Children’s Health, a Texas-based pediatric health system, is teaming up with Proteus to pilot a new program aimed at tackling adherence issues in pediatric heart transplant patients by inserting ingestible sensors into prescribed pills, which can track when the medication was taken. 

The system is made up of a wearable patch worn by the patient and the sensor-infused pill. When the pill is broken down in the stomach, it is activated and transmits a signal to the receiver on the patch worn by the patient. The patch is then able to transmit information to physicians, patients and caregivers through a digital platform. 

The pill can give providers insights into patient activity, including how often they are missing doses, if they are taking their medication late, their activity levels and their resting heart rate, according to officials at Children’s Health. The sensors, made of copper magnesium and silicon, are digestible. 

Why it matters

Across specialities, patient adherence is a universal obstacle in treating patients. The American Heart Association estimates that medication non-adherence in patients with cardiovascular disease results in approximately 125,000 preventable deaths a year.  

The youth population is particularly impacted by this problem.

“We wanted a population that included a spectrum of compliance with taking their medications. The adolescent population is extremely affected by non-compliance,” Kristin Anton, heart failure nurse practitioner at Children’s Health who is working on the pilot, wrote to MobiHealthNews in an email. “We see increased rates once patients hit the teenage age group and missed medications can lead to rejection and death, so improving compliance can save lives. This pilot will give us a baseline of how the various 'patient types' adhere to a medication schedule and will therefore hopefully show us medication schedules that work best for this teenage population.”

Anton and her colleagues said this technology could potentially help care teams identify adherence issues and work with pediatric patients to solve these problems before they are living independently. 

“It helps us to see what are the barriers to them taking their medication on time,” Anton said in a video about the new pilot. “So if they have missed meds completely, or are they just late on the medication, and can we change the time when they are taking their meds, or work with them to figure out why are they having issues with taking their medications on time. [With these] we can make sure they are successful when they leave their parents’ house and go on to college, and don’t have that safety net of their parents to remind them.”

What's the trend

Proteus had its first patch cleared in 2010 and its first pill cleared in 2012. But it made headlines last November when the FDA approved Abilify MyCite, a digital ingestion tracking system combined with a pill. Before, clinicians had to take the pill and add the Proteus chip, whereas this system more closely integrated the sensor and pill.

Abilify MyCite, which was a joint venture between Proteus and Otsuka Pharmaceuticals, is able to remotely track if and when a medication was taken. Abilify MyCite specifically treats schizophrenia, acute manic and mixed episodes associated with bipolar disorder and depression. However, at HIMSS2018 Proteus’ cofounder and Chief Medical Officer Dr. George Savage said the companies plan on rolling out more uses of the tool, including for infectious disease and oncology medications. 

But this invention was not without its skeptics. 

“[Insurance companies] were able, for years, decades, to get away with denying coverage to individuals with pre-existing conditions — conditions that were outside their control,” Kirsten Thomson, chair of the medical device and diagnostics practice group at McDonnell, Boehnen, Hulbert and Berghoff, told MobiHealthNews at the time. “Well now, this is a situation where taking a pill, especially with reminders, is completely within an individual’s control. So you would certainly, from a policy standpoint, have an argument that ‘We’re not going to pay for any hospitalizations or treatments that are directly derived from your failure to take your medications, and we have this very clear, scientific data showing that you consistently failed to take your pill’. So I think they would have a better argument than they had with pre-existing conditions, for example.”