Dexcom's OTC bet: Stelo turns the CGM from prescription-only into a $130M business

Dexcom is the San Diego-based maker of real-time continuous glucose monitors (CGM). Stelo is its 15-day wearable sensor cleared without a prescription for adults 18 and older not using insulin, sold online directly to consumers, mostly on subscription.

Bet: clear the first FDA over-the-counter CGM and sell glucose data directly to ~25M non-insulin Type 2 Americans on subscription, bypassing prescriptions and insurance.

Publicly traded (NASDAQ: DXCM); Stelo extended the company's existing CGM manufacturing and app infrastructure rather than requiring a new venture fund.

Dexcom built its franchise on prescription CGMs like G7, then created a new category with Stelo: on 2024-03-05 the FDA cleared the device for marketing without a prescription for adults 18+ not using insulin, and Dexcom said it would be available online in summer 2024, aimed at the roughly 25 million Americans with Type 2 diabetes who do not use insulin.

Stelo launched in August 2024 as a direct-to-consumer product, and the company pushed subscription adoption and app features including AI-assisted meal logging (over 10 million meals logged since July 2025). Dexcom management credited Stelo with helping drive adoption beyond its core Type 1 and insulin-using customer base.

By January 2026 Stelo had surpassed 500,000 users, mostly on subscriptions, and generated $130M of Dexcom's approximately $4.6B preliminary 2025 revenue — still small next to prescription G7, but proof that an OTC regulatory channel can become a real consumer business.

The FDA clearance created a genuinely new channel: without a prescription requirement, Dexcom could market Stelo directly to consumers, removing the doctor visit and insurance step that gatekept CGMs.

The addressable market was large and unserved — about 25 million US non-insulin Type 2 adults, many without CGM coverage, plus people without diabetes curious about glucose responses.

Subscription distribution converts hardware sales into recurring revenue, which is why Dexcom pushed app features like AI meal logging rather than one-off sensor purchases.

Dexcom had the incumbent advantage: proven G7 accuracy and manufacturing meant Stelo could ship first in the OTC category, though Abbott's Lingo quickly followed at retail.

A regulatory clearance can create a channel, not just a product: FDA's first OTC CGM let Dexcom bypass prescriptions and insurance, turning a medical device into a direct-to-consumer subscription.

As of 2026-09-06 Stelo is a scaling consumer business: over 500,000 users and $130M of 2025 revenue per Dexcom's January 2026 disclosures, with planned international expansion and a redesigned Stelo app for 2026. Competition is intensifying — Abbott's Lingo sells through Walmart while Stelo has been online-only — and the broader OTC-CGM category is unproven beyond early adopters, so the open question is whether continuous glucose data keeps its pull once the wellness novelty fades and how much of the roughly 25 million non-insulin Type 2 market actually converts to paying subscribers.