Everything You Need to Know About the Rise (and the Effectiveness) of Digital Therapeutics

Everything You Need to Know About the Rise (and the Effectiveness) of Digital Therapeutics
Photo: Jeff Somers

The old joke “there’s an app for that!” has finally come for the healthcare industry as medicine moves into the uncharted waters known as Digital Therapeutics (DTx). You might be familiar with the broader category of Digital Health, which includes stuff like the Fitbit designed to support healthy lifestyles or a “smart” blood pressure cuff that does some on-the-spot analytics. These tools are used to collect data and assist a physician, whereas DTx are designed to actually treat a condition using smartphone apps and connected sensors and devices.

DTx aren’t just cooked up by programmers slamming Red Bull — they’re generally supported by clinical research and approved by a regulatory body; the Food and Drug Administration (FDA) is in the process of formalising an approval track for DTx right now. Many are prescribed by physicians, and insurers are increasingly willing to cover them. So your chances of encountering a digital therapeutic — as well as the hype surrounding them — are increasing every day.

There’s a bit of a “gold rush” mentality surrounding DTx right now, with companies racing to get in on a market that’s predicted to be worth more than $US50 (A$71) billion by 2025. So it’s reasonable to wonder if the DTx you’re being urged to use is a real, effective treatment or the product of an overheating market frenzy, especially since you can count the ones approved or cleared by the FDA on two hands with fingers to spare. Here are the DTx in different categories that have real evidence behind them.

Physical Therapy

Hinge Health: Provided through employer benefit plans but not requiring a prescription, Hinge Health is a DTx that delivers at-home physical therapy (PT). When you sign up at their site, you answer a few questions about your pain and mobility. Then the company sends you a kit with a customised Android tablet with the Hinge app pre-installed, along with some custom Bluetooth sensors. Once you calibrate the sensors, the app walks you through a series of customised exercises and therapies. The sensors help you achieve the correct form, and a remote coach will be in touch to encourage you and offer assistance.

PT is one of the best fits for DTx; once a program is developed for you the crucial aspect of PT is compliance — actually doing it. Although an app won’t replace the literal hands-on guidance of a trained therapist, it’s got real evidence behind it and can have a positive impact on your recovery and mobility if you stick with it.

Asthma/COPD

Propeller Health: Propeller Health’s DTx is a sensor that attaches to an inhaler used by someone suffering from asthma or chronic obstructive pulmonary disease (COPD). The sensor then links to an app on their phone to record how often they use their inhaler, how much medicine gets delivered, and the environmental conditions experienced each time. This data can then be analysed to customise the dosage and use of the inhaler, modify lifestyle decisions that impact breathing, and encourage adherence to treatment. It can also be used to find a lost inhaler via the app.

You don’t need a doctor or an approved benefit plan to get the sensor and use the app, though the sensors cost about $US80 (A$114) without one, and if your doctor’s not involved, you won’t necessarily be able to adjust your prescriptions automatically (though you can always bring the app’s data to your physician for a conversation). Studies have shown that Propeller is effective at improving asthma control test (ACT) scores and reducing overall inhaler use.

Insomnia

Somryst and Sleepio: The treatment of chronic insomnia is a perfect argument for DTx due to the varied causes and difficulty in customising treatment. Most insomnia treatments rely on either pharmaceuticals — which come with potential dependence and negative side effects — or less precise approaches like meditation, exercise, or hypnotherapy. DTx like Somryst and Sleepio fill the gap between those extremes. Somryst utilises cognitive behavioural therapy to “train” your brain to get better sleep, while Sleepio combines education and lifestyle adjustments designed to help you fall asleep faster, stay asleep longer, and have better-quality sleep. Both spare you from relying on pills, supplements, or having a friend explain why blockchain is going to change the world until you pass out from boredom.

