Developing and trialling the DAFNEplus (Dose for Adjustment for Normal Eating) intervention. A lifelong approach to promote effective self-management in adults with type 1 diabetes.

Aims and Objectives To answer the following question: In adults with T1D, will modifying the existing DAFNE curriculum and developing structured professional input, using learning from our recent research, behaviour change theory and new forms of technological support, produce: (a) improved and sustained diabetes self-management behaviour (b) better glucose control than currently achieved without compromising quality of life Background Successful treatment of type 1 diabetes (T1D) requires those affected to keep their glucose levels sufficiently close to normal to avoid long-term complications. Current insulin delivery has major limitations, meaning that at every meal, those with the condition have to calculate their insulin dose based on estimating food intake and blood glucose measurements. If they fail to administer the correct insulin dose, their blood glucose either runs high, increasing risks of complications in the long-term or else falls too low leading to hypoglycaemia and acute confusion or coma. Thus, people with T1D must acquire complex self-management skills and apply them effectively every day of their lives. It is now accepted that successful treatment requires diabetes professionals, to ensure that patients implement and sustain effective self-management. The DAFNE intervention was designed to teach insulin dependent adults, with T1D, the skills needed to achieve flexible lifestyles and optimal glucose control. Our recent research confirmed original trial findings showing it is highly valued by patients, improved glucose control short-term, reduces diabetes emergencies and diabetes-related psychological distress. However, a key primary outcome, substantially improved long-term glucose levels was not achieved and patients remain at risk of diabetic complications. Feedback from service users and learning from the programme suggest additional behavioural changes are necessary to maintain optimal self-management and achieve better glucose control. They highlighted the need to integrate within the curriculum both support for behaviour change and structured professional support, utilising new technologies to support self-care. We have built a conceptual model underpinning an enhanced intervention, incorporating theories on which DAFNE is based and incorporated a range of developing technologies within the revised intervention with the potential to support health behaviours in T1D self management. Research Plan The research plan is divided into two broad periods. Period 1) Development and piloting Over years 1-3 we will develop the components of the revised intervention (called DAFNEplus). The outputs from Period 1 will include 1) revision of the curriculum and piloting of the delivery of a revised initial one week DAFNE course, 2) development and piloting of a model of structured professional follow up, 3) technological tools to support DAFNE graduates 4) a revised training course for DAFNE educators teaching the skills of behaviour change. These activities will follow MRC guidance on developing complex interventions. The workstreams will be supported by DAFNE graduates, educators, physicians and expert groups of behavioural and social scientists and technologists. We will work collaboratively to ensure the various components of DAFNEplus are optimised and fit together. Three DAFNE centres will run pilots combining findings from educator and participant interviews, focus groups and feedback sessions to fine-tune the components of the intervention. Period 2) Cluster RCT During the second half of the project (24-65 months) we will deliver a definitive pragmatic cluster RCT of "DAFNEplus" (5 day curriculum and support module) vs standard DAFNE in 14 DAFNE centres across the UK. The trial will be powered to detect clinically relevant improvements in blood glucose control in those individuals who enter the trial with an HbA1c >7.5%, 12 months after the end of either course. We will also meas