Mobile-based insulin dose adjustment for type 2 diabetes in communityand rural populations: study protocol for a pilot randomized controlledtrial

摘要

Background: Insulin initiation and/or titration for type 2 diabetes (T2DM) is often delayed as it is a resource-intensive process, often requiring frequent exchange of information between a patient and their diabetes healthcare professional, such as a credentialed diabetes educator (CDE) for insulin dose adjustment (IDA). Existing models of IDA are unlikely to meet the increasing service demand unless efficiencies are increased. Mobile health (mHealth), a subset of Ehealth, has been shown to improve glycaemic control through enhanced self-management and feedback leading to improved patient satisfaction and could simultaneously reduce costs. Considering the potential benefits of mHealth, we have developed an innovative mHealth-based care model to support patients and clinicians in diabetes specialist community outreach and telehealth clinics, that is, REthinking Model of Outpatient Diabetes care utilizing EheaLth – Insulin Dose Adjustment (REMODEL-IDA). This model primarily aims to improve the glycaemic management of patients with T2DM on insulin, with the secondary aims of improving healthcare service delivery efficiency and the patients’ experience. Methods/Design: A two-arm pilot randomized controlled trial (RCT) will be conducted for 3 months with 44 participants, randomized at a 1:1 ratioto receive either the mHealth-based model of care (intervention) or routine care(control), in diabetes specialist community outreach and telehealth clinics. Theintervention arm will exchange information related to blood glucose levelsvia the Mobile Diabetes Management System developed foroutpatients with T2DM. They will receive advice on insulin titration from theCDE via the mobile-app and receive automated text-messageprompts for better self-management based on their blood glucose levels andfrequency of blood glucose testing. The routine care arm will be followed upvia telephone calls by the CDE as per usual practice. Theprimary outcome is change in glycated haemoglobin, a marker of glycaemicmanagement, at 3 months. Patient and healthcare provider satisfaction, and timerequired 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 inregional Australia.