Somryst is FDA-approved with solid evidence showing its effectiveness. Sleepio isn’t FDA-approved, but there is plenty of evidence that it is effective in improving sleep and reducing instances of insomnia. Neither requires a prescription, and both can be accessed through a benefit program or purchased directly. Considering how sketchy existing insomnia treatments are, this is a clear case where a digital therapeutic might be a huge improvement over more traditional approaches.

Chronic Pain

EaseVRx. Anyone who has had to deal with chronic pain knows how it invades and takes over every aspect of your life. There’s also the very real danger of becoming dependent on opioids, which are commonly prescribed to help people manage chronic pain. EaseVRx is a virtual reality (VR)-based therapy. Patients are supplied with a headset connected to an amplification device that enhances the sound of their own breath to aid in breathing exercises. The app uses cognitive behaviour therapy to address pain through relaxation and meditation techniques.

If you’re thinking that sounds like a lot of hokum, keep in mind the FDA just approved EaseVRx for chronic pain treatment, and studies have shown it to be effective in reducing pain. EaseVRx is only available via prescription from your physician.

Depression

Woebot. Everyone experiences depression, and about 7% of adults in the U.S. have experienced a major depressive disorder. Left untreated, depression can do incredible damage to people’s lives and relationships, but there are many obstacles between people and trained therapists, including the stigma of mental illness and the cost. Having an effective therapy they could access on their own has the potential to be a game-changer.

Woebot is an app you can download to your phone at any time, but unlike most other mental-wellness apps, there’s reason to believe it can actually work. It was granted FDA Breakthrough Device status for postpartum depression, for one thing, and there’s great evidence that Woebot effectively replicates the bond formed between a patient and a human therapist.

Substance Abuse

reSET and reSET-O. Substance abuse continues to be a significant problem in the modern world. And while there are many treatment options proven to be effective, accessing them can be a challenge due to cost, logistics, and the stigma of publicly admitting to a problem. Pear Therapeutics has two of the only digital therapeutics approved by the FDA to treat substance use disorders (SUDs) — reSet is targeted toward non-opioid SUDs, while reSET-O is for people battling an opioid addiction. Both utilise a form of neurobehavioral therapy called “the community reinforcement approach” to help patients change behaviours and avoid patterns that lead to relapses and deepening addiction.

Both reSET and reSET-O are only available via prescription, but once prescribed can be downloaded to any smartphone. Aside from FDA approval, both have significant evidence behind them, making them worth discussing with your doctor if you’re battling a substance use problem.

ADHD

EndeavorRx. Attention deficit hyperactivity disorder (ADHD) is challenging. Difficult to precisely diagnose and often misunderstood, many children struggle with the condition and the medications typically prescribed. EndeavorRx is the only FDA-approved DTx on the market for ADHD in children. It uses video games designed according to cognitive science precepts to help train young brains to pay closer attention and to stay focused longer. The combination of gaming and science makes it a treatment with a high level of adherence for kids.

EndeavorRx is only available via a prescription from a doctor, and there is a growing body of clinical evidence showing that this approach to ADHD therapy is extremely effective in helping children pay attention and be more focused.

Diabetes

iSage Rx. Type 2 Diabetes is one of the most damaging chronic health conditions in the modern world, and it’s becoming more prevalent as people live longer. Diabetes can be self-managed through diet, exercise, and insulin injection, but many patients struggle with keeping up with their blood glucose levels and insulin dosing.

iSage Rx is the only FDA-cleared DTx for Type 2 Diabetics. It’s prescription-only and serves as a coach and support resource to help people to self-manage their condition. Studies have shown that iSage Rx reduces unscheduled physician interactions and helps to maintain a steady insulin regimen while achieving low rates of hypoglycemia. In other words, it works to make people with diabetes healthier.

Both startups and old-school pharmaceutical companies are actively developing new digital therapeutics and working to get them cleared or approved by the FDA. Don’t be surprised if your doctor suggests one at your next checkup — but for the moment, the list of DTx with real evidence is pretty slim.

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