Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence
Initiatives
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The primary objective of this clinical trial is to evaluate the acceptability, tolerability, and efficacy of the ID-Cap system in a healthy population. The ID-Cap is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) trac
- Start Year
- 2016
- Funding
- Sponsors and Collaborators Medical University of South Carolina
Visit Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence
Design
- Study design
- Clinical trial cohort
Marker Paper
https://clinicaltrials.gov/ct2/show/NCT02344251
PUBMED
Recruitment
- Sources of Recruitment
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- Individuals
Number of participants
- Number of participants
- 40
- Number of participants with biosamples
Access
Availability of data and biosamples
| Data | |
| Biosamples | |
| Other |
Timeline
assessing-the-effectiveness-and-safety-of-the-id-cap-system-for-medication-monitoring-and-adherence
Participation in the study takes 3 visits over a period of approximately six weeks. The first visit is a screening visit to determine if participants are eligible to participate. After the initial assessment visit, participants will be randomized to one of two groups
Selection Criteria
- Minimum age
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18
- Maximum age
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65
- Newborns
- Twins
- Countries
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- United States of America
- Territory
- South Carolina
- Ethnic Origin
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- Health Status
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- Other criteria
- Exclusion Criteria: Women who are pregnant, nursing, or plan to become pregnant during the course of the study Must not have evidence of a significant medical condition which may affect capsule passage through the gastrointestinal tract (including, but not limited to, Crohn's disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis) Must not have a current major psychiatric disorder as these may interfere with assessment measures Must not be currently dependent on other substances, with the exception of nicotine or caffeine, within the past 60 days Hypersensitivity to riboflavin or any capsule component; Individuals with embedded electronic devices Patients who, in the investigator's opinion, would be unable to comply with study procedures or assessments, or would be unacceptable study candidates (e.g., poses threat to staff)
Recruitment
- Sources of recruitment
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- General population
- General Population
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- Volunteer enrolment
Number of participants
- Number of participants
- 40
- Number of participants with biosamples
Data Collection Event
Group 1 will have adherence measured by self-report, pill count, and urine riboflavin levels. This group will not receive capsules containing ingestible sensors, but will receive their medication in a bottle capped with a MEMS Track Cap, which records when the medication bottle is opened and closed. Group 2 will receive capsules containing an ingestible sensor and will have adherence measured by self-report, pill count, urine riboflavin levels as needed, and data collected by an ID-Cap reader. Participants randomized to this group will also receive reminder calls and/or text messages to ingest the study medication if a signal is not sent from the ID-Cap reader to the study team within one hour of the scheduled medication administration time. They will also be using biometric identification technology to confirm subject identity, specifically electrocardiogram (ECG).
- Start Date
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2016-06
- End Date
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2017-12
- Data sources
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Smart sensors
- Ingestible sensors
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Smart sensors