Patient compliance remains a significant challenge to optimal clinical outcomes. Whether the healthcare plan includes nutritional recommendations, exercise, physical therapy, bed rest, or simply taking medication, getting patients to follow through and consistently stick to regimens to which they and their care professionals agree is never perfect and too often a failure. According to a 2014 study by the US Department of Health and Human Services and the Kaiser Family Foundation, medication non-adherence rates range from 25% to 50%. Adherence rates vary by disease, patient characteristics, and insurance coverage, but even in the best cases only 75% stick to the plan. Using ingestible sensors that report when patients take medication holds promise for tracking medication adherence.

This week the FDA approved the first pill with a sensor that digitally tracks if patents have swallowed their medication. The approval has been long in coming. The FDA specifically approved Abilify MyCite, an ingestible sensor embedded in a pill used to treat schizophrenia, acute treatment for manic episodes with bipolar disorder, and as complementary medication for depression in adults. The FDA approved of Abilify, the medication, to Otsuka Pharmaceutical Co. in 2002. The sensor technology, including the sensor itself and an external patch to receive signals from the sensor, made by Proteus Digital Health, was first permitted for marketing purposes by the FDA in 2012. We wrote about the Proteus technology in 2015.

The Abilify MyCite sensor system, called Proteus Discover, consists of four components: an ingestible sensor “the size of a grain of sand,” a wearable torso patch, a mobile app, and a provider portal. The ingestible sensor activates when the patient takes the medication. The sensor transmits a signal when it reaches the stomach. The patch receives the signal and sends the data to the mobile app, which further transmits the digital record to the Proteus cloud storage system. Providers with patient permission access the data via a portal. Now that the door has opened for the first medication with ingestible sensors, hopefully the path will clear for further applications. The objective with ingestible sensors is patient compliance, but the greater goal is improved outcomes and more effective treatment.