CLINICAL TRIAL PROTOCOL
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
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Rethinking Models of Outpatient Specialist Care in Type 2 Diabetes Using eHealth: Study Protocol for a Pilot Randomised Controlled Trial.

Conventional outpatient services are unlikely to meet burgeoning demand for diabetes services given increasing prevalence of diabetes, and resultant impact on the healthcare workforce and healthcare costs. Disruptive technologies (such as smartphone and wireless sensors) create an opportunity to redesign outpatient services. In collaboration, the Department of Diabetes and Endocrinology at Brisbane Princess Alexandra Hospital, the University of Queensland Centre for Health Services Research and the Australian e-Health Research Centre developed a mobile diabetes management system (MDMS) to support the management of complex outpatient type 2 diabetes mellitus (T2DM) adults. The system comprises of a mobile App, an automated text-messaging feedback and a clinician portal. Blood glucose levels (BGL) data are automatically transferred by Bluetooth-enabled glucose meter to the clinician portal via the mobile App. The primary aim of the study described here is to examine improvement in glycaemic control of a new model of care employing MDMS for patients with complex T2DM attending a tertiary level outpatient service. A two-group, 12-month, pilot pragmatic randomised control trial will recruit 44 T2DM patients. The control group will receive routine care. The intervention group will be supported by the MDMS enabling the participants to potentially better self-manage their diabetes, and the endocrinologists to remotely monitor BGL and to interact with patients through a variety of eHealth modalities. Intervention participants will be encouraged to complete relevant pathology tests, and report on current diabetes management through an online questionnaire. Using this information, the endocrinologist may choose to reschedule the appointment or substitute it with a telephone or video-consultation. This pilot study will guide the conduct of a large-scale study regarding the capacity for a new model of care. This model utilises multimodal eHealth strategies via the MDMS to primarily improve glycaemic control with secondary aims to improve patient experience, reduce reliance on physical clinics, and decrease service delivery cost.

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