What are digital therapeutics (DTx)?

Digital therapeutics (DTx; or digiceuticals as someone called them) is a promising and fascinating sub-field of digital health.

“DTx deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes”

(definition developed by the Digital Therapeutics Alliance)

The concept is sometimes also referred to as “digital medicine” in a non-specific way (DTx is a subset of digital medicine). To date, they are more frequently developed to address areas such as mental health or behavioral disorders like addiction (e.g. virtually delivering cognitive behavioral therapy) or to manage/prevent chronic diseases (e.g. diabetes).

What do digital therapeutics do?

There are basically 3 categories of digital therapeutics.

They can:

1. Complement/enhance traditional treatments by helping patients manage their (chronic) condition
2. Help preventing diseases or medical disorders
3. And also offer entirely new alternative treatments to drugs

And they may use, through a digital environment, a variety of techniques, from simple reminders and calculations to gamification, cognitive behavioural therapy or virtual reality.

At first glance they’re similar to health & wellness apps but DTx solutions are “medical-grade”/validated and focus on delivering clinical outcomes.

DTx: evidence-based therapeutic interventions

As you had seen at the beginning of the definition, to qualify as DTx, every product must be “evidence-based”.

This concept is extremely important. Indeed, is paramount to properly demonstrate every effectiveness and safety claim through reliable clinical studies.

While performing such studies, sometimes also a new concept emerge: the digital placebo.

But let’s see how some innovative companies applied some of them in the real world.

Real digital therapeutics examples

DTx examples: chronic diseases management and prevention

The management or prevention of chronic diseases like diabetes is one of the therapeutc areas which provided some early real-life examples of DTx:

• BlueStar, developed by welldoc, helps patient with type 2 diabetes lowering blood glucose levels prompting patients to track medications intake and lifestyle (physical activity, food choices, and psycho-social well-being), sharing data with clinicians and thanks to automated and tailored coaching messages.^{1, 2}
• Insulia is another DTx in diabetes care, provided by Voluntis. Insulia provides personalized recommendations of insulin doses and coaches patients to better manage their disorder.
• Propeller, in respiratory care, developed a sensor to be attached to inhalers for asthma or COPD medications. The sensor, together with their digital platform, track and increase adherence to treatments through reminders, but also provide air quality forecasts and disease management tips. It was able to increase adherence to treatment (up to +58%)³ and increased of 21% the days without the need of rescue medication.⁴
• Omada Health, the largest diabetes prevention program, officially recognized also by U.S. Centers for Disease Control and Prevention (CDC). Very briefly, it is a digital behaviour change program which include coaching, interactive lessons, online group discussions with peers and tracking (data are shared with assigned coaches to empower them too). This digital prevention program demonstrates long lasting results, with participants that maintained meaningful reductions in body weight and A1c (glycated haemoglobin) levels 3 years after completion.

DTx examples: treatment

• Akili Interactive developed EndeavorRx (formerly AKL-T01), a “video game” for children with attention deficit/hyperactivity disorder (ADHD) which got FDA regulatory approval, becoming a prescription digital medicine. It is an adaptive digital cognitive platform built to look and feel like a video game while also reliably measuring attention-based abilities. [Learn more: Can video games treat diseases?]
• reSET and reSET-O which use cognitive behavioural therapy to treat patients with substance dependence. Adding reSET-O (the version to treat opioid use disorder) to patient undergoing buprenorphine and contingency management increased retention rate from 64.4% (standard care) to 82.4% through the 12 weeks of digital treatment.⁵ Retention is the amount of time a patient participates in a therapy program, a well-established indicator of successful treatment outcomes in patients with substance abuse disorders.
• Sleepio is a sleep improvement programs which, again, takes advantage of cognitive behavioural therapy techniques.
• appliedVR is a virtual reality (VR) platform to trat patients. For example it could deliver VR treatments to manage chronic pain for example, such as in the ongoing clinical trial set up to prove this indication, but it may also deliver relaxing experiences or allowing patients to escape the confines of the clinic and so on…

DTx and the power of digital analytics and continuous improvemt

Furthermore, unlike traditional therapies, the digital soul of DTx allows a virtuous feedback loop. Indeed, every interaction with digital products may be easily tracked, informing/suggesting possible refinements able to increase users’ engagement and adoption and, thus, health outcomes.

This opportunity further increases the potential of digital therapeutics.

These innovative and evidence-based therapeutic solutions are getting attention and started receiving the firsts regulatory approvals and reimbursements. I hope a lot of these companies will be able to honor their promises and I’m eager to see DTx transform healthcare and really improve our lives.