A networked system for self-management of drug therapy and wellness

ABSTRACT

Background: A networked wellness system is under development to document actual ingestions of oral medications, to differentiate types/doses of drugs taken simultaneously, and to provide these data along with other metrics to patients and providers for individually tailored care. Methods: After ingestion, an edible sensor (embedded in drug) is activated by stomach fluid and communicates to a wearable monitor that identifies the sensor as unique and records ingestion time/date. The monitor also collects physiologic data and communicates via mobile phone to a secure server that integrates the data with other wireless devices (e.g. blood pressure, weight). Summary reports are generated periodically for patient and physician review. Results: No adverse effects were observed in animals using repeated, exaggerated doses of sensors. Two drug-sensor form factors have been tested in 3392 human ingestions with no major and very few minor adverse effects. Sensitivity was 97.0% and specificity was 97.7% when compared to directly observed ingestion. The system identified and differentiated up to 4 simultaneously ingested sensors with an identification accuracy of 100%. Data integration with multiple devices and report generation have been piloted successfully. Conclusions: Pre-clinical and early clinical system safety appear satisfactory; data integration and communication appear to be feasible. By providing context-rich information and fostering communication, this system may enhance patient-provider relationship and care coordination.

References

1. Thinking outside the pillbox: a system-wide approach to improving patient medication adherence in chronic disease. New England Healthcare Institute. 2009.
2. Bova, C. A., et al. Use of electronic monitoring devices to measure antiretroviral adherence: practical considerations. Graduate School of Nursing and Division of Infectious Diseases, University of Massachusetts, Worcester, MA 01655, USA. AIDS Behav. 2005; 9(1):103--10.
3. Wendel, C. S., et al. Barriers to use of electronic adherence monitoring in an HIV clinic. Health Services Research Center, Southern Arizona Veterans Affairs Health Care System, Tucson, AZ 85723-0001, USA. Ann Pharmacother. 2001 Sep; 35(9):1010--5.
4. Olivieri, N. F., Matsui D., Hermann C., and Koren G. Compliance assessed by the Medication Event Monitoring System. Arch Dis Child. 66(12):1399--402, 1991 Dec.
5. Denhaerynck, K., et al. Examining assumptions regarding valid electronic monitoring of medication therapy: development of a validation framework and its application on a European sample of kidney transplant patients. BMC Medical Research Methodology 2008, 8:5.
6. Mackay, R. 1970 Bio-Medical Telemetry. IEEE Press.
7. Johannessen, E. et al. An ingestible electronic pill for real time analytical measurements of the gastrointestinal tract. In Proceedings of the Micro-Total Analysis Systems, Vol 1 (Nara, Japan, November 2002).
8. Cutchis, P. et al. The ingestible thermal monitoring system. Johns Hopkins APL Technical Digest, Vol 9, Jan-Mar 1988, 16--21 (ISSN 0270--5214).
9. Epstein, M. Ingestible Event Marker System -- A novel, physiologically-sized device platform for frequent, repeated use. In Proceedings of the Digestive Disease Week (Chicago, IL, USA, May 31, 2009).
10. Au-Yeung, K., et al. A novel system for electronically confirming adherence to tuberculosis therapy. In Proceeding of the World Healthcare Congress (National Harbor, MD, USA, April 12, 2010).
11. Belknap, R., et al. Feasibility of a microchip-based system for electronically observed tuberculosis therapy. In Proceedings of the American Thoracic Society International Conference (New Orleans, LA, USA, May 14, 2010)

Index Terms

• Hardware

  • Communication hardware, interfaces and storage