The landscape of healthcare is becoming increasingly digital, with concepts such as personalised and precision medicine taking the lead. The integration of health and digital technology has resulted in the development of Digital Health, a broad category of digital health technologies aimed at improving human health and well-being, enhancing the quality and safety of care, expanding access to treatment, improving the efficiency of health services, and lowering overall health-care costs.

Digital therapeutics (DTx) defined by the Digital Therapeutics Alliance as “evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease” [ 1] have emerged as a new therapeutic modality for the prevention, management, or treatment of chronic, behaviour-modifiable disease. To prevent, manage, and/or treat a medical problem, these software-driven medical interventions combine pharmacologic and non-pharmacologic techniques with/without expert supervision. However, many companies follow four primary methods for validation. These include FDA (Food and Drug Administration) approval or clearance for use, registered clinical trials, observational studies or clinical trials, and retrospective studies.

The benefits of digital medicines align with market demand, therefore the market for digital therapeutics is growing worldwide, with an emphasis on advanced medical markets [ 2]. It is a relatively new discipline that uses digital implements like mobile devices, apps, sensors, the Internet of Things, and others to spur behavioural changes in patients. Mostly, DTx systems draw upon the evidence-based principles of behavioral or psychological intervention protocols known as “cognitive behavioral therapy” (CBT) [ 2]. It uses evidence-based techniques to change problematic behaviors and unhelpful cognitive distortions, and to improve emotional regulation and coping skills to solve the current problems [ 3]. Patients, physicians, and payers benefit from digital therapeutics because they provide sophisticated and accessible tools for addressing a wide range of diseases with high-quality, safe, and effective data-driven interventions.

According to the latest data from the International Diabetes Federation (IDF), the global prevalence of diabetes has reached 10.5% of the adult population (ages 20-79), which translates to approximately 537 million adults living with diabetes. Alarmingly, nearly half of these individuals are unaware that they have the condition. Projections indicate that by 2045, the number of adults with diabetes will rise to 783 million, or about 1 in 8 adults [ 4]. By leveraging technology, DTx provide scalable and effective solutions to manage diabetes, ultimately improving patient outcomes and quality of life.

This article will focus on the benefits of novel digital therapeutics for prevention and management of type II diabetes that are currently available in the market.

Comprehensive, structured literature searches were conducted in PubMed, Google Scholar and print media using key words digital therapeutics, digital health, Software as a Medical Device (SaMD), healthcare digitization and technology in healthcare.

Subsequently, the relevant papers and data published from 2010 to 2024 were fully reviewed, and their findings were noted.

The 2024’s breakout funding in digital therapeutics is evidence of an unprecedented mandate for change, across all aspects of healthcare. Investments in digital therapeutics companies in the United States have grown as digital health funding continues to break records during 2024’s blockbuster year, with the three highest-funded quarters ever [ 5]. Due to the increasing prevalence of diabetes, the diabetes application segment dominated the market in 2024.

The global digital therapeutics market size is estimated to grow from USD 2.83 billion in 2024 to USD 19.76 billion by 2035, representing a CAGR of 19.32% during the forecast period 2024-2035 [ 6] (SeeFigure figure 1).

Furthermore, the market is expected to increase due to the cost-effectiveness of digital health technology for providers and patients, as well as rising demand for integrated healthcare systems and patient-centric care.

Digital therapeutics in diabetes offer a range of benefits aimed at improving disease management and patient outcomes. Here are some key aspects:

Personalized Treatment: Digital therapeutics provide tailored interventions based on individual patient data, which can include glucose levels, diet, physical activity, and medication adherence [ 7].

Enhanced Self-Management: These tools empower patients to take control of their diabetes management through continuous monitoring and feedback. This can lead to better adherence to treatment plans and lifestyle changes [ 8].

Improved Clinical Outcomes: Studies have shown that digital therapeutics can help reduce HbA1c levels, improve physical activity, and enhance overall diabetes knowledge [ 9].

Accessibility and Convenience: Digital platforms, including mobile apps and telemedicine, make it easier for patients to access care and support from anywhere, reducing the need for frequent in-person visits [ 10].

Behavioral Support: Many digital therapeutics include features like reminders, educational content, and motivational support to help patients maintain healthy behaviors and manage stress [ 7].

Overall, digital therapeutics offer a promising adjunct to traditional diabetes care, providing scalable and effective solutions to improve patient outcomes and quality of life (8).Table 1 summarizes the DTx currently available in market.

DTxs have shown to enhance clinical outcomes in T2DM patients in cohort studies. Over the course of a 3-month research [ 11], a mobile medical app named FareWell (now changed to Better Therapeutics) that gave intense behavioural treatment together with assistance from a remote multidisciplinary care team showed mean HbA1c reduction of 0.8%. Greater glycemic control was observed with increasing app engagement.

