Smartphone and internet-based glucose management system for gestational diabetes: study protocol for a randomised controlled trial (M♡THer study)

Gestational diabetes (GDM) is defined as carbohydrate intolerance resulting in hyperglycaemia of variable severity with onset or first recognition during pregnancy. GDM is associated with increased risks for both mother and fetus and imposes a substantial burden on pregnant women and healthcare services. Standard care involves frequent ambulatory in-clinic reviews. Smartphone and internet-based glucose management systems offer an alternate model of care through remote monitoring. However, substantial evidence is lacking in evaluating mobile health (mHealth) interventions in GDM. This trial is a pragmatic, unblinded, single-centre, parallel-group, non-inferiority randomised controlled trial with 1:1 allocation, which aims to compare remote blood glucose monitoring using the M♡THer digital platform with conventional clinic-based monitoring in pregnant women with GDM. The intervention enables real-time transmission of capillary blood glucose readings via a validated Bluetooth-enabled glucometer and smartphone application. The primary outcome is the proportion of blood glucose readings within target range during pregnancy. Secondary outcomes include additional glycaemic measures, maternal and neonatal clinical outcomes, healthcare utilisation, and patient satisfaction. Enabling women to monitor their blood glucose levels at home and transmit these data to healthcare providers in near real time represents a potentially effective strategy for the remote management of GDM. This trial will provide high-quality evidence regarding the clinical effectiveness, safety and health service impact of a digitally enabled model of care for women with GDM. The findings may inform future models of diabetes care including implementation in rural and remote settings. Australian New Zealand Clinical Trials Registry, ACTRN12625000547448. Registered prospectively in May 2025.