Rationale and methods for the Exercise for Type 1 Diabetes Education program: a pilot randomized controlled trial of an education program to support adults with type 1 diabetes mellitus (T1DM) to undertake exercise

OBJECTIVE: Regular exercise in people with type 1 diabetes mellitus (T1DM) can result in considerable improvements in health and reduction in cardiovascular events and death. However, a large proportion of people with T1DM are not active. Fear of hypoglycemia and lack of knowledge on how to manage their diabetes are major barriers to exercise in people with T1DM, but few patients receive specific advice about how to adjust insulin and carbohydrate for activity. Furthermore, healthcare professionals (HCP) currently lack the knowledge to advise patients on how to manage their diabetes when active and would like formal training in exercise prescription for people with T1DM. RESEARCH DESIGN AND METHODS: This study is divided into two stages. The first stage develops an education program aimed to support people with T1DM to exercise using the Medical Research Council framework. The second stage is a pilot randomized controlled trial (RCT) that aims to collect the key variables to design a definitive trial to test the efficacy and cost-effectiveness of the education package. We aim to recruit 96 patients with T1DM at two UK hospitals. CONCLUSIONS: This article outlines the protocol for a pilot RCT to develop a program of education that will support adults with T1DM to undertake safe and effective exercise. This is accompanied by training for HCPs to deliver this educational intervention. Successful completion of this program of work will address some of the barriers to exercise in adults with T1DM, and should facilitate an increase in exercise for this group of people. TRIAL REGISTRATION NUMBER: ISRCTN61403534.