Title: Safe management of people with Type 1 diabetes and EAting Disorder StudY (STEADY)
Funder: Department of Health and Social Care

Abstract: Safe management of people with Type 1 diabetes and EAting Disorder studY (STEADY)BackgroundType 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 investigationStage I: Development of STEADYWorkstream 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.

Lay abstract: Type 1 diabetes (T1DM) is a condition in which the immune system destroys the cells that produce the hormone insulin. Insulin is needed in order to use the sugar (glucose, from the food we eat) in the bloodstream for storing and supplying energy to cells, and building muscle. Living with T1DM requires a demanding daily routine to manage a person's blood glucose levels (4-10 daily fingerprick glucose checks, careful carbohydrate counting in food, and self-injecting insulin to match food intake and physical activity levels). These tasks are required to prevent sudden, severe health problems caused by too much or too little insulin, and long-term health problems to the kidneys, eyes, feet, heart and brain. T1DM is usually diagnosed in childhood or young adulthood (but may occur at any age). About 400 000 adults in the UK have T1DM. Some people with T1DM also have an eating disorder (ED). EDs are described as abnormal attitudes towards food and an excessive focus on body weight and shape, leading to a change in eating behaviours, with damaging health consequences (e.g. bulimia, characterized by uncontrolled eating followed by vomiting; or anorexia in which people eat so little that they become dangerously underweight). People with T1DM have double the risk of having an ED than people without T1DM. Studies have found that 8-36% of people with T1DM have some form of ED. A dangerous feature of ED, only possible in patients with T1DM, involves deliberately missing insulin doses with the intention of losing weight. This can rapidly lead to a life-threatening condition called diabetic ketoacidosis in which the body breaks down other tissues as an energy source; and this can also lead to long-term health problems associated with frequently high blood glucose levels. People with T1DM and ED are threefold more likely to die from these problems than people with T1DM without ED. There are currently no interventions for changing dangerous eating and insulin behaviours in people with T1DM. Patients, health care professionals and the National Institute for Health and Care Excellence have all identified the need for a new approach to treating ED in T1DM using expertise from different areas to treat all aspects of the patients' conditions.This project will develop and test a well-rounded intervention for people with T1DM and ED aiming to keep patients safe and improving their chance of recovery. We aim to reduce the unhealthy eating and insulin injecting behaviours and the distress associated with T1DM and ED. People with T1DM (with and without ED), doctors, nurses, psychologists and dieticians will be working together in workshops and focus groups (where intervention topics are discussed and tape recordings will be analysed for common themes that can improve care) to design the intervention together. This will include new approaches to lower the patients' barriers to safely managing diabetes on their own (self-management) e.g. reducing fear of insulin and weight gain; and difficulties in coming to terms with the diabetes diagnosis. We will adapt a previously successful therapy that combines providing knowledge about diabetes self-management with psychotherapy (cognitive-behaviour therapy) to the specific needs of people with T1DM and ED.King's College London and the academic health science centre King's Health Partners support us in developing the intervention. They have a long tradition of combining research and education with service delivery across two teaching hospitals and a mental health trust in South London, and have been driving innovative research for people with T1DM and mental health problems for a long time. There is extensive clinical experience in the treatment of T1DM with ED on site, with large T1DM specialist care centres and an internationally-renowned eating disorder unit.The new intervention will be called STEADY (Safe management of people with Type 1 diabetes and EAting Disorder studY), because we will provide a slow and steady approach to treating ED in T1DM. STEADY will initially be tested in a small group of people with T1DM and ED (group 1) and compared to other patients receiving their usual care (group 2). STEADY group 1 patients will receive 12 one-on-one sessions with diabetes specialist nurses trained in Cognitive Behaviour Therapy over 6 months. Participants in both study groups will have access to routine T1DM and psychiatric care. The aim is to develop and refine STEADY with the help of evaluations and patient feedback. If STEADY is successful, we will aim to test it in a larger study and eventually offer it across the National Health Service in the future.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: METABOLIC AND ENDOCRINE;MENTAL HEALTH