CGM was approved by the Food and Drug Administration in 1999, the diabetes community has advocated for lower prices and better insurance coverage for the quarter-sized devices, which regularly sample a proxy for blood glucose levels and can sound an alarm when they swing too high or too low. The cost-cutting has had an unexpected side effect: Today, glucose monitors are so cheap they’ve spawned a new crop of digital health startups selling the devices to consumers, many of whom don’t have diabetes.

Glucose monitors are only approved in the U.S. for use in people with diabetes who have a prescription. But through networks of remote physicians assembled by these startups, thousands of people have gained access to the devices with off-label prescriptions. NutriSense has shipped about 20,000 CGM units to users since 2019. A company called January came out of stealth last year after its founding in 2017, and launched its product incorporating glucose and heart rate data this January with the announcement of another $8.8 million in funding. Another startup, Levels, is still in beta, with about 6,000 people having gone through the program — and another 105,000 on the waitlist.

The list goes on. In the U.K., where CGMs are available over the counter, there’s MyLevels. Veri, based in Finland and serving the European market, plans to launch in the United States on May 1. Zoe combines blood glucose with microbiome scans and blood fat for nutritional analysis; another app called Sync is still in development.

Glucose monitors are becoming the backbone of a new movement in consumer tech — one that so far is outpacing the evidence.

“You kind of have this dichotomy with the perceived value of CGM,” said Susan Schembre, a researcher at the University of Arizona who has studied the use of CGMs in healthy people. “We have the consumers really driving the market on one end, and then the science kind of resisting it on the other.”

Eventually, the devices and the evidence will converge. Already, clinical CGMs have expanded from their initial patient population: Doctors regularly prescribe them to people who manage their type 2 diabetes with insulin, and sometimes to help type 2 patients tweak their habits and avoid going on medication. Manufacturers are planning for a future in which patients use the devices to both treat and prevent metabolic issues — dramatically increasing their market share. Consumer tech companies are looking for their slice of the pie.

Prices for CGMs have been dropping steadily over the last two decades. But in the last four years, the devices have become dramatically more affordable for people with diabetes — and helped to kickstart this new industry. While most of the companies selling CGMs to a broader audience claim they can plug in to any device on the market, more than 95% of the sensors they send out are Abbott’s FreeStyle Libre, whose latest version was approved by the FDA in 2018.

The upper-arm sensors, which have a tiny filament that measures glucose in the fluid between your cells, cost $70 and last 14 days; the device to apply them costs $75. The other leading device, Dexcom’s G6, costs about $400. Unlike the G6, which streams glucose values continuously via Bluetooth, the Libre uses near-field communication to pull data from the sensor any time you scan it with a special device or your phone. (Technically, that makes it a “flash” glucose monitor rather than a CGM.)

That technology, while cheaper than Bluetooth, was a rate-limiting factor for the consumer market. It was only in September 2019 that Apple updated its operating system so its iPhones would allow all apps to use near-field communication; before that, only trusted partners could incorporate the feature into their apps. “iOS 14 release day was really the critical point,” said Dan Zavorotny, co-founder and COO of NutriSense. “We released the day it became possible.”

The flood of startups belies their belief in the opportunity for glucose monitoring to improve health, especially in the U.S., where the burden of metabolic disease is especially high. Each targets a slightly different subset of users while steering clear of any medical claims. January is focusing its product on people with or at risk of developing diabetes. NutriSense, which incorporates advice from a nutritionist, is looking a little further upstream; “a lot of people who come to us are not yet sick, but they’re on the verge,” said Zavorotny. At Levels, meanwhile, “we’re focused on a broader market in terms of lifestyle,” said co-founder and chief medical officer Casey Means.

“As of right now, they’re kind of in a customer discovery phase,” said Schembre. “My perception of going through the process of signing up was that they’re really trying to identify their target market, and how do they need to build their systems to match the desires of that market.”

In the meantime, evidence for each of those user groups is still being generated. In fact, there’s still debate over whether CGMs are even appropriate and effective to use for people with type 2 diabetes who are not on intensive insulin therapy.

