Title: Type 2 Diabetes (T2D) in 16 – 40 year olds: A Multifactorial Management Intervention to Address Multimorbidity in Early-Onset T2D in Adults (The M3 Research Programme)
Funder: Department of Health and Social Care

Abstract: Background The prevalence of type 2 diabetes (T2D) in younger individuals is increasing. Adults with early-onset T2D (defined as 16-40 years) typically display an extreme risk phenotype, with higher rates of multimorbidity (including psychosocial conditions), and have poorer long-term outcomes compared to individuals diagnosed later in life. They must also balance the management of T2D alongside complex, busy lives at an age which often coincides with life-changing events. However, they remain under-represented in clinical research and existing services are not tailored to their specific needs. Aims and objectives The overall aim of the proposed programme is to develop and test the effectiveness and cost-effectiveness of an innovative multifactorial management intervention to address multimorbidity (M3) in early-onset T2D. Specific aims/objectives include: Aim 1: PPI/E Objective: Utilise existing partnerships with people with early-onset T2D, healthcare professionals (HCPs) and stakeholders to inform the M3 intervention design. Aim 2: Epidemiology/evidence synthesis Objective: Utilise epidemiological and systematic methods to investigate trends, incidence and prevalence of multimorbidity in early-onset T2D. Aim 3: Develop the M3 intervention Objective: Explore opinions of current care provision and preferences for design and content of the M3 intervention. Aim 4: Evaluate the effectiveness of the M3 intervention Objective: Undertake a multi-site randomised controlled trial (RCT) with a cost-effectiveness study to compare M3 to standard care. Aim 5: Dissemination of findings Objective: Engage with people with early-onset T2D, the public and other stakeholders to disseminate a best-practice guide for engagement. Methods To achieve the aims and objectives, this proposed programme consists of three work packages (WP). WP1 - Epidemiology and Evidence Synthesis - Epidemiological analyses will be conducted using real-world evidence in the UK, as well as a systematic review and meta-analysis of prominent outcomes trials in the management of T2D. These will explore the predictive potential of multimorbidity on long-term outcomes in early-onset T2D and examine the efficacy of existing established therapies. WP2 &ndash; M3 Intervention Development and Training - Qualitative analyses and PPI/E activities will explore preferences towards the content, format and delivery. This will see the iterative development of the M3 intervention and associated training package for HCPs. WP3 &ndash; Evaluation - A multi-site RCT will examine the effectiveness and cost-effectiveness of the M3 intervention. A process evaluation will assess the implementation and mechanisms of impact. Timelines for delivery Our three WPs will be conducted over five years. Substantial time will be focused on synthesising the available evidence (WP1: 0-18 months), developing/refining the intervention (WP2: 0-27 months), prior to evaluating its effectiveness (WP3: 9-60 months). PPI/E and Health economics will be embedded throughout the programme. Anticipated impact and dissemination The impact of this proposal is expected to be substantial and diverse. It will see novel engagement with adults with early-onset T2D to improve engagement with diabetes support, healthcare services and reduce the risk of long-term diabetes-related complications. This will be achieved through the development of a best-practice guide, disseminated through face-to-face and online workshops/training packages. Our programme will also produce academic outputs, including open-access peer-reviewed publications and conference presentations.

Lay abstract: What is the problem? Type 2 diabetes (T2D) is a condition where the body struggles to process blood glucose, causing a higher chance of problems like heart attacks and strokes. T2D is becoming more common and adults are getting it earlier (aged under 40). This early-onset T2D is worrying because health problems can develop faster and people can die younger. Early-onset T2D often occurs with other health conditions, including obesity, high blood pressure and mental health problems, like anxiety or depression. The good news is that early treatment and diabetes self-management can reduce the risk of health problems developing. Currently, early-onset T2D care is delivered in the same way as for older adults. However, attendance tends to be low, probably because younger adults have very different lives and needs. We need to better understand their specific needs and circumstances. What have we done so far? We have spoken to people with early-onset T2D, who tell us that their current care doesn t fully address their complex needs. Previous research shows that focusing on other things, like wellbeing and how diabetes impacts their lives may be better. What will we do? We will develop and test a new type of care, which will: Be tailored specifically for early-onset T2D Look at the whole person and their health, including their wellbeing, social care and lifestyle Put the person at the centre of decisions, targeting issues important to them Use technology and other new approaches to help make taking part easier This will benefit people with early-onset T2D and the NHS by: Making care more accessible/effective Increasing engagement in diabetes self-care Reducing development of long-term conditions Improving quality of life How will we do it? We will work closely with people with early-onset T2D, healthcare professionals (HCPs) and decision-makers to develop this new care programme together. We ll organise lots of different activities to involve people from different backgrounds and circumstances (e.g. different ages, ethnicities, occupations and family/childcare arrangements), as well as people with different jobs in the NHS. These activities will include new, exciting ideas like a fully-funded consensus conference , where people from different groups will come together and discuss the programme collectively. This will ensure our programme is person-centred, caters for a wide range of people, and remains practical within the NHS. We will also perform in-depth research studies to: Understand what it s like to live with early-onset T2D Assess the short- and long-term impact Test the new care programme to see if it works and is value for money. What will we do with the results? Our communications team will share our findings with patients, the public, HCPs and NHS decision-makers. Lay representatives recommended a visual version of this summary (see Section6:PPI/E).

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: METABOLIC AND ENDOCRINE