Title: New remission care pathway: Diabetes Adaptive Weight management Network "NewDAWN"
Funder: Department of Health and Social Care

Abstract: Research question Can a new care pathway, offering support for a sequence of NHS weight-loss programmes lead to a higher proportion of people with overweight and newly diagnosed type 2 diabetes (T2D) achieving remission compared with a total diet replacement programme? Background Weight loss can help people who are overweight and recently diagnosed with T2D to achieve remission. Total diet replacement (TDR) programmes are being offered by the NHS but are only suitable for a small proportion of patients. The challenge is to offer a care pathway which supports the varied needs of individual patients so they can each lose as much weight as possible, maximising the population achieving remission. Aims and Objectives The aim is to develop and test whether offering a structured programme with the opportunity to self-experiment with several weight loss programmes: increases the likelihood of people with newly diagnosed T2D who are overweight achieving remission compared with the current best NHS treatment is cost effective for the NHS can be implemented in routine care Methods We will develop the new pathway by reviewing interventions available within the NHS and conducting qualitative research involving people with lived experience of T2D and weight loss attempts, followed by a discrete choice experiment to understand the factors affecting patient preferences. Working with stakeholders and patients, we will use the findings to co-create a new care pathway which allows patients for whom TDR is unsuccessful or unwanted to follow a programme of guided self-experimentation until they find a programme that works for them. We will test the new pathway, against TDR alone (current best care), in a feasibility trial (n=150), assessing feasibility of implementation of the self-experimentation pathway, effectiveness of training for practitioners and the acceptability to patients. We will progressively optimise the intervention. If the trial meets pre-specified criteria, we will proceed to a full trial (n=1788) to test whether the new pathway can increase the rate of remission of T2D compared with referral to a TDR programme. We will measure the effect of the intervention on cardiovascular risk and quality of life and assess the cost-effectiveness of the intervention compared to TDR through modelling. Building on theory-based process evaluation and coproduction with stakeholders, we will prepare materials and identify practices to support implementation. Timelines for delivery We will develop the new care pathway in the first year, conduct feasibility testing and improve the intervention (13-24m), set up and conduct the main trial and process evaluation (24-40m), complete follow-up by 52m, analyse the outcomes, estimate the cost-effectiveness, disseminate the results and, if successful, work with NHSE to embed the pathway in their diabetes programme by end of year 5. Anticipated Impact and Dissemination Our patient advisory group wanted to know about a range of ways to achieve remission and this programme seeks to meet this need. If successful, we will work closely with our patient advisory groups, Diabetes UK, NHSE and other stakeholders to disseminate and implement this new pathway so more people with T2D achieve remission.

Lay abstract: For people with type 2 diabetes (T2D) who are overweight, diabetes can be put into remission (meaning normal blood glucose levels without needing medication) with an intensive weight loss programme, total diet replacement (TDR) that uses special food products to replace meals. NHS England is piloting this approach. Not every patient is willing to try this programme, and while some may succeed, others will find it unsuitable. Currently no other treatment aiming for remission is offered. Patients told us &ldquo;remission is an enticing prospect&rdquo;. They recognised the value of weight loss and wanted support from their healthcare practitioners &ldquo;to find the right diet for me&rdquo;. But outcomes from different weight-loss strategies are highly variable, there are no reliable predictors and patient choice does not increase success. Together with patients and stakeholders, we aim to create a new care pathway for people with T2D that uses guided self-experimentation to find a diet which is suitable and effective. The development phase will identify how to keep people involved, using language that supports a positive sense of engagement. We envisage the final intervention will include: Referral from local practitioners to a diabetes remission hub offering support to lose weight Support for &ldquo;guided self-experimentation&quot;, including up to four different NHS weight-loss programmes, to identify a treatment which is effective. The research programme will have five elements: We will develop the intervention together with people with T2D and stakeholders, including mapping available and effective NHS interventions, interviews about patient preferences, and an experiment to test factors influencing acceptability. A study to test and optimise the training for practitioners and the support for patients to follow this new care pathway. Only if we meet pre-set success criteria will we continue with next steps, while seeking to understand factors influencing success. A clinical trial to test whether the new intervention increases the proportion of people achieving remission after 1 year, compared to TDR (currently the only proven dietary treatment to achieve remission). An economic evaluation to see whether the increased cost of the new pathway is justified by reduced risk of diabetic complications. Preparations for national roll-out, should the intervention be successful, including further engagement with patients and stakeholders. Dissemination: Findings from the programme will be shared with patients and people who provide services, as well as other researchers throughout the programme. Outputs will include a better understanding of patient preferences for weight-loss treatment, experience in delivering a personalised care pathway, outcomes from this new remission-focused care pathway, and an estimate of the programme cost in relation to the health benefits. We will develop materials to support implementation into routine care systems, so this can be offered to everyone newly diagnosed with T2D who is overweight.

Research activity codes: 6.7 PHYSICAL;5.7 PHYSICAL
Health categories: METABOLIC AND ENDOCRINE