Intelligent Pills (Proteus Digital Health™ Feedback System) to Monitor Patient Medication Adherence

June 24, 2013 | Technology Forecasts


Effective medical therapy for many chronic diseases depends heavily on how well patients adhere to physician directions for taking various medications. To improve patient adherence with long-term medical therapy for chronic disease, Proteus Digital Health, Inc. (Redwood City, CA, USA) (formerly Proteus Biomedical, Inc.), has developed a new type of "intelligent pill" technology designed to help clinicians better monitor whether and how patients take their prescribed medications. The company stated that it is evaluating use of its Proteus Digital Health Feedback System to reduce graft rejection in patients who have undergone organ transplantation and in treating tuberculosis, diabetes, heart failure, and mental health conditions.1

The Proteus system collects medication consumption information using an external monitor that tracks the progress of tiny microchips dubbed ingestible sensors (formerly called ingestible event monitors IEMs) that can be taken with conventional pills. The company delivers ingestible sensors to pharmacies inside a small inactive tablet. Proteus Digital Health states that tablets can be delivered to patients in one of three ways, "depending on the pharmacy's capabilities and the physician's prescription: (1) Using stand-alone packaging, with patients directed to co-ingest one sensor-enabled inactive tablet each time they take their medication of interest; (2) Co-packaged in specialty blister packets or sachets, with one sensor-enabled inactive tablet in the same compartment as one dose of the medication of interest; or (3) Inside capsules that co-encapsulate a sensor-enabled inactive tablet and the medication of interest."2,3 According to the manufacturer, ingestible sensors are made from food ingredients and activated by digestive fluids upon reaching the stomach. Researchers affiliated with the manufacturer define these food ingredients as including silicon, copper, magnesium, minerals, and cellulose.4 The wearable sensor, or patch, (formerly called the Raisin Personal Monitor) is a battery-operated data-collection device contained in a skin patch worn on the torso for up to one week (i.e., per patch).1 When a patient ingests a monitored pill, the patch time-stamps the ingestible sensor activation and records the type of drug, dose, and place of manufacture. The patch also collects physiologic data, such as heart rate, activity, and respiratory rate when the ingestible sensor is activated. The patch transmits the data to the patient's Bluetooth-enabled cellular telephone or other wireless computer. That device encrypts the collected patient data and forwards them to a secure online database for review by physicians as well as patients.1 Proteus Digital Health offers the Helius subscription-based monitoring service to patients and physicians to track usage of hypertension and heart failure medications, with other addition of other chronic diseases anticipated in the future.3 The Helius application, which is accessed on a Bluetooth-enabled smart phone or tablet computer, can send prompts and reminders to patients or clinicians when a medication dose is missed.2,3

In May 2013, the U.S. Food and Drug Administration (FDA) reclassified the ingestible sensor component of the...

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