Hypo-RESOLVE database on track

Data upload completed for 71 out of >100 trials

One key objective of Hypo-RESOLVE is the creation of a secure, sustainable database with data from more than 100 clinical trials. Analysing these data will offer tremendous statistical power to establish the glucose threshold(s) below which hypoglycaemia constitutes a risk for clinical outcomes as well as determine risk factors for hypoglycaemia. For the creation of this large database, data from the trials need to be de-identified to ensure patient anonimity, followed by reformatting and harmonisation to a standard (i.e., CDISC) format. After this, the data will be available for extensive statistical analysis, for which a statistical analysis plan is constructed and tested. Secure data transfer procedures have been set up to transfer the data to the Hypo-RESOLVE database on a secured server behind a firewall. Priority has been given to clinical trials that already are in the correct format as well as to those with the largest number of participants or the longest follow-up period and to trials conducted most recently. Thus far, anonymisation of trials and subsequent standardisation and harmonisation of clinical trial and CGM data have been completed for demographics, vital signs and glucose and other laboratory measurements for 71 (out of >100) trials, comprising over 45,000 individuals. Transfer of data on adverse events, medication and patient-reported outcomes (PROs) from these trials is ongoing. The transfer of trials to the database will be completed in the course of next year.