Digital Therapeutics for Chronic Disease Management
All of us have probably been to the pharmacy to pick up a medication. But what if instead of picking up an expensive pill with a laundry list of possible side effects, we could download an app and maybe put on a wearable that could treat and manage the ailment, with no side effects?
This is the goal of a new category of healthcare treatments called digital therapeutics, also known as DTx or “digiceuticals.” Simply put, digital therapeutics are software-based tools or solutions that manage conditions by helping patients modify their behavior. They usually rely on an app, remote monitoring tools, and coaching to help improve long-term outcomes.
Digital therapeutics typically fall into two categories:
- Medical augmentation, which is a combination therapy that is an additive to the typical drug and standard of care.
- Medical replacement, which uses software and remote monitoring tools—and no medications–to help create lifestyle behavior changes. These programs can incorporate tracking sensors that gather patient health data along with regular coaching, that can be delivered through a mobile app.
Many digital therapeutic companies are tackling health problems that have behavioral solutions, including chronic disease. Grand View Research compiled a shortlist of conditions targeted for treatment by DTx that includes: type 2 diabetes (prevention and management), obesity, substance abuse, asthma, insomnia, schizophrenia, ADHD, PTSD, and heart disease.
Digital therapeutics devices and apps are different than your standard activity and sleep trackers specifically in how they are developed and regulated. According to MIT, many digital therapeutic solutions have undergone clinical studies and are seeking FDA regulatory approval, which will give the solutions a higher level of credibility among healthcare providers as an accepted medical treatment.
More apps, fewer drugs
While digital therapeutics are still new and their potential is untapped, the burning question is, do they have the capability to provide significant clinical outcomes? And does a treatment trio that includes an app, coaching, and data monitoring device have the power to create sustainable behavior changes? Early results look promising. Here are three examples and a sampling of their objectives:
Diabetes. Researchers have already found positive results in diabetes management using digital therapeutics. In a study of 40 people with type 2 diabetes, researchers sought to understand if digital health coaching would help people better manage diabetes—specifically as it relates to glucose levels. The intervention group received care through a cloud-based diabetes management program, the early version of Fitbit Care (formerly known as Twine Health). The interventions consisted of regular communications about improving glycemic control and adjusting insulin doses. The solution offered the patient self-tracking tools, shared decision-making interfaces, secure text messages, and virtual “visits” with caregivers via the communications interface.
After three months, the health outcomes in the intervention group (compared to the control group) included:
- A more significant decrease in the A1C levels (the measurement of the amount of hemoglobin in the blood that has glucose attached to it). During the time period in the study, the intervention group had a -3.2 percent decrease, while the control group had a -2.0 percent decrease.
- Greater satisfaction in their diabetes treatment satisfaction questionnaire;
- And less time spent with their healthcare provider during the duration of the study (66 total minutes on average for the intervention group vs. 82 minutes for the control group).
Substance use disorders (SUD). According to the Substance Abuse and Mental Health Services Administration, approximately 20.2 million adults have a type of SUD in the United States. This high number is fueling the search for effective treatments. Earlier this year, Magellan Health partnered with PEAR Therapeutics to measure clinical outcomes of its FDA-approved prescription digital therapeutic, reSET. The pilot program includes 250 patients with SUD who will take a 12-week course using reSET technology. The pilot will use data analytics generated through the reSET therapy and accompanying clinician dashboards to provide technical support and clinical outreach to treatment providers and their patients. The goal is to examine patient abstinence and program retention by using increased engagement and therapy adherence. The full results of the pilot have not yet been released.
The reSET app provides cognitive behavioral therapy to patients via mobile and desktop applications. In a clinical trial, reSET as a standalone therapy was shown to increase rates of abstinence and retention in an outpatient treatment program vs. face-to-face therapy.
Respiratory health. Propeller Health has developed a medical augmentation digital therapeutic. Propeller Health offers a sensor and app for respiratory health management. In this solution, a user attaches the Propeller sensor to an inhaler, and the patient uses the medication as usual. The Propeller software app provides insight into the triggers, helping the patient learn what may be causing the symptoms and improving a patient’s ability to take the medication in a timely manner. Propeller reports that patients using its digital therapeutics experience 79 percent fewer asthma attacks, and 50 percent more doses are taken on schedule.