The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.
This is an open-label study to determine the accuracy of ingestible event marker (IEM) detection and detection latency of the D-Tect patch by completing a series of patch applications and IEM ingestions in the clinic. The participants were enrolled in two cohorts within this study- Cohort 1: healthy participants received the placebo-embedded IEM tablets, Cohort 2: participants with serious mental illness (SMI) i.e schizophrenia, major depressive disorder, or bipolar I disorder received Abilify MyCite® tablets (aripiprazole-embedded IEM tablets). This single-center trial was conducted in the United States. The overall time to participate in this study is up to approximately 17 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
54
Oral placebo-embedded IEM tablet.
Oral aripiprazole-embedded IEM tablet.
The D-Tect patch is a wearable sensor (WS) capable of detecting the ingestion of the IEM and measuring physiologic parameters. The WS automatically logs and stores the time when the IEM reaches the stomach and transmits the data to a smartphone.
Research site
Garden Grove, California, United States
Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch
The PDA is calculated as the number of total positive detections by patch divided by the number of the total DOIs. PDA was estimated by Clopper-Pearson method.
Time frame: At Day 1
Cohort 1 and 2: Patch Detection Latency Period
The patch detection latency period is defined as the time between the ingestion of the tablet and the detection of the tablet ingestion by the patch. Kaplan Meier estimation was used to measure the patch detection latency period.
Time frame: At Day 1
Cohort 1 and 2: Ingestion Data Transfer Latency Period
The ingestion data transfer latency period is measured as the time between the detection of the tablet ingestion by the patch and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the ingestion data transfer latency period.
Time frame: At Day 1
Cohort 1 and 2: Total Detection Latency Period
The total detection latency is measured as the total time between the ingestion of the tablet and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the total detection the latency period.
Time frame: At Day 1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation
TEAEs were defined as AEs that occurred on or after the participant wears any patch or takes any tablet from the study at test day, and the AEs that occurred before the participant wears any patch or takes any tablet and are worsening, serious, related, or resulted in death, discontinuation, or interruption of investigational product. A serious TEAE was defined as a TEAE that is fatal, life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, or requires inpatient hospitalization or prolongation of existing hospitalization.
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Time frame: From Day 1 up to follow-up (up to Day 10)