Digital therapeutics was one of the hot topics during this year's Consumer Electronics Show (CES).

The field has been receiving much attention lately due to its possibility of providing treatment to illnesses and disorders, which are hard to treat with conventional drug-based therapies.

Digital therapy refers to treating diseases with software, such as applications, games and virtual reality, instead of traditional medicines.

In the United States, clinically approved digital treatments have recently been benefiting from the fast track system. The system allows an investigational drug to receive an expedited review to help speed up the development of medicines, which treat a severe or life-threatening condition and fill an unmet medical need.

During the conference, Korea Biomedical Review attended two sessions – each presented by Akili Interactive CEO Eddie Martucci, and Charles O'Connell, CEO and founder of Fitscript and the creator of GlucoseZone – to learn more about digital therapeutics and how the field is developing.

Akili Interactive CEO Eddie Martucci

Akili Interactive CEO Eddie Martucci stresses that digital therapeutics need to undergo a strict approval process to be integrated into mainstream healthcare medicine at CES 2020 in Las Vegas, Nev., on Friday.

Akili is under review by the U.S. Food and Drug Administration for developing a tablet PC game "EVO," which treats attention deficit hyperactivity disorder (ADHD) in children. If EVO passes the FDA review, it will become the first disease treatment game.

"We founded Akili in 2011 with the idea that software can impact health and be used as a medicine," Martucci said.

He believes such an idea is the core of digital therapy.

"What I consider digital therapeutics is when the software is used to have a direct impact on healthcare outcomes," Martucci said. "A lot of digital things are supporting today's medicine or patient engagement. To be a digital therapy, however, it has to impact patient outcomes directly."

As the field has just begun, Martucci stressed that a lot of efforts need to be made to raise awareness, which will help spur the adoption of digital technologies in all different areas of healthcare.

To help accelerate this effort, digital therapeutic companies had formed a Digital Therapeutic Alliance (DTA) in 2017, with the mission of broadening the understanding, adoption and integration of clinically evaluated digital therapeutics into healthcare through education, advocacy and research.

"There is a set of core founding companies that kicked this off, Akili being one of them. Still, the alliance has since grown tremendously and now consists of companies both inside and outside of the U.S.," Martucci said. "We also have several pharmaceutical companies, health insurers, providers, and clinics that have now jointed DTA."

DTA has so far been working on setting the standards and definition of digital therapeutics.

"However, what we'll see going forward is that there will be a big push to educate the world about digital therapeutics to get this integrated into mainstream healthcare medicine," he said.

During the conference, Martucci stressed the requirements for digital therapeutics to thrive further in today's healthcare system.

"A digital technology having therapeutic outcomes should be studied like any other technology or drug that has direct therapeutic outcomes," Martucci said. "The one clear thing about digital therapeutic is that there will is a lot of negative feedback, and when we don't have good technologies coming to the market with solid evidence, such negative feedback will proliferate."

If such a situation happens, it can be harmful to the people that need the technology, Martucci added.

"We also have to respect the people using our application," Martucci said. "Think about how we use something. If it's not simple, seamless and easy to use at a deep level, no one will use it."

That explains why patients should be at the center of any digital therapeutic platform development, Martucci added.

Charles O'Connell, CEO and founder of Fitscript and creator of GlucoseZone

Charles O'Connell (right on screen), CEO of Fitscript and the creator of GlucoseZone, explains why digital therapeutics needs to be integrated into mainstream healthcare medicine at CES 2020 in Las Vegas, Nev., on Friday.

GlucoseZone offers exercise guidance based on the user's real-time glucose levels and other diabetes metrics. The program enables doctors to prescribe exercise to people with diabetes to improve hemoglobin A1c, achieve weight loss, and halt the progression of the disease.

O'Connell said that he created the program because there is a public health crisis regarding diabetes.

"The reality is for patients living with diabetes, the standard of care is not working," O'Connell said. "Since 2005, more than 40 pharmaceutical companies have received FDA approved drugs and brought them to the market."

However, not only has diabetes not gotten any better, but the situation has gotten worse, he added.

O'Connell stressed that the treatment triangle – medication, treatment and exercise – is universally recognized for successful diabetes management.

"Despite billions of dollars invested in the medication component, the triangle is nowhere near perfect," he said. "When we looked at the standard of care and started identifying where the gaps were, it became clear to us that the gap in the standard of care revolves around physical activity and exercise."

While everybody knows exercise is good for diabetes, exercise is different for people living with diabetes, he added.

"Telling diabetes patients to exercise without taking into consideration other factors such as medication styles, type of diabetes, and physical limitations is not a path to success," O'Connell said. "Yet that is the current status of our standard of care for the disease, and this needs to change if we want to solve the diabetes epidemic."

O'Connell offered an insight into what he considered as digital therapeutics.

"Digital therapeutics is still being defined, but my take on digital therapeutics is if we can prescribe an application instead of a drug to achieve a meaningful clinical outcome, then it constitutes a digital therapeutic," he said. "Also, I believe this is where the opportunity for the field lies, as I believe that is what patients want."

Patients don't want more data. They want to reduce, reverse, or take back control of their lives, O'Connell added.

The GlucoseZone founder noted that he believed that throughout the next couple of years, digital therapeutic companies would show how they can use technology to achieve a clinical outcome, instead of a drug.

To do so, however, O'Connell laid out some ground rules that companies need to follow to achieve optimal results.

"For digital therapeutics companies to get integrated into the current healthcare system, there are three goals to keep in mind," he said. "First, if a company is going to build a successful digital therapeutics platform, they have to start with the patient."

Second, the program has to be an easy to use application that's accessible via how they usually conduct their lives, usually their smartphones, he said. O'Connell also stressed that companies need to build something that medical professionals can embrace and not replace them.

"The third and last part of the puzzle is that digital therapeutics has to be embedded in the academia," he said. "It is essential to make digital therapeutics into a curriculum so that when doctors are licensed, they can be familiar with these approaches and be confident in prescribing them."

Song Soo-youn from Las Vegas contributed to this article. — Ed.

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