Safe management of people with Type 1 diabetes and EAting Disorder StudY (STEADY)

Safe management of people with Type 1 diabetes and EAting Disorder studY (STEADY) Background Type 1 diabetes (T1DM) affects approximately 400,000 people in the UK. It is a chronic autoimmune condition in which the pancreatic beta-cells produce little or no insulin, an essential hormone for glucose metabolism causing chronic hyperglycaemia. Poor glycaemic control leads to acute diabetic emergencies, micro- and macrovascular complications and premature mortality. To prevent these complications necessitates adopting multiple self-management skills and psychological adjustment to the life-long need for insulin, self-monitoring of glucose and carbohydrates and objective monitoring of weight and glycaemic control. Eating disorders (ED) are twice as common in people with T1DM (estimated prevalence of 8-36%) than in those without T1DM. A unique and dangerous feature of ED in T1DM is the deliberate omission of insulin with the intention to lose weight which is associated with a 3-fold increased mortality compared to T1DM without ED. Currently there is no effective treatment. Patient groups, health care professionals (HCPs) and policy makers have identified the needs for more research and service development for the treatment of ED in T1DM. Cognitive behaviour therapy (CBT) for people with T1DM delivered by diabetes specialist nurses (DSN) have been successful for supporting self-management in T1DM elsewhere and may be adaptable to ED in T1DM. I propose that CBT integrated into diabetes education delivered by DSNs is a potential intervention for improving diabetes and psychological outcomes for people with T1DM and ED. This needs proof-of-concept and testing for feasibility. A theoretical model has already been developed, a systematic review of diabulimia blogs conducted and input from patients included. Aims 1. To develop an intervention that integrates CBT with diabetes education for people with T1DM and ED to optimise glycaemic control and reduce psychological distress by supporting self management in a steady graded approach (STEADY). 2. To assess the feasibility of comparing STEADY with usual care in a future definitive randomised controlled trial (RCT). Plan of investigation Stage I: Development of STEADY Workstream 1: This will consist of qualitative methods to: 1a: understand the barriers and facilitators that patients with T1DM and ED experience in recovery; 1b: describe challenges and therapeutic strategies of HCPs; Workstream 2: Using Experience-Based Co-Design (EBCD) to 2a: develop CBT modules for T1DM with ED for safe graded insulin titration addressing fear of insulin and weight; 2b: adapt a CBT manual to include diabetes education for people with T1DM and ED; Stage II The co-designed intervention, STEADY will be tested against usual care in a feasibility RCT of n=70 patients with T1DM and ED. STEADY will be delivered in 12 sessions over 6 months by DSNs trained in CBT supervised by a CBT-therapist and a diabetologist. Biomedical and psychiatric measures will be collected at baseline and at 6 (main outcome) and 12 months follow up. The outcome assessor will be blind to allocation. We will: a) calculate response rates during screening; b) measure the time for data collection and analysis; c) calculate a standard deviation for HbA1C to inform a sample size calculation for a definitive trial; d) assess acceptance of the intervention by patients and DSNs; e) assess fidelity and competency of intervention delivery; f) provide proof-of-concept that STEADY improves diabetes control (HbA1c and severe hypoglycaemia and diabetes ketoacidosis event rates) compared to usual care. g) conduct a process evaluation of the context, implementation stragtegies and mechanisms. The findings will inform the contents of a future RCT testing of the hypothesis that STEADY is more likely to improve glycaemic control over 6 months compared to usual care in people with T1DM and ED.