![]() * Corresponding author: Deborah Profit, PhD, Otsuka Pharmaceutical Development & Commercialization, Inc, 508 Carnegie Center Blvd, Ste 300, Princeton, NJ 08540 ( atients with serious mental illness (SMI) such as schizophrenia, bipolar disorder, or major depressive disorder (MDD) are often poorly adherent to prescribed medication. © Copyright 2016 Physicians Postgraduate Press, Inc.ĪClinical Research & Development, Otsuka Pharmaceutical Development & Commercialization, Inc, Princeton, New Jersey Trial Registration: identifier: NCT02091882 No serious adverse events, discontinuations, or clinically significant laboratory/vital signs findings were reported.Ĭonclusions: The DMS implementing modified versions o f t he smartphone application and the wearable sensor has the technical capability to detect and report tablet ingestion with high accuracy and acceptable latency time. Half o f t ransmissions were completed in < 2 minutes, and ~90% of ingestions were registered by the smartphone within 30 minutes of ingestion. Mean latency times for the signal transmission were 1.1-1.3 minutes (from ingestion to the wearable sensor detection) and 6.2-10.3 minutes (from the wearable sensor detection to the server detection). The second substudy tested updated versions o f t he components and showed an overall ingestion detection rate of 96.6%. Results: The first substudy identified areas for improvement using early versions o f t he wearable sensor and the mobile application. Methods: Two sequential substudies enrolled 30 and 29 healthy volunteers between March-April 2014 and February-March 2015, respectively, to assess detection accuracy o f t he ingestible sensor by the DMS and the latency period between ingestion and detection o f t he ingestion by the wearable sensor or the cloud-based server. An umbrella study protocol was designed to rapidly assess the technical performance and safety o f t he DMS in multiple substudies to guide the technology development. ![]() The DMS consists of 3 components: ingestible sensor embedded in a medication tablet, wearable sensor, and secure mobile and cloud-based applications. Background: A digital medicine system (DMS) has been developed to measure and report adherence to an atypical antipsychotic, aripiprazole, in psychiatric patients.
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