Individual Study / Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence

Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence

Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence

Initiatives -
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
  • Individuals

Number of participants

Number of participants
40
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

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
18
Maximum age
65
Newborns
Twins
Countries
  • United States of America
Territory
South Carolina
Ethnic Origin
Health Status
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
  • General population
General Population
  • 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
2016-06
End Date
2017-12
Data sources
  • Smart sensors
    • Ingestible sensors