The impact of video-based educational tools on pregnancy outcomes in pre-existing diabetes mellitus (the ETOS-DM study): study protocol for a national randomised controlled trial

Despite advancements in diabetes management with diabetes technologies, a large proportion of pregnant individuals with type 1 and type 2 (pre-existing) diabetes do not achieve the recommended glycaemic targets, resulting in a high risk of adverse pregnancy outcomes including fetal overgrowth. Novel approaches for diabetes management are urgently needed, and animated videos are increasingly recognised as effective tools for delivering health information across health literacy levels. This study aims to evaluate the impact of adding animated educational videos, available via a smartphone application (app), to usual care, compared to usual care alone, on fetal growth in pregnant individuals with pre-existing diabetes. This national, multicentre, parallel group, open-label randomised controlled trial (RCT) is nested within the Danish Diabetes Birth Registry 2 (DDBR2) study, which includes pregnant individuals with pre-existing diabetes and their offspring. Individuals who consent to participate in the DDBR2 study and fulfil in- and exclusion criteria are enrolled before 14 weeks of gestation, randomised 1:1 and followed until 1 month after delivery. For this study, 15 animated educational videos (1–5 min) were developed using a three-stage framework involving iterative stakeholder input from experts, the target group, and an animation/film director. The videos contain evidence-based information on diabetes self-management in pregnancy. In addition to usual care, the intervention group receives unlimited access to these videos through the “Pregnant with Diabetes” smartphone app, whereas the control group receives usual care alone. Randomisation stratifies for diabetes centre, diabetes type, and the use of multiple daily injections or insulin pumps in individuals with type 1 diabetes. The primary outcome is offspring birth weight standard deviation score. Data analysis will follow the intention-to-treat principle. This study is expected to provide valuable evidence for improving diabetes management during pregnancy for individuals with pre-existing diabetes. The strengths of this large RCT are the involvement of experts and the target group in the development of the intervention and the comprehensive evaluation of fetal outcomes. However, a lack of a systematic mechanism to encourage the use of the intervention may impact its effectiveness. ClinicalTrials.gov NCT06250192. Registered on February 1, 2024