U.S. OTC Continuous Glucose Monitoring (CGM) Devices Market (2026 - 2033)

U.S. OTC Continuous Glucose Monitoring (CGM) Devices Market Summary

The U.S. OTC continuous glucose monitoring (CGM) devices market size was valued at USD 194.0 million in 2025 and is projected to grow from USD 207.2 million in 2026 to USD 403.5 million by 2033, at a CAGR of 9.6% from 2026 to 2033. The rising adoption of lifestyle wellness devices, including CGM to ease diabetes management, and easy access to wearable health tools, are fueling demand. In 2025, nearly 20% of Americans planned to use wearable devices to achieve their health goals, while Abbott reported that two out of three U.S. Lingo members began using an OTC CGM to make healthier decisions in real time.

In the coming 5 to 10 years, the adoption rate is expected to reach 50% among elderly Americans. The growing geriatric population and sedentary lifestyles contribute to the disease burden, imposing the development of advanced monitoring solutions such as CGM. Furthermore, expanding healthcare infrastructure and distribution of CGM devices through e-commerce without a prescription would ease accessibility. Technological advancements like sensor accuracy, app integration, and data sharing further support market growth across urban and semi-urban areas.

 Source: Grand View Research, IR Documents, Primary Interviews, Paid Databases

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As of 2025, nearly 38 million American adults are diagnosed with diabetes, marking 11.5% of the total adult population in the U.S. Furthermore, around 97 million adults are prediabetic in the country. Obesity and a sedentary lifestyle are the major contributing factors to the prevalence of diabetes. Continued surge in type 2 diabetes cases and growing awareness of early diagnoses are likely to boost the demand for OTC CGM devices in the U.S.

Newly introduced OTC CGM devices are suggested to be used by type 2 diabetes that are not on insulin. As type 2 diabetes does not get the insurance for prescription CGM, OTC comes in as a help. OTC CGM sells at an affordable rate and without a prescription. Although the OTC CGMs are not covered by insurance, the HAS/FSA funds are generally accepted.

Avoiding type 2 diabetes requires healthy lifestyle modification, such as consistent physical activity, a low-fat and sugar diet, maintaining a healthy weight, and avoiding tobacco. Experts from the ADA and AACE also highlight the increasing role of Continuous Glucose Monitoring (CGM) devices in proactive diabetes management, especially in non-insulin users and prediabetic patients.

CGMs are transforming diabetes and metabolic health management by providing continuous glucose insights and reducing reliance on routine finger-stick testing. The U.S. OTC CGM landscape has expanded since the first FDA clearance in 2024, with Dexcom Stelo and Abbott’s Lingo and Libre Rio providing OTC options for different consumer and non-insulin-treated populations.

• Dexcom Stelo - Stelo was the first FDA-cleared OTC CGM in the U.S., receiving clearance in March 2024 for adults aged 18 years and older who do not use insulin. In 2025, Dexcom expanded the platform with an AI-powered Smart Food Logging feature, allowing users to photograph meals and receive automatically generated nutritional information and glucose-related insights. In 2026, the FDA expanded Stelo's indication to children aged 2 years and older who do not use insulin, making it the first OTC CGM cleared for pediatric use. Dexcom also announced a redesigned Stelo app with AI-enabled pattern recognition, proactive coaching, and personalized insights.

• Lingo by Abbott - Abbott's Lingo is an OTC glucose-monitoring system designed primarily for adults aged 18 years and older who are not using insulin and are interested in metabolic health and wellness. It is not intended to diagnose diabetes. In 2025, Abbott continued expanding its biowearables strategy, while its broader Libre ecosystem incorporated AI-enabled features such as Libre Assist, which provides personalized insights into how food choices may affect glucose levels.

• Libre Rio by Abbott - Libre Rio was FDA-cleared in June 2024 as an OTC CGM for adults aged 18 years and older with Type 2 diabetes who do not use insulin and typically manage their condition through lifestyle modifications. The FDA continues to classify Libre Rio as an OTC integrated CGM for non-intensive glucose management.

Although the market has only two players, the unsaturated and untapped market space gives beneficial revenue opportunities for new entrants.

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Dexcom Stelo vs. Abbott Lingo: Product Comparison

Market Dynamics

The industry in the U.S. is still in a nascent stage, giving wider room for innovation and expansion. The market players Dexcom and Abbott are targeting a broader application range, falling in preventive measures. Stelo by Dexcom and Lingo by Abbott promise blood glucose range monitoring for non-insulin users or prediabetics. These devices, after successful FDA approval, were made available on Amazon for easy marketing and avoiding healthcare gatekeepers, thus broadening the product’s image to a lifestyle wellness tool.

