What are digital therapeutics?

Digital therapeutics (DTx) is a new kind of medical treatment that uses software and applications to provide therapy for patients. These programs, based on solid scientific evidence, can help prevent, manage, or treat various medical conditions, improving the quality of life.¹

The global pandemic showed gaps in healthcare and made it clear that we need more remote care options. So, the DTx field has made rapid progress in recent years. It's expected that the digital therapeutics (DTx) market will reach a value of $9 billion (USD) by 2025.

DTx uses tools like mobile devices, applications, sensors, virtual reality, and the Internet of Things (IoT). These tools encourage patients to change their behaviour for better health. Since DTx is tailored to meet patients' specific needs, it can offer very personalised health services.

Like prescription medications or medical equipment, digital therapies (DTx) are subjected to a thorough assessment process. Regulatory bodies like the US Food and Drug Administration FDA or the German Federal Institute for Drugs and Medical Devices BfArM approve DTx only when there is enough clinical evidence of their effectiveness, safety, and quality.¹

Digital therapeutics (DTx) can be used alone or with traditional treatments like medicine or face-to-face therapy, which is called digitally enabled therapy. They can also work with devices that measure or affect the body. DTx treatments rely on collecting and processing digital data from patients.

Because they are digital, DTx can gather and analyse data to track progress and prevent issues. Right now, DTx treatments are being developed for many conditions, including some chronic disorders. These include type II diabetes, heart failure, Alzheimer's disease, anxiety, depression, and more.¹

How digital therapeutics (DTx) work, their potential, and how they're used

DTx comes in a variety of forms, such as mobile applications, web tools, virtual reality, artificial intelligence (AI) applications, video games, and approved medical devices. DTx may use tech like advanced machine learning, data analysis, and behavioural psychology to treat, manage, and prevent diseases. They show promise in treating a variety of conditions, such as psychiatric disorders, heart conditions, diabetes, gastrointestinal issues, and neurological diseases.²

In treating chronic diseases like diabetes, DTx uses web platforms, mobile apps, AI, and even automated calls to track and support patients. This helps people manage their blood sugar levels and weight through personalised coaching and social support.²

Furthermore, DTx works best when used alongside traditional therapies. They allow patients to access treatment conveniently from home, potentially improving outcomes and adherence compared to hospital-based care. DTx also broaden access to treatment for a wider audience.²

Also, when using DTx instead of conventional medication treatments, there could be fewer dangers involved. However, developers must ensure these software products are safe and ethically used for patient care.²

To sum up, DTx provides innovative tools designed to manage chronic conditions by encouraging behavioural changes and offers new possibilities for treatment across different medical fields.

Digitally enabled therapies: NHS

Digitally enabled therapy (DET) products deliver most of their therapy online using digital therapeutics (DTx) but also include help from a therapist. DETs in NHS Talking Therapies must include support from a practitioner or therapist who regularly monitors patient safety and progress. 

DET products have been evaluated to ensure they are suitable for NHS Talking Therapies for long-term mental health conditions such as generalised anxiety disorder (GAD) and depression. It has been demonstrated that people with depression are more likely to develop chronic diseases. These include heart disease, diabetes, stroke, chronic pain, osteoporosis, and Alzheimer's disease. These digital therapies provide a flexible way for people to get help, fitting better into their schedules and locations.

For example, in England, one in six people experiences common mental health issues like anxiety and depression each week. There is a significant waiting list of up to six weeks for NHS talking therapy due to strong demand.

It is believed these digital therapeutics could allow more people with mental health issues to access NHS Talking Therapies. Digital therapies might require less therapist time than traditional methods, potentially helping over 40,000 people.

NICE recommended DTx for mental health

Assessments completed using a new fast-track process from the National Institute for Health and Care Excellence (NICE) revealed six technologies to help adults with long-term mental health disorders:

• For body dysmorphic disorder (BDD), perspectives with support from a highly trained BDD therapist in BDD
• For GAD or unspecified anxiety disorder,  help from a psychological well-being practitioner or a highly trained therapist
• For post-traumatic stress disorder (PTSD), support from a highly trained therapist in PTSD
• For social anxiety disorder, support from a highly trained therapist in social anxiety disorder
• For depression, the committee conditionally recommended three online cognitive behavioural therapy (CBT) programmes

Before using these technologies in the NHS, they must get regulatory approval. This includes meeting the Digital Technology Assessment Criteria (DTAC) from NHS England, obtaining CE or UKCA marking, and complying with the NHS Talking Therapies DET assessment criteria.

