Patient-Centered Home Care Using Digital Medicine And Telemetric Data For Hypertension: Feasibility And Acceptability Of An Innovative Paradigm For Objective Ambulatory Assessment

Objective: Feasibility of an integrated approach for ambulatory assessment using digital medicine, and automated data collection and bi-directional communication, was piloted in stable patients treated for hypertension. Design and method: 37 subjects (23 males; age 62 ± 9 years) participated for 6 weeks. Digital medicine consisted of valsartan 80 mg or 160 mg placed in a gelatin hemi-capsule having an excipient tablet as a “stopper”. On the external stopper surface, a poppy-seed size ingestible sensor (IS) made of foodstuff created a biogalvanic current upon ingestion to alert an adhesive wearable sensor (WS) worn on the torso. The WS stored ingestion dates and times, and measured and stored daily step count. Data were automatically relayed and integrated automatically with telemetered twice-daily BP and once daily weight (WT) into a display. Automatic reminders were sent via SMS whenever BP or WT was not telemetered within a 24-hour period. During clinic visits, dosing was directly observed and compared to the accuracy of concurrent automated detection of ingestion (PDA). None of this pilot data was used for diagnosis or treatment. Results: PDA of dosing in clinic was 98%. Mean taking and scheduling adherence between clinic visits was 90% and 83% with some tapering at weeks 5 and 6. Automatic SMS was sent and 100% confirmed for 267 missed BPs or WTs (6%). Subjects appeared to be more compliant with taking WT than BP. Activity averaged 2.0 ± 1.5 hours/day with step count > = 60 steps/minute for 88% of subject-days. The mean morning BP was 132/78 and the mean evening BP was 127/73 during system use. Mild and transient WS-related skin irritation occurred; there were no IS-related adverse events. Ninety percent of patients did not mind swallowing the IS, and 75% had a positive overall experience using it. Conclusions: Automated ambulatory assessment appears feasible and acceptable, and objective information can be obtained to aid in determining whether lifestyle modification, medication use, and/or treatment escalation should be the BP management focus. Versions of better tolerated WSs are now available, and development of medicinals having an IS within each tablet is underway.