Buzz
The well-known saying 'there’s an app for that!' has finally made its way into healthcare as the industry ventures into the evolving world of Digital Therapeutics (DTx). While you may be familiar with the broader Digital Health category—such as the Fitbit for promoting healthy habits or a ‘smart’ blood pressure cuff providing real-time analytics—DTx goes further. These are designed to actively treat medical conditions through smartphone apps and interconnected sensors and devices.
DTx aren't just the result of programmers fueled by energy drinks—they are typically backed by clinical trials and approved by regulatory agencies. In fact, the Food and Drug Administration (FDA) is in the process of developing a formal approval path for DTx. Many of these therapies are prescribed by doctors, and insurance companies are increasingly covering them, meaning your chances of encountering a digital therapeutic—and the associated hype—are growing every day.
There’s currently a 'gold rush' mentality around DTx, with companies scrambling to capitalize on a market projected to exceed $50 billion by 2025. This makes it reasonable to question whether the DTx you're being encouraged to use is a legitimate, effective treatment or just a product of an overheated market. After all, there are still only a handful of DTx that have received FDA approval or clearance. Here are some DTx across various categories that have solid evidence supporting their effectiveness.
Physical Therapy
Hinge Health: Available through employer-sponsored benefit plans and not requiring a prescription, Hinge Health is a digital therapeutic (DTx) offering at-home physical therapy (PT). After signing up on their website, you’ll answer a few questions about your pain and mobility. The company then ships you a kit that includes a customized Android tablet with the Hinge app pre-installed, as well as Bluetooth sensors. Once calibrated, the app guides you through a series of personalized exercises and therapies. The sensors help ensure proper form, while a remote coach provides support and encouragement throughout.
Physical therapy is a natural fit for DTx; once a personalized program is designed for you, the key to success in PT is adherence—actually doing the exercises. While an app can’t fully replace the hands-on guidance of a licensed therapist, it is supported by real evidence and can significantly aid your recovery and mobility when followed consistently.
Asthma/COPD
Propeller Health: The Propeller Health DTx is a sensor that attaches to an inhaler used by individuals with asthma or chronic obstructive pulmonary disease (COPD). This sensor syncs with an app on their phone to track inhaler usage, medicine delivery, and environmental factors each time. The gathered data can then be analyzed to optimize inhaler dosage and usage, adjust lifestyle choices that affect breathing, and improve treatment adherence. The app also offers the ability to locate a misplaced inhaler.
You don't need a doctor's approval or an employer-sponsored plan to obtain the sensor and use the app, although the sensors cost approximately $80 without one. Without a doctor’s involvement, you won’t be able to automatically adjust your prescriptions, but you can always bring the data from the app to your physician for a discussion. Studies have shown that Propeller is effective at improving asthma control test (ACT) scores and reducing overall inhaler use.
Insomnia
Somryst and Sleepio: Treating chronic insomnia is a prime example of where DTx shines, given the complex causes and difficulty in tailoring treatments. Traditional insomnia treatments usually rely on pharmaceuticals—which can lead to dependency and unwanted side effects—or less targeted options like meditation, exercise, or hypnotherapy. DTx solutions like Somryst and Sleepio bridge the gap between these extremes. Somryst uses cognitive behavioral therapy to ‘retrain’ your brain to sleep better, while Sleepio combines education and lifestyle changes to help you fall asleep faster, stay asleep longer, and improve sleep quality. Both offer an alternative to relying on pills or tedious conversations about blockchain to make you doze off.
Somryst is FDA-approved with strong evidence backing its effectiveness. Sleepio, while not FDA-approved, has ample evidence supporting its ability to improve sleep and reduce insomnia. Somryst requires a prescription, whereas Sleepio does not, and both can be accessed through a benefits program or purchased directly. Given the shortcomings of traditional insomnia treatments, these digital therapeutics could offer a significant improvement over more conventional methods.
Chronic Pain
EaseVRx. For those suffering from chronic pain, it often consumes every aspect of life, and the risk of opioid dependence is a dangerous reality. EaseVRx offers a solution through virtual reality (VR) therapy. The system includes a headset connected to an amplification device that enhances the sound of your breath, aiding in breathing exercises. By utilizing cognitive behavioral therapy (CBT), the app helps address pain through guided relaxation and meditation techniques.
If you’re doubting the effectiveness of this approach, remember that EaseVRx has been approved by the FDA for chronic pain treatment, and research has shown that it significantly reduces pain. However, it is only available with a prescription from your healthcare provider.
Depression
Woebot. Nearly everyone will experience depression at some point, and approximately 7% of adults in the U.S. have encountered major depressive disorder. If left untreated, depression can have devastating effects on individuals and their relationships. Unfortunately, the stigma surrounding mental health and the high cost of therapy often create barriers to getting the help needed. Access to a self-managed, effective therapy could be a breakthrough.
Woebot is an app that can be downloaded to your phone at any time, but what sets it apart from other wellness apps is its proven effectiveness. It has been awarded FDA Breakthrough Device status for treating postpartum depression, and there is strong evidence supporting its ability to replicate the therapeutic bond typically formed with a human therapist.
Substance Use Disorders (SUDs)
reSET and reSET-O. Substance use continues to pose a major challenge in today's society. While a variety of treatment options have proven efficacy, barriers such as cost, logistical issues, and the social stigma associated with admitting an addiction make access difficult. Pear Therapeutics offers two of the few FDA-approved digital therapeutics designed for treating substance use disorders (SUDs)—reSET for non-opioid dependencies and reSET-O for opioid addiction. These treatments leverage neurobehavioral therapy, specifically the community reinforcement approach, to encourage behavioral changes and prevent relapse.
Both reSET and reSET-O require a prescription, but once prescribed, they can be easily downloaded onto any smartphone. In addition to their FDA approval, both treatments are supported by robust evidence, making them worthwhile to discuss with your healthcare provider if you are struggling with substance use issues.
ADHD
EndeavorRx. Attention Deficit Hyperactivity Disorder (ADHD) presents significant challenges. Often difficult to diagnose accurately and frequently misunderstood, children with ADHD face unique struggles, especially with traditional medication treatments. EndeavorRx is the only FDA-approved digital therapeutic for ADHD in children. It employs a video game-based approach grounded in cognitive science principles to help children improve focus and attention span. The fusion of gaming and scientific methodology enhances the adherence rate, making it an effective solution for young patients.
EndeavorRx is available exclusively through a doctor's prescription, and clinical studies continue to demonstrate that this approach to treating ADHD is highly effective in helping children enhance their attention and focus.
Diabetes
iSage Rx. Type 2 Diabetes is one of the most widespread and debilitating chronic conditions in the modern world, and its prevalence continues to rise as people live longer. While it can be managed through diet, exercise, and insulin, many individuals find it challenging to maintain consistent blood glucose levels and manage insulin dosages.
iSage Rx is the only FDA-cleared digital therapeutic specifically for Type 2 Diabetics. Available by prescription only, it acts as a supportive coach to help individuals better manage their condition. Studies have demonstrated that iSage Rx significantly reduces unplanned doctor visits, supports consistent insulin administration, and helps avoid dangerous hypoglycemic events, ultimately improving the health of diabetes patients.
Both emerging startups and established pharmaceutical companies are actively innovating digital therapeutics and striving to secure FDA approval. Don't be surprised if your doctor recommends one at your next appointment—but for now, the list of DTx with robust evidence is still relatively small.
This article was last updated on 12/7/2021 at 5:10 p.m. to clarify that Somryst is available only with a prescription.