Market Concentration & Characteristics

The industry is concentrated, with currently two players dominating market share through advanced technology and established distribution networks. The industry is characterized by rapid innovation, increasing demand for real-time glucose monitoring, and growing awareness of early diagnosis. New players and startups are projected to enter the field owing to the rising digital health adoption. The market has seen significant vertical expansion via e-commerce channels. High regulatory standards and pricing sensitivity also define the landscape, making innovation and affordability key to sustained growth and market penetration.

The industry has witnessed moderate but steadily increasing merger and acquisition (M&A) activity in recent years, driven by the growing demand for convenient, real-time glucose tracking solutions. Strategic acquisitions are primarily aimed at expanding product portfolios, integrating advanced sensor technologies, and gaining regulatory expertise to accelerate market entry. Larger medical device companies are acquiring innovative startups to access proprietary CGM technologies and strengthen distribution networks. Additionally, partnerships with digital health firms are common, enabling integration with mobile platforms and health apps. However, regulatory complexities and reimbursement challenges continue to influence the pace of M&A deals.

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Regulations significantly impact the industry by ensuring safety, quality, and compliance. Under the FDA regulations, OTC CGM devices are classified as Class II medical devices under 21 CFR 862.1355, requiring FDA 510 (k) premarket notification approval for manufacturing and import. These regulations align U.S. standards with global practices, improving product reliability and user trust. However, they also pose challenges for smaller manufacturers due to complex documentation and extended approval timelines, potentially slowing market entry while encouraging innovation and adherence to international norms.

The key substitutes include prescription CGM devices that are widely adopted due to the favorable insurance scenario. Traditional self‑monitoring of blood glucose (SMBG) through finger-prick glucometers is another substitute for OTC CGM owing to its lower cost and easier accessibility. Flash glucose monitoring systems providing intermittent glucose readings without real-time alert also serve as alternatives. Adding to this, OTC at-home A1c test kits act as an alternative to OTC CGM.

The market is expanding beyond major metropolitan areas into Tier-2 and Tier-3 cities, driven by growing diabetes prevalence, rising awareness about metabolic health, easy availability, and rising disposable incomes. Urban regions remain the primary adopters due to better infrastructure and digital literacy. However, growth in the outskirts of the nation and semi-urban areas is increasing due to telemedicine, mobile health services, and e-commerce. Companies are adopting oligo-channel policy to reach a larger patient pool. Such approaches would reflect positive growth in the long run.

Analyst Perspective

The market represents an emerging segment of glucose monitoring, supported by increasing consumer interest in metabolic health, preventive monitoring, and convenient access to continuous glucose data without a prescription. The market includes OTC CGM sensors, digital monitoring platforms, and associated applications targeting non-diabetic, prediabetic, and non-insulin-treated diabetic consumers. Market growth is supported by increasing awareness of glucose management, expanding retail and direct-to-consumer distribution, product innovation, and the presence of established players such as Dexcom and Abbott. The availability of user-friendly CGM solutions is further broadening adoption beyond traditional diabetes management into lifestyle and wellness applications.

User Insights

The non-diabetic users segment dominated the market and accounted for the largest revenue share of 41.6% in 2025. Due to rising awareness about preventive care for diabetes and metabolic health, the adoption of OTC CGM is being observed in non-diabetic or fitness enthusiasts. For instance, by 2024, over 120 million Americans were active wellness tracker users, of which 66% accounted for adult Americans. Their wider adoption stems from ease of use, affordability, and accessibility across urban and emerging markets. Users benefit from continuous data, alerts, and insights into glucose trends without needing complex system integrations.

The prediabetic user segment is projected to experience the fastest growth in the market over the forecast period. The constant rise in the number of prediabetic populations in the U.S. is enhancing the adoption of diabetes monitoring devices, including OTC CGM. Their advanced features, such as real-time data collection and remote monitoring capabilities, appeal to patients seeking smarter and more fitting care. As technology becomes more affordable and users become more health-conscious, adoption is rising among tech-savvy consumers and healthcare providers. Regulatory approvals and increasing physician awareness will further drive market penetration and growth in this segment.

Application Insights

The lifestyle wellness segment dominated the market with a revenue share of 62.0% in 2025. OTC CGM like Dexcom Stelo is suggested to be used by non-insulin users and as a wellness tracker instead of a diabetes management device. The device fails to read blood glucose levels when out of range. An individual living with diabetes goes through out-of-range blood sugar hits often. In such instances, the failed alert on high or low blood glucose might cause inconvenience to the users, especially for diabetic patients who often face hyperglycemia. In addition, early onset and the need for continuous care are driving demand for real-time monitoring solutions, including OTC CGM for lifestyle wellness applications.

