Unpacking Digital Medicine

In Cardiovascular Disease, Diabetes, FDA, Medical Device by Emily Burke

CAN APPS PROGRAM BETTER HEALTH?

Digital medicine is defined by the field’s pioneer Dr. Eric Tool of the Scripps Translational Science Institute (La Jolla, CA) as “the ability to digitize human beings, by a variety of means (sequencing, sensors, imaging, etc.), fully exploiting our digital infrastructure of ever-increasing bandwidth, connectivity, social networking, the Internet of all things, and health information systems.” This new field is changing the way diseases from diabetes to substance abuse are prevented and treated.

“Digitizing human beings” may sound impersonal — but in fact the opposite is true. By enabling better access to individual health data, patients and physicians can create truly personalized health management plans. In this WEEKLY, we’ll take a look at this emerging biotech sector and the companies leading the way into the land of digital medicine.

THERE’S AN APP FOR THAT

There is a wealth of potential to delay the onset of diseases confronting our population, and a number of companies are developing digital medicine apps — similar to the ones you have already downloaded onto your phone such as your favorite music streaming app. Most of today’s digital medicine falls under the heading of “medication augmentation” — interventions meant to supplement rather than replace medication.

Chronic diseases such as diabetes can be managed much more effectively with “continuous intervention” — a day-to-day monitoring of the patient’s lifestyle choices and medication compliance. In many cases, these apps are highly sophisticated, clinically validated, and FDA-approved. The disease areas most commonly being tackled include Type 2 diabetes, chronic respiratory disease, chronic cardiovascular conditions, and mental health conditions.

Let’s unpack some of the digital medicine coming to an app store near you.

DIABETES

Diabetes management is a prime target for digital medicine intervention, as the number of people diagnosed with the disease has quadrupled over the past 35 years, from 5 million to 20 million (Centers for Disease Control).

WellDoc’s (Columbia, MD) BlueStar smartphone-based app is the first FDA-cleared mobile prescription therapy. The app allows users to enter data including levels of blood glucose, carbohydrates consumed, medications taken, exercise amount, hours of sleep, and perceived stress levels. BlueStar then makes personalized recommendations regarding diet, exercise, and medication, and even pinpoints the best times of day for the patient to test blood glucose levels. This information is easily shared with a physician.

In clinical testing, patients assigned the BlueStar app showed an average 1.9% drop in glycosylated hemoglobin (HbA1C) levels when compared to patients treated according to the current standard of care and no continuous intervention app. HbA1C is a reflection of average blood glucose levels over the past three months. Patients must receive a doctor’s prescription for the BlueStar app.

Another leader in digital therapeutics diabetes management is Omada Health (San Francisco, CA), whose interactive behavioral intervention program reduces the development of Type 2 diabetes in prediabetics through personal coaching via the integration of web, mobile, and smart devices. The goal is to help patients lose weight and increase physical activity. Although not FDA-approved, the platform is recognized by the Centers for Disease Control as an effective diabetes prevention tool.

CHRONIC RESPIRATORY DISEASE

In some cases, digital health companies are partnering with pharma companies to ensure better use of a therapeutic drug. Propeller Health (Madison, WI) has joined forces with GlaxoSmithKline for a “digitally guided therapy” platform for use with inhalers to treat asthma and chronic obstructive pulmonary disease (COPD).

The platform consists of sensors, provided by Propeller, that are attached to patients’ inhalers; a smartphone app for patient use; a website for physician use and data from a network of air-quality sensors. Propeller monitors inhaler use, tracking patients over time and providing data on disease management as it relates to environmental factors (air quality). The Propeller system has four FDA clearances which allow the company to claim the system can be used to increase medication adherence, predict exacerbations, and reduce the frequency of symptoms and exacerbations in asthma and COPD.

HEART DISEASE

No discussion of digital medicine would be complete without a nod to the legendary story of Dr. Eric Topol using AliveCor’s (Mountain View, CA) mobile electrocardiography (ECG) device and app to diagnose a heart attack mid-flight. Dr. Topol was actually using a prototype model during his in-flight diagnosis; today, the Kardia Mobile device — essentially two sensor pads — is FDA-cleared and available for $99. After downloading the accompanying smartphone app, users can get an ECG reading in 30 seconds by opening the app on a phone placed nearby and placing their fingertips on the sensor pads. An irregular reading indicates possible atrial fibrillation, potentially indicating a heart attack.

ADDICTION & SLEEP

Pear Therapeutics (Boston, MA) is tackling substance abuse disorders with its digital therapy. Their lead product, reSET, is a smartphone app for patients with a clinician-facing web interface. It is designed to deliver behavioral therapy through a series of learning modules. The goal is to keep patients interested and engaged in their treatment between therapist visits. The apps have been clinically tested in five different trials. Patients who received reSET treatment in addition to standard addiction therapy showed better rates of drug abstinence. The app has been submitted to the FDA for approval.

Big Health (San Francisco, CA) has developed a digital therapy, Sleepio, to help with insomnia. The app consists of cognitive behavior therapy (CBT)-based exercises delivered by an online, animated therapist dubbed The Prof. When tested against an online version that included interaction with the Prof but lacked CBT-based activities, Sleepio was more effective at helping 75% of the participants to fall asleep.

THE FUTURE

The companies and apps described here are really just the tip of the iceberg of this new therapeutic world. Additional disorders for which digital therapies are being developed include obesity, hypertension, hyperlipidemia, smoking cessation, chronic pain, coronary artery disease, and even serious mental illnesses such as schizophrenia. The field is still in its infancy, but the dramatic benefit already seen by many adopters suggests a bright future.