Are Ingestible Sensors Making a Comeback?

A study led by Brigham and Women's Hospital found that a sensor-embedded pill can accurately track vital signs in patients being treated for sleep apnea and can be used to monitor fentanyl overdoses.

Researchers at Brigham and Women’s Hospital are reporting good results from a study that used a sensor-embedded ‘pill’ to monitor a patient’s vital signs.

The study, published in Device, gives new value to a digital health form factor that has seen its share of ups and downs, but could prove valuable in remote patient monitoring programs for a wide variety of health conditions.  

“We have developed an ingestible electronic capsule that detects different movements associated with specific vital signs,” Giovanni Traverso, MB, BChir, PhD, a gastroenterologist in the hospital’s Division of Gastroenterology, Hepatology, and Endoscopy and co-corresponding author of the study, said in a press release. “We anticipate that there will be broad applications for this device, with the potential to improve monitoring for sleep apnea and other breathing conditions.”

In their research, Traverso and his colleagues tested the Vitals Monitoring Pill (VM Pill) on 10 patients living with sleep apnea. They found that the device, developed by Massachusetts-based Celero Systems, which was launched through the Mass General Brigham innovation network, captured respiratory and heart rate data that was comparable to other monitoring devices. It also captured moments when the patient stopped breathing, either intentionally (when a patient holds his or her breath) or during a sleep apnea event.

The device was also tested in a preclinical model for fentanyl overdose, and was able to detect respiratory depression caused within a minute of overdose in real-time. That capability is timely, given the nation’s opioid abuse epidemic and efforts to find new ways to monitor patients and reduce deadly overdoses.

The study was done by researchers at Brigham and Women’s, a member of the Mass General Brigham health system, the Massachusetts Institute of Technology, and West Virginia University, as well as members of Celero’s team. Some 57 hours of data was gathered from the patients at WVU Medicine’s Sleep Evaluation Center.

Healthcare organizations and pharmaceutical companies have been experimenting with ingestibles for years, but have struggled to find the right technology and use case. One of the first companies to develop “smart pills’ was Proteus Digital Health, which at one point was valued at $1.5 billion and had a partnership with Otsuka under its belt before filing for bankruptcy in 2020. Smaller, more recent studies have centered on monitoring GI issues and delivering and tracking the effectiveness of timed doses of medications.

Traverso, who launched Celero in 2017 and sits on its board of directors, says sensor-enhanced pills have great potential in RPM programs where providers need accurate data without worrying that the patient will affect the data-gathering. Data is transmitted from the pill to a receiver attached via USB interface to a laptop until the pill is discharged.

“Our study provides a tangible product with real commercial value,” he said. “Ingestible vital monitors can really transform our capacity to rapidly respond to life-threatening events.”