DIABASE: an automatically filled single-centre registry of diabetes mellitus in the Netherlands, combining clinical data with real-world longitudinal wearable device data-a study protocol

Introduction Advancements in technology for treating diabetes mellitus (DM) are progressing rapidly. With the growing availability and use of continuous glucose monitoring (CGM) systems and continuous subcutaneous insulin infusion (CSII), glucose regulation is improved in individuals with DM, which will lead to less long-term complications and reduce the overall disease burden on patients with DM. Collecting vast amount of biomedical data, these devices combined with clinical outcome data provide more insight into the development and treatment of the disease. The objective of the DIABASE initiative is to collect and examine real-world data from medical devices and clinical practice in a registry. Methods and analysis The ongoing study is structured as an observational study registry. Clinical data and real-world data from diabetes wearable devices, such as CGM and CSII, are aggregated in the database. Clinical data is automatically extracted from the hospital’s electronic health record. Data from wearables is periodically collected manually from the various online data platforms for sharing and automatically added to the database. Ethics and dissemination This study is exempted from ethics approval by the Medical Research Ethics Committees United (MEC-U) since participants are not subject to procedures and are not required to follow rules of behaviour (approval ID: AW23.009/W20.197). The execution of this study has been approved by the board of the study site Hospital Group Twente (ZGT) (ZGT20-40). Results will be shared through scientific meetings and publications and through articles for the general public.