Continuous Glucose Monitors Split Into Two Markets as Year-Long Implants and OTC Wellness Sensors Reshape Diabetes and Consumer Health
Real-world data from the first year-long implantable CGM arrives as over-the-counter glucose biosensors pivot toward AI-driven wellness coaching, splitting the market between clinical precision and consumer accessibility.
Overview
The continuous glucose monitoring market is diverging into two distinct trajectories. On one end, Senseonics has published the first real-world evidence that an implantable sensor can track blood glucose accurately for an entire year, while on the other, Dexcom and Abbott are racing to turn over-the-counter glucose biosensors into AI-powered wellness coaches for consumers who have never been diagnosed with diabetes. The split reflects a broader transformation in wearable health technology, accelerated by an FDA policy that now explicitly exempts non-medical-grade wearable data from regulatory oversight.
Year-Long Implantable CGM Delivers Real-World Results
At the 19th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Barcelona in March 2026, Senseonics presented the first real-world evidence from its Eversense 365 system, according to data published by the company. The study evaluated 5,059 sensors used by patients in the United States on open-loop insulin regimens.
The results showed a mean glucose management indicator (GMI) of 7.14 percent and a mean time in range (TIR) of 66 percent, with more than 75 percent of users achieving international hypoglycemic targets. Critically, performance remained consistent across both six-month halves of the sensor’s lifespan, with patients maintaining an average transmitter wear time of 93.8 percent, according to the same data release.
Older adults performed particularly well: patients over 65 recorded a mean GMI of 6.99 percent, TIR above 70 percent, and hypoglycemic target achievement above 85 percent, with transmitter wear exceeding 95 percent. Young adults aged 18 to 25 showed a mean GMI of 7.3 percent and wear time above 90 percent.
“The promise of a year-long CGM has now been demonstrated in the real world,” said Dr. Francine Kaufman, Senseonics’ chief medical officer, as quoted in the ATTD data release.
The Eversense 365 is surgically implanted under the skin of the upper arm by a trained healthcare professional and transmits glucose readings every five minutes via Bluetooth to a mobile app. Unlike disposable sensors that must be replaced every 7 to 15 days, it requires only a single insertion for an entire year. The system received European CE Mark approval in January 2026, as announced by Senseonics.
Automated Insulin Delivery Integration
The implantable sensor has also become the foundation for a new automated insulin delivery (AID) system. In February 2026, Sequel Med Tech and Senseonics launched the combination of the twiist insulin pump with the Eversense 365, making it the first AID system compatible with a year-long CGM, as announced by the companies.
Early real-world data from approximately 120 users who had been on the combined system for more than seven days showed a mean GMI of 6.79 percent, mean TIR of 77 percent, and time in hypoglycemia of 2.7 percent, all meeting international consensus targets, according to data presented at ATTD. The twiist system uses direct volume measurement for each microdose of insulin and features proprietary technology that detects pump blockages up to nine times faster than competitors, according to the launch announcement.
Users can choose between the Eversense 365 and Abbott’s FreeStyle Libre 3 Plus as their CGM sensor for the twiist system, but only the Eversense option eliminates the need for frequent sensor changes.
OTC Glucose Sensors Pivot to AI Wellness Coaching
While the implantable market deepens its clinical focus, the over-the-counter segment is moving in the opposite direction, targeting healthy consumers interested in metabolic optimization.
Dexcom announced in February 2026 that its Stelo over-the-counter glucose biosensor would receive enhanced AI-powered features, including a redesigned Daily Insights system that provides up to three personalized recommendations based on the previous day’s glucose, activity, nutrition, and sleep data, as reported by Dexcom. The update also expanded the Smart Food Logging feature with a nutrition database covering more than one million foods, accessible via text search, barcode scanning, or meal photography.
The system uses AI to maintain day-over-day context, delivering what Dexcom described as “consistent and evolving personalized coaching that adapts to individual patterns and progress,” according to the same announcement.
Abbott’s competing OTC products, Lingo and Libre Rio, cleared the FDA in mid-2024. Lingo targets general consumers seeking metabolic insights, while Libre Rio serves adults with type 2 diabetes who do not use insulin. Both use 14-day arm-worn sensors based on Abbott’s FreeStyle Libre technology.
FDA Draws a Regulatory Line
The divergence between clinical and consumer glucose monitoring is now reflected in federal policy. On January 6, 2026, FDA Commissioner Dr. Marty Makary announced that wearable devices providing non-medical-grade information would not be subject to FDA regulation, as reported by Fox Business.
“We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation,” Makary stated. He added a critical caveat: “We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter.”
The policy creates a clear incentive structure. Devices like the Eversense 365 and twiist, which directly inform insulin dosing decisions, remain under full FDA oversight. OTC biosensors like Stelo and Lingo, which frame glucose data as lifestyle information rather than clinical guidance, can operate with lighter regulatory requirements, provided their marketing stays within wellness claims.
The distinction is not purely theoretical. In July 2025, the FDA issued a warning letter to WHOOP, Inc. for marketing its blood pressure feature with “medical grade” claims without required clearance, demonstrating that the agency will enforce the boundary when companies cross from wellness positioning into medical territory.
What We Don’t Know
Several questions remain unresolved. The Eversense 365 real-world data comes from the first wave of U.S. patients, and longer-term population-level outcomes across diverse demographics have yet to be published. Whether the twiist-Eversense combination can maintain its early performance metrics as the user base scales beyond the initial 120 patients is also unclear.
On the consumer side, no large-scale studies have demonstrated that OTC glucose monitoring produces lasting health behavior changes in non-diabetic users. The AI-driven coaching features from Dexcom and Abbott are designed to encourage sustained engagement, but their clinical impact on metabolic outcomes in healthy populations remains unmeasured.
The regulatory boundary between wellness and medical devices also faces ongoing pressure. As OTC biosensors grow more sophisticated and their AI systems deliver increasingly specific health recommendations, the line between “providing information” and “guiding medical decisions” may become harder to maintain.
Analysis
The CGM market’s bifurcation reflects a pattern seen across wearable health technology: as sensors become more capable, the same underlying technology serves radically different user needs and regulatory contexts. An implantable sensor that lasts a year and feeds an automated insulin pump is fundamentally a different product from a disposable arm patch that photographs meals and offers dietary suggestions, even though both measure glucose in interstitial fluid.
For diabetes patients, the Eversense 365 data is meaningful. A 93.8 percent transmitter wear rate over a full year suggests that removing the burden of frequent sensor changes translates into better adherence, particularly for older adults. The twiist integration moves the technology closer to what endocrinologists have long sought: a set-it-and-forget-it system that minimizes the daily cognitive load of insulin management.
For the OTC market, the challenge is different. The wellness CGM segment must prove that glucose data, presented through AI coaching, can sustain consumer engagement beyond the initial novelty. The non-diabetic wellness segment accounted for roughly 62 percent of U.S. OTC CGM device revenue in 2024, but whether that share holds as the market matures depends on whether consumers perceive lasting value in continuous metabolic tracking.
The FDA’s January 2026 policy gives manufacturers room to experiment, but the WHOOP enforcement action serves as a reminder that the agency is watching the claims these companies make. As these two markets continue to separate, the regulatory framework will need to evolve alongside them.