title: Feasibility of an ingestible sensor-based system for monitoring adherence to tuberculosis therapy.
abstract: Poor adherence to tuberculosis (TB) treatment hinders the individual's recovery and threatens public health. Currently, directly observed therapy (DOT) is the standard of care; however, high sustaining costs limit its availability, creating a need for more practical adherence confirmation methods. Techniques such as video monitoring and devices to time-register the opening of pill bottles are unable to confirm actual medication ingestions. A novel approach developed by Proteus Digital Health, Inc. consists of an ingestible sensor and an on-body wearable sensor; together, they electronically confirm unique ingestions and record the date/time of the ingestion. A feasibility study using an early prototype was conducted in active TB patients to determine the system's accuracy and safety in confirming co-ingestion of TB medications with sensors. Thirty patients completed 10 DOT visits and 1,080 co-ingestion events; the system showed 95.0% (95% CI 93.5-96.2%) positive detection accuracy, defined as the number of detected sensors divided by the number of transmission capable sensors administered. The specificity was 99.7% [95% CI 99.2-99.9%] based on three false signals recorded by receivers. The system's identification accuracy, defined as the number of correctly identified ingestible sensors divided by the number of sensors detected, was 100%. Of 11 adverse events, four were deemed related or possibly related to the device; three mild skin rashes and one complaint of nausea. The system's positive detection accuracy was not affected by the subjects' Body Mass Index (p = 0.7309). Study results suggest the system is capable of correctly identifying ingestible sensors with high accuracy, poses a low risk to users, and may have high patient acceptance. The system has the potential to confirm medication specific treatment compliance on a dose-by-dose basis. When coupled with mobile technology, the system could allow wirelessly observed therapy (WOT) for monitoring TB treatment as a replacement for DOT.
authors: Denver Public Health, Denver Health and Hospital Authority, Denver, Colorado, United States of America. robert.belknap@dhha.org
authors: Robert
authors: R
authors: Belknap
authors: Steve
authors: S
authors: Weis
authors: Andrew
authors: A
authors: Brookens
authors: Kit Yee
authors: KY
authors: Au-Yeung
authors: Greg
authors: G
authors: Moon
authors: Lorenzo
authors: L
authors: DiCarlo
authors: Randall
authors: R
authors: Reves
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000995:Antitubercular Agents / Q000494:pharmacology / Q000627:therapeutic use*; D015374:Biosensing Techniques / Q000295:instrumentation* / Q000379:methods; D015992:Body Mass Index; D023801:Directly Observed Therapy / Q000941:ethics / Q000379:methods*; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology; D008875:Middle Aged; D011446:Prospective Studies; D011634:Public Health / Q000941:ethics; D012680:Sensitivity and Specificity; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*; D016903:Drug Monitoring
chemical_list: D000995:Antitubercular Agents