Title: 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.
Funder: Department of Health and Social Care

Abstract: 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 &ldquo;DAFNEplus&rdquo; (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 measure psychological outcomes including proximal outcomes that most strongly predict HbA1c (including patient-reported process measures), cost effectiveness and conduct a qualitative sub-study. Finally we will measure HbA1c and hypoglycaemia rates at the 2 year annual review. Projected outputs & dissemination plans Outputs will include: conventional presentations and publications plus meetings to discuss findings with patients. A detailed description of the intervention and resources to enable DAFNE centres and beyond to implement DAFNEplus if results are positive. Diabetes UK will help disseminate the results to the diabetes community. We will also communicate our findings to the National Clinical Director of Diabetes and NICE. Benefits to patients and the NHS. Over the first 3 years, we will develop a new course incorporating new approaches to behaviour change, construct and deliver a structured model of support, incorporate technologies to support and motivate adults with T1D in managing their diabetes and develop a training package for professionals which can be extended to the 65+ DAFNE centres and beyond. By the end of 5.5 years we will have compared the revised curriculum, support package and technology (DAFNEplus) against the current DAFNE intervention. We aim to provide the complex intervention as a sustained model of support rather than a brief initial stand-alone course. This approach could be applied to other age-groups, people with type 2 diabetes and in other long-term conditions.

Lay abstract: DAFNE stands for Dose Adjustment For Normal Eating. It is a 5-day training course for adults with type 1 diabetes, delivered in small groups. DAFNE has been delivered to over 30,000 adults in the UK. The aim of DAFNEplus is to develop and convert DAFNE into a lifelong package to help people better manage their blood glucose levels lifelong, as high levels can cause dangerous complications. Our recent research confirmed that after attending a DAFNE course, people have better quality of life, better glucose levels (in the short-term) and are admitted to hospital less often for diabetes emergencies. Although participants find DAFNE training useful, some find it tough to keep up the skills needed to maintain glucose levels to prevent diabetic complications. Specific challenges include checking glucose before every meal, counting the amount of carbohydrate about to be eaten, and then calculating the right amount of insulin to inject. After the course, people also find it hard to get support from health professionals. They have asked us to improve the course to help others develop and keep their skills over the long term. DAFNE graduates, diabetes teams and psychologists will work together to develop a more effective course. People from a range of backgrounds, including those of non-white ethnicity and from deprived areas, will inform both the development of the course and support packages. The training will be developed to include skills of managing diabetes as part of peoples everyday lives. We will also improve the support that health professionals provide after the course, helped by new technology. We will then run a trial to evaluate the new approach at 14 UK centres. Over 1 year, we will compare the results of around 300 people trying the new DAFNEplus course with 300 people on the standard course. We will measure their glucose levels and quality of life. We will also determine the effectiveness of formal professional support and improved training for educators. Throughout our research, we will work with a patient advisory group which includes DAFNE graduates and members of the Sheffield Teaching Hospital Diabetes and Endocrinology Patient Panel, some of whom struggle to manage their Type 1 Diabetes. We will use the results to inform training on effective self-care delivered by the UK DAFNE collaborative each year to 1500 adults with type 1 diabetes. Diabetes UK will help us communicate research findings to all diabetes centres across the country. This work will also help us develop better training for other groups (especially children and young people). The results may also be relevant to other long-term conditions, where people need to learn and apply complicated skills to manage their own condition as part of their everyday lives.

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