George Savage

An ingestible sensor for measuring medication adherence.

In this paper, we describe the design and performance of the first integrated-circuit microsensor developed for daily ingestion by patients. The ingestible sensor is a device that allows patients, families, and physicians to measure medication ingestion and adherence patterns in real time, relate pharmaceutical compliance to important physiologic metrics, and take appropriate action in response to a patients adherence pattern and specific health metrics. The design and theory of operation of the device are presented, along with key in-vitro and in-vivo performance results. The chemical, toxicological, mechanical, and electrical safety tests performed to establish the devices safety profile are described in detail. Finally, aggregate results from multiple clinical trials involving 412 patients and 5656 days of system usage are presented to demonstrate the devices reliability and performance as part of an overall digital health feedback system.

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

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.

A Digital Health Solution for Using and Managing Medications: Wirelessly Observed Therapy

Several approaches are currently used to assess medication taking. The most reliable method is directly observed therapy (DOT), which consists of a clinician observing and documenting the date and time of the patients swallowing each dose of medication. In some cases, this is done by video recording of the patient taking the medication. Other indirect methods for monitoring adherence include patient questioning, patient pill diaries, pill counts, daily weighing of pill containers, and prescription refill rates. Electronically documenting the date and time when the cover of a pill container has been opened is another option. Each of these methods, however, is limited in scope and provides only an estimated measure of actual drug intake, as none of them reliably record whether the patient has actually ingested the medication.

Patient-Centered Home Care Using Digital Medicine and Telemetric Data for Hypertension: Feasibility and Acceptability of Objective Ambulatory Assessment.

Objective information that can be passively obtained in an ambulatory setting could be potentially useful for determining appropriate care in blood pressure (BP) management. This study utilized digital medicine (DM) prototypes and telemetric data acquisition to directly confirm medication use and to assess habits of daily living in a hypertensive population. Thirty‐seven patients (23 men age 62±9 years) used the system for 6 weeks. DM prototypes consisted of valsartan 80 mg or 160 mg placed in a gelatin hemicapsule with an excipient tablet as a “stopper,” with a poppy seed–sized ingestible sensor (IS) made of foodstuff on its external surface and capable of creating a biogalvanic current on ingestion to alert a wearable sensor (WS) that was worn on the torso. Passive data collection included IS ingestion dates and times, daily step count, BP, and weight. Automatic short message service (SMS) reminders were sent whenever BP or weight values were not received. Passive detection of DM ingestion was 98% when compared with directly observed dosing. Mean taking and timing adherence rates were 90% and 83%, respectively, and the average step count at a pace of ≥60 steps per minute was 2.0±1.5 h/d. An automatic SMS was sent and 100% confirmed for 251 BP and 14 weight values that were not received. Mild and transient WS‐related skin irritation was the most common device‐related adverse event. There were no serious or unanticipated adverse events. Ninety percent of patients did not mind swallowing a DM capsule, and 75% had a positive overall experience with the system. Ambulatory evaluation of medication adherence and habits of daily living appear to be feasible and acceptable using DM and passive acquisition of telemetric data.