OBJECTIVES: A personalized clinical data collection system for people living with diabetes using advanced hybrid closed loop (AHCL) systems was developed to support health care providers’ (HCPs) to collect real-world data.

METHODS: The data collection system efficiently collects clinical, device, and patient reported outcomes data. Clinical data is collected in ad-hoc electronic case report forms (e-CRFs), accessible via a web-based system. The system is designed to allow the collection of device, medical history, laboratory, pharmacological therapies, and clinical events data. Device data comes directly from the diabetes management software and patient reported outcomes data from a dedicated patient app in which four validated questionnaires are included: Clark, Gold, DTSQ and the VAS scale.

RESULTS: All collected data are analyzed periodically and updated on the data collection system in the form of reports. The data collection system also gives the possibility to carry out ad hoc analyses. Topics like glycemia variation during Ramadan, time in range in pregnancy and the use of technology in ageing patients can be evaluated. With consent from the clinics, data from reports can also be shared and aggregated across clinics to foster research and collaboration. By combining data from multiple sources, analyses will have the statistical power to draw timely and valuable scientific insights, which convert data into real-world evidence.

CONCLUSIONS: The clinical data collection system represents an innovative solution and service to easily collect users’ real-world data to support HCPs in identifying trends and insights for patient management while aggregating data from different sources to obtain a holistic patient overview and to foster scientific collaboration.