That data gap is even more pronounced once you look beyond patients with diabetes and try to understand the role of glucose monitoring in at-risk or healthy populations. That work is happening, albeit slowly, both within the companies and in the academic sphere.

“When you go looking for the data, you find that people are using CGM for different applications, but you don’t really see a paper that says, ‘Here’s how we can use CGM to improve people’s health regardless of their health status,’” said Schembre. “It’s really all quite new.”

That doesn’t seem to bother these companies’ first customers, a self-selecting set of early adopters (Orlando Bloom included) who are willing to shell out for the technology. January’s Season of Me, a 90-day program that includes 28 days of glucose sensors, costs $488, with a $200 promotion to pull in more users. Levels costs $399 for a month, and $350 for NutriSense, with prices dropping if you extend beyond the first month. And there’s little to no chance for reimbursement from insurers.

“The people that will adopt these types of solutions are kind of the same renegades as the first Fitbit users,” said Marissa Schlueter, a telehealth analyst at CB Insights.

Those prices will necessarily limit the scale of the consumer CGM market for now. But the promise of getting in on the ground floor could be well worth the sacrifice — and explain why so many companies have tried to establish themselves early.

“It’s a very nascent market, and I think there’s definitely room for more than a dozen companies,” said Noosheen Hashemi, CEO and co-founder of January. The falling cost of FreeStyle Libre and other CGMs also provides a natural on-ramp for diabetes device manufacturers eyeing an expansion into broader metabolic management.

In a February investor presentation, Dexcom put its core user base — people with type 1 diabetes, and people with type 2 who are reliant on intensive insulin therapy — at about 4 million people in the U.S. But if it expanded to make its devices accessible to Americans with type 2 diabetes who don’t already use insulin and those with prediabetes, it could reach another 30 million and 88 million potential users, respectively. “We’ve made significant progress in our work to bring Dexcom’s CGM to people with type 2 diabetes, including both those on intensive insulin therapy and those who are not,” said Dexcom CEO Kevin Sayer in the company’s latest earnings call.

Abbott’s ambition is clear when you look across the ocean, where the company has launched the Libre Sense, a version of its glucose sensor modified for sports, in Europe.

In 2020, the company received a CE mark for the Bluetooth-enabled device, with a limited glucose reporting range that prevents its use in diabetes management. Through a partnership with Atlanta-based company Supersapiens, Abbott is targeting the device to athletes, who can use the continuous data to fuel up to just the right level. In its latest earnings call, CEO Robert Ford called it “the first product in our strategy to expand use of our wearable biosensors technology into mass market opportunities beyond diabetes.”

While the pandemic has delayed the device’s path to FDA approval, said Phil Southerland, CEO and founder of Supersapiens, “we’re getting a lot of data so when we finally do come to the U.S. we’ll come with the perfect mousetrap to drive value to the consumer.”

You can see that glimmer in Dexcom’s eye, too, in the accelerometer rumored to be included in the company’s next CGM rollout, the G7. “For CGM to be widely adopted by other consumer groups, it will take CGM systems and user experiences designed specifically for those populations,” the company said in a statement.

Abbott and Dexcom don’t promote the use of their FDA-approved devices for off-label use; in a statement, Abbott emphasized that it is not affiliated nor partnering with companies using the FreeStyle Libre in this way.

“The other companies are taking the Uber approach of, ‘We don’t care about the rules, we don’t care about the FDA, and we’re going to come to market now using off-label usage,’” said Southerland.

But these consumer-focused companies, by introducing a wider audience to the concept of continuous glucose monitoring, are laying the groundwork for a strategy that device manufacturers — Abbott, Dexcom, Medtronic, and a slew of new entrants expected in the next several years — are likely to appreciate.

Some of these consumer companies’ users will be at risk of developing diabetes, with emerging signs of insulin resistance. So as clinical evidence accumulates, CGMs could be adopted and approved as a preventive tool for people with prediabetes, or even pre-prediabetes. Critically, that use case would also likely lead to insurance reimbursement pathways.

“There’s a baseline case for wellness, but it also can be a really good way to monitor situations before it gets out of hand and someone develops prediabetes and then eventually diabetes,” said Schlueter. “That’s the goal here with all these.”

The original article can be found at: StatNews