Individual Study / Belknap et al.; PLoS One. 2013

Feasibility of an ingestible sensor-based system for monitoring adherence to tuberculosis therapy.

Feasibility of an ingestible sensor-based system for monitoring adherence to tuberculosis therapy.

Initiatives -
The primary objective was to determine the detection accuracyof the ingestible sensor system when co-administered under directobservation with active TB medications. This included the abilityto correctly register when ingestions occurred (positive detectionaccuracy) and the ability to correctly identify the unique signaturesof multiple sensors ingested simultaneously (identification accura-cy). A secondary objective was to measure whether the wearablesensor would detect any false signatures. Other secondaryobjectives were monitoring for adverse events and obtainingfeedback from providers and participants. Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
Start Year
2013
Funding
The authors have no support or funding to report.

Design

Study design
Patients' cohort

Marker Paper

Belknap R, Weis S, Brookens A, et al. Feasibility of an ingestible sensor-based system for monitoring adherence to tuberculosis therapy. PLoS One. 2013;8(1):e53373. doi:10.1371/journal.pone.0053373

PUBMED 23308203

Recruitment

Sources of Recruitment
  • Individuals

Number of participants

Number of participants
30
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

Thirty patients completed 10 DOT visits and 1080 co-ingestion events. Each participant co-ingested two inert tablets with their TBmedications during 10 consecutive DOT visits. Of the 20 inerttablets, 18 carried two ingestible sensors affixed on opposite sidesand two tablets were ‘‘dummies’’ with no active sensors.
Selection Criteria
Minimum age
18
Newborns
Twins
Countries
  • United States of America
Territory
Denver, Colorado and Fort Worth, Texas.
Ethnic Origin
Health Status
  • Patients taking active TB treatment were eligible to participate if they had received more than 10 days of medications for suspected or confirmed TB.
Other criteria
Exclusion criteria included pregnancy, acute gastrointestinal (GI) symptoms, history of major GI surgery, end-stage liver or kidney disease, presence of an implanted electronic medical device, current alcohol or drug abuse that could impair follow-up, known allergies to any substances that could compromise patient safety, and recent participation in another medical device studyevents.

Recruitment

Sources of recruitment
  • Specific population
Specific Population
  • Clinic patients

Number of participants

Number of participants
30
Number of participants with biosamples
Data Collection Event
This was a prospective, non-randomized, descriptive study of the safety, performance and acceptability of an ingestible sensor system in patients with active TB. The system consists of a 1.0 mm×1.0 mm ingestible sensor and an on-body wearable sensor. The ingestible sensors are activated by gastric fluids, independent of the acidity level, and communicate unique identifying signatures to the body surface. The system uses a conductive method of communication and not radio-frequency which ensures the information is confined to the body of the user, thus preserving privacy. The on-body sensor counts the number of times each unique signature is received. For this study, the ingestible sensors were attached to inert tablets and co-ingested with the TB medications
Start Date
2013
End Date
2013
Data sources
  • Smart sensors
    • Ingestible sensors