The U.S. continuous glucose monitoring (CGM) market is undergoing a structural transformation as diabetes management shifts from periodic blood glucose testing toward continuous, connected and increasingly automated glucose monitoring. What was once primarily a technology for people with Type 1 diabetes and intensive insulin requirements is becoming relevant to a wider population, including individuals with Type 2 diabetes, people not using insulin and consumers interested in understanding their metabolic health.
This evolution is creating opportunities across wearable biosensors, digital health platforms, insulin delivery systems, pharmacy distribution and healthcare services. For manufacturers and investors, however, understanding the U.S. CGM market requires more than projecting sensor shipments. It requires careful evaluation of reimbursement, patient eligibility, actual product revenue, sensor utilization and the competitive dynamics between established and emerging suppliers.
CGM Adoption Is Moving Beyond Traditional Patient Groups
The clinical value of CGM comes from its ability to provide glucose readings and trends throughout the day and night. Unlike conventional self-monitoring blood glucose (SMBG) devices, which provide readings at individual testing points, CGM systems help users and clinicians understand glucose patterns, variability and responses to medication, food and activity.
In the United States, CGM adoption has historically been strongest among insulin-treated patients. Expansion into broader Type 2 diabetes populations represents a major commercial opportunity because this patient group is substantially larger than the population requiring intensive insulin therapy.
Yet market penetration is not determined by clinical potential alone. Insurance coverage, out-of-pocket costs, clinician recommendations, patient engagement and the perceived usefulness of continuous monitoring all influence adoption.
The next phase of market development will therefore depend on making CGM clinically valuable, economically accessible and simple enough for sustained everyday use.
Reimbursement Could Become a Major Market Catalyst
U.S. reimbursement policy remains one of the most important determinants of CGM adoption.
Medicare coverage has already expanded beyond patients using intensive insulin regimens to include eligible insulin-treated beneficiaries and certain individuals with documented problematic hypoglycemia. This broadened access has helped support adoption among older adults with diabetes.
Further coverage expansion for non-insulin-treated individuals has been under discussion in 2026. Any additional eligibility changes could materially enlarge the reimbursed patient population, although proposed or anticipated policy changes should not be treated as implemented coverage until officially confirmed.
Commercial insurers, pharmacy benefit managers and healthcare providers will also influence future penetration. Manufacturers able to demonstrate improvements in glycemic outcomes, patient engagement and healthcare resource utilization may be better positioned in reimbursement negotiations.
For market forecasting, it is essential to distinguish between the total population that could benefit from CGM and the smaller population that can currently obtain it through reimbursed or affordable channels.
Dexcom and Abbott Continue to Shape the Competitive Landscape
Dexcom and Abbott are central to the U.S. CGM market, supported by extensive sensor portfolios, established distribution networks, clinical evidence and investments in software and connected diabetes care.
Dexcom reported approximately USD 4.66 billion in worldwide revenue for 2025, reflecting continued expansion of its CGM business. Abbott also reported sustained growth in continuous glucose monitoring, with approximately USD 2.0 billion in worldwide CGM sales during the fourth quarter of 2025.
These figures demonstrate the scale of commercial demand, but they should not be added together and presented as the U.S. market size. Dexcom's reported revenue includes international operations, while Abbott's CGM sales also span multiple geographic markets. A credible U.S. market estimate must isolate domestic sales and account for additional competitors, relevant revenue definitions and channel differences.
Beyond these two companies, the competitive landscape includes Medtronic, Senseonics and other companies developing wearable, implantable or connected glucose monitoring technologies.
Competition is increasingly extending beyond sensor accuracy into wear duration, convenience, interoperability, data interpretation, distribution access and integration with treatment decisions.
Over-the-Counter CGM Creates New Commercial Possibilities
The introduction of over-the-counter CGM products has opened a new channel outside conventional prescription-driven diabetes monitoring.
A significant development occurred in June 2026, when the U.S. Food and Drug Administration cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in people aged two years and older who do not use insulin, expanding its previous adult indication.
This illustrates how glucose monitoring is becoming relevant to additional user populations and potentially new models of preventive and personalized care.
Nevertheless, consumer interest should not automatically be interpreted as recurring long-term demand. The commercial success of OTC CGM will depend on pricing, repeat purchases, perceived benefits, software experience and evidence that continuous data can meaningfully influence user behavior.
CGM and SMBG: Will One Technology Replace the Other?
One of the most important questions for the U.S. diabetes monitoring industry is when CGM revenue could overtake traditional SMBG revenue and how quickly the technologies will substitute for one another.
CGM offers more comprehensive glucose information, particularly for patients who require frequent monitoring or treatment adjustments. Its recurring sensor replacement model also creates a different revenue profile from blood glucose meters and test strips.
However, SMBG is unlikely to disappear completely.
Fingerstick testing remains useful for confirming unexpected sensor readings, monitoring certain patients who do not require continuous data and serving populations where CGM access is limited by cost or reimbursement. SMBG can also remain relevant as a backup to continuous monitoring.
Consequently, the transition should be modeled as a gradual shift in patient utilization and revenue composition rather than an immediate replacement of one technology by another.
A reliable crossover analysis must separately estimate CGM users, annual sensor consumption, realized selling prices, SMBG testing frequency and test-strip revenue. Changes in reimbursement and patient eligibility can materially alter the timing of that crossover.
Technology Innovation Is Changing the Basis of Competition
The U.S. CGM market is increasingly influenced by improvements in wearable sensor design and the digital ecosystem surrounding the device.
Important technology trends include longer sensor wear, simplified application, smaller form factors, smartphone integration, automated insulin delivery compatibility and cloud-based glucose data sharing.
Artificial intelligence and advanced analytics could also support more personalized glucose interpretation, although the clinical usefulness and regulatory status of individual applications must be evaluated separately.
For device manufacturers, sustained differentiation may increasingly depend on combining sensor reliability with ease of use, actionable insights and compatibility with broader diabetes management platforms.
Opportunities for Healthcare and Technology Companies
The U.S. CGM market offers opportunities across several connected value chains.
Sensor manufacturers can pursue new patient groups and improvements in production efficiency. Semiconductor and component suppliers can support miniaturized sensing and connectivity. Software companies can develop data platforms and clinical decision-support capabilities. Healthcare providers and payers can explore remote monitoring and outcomes-based care models.
At the same time, manufacturers face challenges related to reimbursement pressure, product pricing, competitive differentiation, cybersecurity, regulatory compliance and patient retention.
Companies entering this market need to understand not only the overall revenue opportunity but also which patient segments are commercially accessible, which channels drive recurring purchases and where established suppliers maintain competitive advantages.
Outlook: A Larger Market, but Not a Uniform Growth Story
The outlook for U.S. continuous glucose monitoring remains favorable, supported by diabetes prevalence, technological improvement and the gradual expansion of eligible patient populations.
However, growth will vary by patient type, reimbursement channel, device category and competitive positioning.
Prescription CGM, OTC glucose monitoring and integrated automated insulin delivery represent related but distinct commercial opportunities. Treating them as one undifferentiated market can obscure important differences in adoption, pricing and revenue potential.
For manufacturers, investors and healthcare organizations, detailed market segmentation and evidence-based revenue estimation will be critical to understanding where the next phase of growth will occur.
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