Overall design
NCT03588104, diabetes
DIABETES
This RCT (NCT03588104, ClinicalTrials.gov) aimed to test the effectiveness and safety of an integrated e-health system (POWER2DM) to support individuals with diabetes and healthcare professionals in diabetes self-management and SDM compared with usual care during 37 weeks of follow-up. The study was performed using the same methods in both the Netherlands and Spain. The study was approved by the Medical Ethical Committee Leiden/Den Haag/Delft under the Medical Research Involving Human Subjects Act, and by the Research Ethics Committee of Reina Sofía University Hospital as part of the Sistema Sanitario Público de Andalucía Research Ethics Committee Network, and complies with the Declaration of Helsinki.