The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
The OSMITTER study protocol was designed as a master protocol governing multiple substudies for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy was conducted to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral placebo-embedded IEM tablet.
Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone
Unnamed facility
Walnut Creek, California, United States
Percentage of Participants With Accuracy of Ingestible Event Marker (IEM) Detection
The accuracy of IEM signal detection was collected by comparing the time of ingestion recorded by MIND1 system at different timepoints with the time recorded by the clinic staff. The percentage of participants with the accurate time of IEM detection are reported for each ingestion separately at Hours 0, 2, 4 and 6 on Day 1.
Time frame: Up to Hour 6 on Day 1
Latency Period From Ingestion to Detection of IEM
Latency period was defined as the time in minutes from the IEM ingestion for both aripiprazole and placebo to the time of detection of IEM by MIND1 system on a smartphone. The latency period is calculated as the difference in the time recorded by the clinic staff of IEM ingestion and the time displayed on the MIND1 application.
Time frame: Day 1 at Hours 0, 2, 4, 6
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