Software As A Medical Device (SaMD) For Diabetes Management Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Software As A Medical Device (SaMD) For Diabetes Management Market Trends and Insights

Rising Adoption of CGM-Connected Software and Automated Insulin Delivery

CGM-connected software is becoming a core part of diabetes care, pushing the SaMD for diabetes management market toward higher-value regulated tools. In January 2026, Diabeloop received FDA 510(k) clearance for DBLG2, adding another automated insulin delivery algorithm to DIABELOOP’s cleared product base. Medtronic also announced FDA clearance for the MiniMed Go Smart MDI system in January 2026, indicating broader clinical adoption of software-guided dosing support. A May 2026 study on the MiniMed 780G system showed similar glycemic outcomes across two integrated sensor brands, highlighting the growing value of algorithm performance and interoperability.^{[1]Nature Portfolio, “AI Predictive Digital Twins for Between-Visit Diabetes Care,” npj Health Systems, nature.com} These developments expand opportunities for software-led vendors that can work across devices and demonstrate consistent real-world outcomes, while broadening the addressable base beyond type 1 diabetes into larger insulin-managed populations.

Expansion of Remote Patient Monitoring and Chronic Care Management

Remote monitoring is changing how providers, employers, and health plans use the SaMD for diabetes management market in routine care. Buyers now seek ongoing support for titration, adherence, symptom tracking, and escalation between visits, rather than only post-visit glucose review. This demand is also increasing with wider metabolic therapy use, especially when patients need closer follow-up during dose adjustments and tolerability changes. In 2026, Twin Health introduced a precision GLP-1 stewardship model combining CGM data, quarterly labs, a smart scale, and activity tracking in one continuously learning system. This shift supports demand beyond glucose logging and favors vendors that combine software, review tools, and managed support in a single offering.

Payer Preference for HbA1c Improvement and Utilization

Payers are shifting from passive reimbursement to active procurement, changing how vendors compete in the SaMD for diabetes management market. DarioHealth signed 85 new commercial agreements in 2025, reported a contracted late-stage ARR pipeline of USD 12.9 million expected to convert to revenue in 2026 and 2027, and ended 2025 with an overall commercial pipeline of USD 122 million. The shift also changes channel strategy, as large covered populations are now often reached through health plan and platform intermediaries rather than direct sales alone. In July 2026, DarioHealth signed a new agreement through its Amwell channel partnership, adding access to a major Arizona insurer's ASO-covered lives and increasing total covered-life reach through channel partners to 116 million. This structure favors vendors that can report utilization, sustain engagement, document outcomes at scale, and support subscription-based care models tied to measurable performance.

AI-Enabled Personalization for Dose Support and Behavioral Change

AI-enabled personalization is becoming more important as the SaMD for diabetes management market addresses engagement and adherence gaps. In June 2026, the American Diabetes Association Innovation Fund invested in UpDoc and described it as an FDA-cleared agentic AI platform for chronic disease management and prevention.^{[2]American Diabetes Association, “The American Diabetes Association’s Innovation Fund Invests in UpDoc to Accelerate the Future of AI-Driven Chronic Disease Management and Prevention,” PR Newswire, prnewswire.com} Academic support also strengthened, as npj Health Systems published a framework for AI predictive digital twins for between-visit diabetes care in July 2026. These tools can deliver more relevant guidance than fixed educational modules by responding to user data, timing, and clinical context. They can also reduce patients’ manual burden by converting passive data streams into tailored prompts and dose support, helping improve persistence, payer confidence, and renewal performance.

Regulatory Uncertainty Across Device, CDS, and Wellness Classifications

Regulatory boundaries remain a key operating constraint for the SaMD for diabetes management market. Companies face different requirements across medical device software, clinical decision support (CDS), and wellness applications, even when buyers view these products as similar at the point of use. The challenge increases when vendors seek access across the United States and Europe, as they must manage clearance requirements, technical documentation, post-market follow-up, and clinical evidence across multiple regulatory systems. Smaller developers face higher exposure because quality systems, audit readiness, evidence generation, data residency rules, and cybersecurity reviews can increase costs and delay cloud and hybrid products that handle sensitive patient information across borders.

