Software-Based Diabetes Treatment: The Future of Digital Therapeutics (DTx)

Medical device software-based digital therapeutics (DTx) represent one of the most noteworthy advances in modern medical technology and have become an increasingly prominent field of innovation. A quintessential example is the “BlueStar” application developed by WellDoc. This app was designed to assist in the treatment of diabetes and represents one of the first prescription digital therapeutics approved in the United States. BlueStar stands as a landmark product that has opened new possibilities for the future of DTx.

BlueStar’s Revolutionary Characteristics

BlueStar, interestingly, was a second-mover product. Competing applications that preceded it operated exclusively on desktop computers. BlueStar’s breakthrough innovation was enabling it to run on smartphones. This technological shift fundamentally transformed how patients could manage their health within the rhythms of everyday life, making self-care considerably more accessible.

As a “prescription app,” BlueStar operates under the same regulatory framework as prescription pharmaceuticals. A healthcare provider must issue a special access code—referred to as a prescription key—to enable patient use of the application. In this sense, it functions analogously to a prescription. Consequently, BlueStar is provided under strict regulatory oversight as a medical device. As a Prescription Digital Therapeutic (PDT), patient access to the app is exclusively through physician prescription, and its use occurs under the supervision of the healthcare team.

BlueStar’s Functions and Clinical Value

BlueStar was designed to assist patients with both Type 1 and Type 2 diabetes in controlling blood glucose levels and improving lifestyle habits through supported self-management. The application incorporates numerous features needed by diabetes patients, enabling bidirectional communication between patients and healthcare providers.

Patient-Facing Features: Patients can record blood glucose values at home and easily input information about meals consumed, physical activity, and medication adherence. The user interface has been designed intuitively, requiring no specialized medical knowledge and minimizing the burden of daily data entry. The app analyzes input data in real time and delivers individualized feedback and educational support based on blood glucose fluctuation patterns and lifestyle habits. This algorithm-driven approach enables patients to develop deeper health understanding and engage actively in their treatment plans. Additionally, patients can pose questions to healthcare professionals and obtain immediate responses through integrated messaging functionality.

Healthcare Provider Features: Physicians can monitor patient status in real time during office downtime and utilize individualized diagnostic support information derived from patient data. Prior to appointments, physicians automatically receive comprehensive reports containing blood glucose readings, medication adherence, health status records, and treatment progress. This systematic data sharing enables physicians to develop a more accurate understanding of patient conditions and establish more appropriate and efficient treatment plans. Through such bidirectional data exchange, persistent healthcare challenges—such as the “three-hour wait for a five-minute appointment”—can be substantially ameliorated, allowing consultation time to be deployed more effectively.

BlueStar’s Clinical Efficacy and Regulatory Approval History

BlueStar’s effectiveness has been demonstrated through multiple large-scale clinical trials. Numerous peer-reviewed clinical publications document that patients using BlueStar achieve average hemoglobin A1C (HbA1c) reductions of 1.7 to 2.0 percentage points, demonstrating therapeutic efficacy equivalent to or exceeding many diabetes medications. The application received FDA 510(k) clearance in 2010, establishing BlueStar as a landmark example of DTx efficacy and safety while becoming an important pioneer in healthcare digitalization. Subsequent to this initial clearance, BlueStar has undergone continuous regulatory expansion, acquiring more than ten additional 510(k) clearances through 2024, with functional extensions to address long-acting insulin management, rapid-acting insulin dosing, and Type 1 diabetes support.

The Evolving Regulatory Environment for Digital Therapeutics

As digital therapeutics have undergone rapid development, regulatory authorities worldwide, including the FDA, have accelerated the establishment of comprehensive regulatory frameworks. In December 2024, the FDA issued final guidance on “Predetermined Change Control Plans for Artificial Intelligence-Enabled Device Software Functions,” and in January 2025, published draft guidance on “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” These guidances clarify the development, approval, and post-market continuous improvement processes for digital therapeutics incorporating machine learning and artificial intelligence capabilities.

In November 2024, the newly established FDA Digital Health Advisory Committee (DHAC) held its inaugural meeting to discuss regulatory approaches for generative AI-enabled digital medical devices. This committee emphasizes transparency and trustworthiness improvement, recommending that manufacturers publicly disclose intended use, training data, and error rates in standardized formats.

The regulatory landscape for Software as a Medical Device (SaMD) continues to evolve. As of 2025, over 1,250 AI-enabled medical devices have received FDA authorization. The majority of these employ predictive models, while generative AI applications in healthcare remain in the research and development phase. SaMD regulation increasingly emphasizes enhanced clinical validation, implementation of robust cybersecurity protocols, and ongoing collection of Real-World Evidence (RWE) post-approval.

Business Opportunities and Challenges for Pharmaceutical and Medtech Companies

Digital therapeutics such as BlueStar present new business models for pharmaceutical and medtech enterprises. While new drug development requires substantial investment and extended timelines, digital therapeutic development can proceed more expeditiously, with more efficient pathways to patient availability. Furthermore, digital therapeutics enable continuous aggregation of patient real-time data, allowing companies to iteratively improve therapeutic efficacy—thereby creating novel revenue models for pharmaceutical organizations.

However, challenges persist. In 2016, the FDA established policy that SaMD would become ineligible to receive National Drug Codes (NDC) after September 2021. This regulatory shift impacted the commercialization pathway for digital therapeutics through traditional pharmaceutical reimbursement channels. Nonetheless, major healthcare insurers and pharmacy benefit management (PBM) companies established independent digital health formularies beginning in late 2019, creating alternative reimbursement mechanisms. Major enterprises such as Johnson & Johnson, Samsung, CVS, and ExpressScripts have established strategic partnerships to facilitate digital therapeutic deployment.

BlueStar’s Expansion and Application to Other Chronic Diseases

BlueStar’s success has accelerated development of digital therapeutics applicable to other chronic disease management. WellDoc is currently expanding its platform to address multiple disease areas including hypertension management, congestive heart failure, weight management, and mental health support. Through such expansion, a future in which numerous patients can readily access healthcare benefits is being constructed.

Digital therapeutics represent more than mere technological innovation; they symbolize healthcare’s transformation toward “patient-centered digital support.” As prescription apps, these tools integrate seamlessly into patients’ daily lives and extend connections with healthcare providers, thereby establishing new standards for chronic disease management. The evolution of digital therapeutics promises to fundamentally transform healthcare delivery and enhance patient-physician relationships. Particularly significant are expected advances in artificial intelligence and machine learning implementation, increasingly sophisticated real-time data analytics, enhanced patient engagement, and market expansion through international regulatory harmonization.