Introduction. Cystic Fibrosis (CF) is a disease without a primary cure that requires lifelong care and is characterized by pulmonary exacerbations (PEx). Wearable devices could provide a way for long-term monitoring of disease progression and early signs of PEx to intervene as early as possible, thereby improving long-term outcomes.
Methods. In-hospital feasibility study (n = 26) to 1) assess the ability of Byteflies Sensor Dot to collect relevant cardiorespiratory data in people with CF and its compatibility with clinical workflows, 2) identify candidate digital biomarkers, and 3) collect user feedback from patients and healthcare providers.
Results. Collected sample-level biopotential, bioimpedance and actigraphy data were of high quality. Sensor Dot heart rate (HR) correlated with hospital HR, whereas respiratory rate (RR) did not. HR and RR were associated with CF severity, and HR and coughing with PEx. Willingness to use the device was very high with CF patients and study coordinators considered the device easy-to-use.
Conclusion. Determining if a wearable is fit-for-purpose is a long and multidisciplinary process that requires involvement from all stakeholders as early as possible in the development process. Our pilot identified interesting correlations between cardiorespiratory parameters as measured by the wearable, and CF severity and PEx. Together with the usability data, this will inform the next steps in the clinical development process.
Palivizumab and Long-term Outcomes in Cystic Fibrosis