Digital therapeutics for heart failure management

Heart failure is the final stage of several chronic heart conditions. Even with treatments like medications, heart devices, and transplants, Heart failure patients often have low survival rates and a poor quality of life. A 2022 systematic review of scientific studies found that using digital therapies for heart rehabilitation improves exercise ability and quality of life in heart failure patients.³ 

Digital therapeutics (DTx) for cardiac rehabilitation allow continuous monitoring and management. They let patients and families interact in a familiar setting, reducing anxiety and improving exercise adherence and overall quality of life. Many studies now focus on the mental health of heart failure patients. According to the 2022 review, DTx-based cardiac rehabilitation improves mental health more than conventional techniques. Patients get exercise training and psychological support remotely, with monitoring by a team of nurses, doctors, and physiotherapists. This comprehensive review suggests that digital therapeutics under the umbrella of telemonitoring technology for heart failure management could be a helpful option, especially during pandemic-type scenarios.³ 

Digital therapeutics for diabetes treatment

Several digital therapeutics (DTx) have been approved by the FDA for managing Type I and/or Type II diabetes. Most of these are mobile apps designed to help adjust insulin doses effectively. They use algorithms to analyse patient data, aiding healthcare professionals and patients in personalised diabetes management.² 

They provide digital coaching and insights to optimise treatment plans. For example, some approved digital therapeutics include a smart meter and an app for patients to test their blood sugar levels at home. It offers live coaching and real-time data analysis for personalised support. Usually, these apps work with various types of insulin. However, poor adherence to these DTx products for glucose monitoring can be a problem. Inconsistent use may limit the reliability of the data collected by the software.²

Future trends

DTx needs more evidence to prove its effectiveness. This research is vital for understanding how DTx can adapt and improve outcomes after they are used. Hence, patient-reported outcomes (PROMs) are crucial for assessing the value DTx bring to patients. With added patient-reported outcomes (PROMs) evaluation, DTx will allow continuous monitoring of indicators like quality of life, pain levels, and disease impact.¹

Further research on health analytics and AI and their impacts and risks in DTx is needed. Some DTx apps use smartphone cameras to track movements, creating lots of data for personalised training programs. They also improve these programs with real-world evidence over time. Virtual bots have also been developed to mimic human therapist behaviours.¹

Challenges and considerations

While we're seeing positive effects from DTx on patient care, there's been less focus on how it affects medical staff workload, healthcare costs, and negative outcomes. Unlike traditional biomedical research that clearly defines harmful events, understanding and measuring issues like adverse treatment reactions, side effects, treatment failures, or worsening conditions related to DTx is still an open area.¹

We need to pay more attention to the unintended consequences of these "technology-focused designs," which could include stress from using medical apps, negative impacts from algorithms, being pushed into critical situations by nudges, or even unintentional addiction to therapy. There's a lack of research on suitable outcomes and methods for studying these areas, which presents significant opportunities for further investigation.¹

Moreover, while exploring AI's potential in digital therapeutics, we need to carefully consider when and why to use AI in DTx, how AI makes decisions, how accurate these decisions are, and whether they truly benefit patient care. There are also important ethical and legal questions, like whether algorithms can take responsibility or how to handle biased decisions caused by incomplete or misleading training data.¹

Summary

Digital therapeutics (DTx) are innovative treatments that use software and apps to help manage various health conditions by promoting healthier behaviours. The COVID-19 pandemic has highlighted the need for such remote healthcare options, leading to rapid advancements in the field. DTx tools, which include mobile apps, sensors, and virtual reality, offer personalised treatments and can work alongside traditional therapies. Regulatory bodies ensure their safety and effectiveness. DTx is particularly promising for managing chronic conditions like diabetes and heart failure, improving patients' quality of life through continuous monitoring and personalised support. Despite their potential, challenges remain, including ensuring safe use and understanding their impact on healthcare costs and staff workload. Further research is needed to fully realise their benefits and address ethical concerns, especially regarding the use of AI in these therapies.