By Eric Wicklund, mHealth Intelligence | December 13, 2018

Researchers at MIT and Brigham and Women’s are working on an mHealth platform consisting of an ingestible capsule that can be monitored and controlled by a Bluetooth-enabled mobile health device for several days.

Researchers at Boston’s Brigham and Women’s Hospital and MIT are working on a mHealth platform that would enable healthcare providers to control an ingestible digital health sensor for up to a month after it’s swallowed.

The connected health platform holds potential for care management situations in which medications are delivered in measured doses, at specific times or in response to a biological trigger, such as an infection or allergic reaction. The platform is especially promising in cases where providers need to monitor and even regulate medication management for patients who might not be able to do it on their own, such as those with behavioral health issues, small children and seniors.

“Our system could provide closed-loop monitoring and treatment, whereby a signal can help guide the delivery of a drug or tuning the dose of a drug,” Giovanni Traverso, PhD, a visiting scientist in MIT’s Department of Mechanical Engineering who’s scheduled to join the faculty next year, told Genetic Engineering & Biotechnology News.

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“We are excited about this demonstration of 3D printing and of how ingestible technologies can help people through novel devices that facilitate mobile health applications,” added Robert Langer, ScD, a professor in MIT’s Koch Institute for Integrative Cancer Research.

The research team, which includes technicians from Draper, has been working for several years on an ingestible mHealth capsule that can be controlled from outside the body through a digital health device with Bluetooth connectivity. The capsule, which could be manufactured with 3-D printing technology, would include compartments for various medications.

As detailed in a paper published in Advanced Materials Technologies, the capsule – called a gastric resident electronic system, or GRE – could enable healthcare providers to monitor a patient for several days and release medications as needed.

“Long‐term implantation of biomedical electronics into the human body enables advanced diagnostic and therapeutic functionalities,” the paper, authored by Traverso, Langer and University of Utah Professor Yong Lin Kong, PhD, points out. “However, most long‐term resident electronics devices require invasive procedures for implantation as well as a specialized receiver for communication. Here, a gastric resident electronic (GRE) system that leverages the anatomical space offered by the gastric environment to enable residence of an orally delivered platform of such devices within the human body is presented. The GRE is capable of directly interfacing with portable consumer personal electronics through Bluetooth, a widely adopted wireless protocol.”

The researchers said the capsule could also be configured to communicate with other wearable or implanted medical devices.

Ingestible mHealth sensors – part of the growing field of digital therapeutics – have for the most part been limited to research and small studies until late last year. In November 2017, the US Food and Drug Administration gave the green light to an mHealth platformdeveloped by Proteus Digital Health that includes a sensor embedded in a pill and a companion mHealth patch.

Proteus is now working with Otsuka Pharmaceutical to market the treatment for patients with schizophrenia. acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.

“Medication adherence is crucial in shaping clinical outcomes,” Dr. Clint Purvance, CEO of Lake Tahoe-based Barton Health, told in a 2016 interview, at which time the hospital was conducting a pilot with Proteus. “This allows both doctors and their patients to have the best data available to make decisions on a future course of action.”