Real-Time Monitoring Of The Digital Patient In Clinical Trials

We deployed commercially available devices and sensors to a number of healthy volunteers located in non-clinical settings in multiple countries. We used FDA-cleared and consumer devices to generate physiological data similar to that used routinely in clinical trials: heart rate, activity/sleep, oximetry, weight and blood glucose. The data were integrated into an informatics hub via a digital health platform for central analysis alongside user attributes. We used a unique security token to maintain a deidentified flow of data.

This poster reports a framework for the real-time monitoring of subjects using wearable and patient-centric devices from multiple vendors. Wearable technology is a key component in the design of more patient-centric clinical trials.