Managing blood glucose levels is essential to reduce perinatal complications in gestational diabetes mellitus (GDM). Insulin therapy often necessitates frequent hospital visits for dose adjustment, which can be inconvenient for pregnant patients. Telemedicine offers a potential approach to minimize these visits, with prior studies indicating its safety in GDM care. This study aims to investigate the effectiveness of telemedicine in GDM management, focusing on patient satisfaction and economic outcomes. This randomized, open-label, parallel-group trial will be conducted at a single center, Keio University School of Medicine, Japan. Pregnant patients diagnosed with GDM via oral glucose tolerance test (OGTT) before 30 weeks of gestation, requiring self-monitoring of blood glucose and insulin therapy, are eligible. Participants will be randomly assigned to either the telemedicine intervention group using the MeDaCa system (Medical Data Card, Inc., Tokyo, Japan) or a control group receiving routine in-person visits every 2–3 weeks. Primary outcomes include patient satisfaction and health economic measures, assessed through a cost-consequence framework. Secondary outcomes encompass glycemic control and perinatal results. Participant enrollment is ongoing and will continue until the target sample size is achieved, aiming to provide evidence for the clinical and economic benefits of telemedicine in GDM care.
