Mobile-based insulin dose adjustment for type 2 diabetes in community and rural populations: study protocol for a pilot randomized controlled trial.

A two-arm pilot randomized controlled trial (RCT) will be conducted for 3 months with 44 participants, randomized at a 1:1 ratio to receive either the mHealth-based model of care (intervention) or routine care (control), in diabetes specialist community outreach and telehealth clinics. The intervention arm will exchange information related to blood glucose levels via the Mobile Diabetes Management System developed for outpatients with T2DM. They will receive advice on insulin titration from the CDE via the mobile-app and receive automated text-message prompts for better self-management based on their blood glucose levels and frequency of blood glucose testing. The routine care arm will be followed up via telephone calls by the CDE as per usual practice. The primary outcome is change in glycated haemoglobin, a marker of glycaemic management, at 3 months. Patient and healthcare provider satisfaction, and time required to perform IDA by healthcare providers in both arms will be collected. This pilot study will guide the conduct of a large-scale pragmatic RCT in regional Australia.