My Diabetes & Me: study protocol for a randomised controlled trial to test the clinical and cost-effectiveness of a diabetes self-management education programme for adults with intellectual disabilities.

Background: International guidelines recommend structured diabetes education to empower individuals with type 2 diabetes (T2D). While DESMOND is an effective programme for T2D management, it is often inaccessible to people with intellectual disabilities (ID) due to their unique needs. There is limited evidence on the effectiveness of adapted T2D education for this group, despite the importance of tailored support in preventing complications and early mortality.We previously adapted the DESMOND programme for adults with ID, creating DESMOND-ID. A feasibility study showed it is possible to recruit and deliver the programme to adults with ID and their carers, who found it valuable. Initial findings suggest DESMOND-ID may improve blood glucose control, warranting further investigation through a large-scale randomised controlled trial (RCT). Methods: The "My Diabetes & Me" study will be conducted in two stages: an internal pilot and a main RCT. The pilot will recruit 108 participants over 10 months to assess recruitment and retention, using glycated haemoglobin (HbA1c, mmol/mol) at six months as the primary outcome. This will inform the design of the main study.Across both stages, 450 participants will be randomly assigned to receive either the DESMOND-ID intervention or treatment as usual (TAU). The intervention group, with their carers, will attend weekly sessions for seven weeks, plus two booster sessions at one and three months post-programme.Primary outcome is HbA1c at six months. Secondary outcomes include HbA1c at 12 and 18 months (pilot only), anthropometric data, self-reported outcomes, and other risk factors. A process evaluation will explore barriers and facilitators to implementation using qualitative and quantitative methods. Conclusion: DESMOND-ID is the first structured T2D education programme tailored for adults with ID, and this RCT is the first to evaluate its clinical and cost-effectiveness. Trial Registration: 09/11/2022ISRCTN83150600 ( https://doi.org/10.1186/ISRCTN83150600).