Digital therapeutic applications (DTx) like Blue Star, Diabeo System, Livongo Diabetes Program, and Tidepool, use web-based applications/cloud platforms to provide evidence based, personalized, rapid point of care management of chronic, behavior-modifiable conditions like diabetes mellitus (DM). It has significantly improved patient compliance, therapeutic success and economic outcomes in DM management by enabling active patient engagement, lifestyle change, comprehensive medical care, and periodic monitoring of glycemic status [ 12].

Regulated digital therapeutics are those that have been approved by the FDA and follow a prescription model similar to medical technology and pharmaceuticals. Software algorithms that administer insulin are one example in diabetes. Some examples of insulin dosage algorithms have been [ 13] certified by the FDA and are commercially accessible - Tandem, Voluntis, Hygieia, and Welldoc. Livongo's effort to combine remote monitoring and coaching with blood glucose monitoring is an excellent example of digital therapeutics that complement devices and pharmaceuticals. Onduo and Welldoc's work are two further examples which are working globally to reduce the disease burden. While in the Indian market, Mumbai based Fitterfly is a leading digital therapeutics company that provides a 360-degree holistic care and support to patients to help manage their diabetes.

In a recent study of 109 participants in the Fitterfly Diabetes CGM program, there was significant reduction in the mean HbA1c levels, weight, and BMI of the participants, emphasizing a high level of engagement with the program [ 14].

Another tool named MayaMD.AI [ 15] has features of recording vitals and care program through which remote patient monitoring is possible. This application consists of a customized and evidence-based medicine curated ‘Care Program’ (SeeFigure figure 2) for wide range of lifestyle diseases like Hypertension, Diabetes, CKD and CHF etc. The symptom checker is intended to assist patients in deciphering their medical symptoms and provide them with reliable information to help them maintain their health. For instance, to have a look at the blood glucose levels in case of diabetes along with timely vital check, right diet consumption and exercises in order to maintain healthy lifestyle. The Connect with Care team feature consists of a team of expert professional doctors further aiding in pharmaceutical intervention along with lifestyle intervention.

It has a dedicated medical records section designed to help patients to store and access their health information making them track their own progress or health journey. It also increases portability of clinical information including the better interaction between patient and health service provide. Patients can even take their medical records to a new provider for second opinions. One can very easily use the application for doing daily wellness check in order to track progress and motivate themselves. The medication and refilling section provide system generated alerts in order to remind the user in case of medicine stock refilling ahead in time to keep patient constantly motivated towards the healthy goals.

The MayaMD.AI app presently allows customers to make simple digital payments and view their health insurance coverage information, ensuring that the buyer-seller service is transparent about treatment costs. It not only provides therapy but educates the patient about diabetes making patient self-aware, conscious controller of their own health. Medication increases control attributions while decreasing behavior management stability. As a result, medication and behavior therapy combined with a focus on overall comprehensive disease management are recommended to promote compliance.

Digital therapeutics in diabetes prevention and management can have profound benefits in the overall health of the patient. It can help improve medication and dietary adherence, thereby helping in weight loss, better glycemic control and lower medication requirement. Increased app usage has been linked to better diabetes management, including increased diabetes awareness and diabetes self-management behaviors like blood glucose monitoring and insulin administration [ 16,17].

Despite the benefits, there is still scope of work pertaining to the quality of clinical data and real-world evidence, as well as adapting digital therapeutics’ business model to meet the demands of payers, providers, and health systems. The benefits and limits [ 18] of digital therapeutics is well summarized inFigure 3.

There are several benefits that have a significant influence on all stakeholders (patients, physicians, caregivers, nurses, healthcare system, pharmaceutical firm), with limitations linked to technological problems, regulatory restraints, prices, and practice adjustments [ 19]. Although many medications and medical devices have undergone several validation and stability testing throughout time, the hurdles to approval for DTx are thought to be very low when compared to traditional drugs and medical devices [ 20]. Moreover, as technology gathers additional data, the proof will need to be updated on a frequent basis.

In a short span of time, digital therapeutics has become an integral part of healthcare systems. With chronic lifestyle diseases like diabetes on the rise, technology support would be required in effective management especially in monitoring. This technology would partly empower the patient to take charge of their health. While DTx cannot take the place of healthcare providers (HCPs), it will support the HCPs in decision making and treatment planning, thereby making their work easier and organized. Considering some aspects of healthcare may never be completely replaced by technology, it is probable that DTx will be used in conjunction with other treatments to enhance patient results.