Title: Supporting adult patients with Type 1 Diabetes (T1DM) to undertake exercise; Developing and piloting an education programme on exercise and Type 1 diabetes.
Funder: Department of Health and Social Care

Abstract: Background Physical activity is an important part of the management plan in patients with T1DM. Regular exercise improves physical fitness and strength, reduces cardiovascular risk factors, mortality and improves well-being in patients with T1DM. Based on this evidence Diabetes UK and the American Diabetes Association recommends people with T1DM should undertake at least 150 min per week of moderate to vigorous aerobic exercise. In spite of these benefits retrospective and prospective studies show that less than 40% of patients with T1DM participate in regular exercise. Common reasons cited are fear of hypoglycaemia and lack of knowledge as to what nutritional and insulin dose changes are required. Studies from our group show that whilst 96% of 652 adults with T1DM felt that being informed about nutritional adjustments for safe exercise was important, only one in five people felt they had received this information. We also found that healthcare professionals feel ill-equipped to educate T1DM patients around exercise. Aims We will develop and pilot an education programme for patients and health care professionals to guide insulin and carbohydrate adjustment for safe and effective exercise. Methods We will follow the revised MRC guidelines for developing a multi-component or complex intervention. Following a literature review, we will develop an outline curriculum. Exercise and diabetes experts, people with T1DM, and experts in developing structured education programmes will inform the content of this curriculum. Accompanying supporting resources will be developed including web-based tools. This will then be tested in a small group of people with T1DM (n=8-10). Using action research methodology, this initial programme will be refined according to structured observation and patient feedback. We will repeat this process three times to ensure we have the best programme. It is anticipated that the contact time for such a programme will be 3-5 hours but this will be informed by the development work. The development phase of the participant programme will also inform both the training required by educators to deliver the intervention effectively and the process to ensure intervention fidelity during the pilot. This will involve production of a training manual, training resources and quality assessment tools. The second phase of the study is a randomised control pilot study in which 80 patients with T1DM will be randomised to receive the education programme or normal care. This will provide data on how many patients with T1DM are eligible and willing to take part in a study of this programme, the likely rates of adherence to the intervention, participant drop-out, the most effective outcome measures and the optimum way of measuring these and how best to recruit, randomise, treat and follow-up patients in a RCT of this programme. This information will enable us to design a definitive RCT to assess the effect of this education programme in people with T1DM. Potential benefits to the patients and the NHS Development of this programme will enable people with type 1 diabetes to acquire the skills, knowledge and confidence to exercise safely at all levels of physical activity, and with a reduced risk or fear of high/ low blood glucose levels. Over time, this could lead to more people with T1DM increasing physical activity levels and improving physical and mental health. Patients involved in the pilot study will see these benefits during the lifetime of their participation. If a following larger RCT work is successful, the programme could be formally commissioned and implemented nationally within a 7-10 year period to benefit all with T1DM.

Lay abstract: Exercising regularly has huge benefits for people with type 1 diabetes mellitus (T1DM) but less than 40% undertake regular exercise. People with T1DM say they do not exercise because they are scared of their blood sugars going low, and because they aren t sure what changes to food and insulin-dose should be made when exercising to prevent this. We have shown that although almost all (96%) T1DM adults felt that education about nutritional adjustments for safe exercise was important, only one in five felt they had received this information. We also found that healthcare professionals (HCPs) feel ill-equipped to educate T1DM patients around exercise. We will develop and test the UK s first education programme for T1DM patients and HCPs to guide insulin and carbohydrate adjustment for safe and effective exercise. We will follow a recognised process (described by the Medical Research Council) to develop our intervention. Focus groups will be run with people with T1DM and with HCPs to gain views on the intervention. This information will then be used to develop the new programme. HCPs and people with T1DM in Bristol and Birmingham will be identified to test our new programme in groups of 8-10 people. This will help improve our intervention further. We will repeat this process three times to ensure we have the best programme. Next, 80 people with T1DM will be recruited and randomly put into 2 groups. One group will receive routine treatment for their diabetes, and the other will attend our education programme. At 6 months after completion of the course we will look at how well they are managing their diabetes around exercise. Findings from this study will help us design a larger study to test whether this programme would work throughout the UK.

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