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)

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 – 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 – 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.