The diabetes monitoring segment is expected to register the fastest growth over the forecast period, driven by the rising prevalence of diabetes and prediabetes, increasing health awareness, and demand for convenient, needle-free glucose tracking. Advancements in sensor accuracy, wearable comfort, and smartphone integration are making CGM devices more appealing for daily monitoring without clinical supervision. Supportive regulatory approvals for OTC use, along with growing retail availability, are further accelerating adoption. Additionally, the trend toward preventive healthcare and self-management is boosting demand, positioning diabetes monitoring as the key growth driver in this segment.

Sales Channel Insights

The company website segment dominated the market, accounting for the largest revenue share in 2025, supported by manufacturers' established direct-to-consumer platforms and broad digital reach. Leading companies, including Dexcom and Abbott, leverage their websites to facilitate direct purchasing of OTC CGM products, provide product education, and offer customer support and subscription services. Dexcom’s Stelo and Abbott’s Lingo are promoted through company-owned digital channels, enabling consumers to access detailed product information, pricing, usage guidance, and compatibility details before purchase. Growing consumer preference for online healthcare shopping and increasing awareness of OTC CGM benefits are further supporting direct company website sales.

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The retailers segment is poised to achieve the fastest growth in the market due to various contributing factors. Majorly due to its convenient buying, it allows users, especially in remote and semi‑urban areas, to access a wide range of OTC CGM products without relying on company sites. Users could easily buy the OTC CGM along with other goods and avoid dealing with multiple packages. Moreover, inexpensive online pricing, frequent promotions, and bundled deals make OTC CGM devices more affordable. Add to this, e-commerce retailers such as Amazon offer features like ease of comparing specifications, reading peer reviews, and accessing customer support via digital platforms, which build user confidence, driving adoption across diverse demographic segments.

Key U.S. OTC Continuous Glucose Monitoring (CGM) Devices Company Insights

Key U.S. OTC continuous glucose monitoring (CGM) devices market players are Abbott and Dexcom, who have positioned themselves significantly in the U.S. OTC CGM market through innovation and competitive pricing. By focusing on the pricing side for users, user-friendliness by skipping the requirement for a prescription, and expanded access, they have significantly driven OTC CGM adoption.

Key U.S. OTC Continuous Glucose Monitoring Devices Companies

The following are the leading companies in the U.S. OTC continuous glucose monitoring devices market. These companies collectively hold the largest market share and dictate industry trends.

• Abbott Laboratories

• Dexcom Inc.

Recent Developments

• In August 2026, Abbott and Google Health announced a multi-year partnership integrating glucose insights from Abbott’s Lingo OTC CGM with Google Health’s AI capabilities. The collaboration aims to deliver personalized metabolic-health guidance by combining glucose, activity, sleep, and wellness data while supporting large-scale research into everyday behaviors and metabolic health.

“The biggest challenge in healthcare isn't treating disease its helping people stay healthier longer. Abbott's leadership in biowearables and Google's expertise in AI and consumer technology create a powerful opportunity to make personalized insights available at unprecedented scale. Additionally, we are advancing metabolic health research through one of the largest real-world studies of its kind, generating new insights into the relationship between glucose and everyday behaviors. That research will help shape future AI-powered guidance and metabolic health innovation. Together, we can help people better understand their bodies and take action before health challenges become health conditions."

-Divisional Vice President of Abbott's Lingo Business

• In February 2025, Abbott announced the availability of its Lingo OTC CGM device on Amazon. With the exclusive distribution deal, the company is targeting to expand the clientele in the nation and capture the untapped market.

• In May 2025, Dexcom made its Stelo OTC CGM available via Amazon. The supply dealership with Amazon is expected to broaden Stelo’s (Dexcom) penetration into Type 2 diabetes, prediabetes, and lifestyle wellness.

U.S. OTC Continuous Glucose Monitoring (CGM) Devices Market Report Segmentation

This report forecasts revenue growth at the country level and analyzes the latest industry trends and opportunities in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. OTC continuous glucose monitoring (CGM) devices market report based on user, application, and sales channel.

• User Outlook (Revenue, USD Million, 2021 - 2033)

  • Non-diabetic

  • Prediabetic

  • Diabetic

• Application Outlook (Revenue, USD Million, 2021 - 2033)

  • Lifestyle Wellness

  • Diabetes Monitoring

• Sales Channel Outlook (Revenue, USD Million, 2021 - 2033)

  • Company Website

  • Retailers

Research Methodology

The U.S. OTC continuous glucose monitoring (CGM) devices market figures in this report are based on a proven research process that combines executive interviews with secondary research from proprietary databases, company filings, and recognized regulatory and institutional sources. Market size is built through value-chain sizing - reconciling supply-side and demand-side estimates - and triangulated with bottom-up and top-down approaches. Every estimate passes multiple levels of expert validation before publication, with each U.S. OTC continuous glucose monitoring (CGM) devices segment quantified using the revenue-capture definitions in the table below.

Delivered Customizations

This report has been delivered with the following In-depth customizations