Feasibility of an Ingestible Sensor-Based System for Monitoring Adherence to Tuberculosis Therapy
Open accessAbstract
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.
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Prior clinical studies suggested this DMO can identify reasons for uncontrolled hypertension and help patients achieve blood pressure control.
“and suggested this DMO can identify reasons for uncontrolled HTN and help patients achieve BP control [16-21].”
From Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial (2017) · cites this paper as [17]
The Results report that the ingestible-sensor system detected medication ingestions in patients receiving tuberculosis therapy, and the Discussion says it could help identify poor adherence. The study did not investigate uncontrolled hypertension, determine its causes, or measure whether patients achieved blood-pressure control. (LLM, conf=0.83)
Experimental — accuracy not yet measuredPrior clinical studies demonstrated the accuracy, safety, and feasibility of using the DMO in patients across a range of medical conditions, including hypertension and type 2 diabetes mellitus.
“Prior clinical studies demonstrated the accuracy, safety, and feasibility of using the DMO in patients across a range of medical conditions, including HTN and type 2 diabetes mellitus (T2DM)”
From Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial (2017) · cites this paper as [17]
The Abstract and Discussion report accuracy, adverse events, and feasibility for an ingestible sensor system in patients receiving tuberculosis treatment. The Introduction mentions earlier studies in healthy volunteers and other small cohorts, but our copy does not establish the claimed findings in patients with hypertension or type 2 diabetes. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThe uncontrolled prior studies did not focus on disease control.
“However, these uncontrolled studies did not focus on disease control.”
Ingestible sensors combined with or embedded in tablets may accurately determine taking adherence.
“Ingestible sensors combined with or embedded in tablets may accurately determine taking adherence[23,24].”
From Adherence is associated with a favorable outcome after lung transplantation (2019) · cites this paper as [24]
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- Authors
- Belknap, R., Weis, S., Brookens, A., Au-Yeung, K. Y., Moon, G., DiCarlo, L., & Reves, R.
- Affiliations
- Denver Public Health (US)
- University of Washington (US)
- Proteus Digital Health (US)
- Corresponding author
- Belknap, Robert
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2013-01-07
- Volume
- 8
- Issue
- 1
- Pages
- e53373
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC3538759
- OpenAlex
- W1988611386
- Cited by
- 160
- References
- 18
- Citations by year
- 2026: 5 · 2025: 10 · 2024: 7 · 2023: 6 · 2022: 20 · 2021: 12 · 2020: 22 · 2019: 16 · 2018: 11 · 2017: 19 · 2016: 18 · 2015: 11 · 2014: 1 · 2013: 2
- FWCI
- 9.05
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- tuberculosis, medication adherence, ingestible sensors, directly observed therapy, wearable sensors, detection accuracy, adverse events, body mass index
- MeSH terms
- Administration, Oral, Adult, Aged, Antitubercular Agents, Drug Administration Schedule, Feasibility Studies, Female, Humans, Male, Middle Aged, Prospective Studies, Public Health, Sensitivity and Specificity, Tuberculosis, Pulmonary, Biosensing Techniques, Body Mass Index, Drug Monitoring, Directly Observed Therapy, Medication Adherence
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