Title: Delivering a realistic Diabetes Prevention Programme in a UK community
Funder: Department of Health and Social Care

Abstract: Aims & Objectives. The main aim of this 5 year programme is to test the hypothesis that our novel Type 2 diabetes (T2DM) prevention programme reduces the risk of T2DM in a high risk Norfolk population. We will use established strategies with limited impact on general practices, in a programme in part delivered by lay trainers with T2DM, and which could be used by NHS commissioners as an ‘off the shelf’ diabetes prevention programme. The programme has been piloted in our NIHR feasibility programme grant (0606-1099) which has provided substantial data on participant recruitment and retention, recruitment of lay trainers, practice engagement, staff training, IT and database creation, study materials, and has Research Ethics and Governance approval. Background. The importance of T2DM is well recognised. Landmark clinical trials have shown diet and lifestyle interventions reduce the risk of developing T2DM by > 50% over 3 years in people with impaired glucose tolerance. Translation of the resources used in these large clinical trials to NHS clinical practice is entirely unaffordable, a point recognised by the researchers. We need a realistic diabetes prevention intervention for a financially constrained NHS, which has limited financial impact on general practices. Cultural changes in the NHS put patients at the centre of health choices and we propose to develop the role of people with T2DM as lay lifestyle trainers (Diabetes Prevention Mentors; DPMs) and will develop and test this new role alongside healthcare professionals known as Diabetes Prevention Facilitators (DPFs). Research Plans: •Project 1: Carry out a high volume (n = 10,000) two year screening programme in participants at higher risk of T2DM, based on age and body mass index (BMI) criteria to identify subjects with impaired fasting glucose (IFG), using piloted recruitment strategies and existing NHS services. •Project 2: A 3 year Randomised Controlled Trial (RCT) of our piloted diabetes intervention programme (UEA–IFG) in 390 participants with screen detected IFG (isolated IFG or with IFG + Impaired Glucose Tolerance) with transition to T2DM as the primary end point compared to 170 standard care controls. •Project 3: Evaluate the additional impact of using DPM in the UEA–IFG intervention in a 3 year RCT in a further 390 IFG subjects, with transition to T2DM as the primary end point, compared to the UEA–IFG intervention alone (n=390), and the potential for the DPM to deliver the intervention independently. •Project 4: Evaluate the UEA–IFG intervention (with or without DPM support), in a three - arm RCT in 240 screen detected T2DM patients with the primary end point of glycaemic control compared to standard care over 3 years. •Project 5: Evaluate cost effectiveness of all programme elements with modelling of longer term health costs. •Project 6: Disseminate the programme’s findings to UK national commissioning bodies and policy makers, and develop a marketing strategy with industry. •Project 7: Examine the integration of the new roles of DPMs and DPFs in NHS and international workforce planning. Research team. The research team is an established group of NHS and academic staff that includes clinical epidemiologists experienced in health service research and diabetes modelling (Harvey/Bachmann/Niessen), NHS diabetes specialists with academic interests in obesity and diabetes (Turner/Dhatariya/Wallace/Sampson), expertise in academic and clinical primary care and qualitative methods (Howe/Hadley–Brown), lay diabetes champion (Rea), clinical chemistry and HbA1c standardisation (John), clinical and health psychology of chronic disease (Hobbis/Smith), economic evaluation (Barton), RCT statistical management (Clark), and service delivery at board level (Sethia). Research environment. A large NHS Clinical Research and Trials unit, satellite locations throughout Norfolk, and substantial research network support. Public involvement. Public involvement is at the core of this proposal. All materials have been developed with patient research groups, and overall study management will be guided by a Participant Advisory Board (PAB). Operational management will be jointly led by research staff and participants, and the intervention itself will be delivered by lay volunteers with T2DM. Ethical issues. Significant ethical issues include the permissive effect of a normal screening result in higher risk groups, the use of controls, the use of people with T2DM as part of the intervention, confidentiality in group work, transition to full programme. Anticipated outcomes. The main outcome of this programme will be a practical diabetes prevention programme with NHS validity, available to health care planners by 2015, delivered by in part by people with T2DM. Justification for resources. The resources requested are the same as in the feasibility programme, and are largely salary costs for the now fully trained UEA–IFG team.

Lay abstract: This section was written with the patient and public involvement in research group (PPIRES) In this 5 year programme, which leads on from our current NIHR 2 year programme, we aim to reduce the risk of Type 2 (adult onset) diabetes mellitus (T2DM), through improved diet and exercise. T2DM is a major and growing health problem in the UK, affecting over 2.4 million people, and which results in lower quality of life. Studies show that intense efforts to improve diet and exercise levels halves the risk of developing T2DM. However, the staffing required for this is not possible in the NHS, and peer education could have greater effects on health behaviour than professional advice. We aim to develop a novel programme which could be run within the NHS. We will investigate the following 7 projects: 1: Before people develop T2DM their blood glucose levels are higher than normal. A blood test, taken after a period not eating, can identify this, known as Impaired Fasting Glucose (IFG). We aim to identify people with IFG and find the best method of detecting people without adding too great a workload on practices. 2: We have developed a structured diet and lifestyle programme (called UEA-IFG) for people at risk of T2DM. New staff ‘Diabetes Prevention Facilitators’ (DPFs), will run the programme. We will measure how successful the programme is by changes in blood glucose levels and development of T2DM. 3: A unique part of the programme will involve training members of the public with T2DM to become volunteers to motivate IFG participants and share their experiences. These volunteers, known as Diabetes Prevention Mentors (DPMs), will have NHS honorary contracts and be fully trained. 4: The screening study will also identify by chance, people with T2DM. For these participants we will measure the impact of the programme on their blood sugar control and quality of life. We will record the views of all participants on the value of this programme. 5: We will assess the costs (to NHS and participants) of the programme, and how taking part may improve health outcomes compared to usual care, in the short and long term. We will review how costs compare to additional health benefits and if the programme offers value for money. 6: We will see if the programme could be adopted throughout the NHS and consult key NHS staff on their views of the programme. 7: We will measure satisfaction of DPFs and DPMs and consider how well these new roles fit within the NHS workforce.

Research activity codes: 4.4 POPULATION SCREENING;3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: METABOLIC AND ENDOCRINE