SMCMA Physician

Ingestible Sensor Can Provide Critical Feedback

A Redwood City company, Proteus Digital Health, is the first to have received FDA approval of an ingestible sensor that works along with prescribed medicine to provide a critical feedback loop for patients and providers. Digital medicines, as these are often called, have incredible potential benefits. These go beyond just addressing medication non-adherence, which is a problem estimated to cause nearly 125,000 deaths, 10 percent of all hospitalizations, and cost the healthcare delivery system $100–$289 billion per year. Digital medicines also are able to provide objective information that can be important for treatment and allow for more precise medicine delivery. 

Proteus has been actively commercializing digital medicine and demonstrating the value-based approach that comes with them by providing this tool to physicians and care teams at health systems across the U.S. 

One of these health systems is Fairview Health at the University of Minnesota. Providers at the University of Minnesota Health are the first to use digital medicines with oncology patients to support treatment regimens and improve outcomes. The collaboration with Proteus Digital Health, announced in January 2019, helps patients complete oral chemotherapy cycles while oncologists gain new insights into their patients’ treatment progress and overall health status.

This Proteus invention makes it possible to telemetrically measure dose-by-dose medication ingestion, providing near real-time adherence feedback to patients and healthcare professionals, enabling better medical decisions and improved patient outcomes.  The Proteus product is based on Ingestible Event Marker (IEM) technology, and was initially approved in 2012 under FDA product code OZW.  It is cleared for marketing by the FDA (K150494).  The indication for use statement reads in part, “When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence.”

To improve patient convenience by simplifying co-ingestion of the prescribed FDA approved medication with the appropriate IEM, upon prescription order, pharmacists are co-encapsulating the prescribed medication together with the IEM in a standard capsule.

Here’s how it works: The patient ingests the sensor-enabled medication, also known as digital medicines or DigiMeds™, which sends a conductive signal, similar to an EKG reading, to the FDA-approved patch. The patch records the time the patient ingests each digital medicine as well as a panel of biometric data (heart rate, rest, step count, and activity patterns) that enable care teams to understand if a patient is not doing well. This information is displayed on an app on the patient’s mobile device.  If the patient consents, the information can be automatically shared with the patient’s healthcare team in a secure, HIPAA-compliant web-based portal to help inform treatment decisions.

Medicines enabled with IEM technology have consistently shown to be safe and effective in improving patient care as highlighted below.

• Amassed an attractive safety record over more than ten years of human use with zero serious or unanticipated adverse device events related to the IEM. 
• Demonstrated improved patient outcomes in randomized clinical trials and a variety of therapeutic indications, including the management of drug refractory hypertension, type 2 diabetes mellitus (T2DM), and hyperlipidemia.
• Proved superiority over directly observed therapy in tuberculosis management. 
• Highly effective and valuable for expanding clinical access to underserved patients with hepatitis C, and other conditions.
• Real World Evidence (RWE) generated in commercial use replicates positive clinical study findings in the treatment of hypertension, T2DM, hepatitis C and congestive heart failure. 
• Sustained durability over time in cardiometabolic diseas with improved clinical results sustained beyond a year of follow-up and in congestive heart failure with marked reductions in hospitalization and high patient satisfaction. 

To learn more about the impact of digital medicines visit https://www.proteus.com/evidence/.

Rob Duck is the Director of Automation & Test at Proteus Digital Health, Inc.