A networked system for self-management of drug therapy and wellness

Background: A networked wellness system is under development to document actual ingestions of oral medications, to differentiate types/doses of drugs taken simultaneously, and to provide these data along with other metrics to patients and providers for individually tailored care. Methods: After ingestion, an edible sensor (embedded in drug) is activated by stomach fluid and communicates to a wearable monitor that identifies the sensor as unique and records ingestion time/date. The monitor also collects physiologic data and communicates via mobile phone to a secure server that integrates the data with other wireless devices (e.g. blood pressure, weight). Summary reports are generated periodically for patient and physician review. Results: No adverse effects were observed in animals using repeated, exaggerated doses of sensors. Two drug-sensor form factors have been tested in 3392 human ingestions with no major and very few minor adverse effects. Sensitivity was 97.0% and specificity was 97.7% when compared to directly observed ingestion. The system identified and differentiated up to 4 simultaneously ingested sensors with an identification accuracy of 100%. Data integration with multiple devices and report generation have been piloted successfully. Conclusions: Pre-clinical and early clinical system safety appear satisfactory; data integration and communication appear to be feasible. By providing context-rich information and fostering communication, this system may enhance patient-provider relationship and care coordination.