Digital Therapeutics for Diabetes Management

Digital Therapeutics for diabetes management and care has witnessed a lot of transformation in 2025, with digital therapeutics (DTx) offering safe, accessible, evidence-based alternatives to traditional treatment. These FDA-cleared solutions — including apps, software platforms, and connected devices — empower patients to monitor, manage, and even reverse the effects of Type 2 diabetes from their smartphones, with better outcomes, and reduced healthcare costs. In this article, we explore the best DTx options for diabetes management in 2025, key clinical outcomes, and how the landscape is evolving.

1. What Are Digital Therapeutics?

Digital therapeutics are software-based treatments grounded in clinical evidence. Unlike wellness apps, DTx undergo rigorous trials and often secure FDA clearance or CE marks. For diabetes, DTx can deliver personalized insights, real-time glucose monitoring, behavior coaching, and even dose recommendations — all backed by science.

2. Diabetes in 2025: Why DTx Is Needed

According to the IDF, approximately 589 million adults (20-79 years) are living with diabetes in 2024, and projected to rise to 853 million by 2050, with over 4 in 5 adults (81%) living with diabetes live in low- and middle-income countries. Traditional care — primarily reliant on in-person visits and reactive treatment — fails to address behavioral and lifestyle components at scale. Digital therapeutics help fill this gap through ongoing engagement and timely interventions.

3. How DTx Supports Diabetes Management

• Continuous glucose monitoring (CGM) integration
• AI-driven food and activity recommendations
• Behavioral nudges to encourage adherence
• Secure clinician dashboards for remote support
• Medication and insulin titration support (where approved)

4. FDA-Cleared Digital Therapeutics for Diabetes Management

In the U.S., digital solutions must go through the FDA’s De Novo or 510(k) clearance pathways. Notable approved solutions include:

• BlueStar® by Welldoc
• Virta Health (Type 2 diabetes reversal)
• DarioHealth (Connected monitoring + coaching)
• One Drop (Predictive insights + data tracking)

5. Spotlight: BlueStar by Welldoc

BlueStar is one of the first FDA-cleared DTx platforms for Type 1 and Type 2 diabetes. It uses AI to provide actionable insights based on CGM data, medications, food intake, and physical activity. Studies show BlueStar users achieve significant A1C reductions within 3-6 months of use.

Clinical Outcome: In trials, BlueStar users saw a 1.7-point reduction in HbA1c over 6 months.

Payer Engagement: Cigna, Anthem, and multiple self-insured employers offer BlueStar to patients.

6. Spotlight: Virta Health

Virta uses a continuous care model to help reverse Type 2 diabetes without medications. Patients follow a medically supervised ketogenic diet with real-time telemedicine support. Clinical trials have shown over 60% of participants reduce or eliminate insulin within 12 months.

2025 Update: Virta launched a hybrid virtual-primary care model to integrate DTx with in-home labs and CGM-based care.

7. Spotlight: DarioHealth

DarioHealth as a personalized platform, combines AI-driven insights, connected medical devices, and real-time coaching to help users make lasting behavior changes. It empowers users track glucose levels, blood pressure, activity, and nutrition all in one app. DarioHealth is shaping the future of proactive, digital-first care.

New in 2025: Dario now includes integrated blood pressure and mental health modules to address comorbidities.

8. Spotlight: One Drop

One Drop offers a sleek, Bluetooth-enabled glucose meter, personalized health coaching, and real-time data tracking—all through a user-friendly mobile app. One Drop’s predictive insights use AI to forecast blood glucose trends and offer proactive guidance. With a strong focus on behavior change and measurable health outcomes, One Drop is empowering users to take control of their health every day.

Studies: Users experience significant reductions in A1c and average blood glucose levels, with some studies reporting an average A1c reduction of 1.0 percentage point (from 8.2% to 7.2%). 

9. Other Promising DTx Solutions in 2025

• OmadaHealth: Combines smart glucose meters with digital coaching.
• Glooko: Integrates data from 95% of diabetes devices globally.
• ZyterDiabetes: Offers employer-focused, remote diabetes monitoring programs.

10. Benefits Over Traditional Diabetes Care

• 24/7 support vs. sporadic clinic visits
• Data-driven personalization vs. standardized plans
• Higher adherence through reminders and gamification
• Reduced healthcare costs and ER visits

11. Clinical Results & Patient Outcomes

Studies published in Diabetes Care and JMIR show that DTx platforms consistently lower A1C by 0.5% to 1.4%, improve quality of life, and reduce medication dependency. For instance, BlueStar users reduced ER visits by 58% over one year.

12. What’s Ahead: The Future of Diabetes DTx

Expect greater integration with smartwatches, non-invasive glucose sensors, and AI-driven decision support in 2025 and beyond. M&A activity is heating up, and partnerships between pharma, payers, and tech giants signal sustained investment in DTx solutions for chronic care.

• Closed-loop glucose + coaching systems combining CGM + DTx + wearables
• Interoperability with EHRs via FHIR APIs
• Medicaid & Medicare coverage expansion for DTx programs
• Global rollout of U.S.-based DTx in India, Africa, and Latin America