Patient Drop-Off, Low App Engagement, and Long-Term Adherence

Long-term engagement remains a challenge for many app-led solutions in the SaMD for diabetes management market. A 2026 JMIR mHealth and uHealth review of 23 commercially available gestational diabetes apps found that most apps relied heavily on text-based and manual features rather than responsive automated interactions. As daily use declines, vendors find it harder to defend the gap between trial outcomes and real-world deployment outcomes in payer discussions. Companies that fail to improve engagement through CGM feeds, connected pen logs, and AI-driven micro-interventions may struggle to defend pricing, maintain evidence quality, and renew contracts over time.

*Our forecasts treat driver/restraint impacts as directional, not additive. The impact forecasts reflect baseline growth, mix effects, and variable interactions.

Segment Analysis

By Component: Managed Services Are Reshaping a Platform-Led Base

Software platforms accounted for 70.65% of the SaMD for diabetes management market size in 2025, reflecting the established role of apps, dashboards, viewers, and dose support tools. This base grew from products focused on CGM viewing, insulin guidance, and population management workflows. Services are projected to grow at a 15.93% CAGR through 2031, well above the overall market rate, as buyers place greater value on managed outcomes than on software access alone.

This shift shows that buyers no longer view the SaMD for diabetes management industry only as a software category. DarioHealth's 2025 results highlighted this change, as the company linked new commercial growth to integrated service delivery along with its platform. Platforms remain the core layer because they organize device data, reporting, and care workflows across users and providers. Vendors that do not integrate services into their offer may face pricing pressure as payer contracts become more outcome focused.

By Product Type: Automation Is Gaining Ground Beyond Basic App Use

Diabetes management mobile applications held the largest share at 38.23% in 2025, showing the scale of the installed base for guidance, logging, and coaching tools. Closed-loop and automated insulin dosing software is the fastest-growing product type, with a 14.67% CAGR through 2031. Diabeloop received FDA clearance for DBLG2 in January 2026, and Medtronic announced a new FDA-cleared dosing support system in the same month. Product leadership is shifting toward automation quality, real-time performance, and broad device compatibility.

The SaMD for diabetes management industry is also expanding across adjacent product categories. At the ADA 86th Scientific Sessions in June 2026, Insulet reported that its next-generation Omnipod 6 algorithm outperformed Omnipod 5 across all efficacy endpoints, including a 5.2% increase in time in tight range. Decision support and coaching software is gaining traction as employers and health plans seek tools covering diabetes, hypertension, and weight management. Glooko's expanded partnership with mylife Diabetes Care in May 2026 made Glooko the primary platform for all mylife products, including mylife Loop powered by CamAPS FX.

By Clinical Use Case: Type 2 Leads on Scale While Gestational Care Leads on Growth

Type 2 diabetes management represented 48.45% of the SaMD for diabetes management market size in 2025, consistent with the scale of global type 2 prevalence. Gestational diabetes management is the fastest-growing clinical use case, at a 16.35% CAGR through 2031. Gestational care has gained priority because treatment windows are short and timely monitoring is critical. A 2025 pilot observational study in Scientific Reports found that a smartphone app for gestational diabetes remote monitoring improved glycemic control and birth outcomes.

Type 1 diabetes remains the main proving ground for algorithm depth, while commercial value is extending into broader populations. Insulet initiated the EVOLVE pivotal study in June 2026, after receiving FDA IDE approval in March 2026, to evaluate its fully closed-loop system in up to 350 adults with type 2 diabetes across up to 40 U.S. sites. If this pathway advances, software architecture proven in type 1 care could move into a much larger type 2 base. This supports platform reuse across more than one clinical need, including pregnancy care, insulin management, and broader metabolic follow-up.Cloud-based deployment held 62.65% of the SaMD for diabetes management market size in 2025, reflecting the need for scale across dashboards, analytics, and payer reporting. Health systems and insurers use cloud tools because they support large user pools and centralized monitoring. Hybrid deployment is projected to grow at a 14.78% CAGR through 2031, making it the fastest-growing mode. Automated insulin delivery also requires fast local processing for dosing decisions, while cloud layers support updates, review, reporting, and data exchange.

