Smartphone and Internet-Based Remote Glucose Monitoring for Gestational Diabetes management: Protocol for a Randomised Controlled Trial (The M♡THer Study) — ASN Events
  1. Schedule
  2. Lunch & Poster Session
  3. Smartphone and Internet-Based Remote Glucose Monitoring for Gestational Diabetes management: Protocol for a Randomised Controlled Trial (The M♡THer Study)

Smartphone and Internet-Based Remote Glucose Monitoring for Gestational Diabetes management: Protocol for a Randomised Controlled Trial (The M♡THer Study) (#109)

Rinky Giri 1 2 3 , I-Lynn Lee 1 2 , Kathleen Gray 3 , Dev Kevat 1 2
  1. Department of Endocrinology and Diabetes, Western Health, St Albans, Victoria, Australia
  2. Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
  3. Centre of Digital Transformation of Health, Faculty of Medicine, Dentistry and Health Sciences , Melbourne, VIC, Australia

Background

Gestational diabetes mellitus (GDM) prevalence continues to increase globally, placing growing demand on maternity and diabetes services. Traditional models of care rely on frequent in-person review of self-monitored blood glucose readings, which can be burdensome for women and resource-intensive for health services. Digital health solutions offer the potential to support timely treatment adjustments while improving accessibility and efficiency of care delivery. However, despite increasing interest in mobile health (mHealth) interventions, robust evidence evaluating clinically meaningful glycaemic outcomes within real-world care settings remains limited.

Methods

The M♡THer Study is a pragmatic, unblinded, single-centre, parallel-group non-inferiority randomised controlled trial conducted at Joan Kirner Women's and Children's Hospital, Melbourne, Victoria. Women aged ≥18 years with confirmed GDM at ≥14 weeks' gestation are eligible. Participants are randomised 1:1 to either remote glucose monitoring via the M♡THer digital platform (Bluetooth-enabled Roche Accu-Chek® glucometer integrated with a smartphone application and clinician web dashboard) or standard clinic-based care. The intervention arm receives twice-weekly remote review by an endocrinologist or diabetes nurse practitioner, with telephone follow-up triggered by predefined out-of-range thresholds. A total of 220 participants are required to achieve 80% power with a non-inferiority margin of 5%. The primary outcome is the proportion of blood glucose readings within target range across the duration of gestation. Secondary outcomes include glycaemic variability, maternal and neonatal clinical outcomes, healthcare utilisation, and patient and clinician satisfaction. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12625000547448).

Discussion

This trial will generate high-quality evidence on the clinical effectiveness, safety, and health service impact of a digitally enabled model of care for GDM management in the Australian public health context. If non-inferiority is demonstrated, the M♡THer platform has potential to reduce frequency of clinic attendance and improve scalability of GDM management, including in rural and remote settings.