Dexcom and Abbott’s FDA-Cleared CGMs: A Consumer Market Revolution

Leading device makers are now launching their own consumer-grade continuous glucose monitors (CGMs). Dexcom and Abbott have both officially received FDA clearance to market their CGMs to individuals without insulin-dependent type 2 diabetes. Essentially, these are over-the-counter CGMs!

But what does this mean for all those startups offering CGMs, when the devices in use are made by Dexcom and Abbott?

In this article, I’ll highlight the latest from Dexcom and Abbott regarding their consumer-grade CGMs, revisit the CGM market, and share three trends I’m seeing in the space.

The Deets: Dexcom Stelo and Abbott Lingo

Dexcom will launch its FDA-cleared consumer-grade CGM, Stelo, this summer. Abbott has also received FDA clearance to offer their CGM device, Lingo, over the counter in the U.S.

CGMs are wearable devices that provide real-time feedback on blood glucose levels. Initially for insulin-taking patients, they are now being targeted at those not on insulin, a move to “direct-to-consumer.”

Dexcom and Abbott are targeting a large market. The Stelo and Lingo aim at individuals with type two diabetes, not on insulin, which includes over 20 million Americans. Additionally, they are likely to attract those with pre-diabetes—nearly 100 million Americans—and the wellness-focused.

Dexcom Stelo

Dexcom’s Stelo is marketed to individuals with type 2 diabetes who are not on insulin. It is over-the-counter, so no prescription is needed.

Dexcom already dominates the medical-grade CGM market, capturing 40% of it. For physicians, the key difference between the G7 and Stelo is:

• Stelo provides real-time readings instead of frequent alerts for low/high blood sugar seen on the G7.

Dexcom will price Stelo competitively at $800-$900 per year or around $90 per month. Consumers can use HSA or FSA to purchase the device, lowering OOP costs. Analysts expect Stelo to add $31 million in sales this year, reaching $200 million by 2025.

Abbott Lingo

Abbott launched Lingo last year in the U.K., priced at 120 euros per month. Unlike Stelo, Lingo is marketed to the general wellness consumer. Their website targets the wellness-focused demographic and resembles a startup despite Abbott being an incumbent.

With FDA clearance, Abbott will likely launch Lingo in the U.S. within the next year. Currently, Abbott captures around 35% of the market.

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The Consumer Continuous Glucose Monitoring Market

The direct-to-consumer CGM space is new, with only a few companies offering integrated CGM programs. These devices are optimized for user experience and integrate seamlessly with mobile apps.

Nearly all companies use devices by Dexcom or Abbott, as they need FDA clearance to prove accuracy for automated insulin delivery. Abbott was the first non-startup to offer its CGM, Lingo, to consumers in the U.K., and now, Abbott won FDA clearance to offer Lingo over the counter in the U.S. Dexcom’s Stelo will also launch this summer.

Below are companies offering continuous glucose monitoring:

• Levels: Combines CGMs and a mobile app to improve metabolic health through diet and lifestyle changes.

• Signos: Personalized weight loss using CGM and AI technology for real-time blood sugar data and nutritional advice.

• Veri: CGM and a mobile app offering insights for improving metabolic health through diet and lifestyle adjustments.

• Nutrisense: Uses CGMs and nutritionist support to optimize metabolic health and wellness goals.

• January.ai: AI-powered glucose tracking to improve eating habits and metabolic health.

• Zoe: Uses CGM and nutritional insights to optimize metabolism, energy, and mood.

• Supersapiens: Enhances metabolic efficiency, energy, exercise, and recovery through real-time glucose insights.

Cost is the major barrier since CGMs are not covered by insurance if you’re not on insulin. Memberships cost $100+ per month. It will be interesting to see if Dexcom and Abbott prices are competitive enough to impact these startups.

Dashevsky’s Dissection

There are three interesting trends I’m noting within the continuous glucose monitoring space.

Trend #1: Device Makers Go Consumer

Abbott and Dexcom’s move into the consumer space mirrors pharmaceutical trends. For example, Eli Lilly launched Lilly Direct to improve access to its anti-obesity medication. Given the popularity of CGMs and GLP-1 medications, expanding to consumers is likely to generate substantial revenues.

Trend #2: Metabolic Health for the Consumer

Initially, I thought companies in metabolic health (diabetes management, weight management) needed a business-to-business model to succeed. Considering the costs of GLP-1s and CGMs, it seemed the market could quickly become saturated, with only the wealthy affording high fees and medications. However, major device makers entering the consumer market show significant economic potential, likely backed by research.

Trend #3: CGM for Pre-diabetes

CGMs have significant potential to prevent the progression from prediabetes to type 2 diabetes in the ~100 million Americans at risk. One study estimated that 70% of those with prediabetes will develop type 2 diabetes. “Lifestyle modifications” are often prescribed for prediabetes, but these can be challenging due to varying social determinants of health. CGMs offer tangible insights into how diet impacts glucose levels, providing real-time feedback and a clearer path to managing prediabetes, potentially preventing progression to type 2 diabetes.

In summary, Dexcom and Abbott are entering the consumer market with FDA-cleared CGMs, Stelo and Lingo, aimed at individuals without insulin-dependent type 2 diabetes. This shift to direct-to-consumer sales opens significant revenue opportunities, highlighting three key trends: device makers moving into the consumer space, the growing market for metabolic health solutions, and the potential for CGMs to prevent the progression from prediabetes to type 2 diabetes. The entry of these major players suggests a promising future for consumer-grade CGMs, potentially reshaping the landscape for startups and established companies alike.

OUTSIDE THE HUDDLE

The top three articles I’ve read this week.

1) UnitedHealth Execs Cashed Out Amid Ransomware Crisis

UnitedHealth Group executives, including CEO Andrew Witty, sold $17.7 million in company stock on the same day the Change Healthcare ransomware attack began. The attack, partly due to UnitedHealth's negligence in not using multi-factor authentication, cost the company an estimated $1.6 billion and exposed the health information of a third of Americans. This definitely raises concerns about some questionable ethics!

2) The Impact of Virtual MSK Care

The Peterson Health Institute published their next critical analysis on digital health solutions, this time focusing on virtual musculoskeletal solutions. Such solutions include app-based exercise therapy, physical therapist–guided solutions, and remote therapeutic monitoring (RTM)-augmented PT. While app-based solutions benefit pain reduction for low-acuity cases, physical therapist–guided solutions offer comparable results to in-person PT, and RTM-augmented solutions demonstrate high clinical efficacy but at increased costs. They conclude that integrating these virtual solutions into medical benefits and adopting value-based payment models can enhance their economic impact and accessibility for patients with MSK disorders.

3) Walmart Lost ~$230 million in Retail Health Gig Last Year

Rumor has it that Walmart lost around $230 million last year in the primary care business after struggling to grow patient panels. And so the story goes…. Last week, I covered the rise and fall of retail health, emphasizing why giant retailers struggle to break into the healthcare delivery space. It’s just tough. Simple as that.

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