By Deployment Mode: Cloud Keeps the Lead While Hybrid Gains Speed

Cloud-based deployment held 62.65% of the SaMD for diabetes management market size in 2025, reflecting the need for scale across dashboards, analytics, and payer reporting. Health systems and insurers use cloud tools because they support large user pools and centralized monitoring. Hybrid deployment is projected to grow at a 14.78% CAGR through 2031, making it the fastest-growing mode. Automated insulin delivery also requires fast local processing for dosing decisions, while cloud layers support updates, review, reporting, and data exchange.

This deployment split is visible in commercial products within the SaMD for diabetes management market. Diabeloop and ViCentra launched the DBLG2 system for prescription in Germany in July 2026, combining smartphone-based control with cloud-linked review and device integration. This model helps vendors balance real-time speed with clinical oversight and service visibility. On-premises deployment remains relevant where health systems face strict localization or residency rules for patient data.

By End User: Patient Reach Is Broad While Payer Depth Is Growing Faster

Patients and caregivers held 54.33% of the SaMD for diabetes management market share in 2025, reflecting the wide installed base of CGM-linked apps, insulin guidance tools, and digital coaching products. This segment remains the largest because patient-facing software sits at the center of everyday use. Payers and pharmacy benefit managers are projected to grow at a 15.25% CAGR through 2031, making them the fastest-growing end-user group. The market is shifting from direct user uptake toward institutionally purchased programs.

Ambulatory care settings are gaining relevance as diabetes software moves beyond specialist endocrinology into broader cardiometabolic care. In July 2026, DarioHealth said a top national health plan extended its agreement and expanded the partnership into cardiometabolic care, with the potential to approximately triple revenue opportunity under that relationship and contribute revenue in 2026. Employers and wellness programs are also emerging as practical buyer channels through plan intermediaries. The SaMD for diabetes management market is rewarding companies that can serve both everyday users and contracting institutions through the same connected platform.

Geography Analysis

North America held 39.56% of the SaMD for diabetes management market share in 2025, maintaining its leading regional position. The United States remained the key demand center, supported by a large base of FDA-cleared products, a mature employer-sponsored benefits structure, and stronger payer engagement. The region favored vendors that demonstrated post-market outcomes, managed reporting, and supported broad commercial rollouts. Canada remained a smaller but meaningful growth pocket, and One Drop expanded its digital coaching program there in February 2025. Mexico remained at an earlier adoption stage, with demand concentrated in private insurance and employer wellness programs across major urban markets.

Europe held the second-largest position in the SaMD for diabetes management market. Germany led regional adoption, as its reimbursement framework supported regulated digital therapeutics and connected care tools. In July 2026, Diabeloop and ViCentra launched DBLG2 for prescription use in Germany, with Dexcom G7 and Kaleido integration, and the product was set to reach the Netherlands later in 2026. The United Kingdom, France, Italy, Spain, and the Nordic countries remained important markets, but documentation requirements and Notified Body costs favored vendors that could distribute compliance work across several countries.

Asia-Pacific was the fastest-growing regional segment, with a 14.56% CAGR through 2031. China and India accounted for much of this momentum, driven by large diabetes populations and expanding digital health investment. Japan and South Korea added demand from connected care users comfortable with CGM-supported monitoring and premium device-linked services. The Middle East and Africa remained a smaller part of the global base, while GCC digital transformation programs supported gradual adoption of structured chronic care tools. South America remained relevant, with Brazil standing out as the largest country opportunity due to rising private insurance and employer investment in metabolic care.