Feasibility of an ingestible sensor-based system for monitoring adherence to tuberculosis therapy.
Initiatives
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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
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- Individuals
Number of participants
- Number of participants
- 30
- Number of participants with biosamples
Access
Availability of data and biosamples
| Data | |
| Biosamples | |
| Other |
Timeline
active TB patients
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
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18
- Newborns
- Twins
- Countries
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- United States of America
- Territory
- Denver, Colorado and Fort Worth, Texas.
- Ethnic Origin
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- Health Status
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- 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
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- 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
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2013
- End Date
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2013
- Data sources
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Smart sensors
- Ingestible sensors
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Smart sensors