In this paper, we describe the design and performance
of the first integrated-circuit microsensor developed for daily ingestion
by patients. The ingestible sensor is a device that allows
patients, families, and physicians to measure medication ingestion
and adherence patterns in real time, relate pharmaceutical compliance
to important physiologic metrics, and take appropriate
action in response to a patient’s adherence pattern and specific
health metrics. The design and theory of operation of the device
are presented, along with key in-vitro and in-vivo performance results.
The chemical, toxicological, mechanical, and electrical safety
tests performed to establish the device’s safety profile are described
in detail. Finally, aggregate results from multiple clinical trials involving
412 patients and 5656 days of system usage are presented
to demonstrate the device’s reliability and performance as part of
an overall digital health feedback system.