Medication Adherence Assessment: High Accuracy of the New Ingestible Sensor System in Kidney Transplants
Open accessAbstract
BACKGROUND: This open-label single-arm exploratory study evaluated the accuracy of the Ingestible Sensor System (ISS), a novel technology for directly assessing the ingestion of oral medications and treatment adherence. METHODS: ISS consists of an ingestible event marker (IEM), a microsensor that becomes activated in gastric fluid, and an adhesive personal monitor (APM) that detects IEM activation. In this study, the IEM was combined to enteric-coated mycophenolate sodium (ECMPS). Twenty stable adult kidney transplants received IEM-ECMPS for a mean of 9.2 weeks totaling 1227 cumulative days. RESULTS: Eight patients prematurely discontinued treatment due to ECMPS gastrointestinal symptoms (n=2), skin intolerance to APM (n=2), and insufficient system usability (n=4). Rash or erythema due to APM was reported in 7 (37%) patients, all during the first month of use. No serious or severe adverse events and no rejection episode were reported. IEM detection accuracy was 100% over 34 directly observed ingestions; Taking Adherence was 99.4% over a total of 2824 prescribed IEM-ECMPS ingestions. ISS could detect accurately the ingestion of two IEM-ECMPS capsules taken at the same time (detection rate of 99.3%, n=2376). CONCLUSIONS: ISS is a promising new technology that provides highly reliable measurements of intake and timing of intake of drugs that are combined with the IEM.
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Prior 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 [18]
The Study Design and Safety sections describe an ingestible-sensor study in kidney transplant recipients, with accurate detection and no serious or severe adverse events, though some patients stopped using the system because of skin intolerance. Our copy does not establish the claimed results across medical conditions, including hypertension and type 2 diabetes; searches for those conditions found no relevant passage. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe uncontrolled prior studies did not focus on disease control.
“However, these uncontrolled studies did not focus on disease control.”
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 [18]
The Study Design and Discussion describe an ingestible sensor used to assess medication adherence in kidney transplant recipients. Our copy does not address uncontrolled hypertension or blood-pressure control; searches for hypertension and blood pressure found no relevant passage. (LLM, conf=0.76)
Experimental — accuracy not yet measured
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Cites
Osterberg, L., & Blaschke, T. (2005) · New England Journal of Medicine · doi:10.1056/nejmra050100 · Cited by 7,974 · see citing works
Special Issue: KDIGO Clinical Practice Guideline for the Care of Kidney Transplant Recipients
Eckardt, K., Kasiske, B. L., & Zeier, M. G. (2009) · American Journal of Transplantation · doi:10.1111/j.1600-6143.2009.02834.x · Cited by 1,539 · see citing works
Dew, M. A., DiMartini, A. F., Dabbs, A. D. V., Myaskovsky, L., Steel, J. L., Unruh, M. L., Switzer, G. E., Zomak, R. A., Kormos, R. L., & Greenhouse, J. B. (2007) · Transplantation · doi:10.1097/01.tp.0000258599.65257.a6 · Cited by 571 · see citing works
Butler, J. A., Roderick, P., Mullee, M., Mason, J. C., & Peveler, R. (2004) · Transplantation · doi:10.1097/01.tp.0000110408.83054.88 · Cited by 541 · see citing works
Transplant Outcomes and Economic Costs Associated with Patient Noncompliance to Immunosuppression
Pinsky, B. W., Takemoto, S., Lentine, K. L., Burroughs, T. E., Schnitzler, M. A., & Salvalaggio, P. R. D. O. (2009) · American Journal of Transplantation · doi:10.1111/j.1600-6143.2009.02798.x · Cited by 331 · see citing works
Nonadherence Consensus Conference Summary Report
Fine, R. Ν., Becker, Y. T., Geest, S. D., Eisen, H. J., Ettenger, R. B., Evans, R., Rudow, D. L., McKay, D. B., Neu, A. M., Nevins, T. E., et al. (2008) · American Journal of Transplantation · doi:10.1111/j.1600-6143.2008.02495.x · Cited by 297 · see citing works
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Frias, J., Virdi, N., Raja, P., Kim, Y., Savage, G., & Osterberg, L. (2017) · Journal of Medical Internet Research · doi:10.2196/jmir.7833 · Cited by 211 · see citing works
- Authors
- Eisenberger, U., Wüthrich, R. P., Bock, A., Ambühl, P., Steiger, J., Intondi, A., Kuranoff, S., Maier, T., Green, D., DiCarlo, L., Feutren, G., & De Geest, S.
- Affiliations
- University Hospital of Bern (CH)
- Kantonsspital Aarau (CH)
- Stadtspital Waid (CH)
- University Hospital of Basel (CH)
- Proteus Digital Health (US)
- Novartis (Switzerland) (CH)
- Corresponding author
- Eisenberger, Ute
- Venue
- Transplantation
- Published
- 2013-08-15
- Volume
- 96
- Issue
- 3
- Pages
- 245-250
- ISSN
- 0041-1337 (ISSN-L)
- PMC
- PMC3749815
- OpenAlex
- W2080635711
- Cited by
- 85
- References
- 6
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 6 · 2023: 5 · 2022: 11 · 2021: 6 · 2020: 12 · 2019: 5 · 2018: 5 · 2017: 10 · 2016: 6 · 2015: 9 · 2014: 5
- FWCI
- 5.66
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- Transplantation (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- Lirias (submittedVersion, other-oa)
- edoc (University of Basel) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Topics
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Medicine › Transplantation › Renal Transplantation Outcomes and Treatments
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- medication adherence, kidney transplantation, mycophenolate sodium, enteric-coated tablets, adverse events
- MeSH terms
- Adult, Aged, Female, Humans, Immunosuppressive Agents, Male, Middle Aged, Mycophenolic Acid, Tablets, Enteric-Coated, Kidney Transplantation, Medication Adherence
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