The purpose of this study is 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 is designed as a master protocol governing multiple substudies for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy is being 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. Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Approximately 30 healthy volunteer subjects will be enrolled in the substudy. The duration of this substudy from Visit 1 (Day 1) to safety follow-up will be approximately 1 week, of which approximately 1 day will be allotted for active subject participation, plus a 1-week safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Subjects may eat as they wish over the course of the day. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Clinic staff will record the time of each ingestion of an IEM. Clinic staff will check the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and will record the time it is detected by the MIND1 System compatible computing device (eg, smartphone).
Unnamed facility
Walnut Creek, California, United States
Accuracy of Placebo-embedded IEM Detection by the MIND1 System Measured by the Percentage of Participants With IEM Detection Reported for Each of the 4 Time Points
All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the accuracy of IEM detection by the MIND1 System using the placebo + IEM by the proportion of participants with IEM detection reported for each of the 4 time points.
Time frame: Day 1 Visit, at hours 0, 2, 4, 6
Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch
All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To evaluate the latency period between site-reported ingestion time and detection of the ingestion event by the patch which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline.
Time frame: Day 1 Visit at 0, 2, 4 and 6 hours
The Latency Period Between the Patch Detection of an Ingestion Event (eg, the Acquisition Time Stamp) and the Detection of the Ingestion Event in the Otsuka Cloud Server (eg, Server Time Stamp).
All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the latency period between the patch detection of an ingestion event and the detection of the ingestion event on the Otsuka Cloud Server which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline ingestion tile after each scheduled ingestion event. The various information transmissions measured were patch Acquisition of IEM to Medical Device Data Systems (MDDS), MDDS to Otsuka software application registration, Otsuka software application registration to Cloud Server and patch Acquisition of IEM to Cloud Server
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Time frame: Day 1 Visit at 0, 2, 4 and 6 hours
Number of Participants With AEs Due Study Treatment and MIND1 System
Safety and tolerability of the system components was assessed by the device-related AEs, non-serious AEs (NSAEs), serious AEs (SAEs), AEs leading to discontinuation, and unanticipated adverse device effects.
Time frame: At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit)