A practice nurse with two hours of training over six months could help people with type 2 diabetes put their condition into remission using real food, not meal replacement shakes. This matters because while total diet replacement programmes (shakes and soups) can induce diabetes remission, they are expensive and do not appeal to everyone. The DIAMOND programme tests a cheaper, food-based alternative: a low-energy (800–1000 kcal/day), low-carbohydrate diet supported by nurses in GP practices. A feasibility trial showed participants lost 9.5 kg and reduced HbA1c by 16 mmol/mol in three months, with substantial blood pressure drops. If successful, the programme could become a second treatment option within NHS England’s existing 5000-patient low-energy diet rollout. It would be much cheaper than current formula-based programmes and could help make remission the first-line treatment for newly diagnosed type 2 diabetes. The researchers will also model long-term cost-effectiveness and healthcare savings, and work with Oxford Innovations to support NHS adoption. The trial recruits 508 participants from 56 socially diverse practices across the UK, with follow-up through the National Diabetes Audit.
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Research question Does a practice-nurse delivered behavioural support programme designed to motivate and enable people with type 2 diabetes (T2D) and overweight to follow a low energy low carbohydrate diet lead to greater remission from diabetes than usual care? Background Substantial weight loss achieved through a total diet replacement programme can induce remission of type 2 diabetes, but such programmes may not appeal to all. Our feasibility trial showed that a food-based programme with similar energy content (800-1000kcal/day), based on a low carbohydrate diet passed all feasibility criteria. Participants with type 2 diabetes lost 9.5kg and reduced HbA1c by 16mmol/mol at three months, with substantial reductions in blood pressure. Aims and objectives The aim is to assess whether a low energy low carbohydrate diet and behavioural support from practice nurses is more likely to lead to remission compared with usual care in people with T2D diagnosed in the last six years. The objectives are to assess the impact on: • Diabetes remission • glycaemic control • cardiovascular risk • weight • quality of life (QoL) • diet quality • cost-effectiveness over the lifetime and return on investment in the short-term. at one year with follow-up thereafter of diabetes status, weight, glycaemic control and cardiovascular risk through the National Diabetes Audit/NHS Digital. We will also assess equity of programme uptake and the impact on these outcome measures of population characteristics including socioeconomic status and ethnicity. Methods 56 practices will be recruited nationally to be socially representative of the UK (including traditionally underserved regions and populations and in particular ensuring diversity of ethnicity in invited populations) and randomised to give the DIAMOND programme or usual care. Nurses offering the DIAMOND programme will provide two hours of support over seven appointments over six months plus comprehensive resources, co-developed by people with diabetes. 508 participants will be enrolled, half receiving the intervention, half usual care. We will estimate cost-effectiveness from a healthcare perspective over several time horizons using an existing diabetes microsimulation model. Timelines for delivery The study will recruit participants over 14 months for a baseline follow-up assessment of weight and HbA1c at 6 months and all outcome measures at 12 months. The project takes 39 months, allowing time for study set-up, analsysis, and dissemination. Anticipated impact and dissemination NHS England is commissioning several low energy diets in a 5000-patient pilot rollout. This programme could offer an alternative option for people who do not want to use formula products and would be much cheaper than current treatment programmes offered and if successful, could be incorporated into the national rollout of low energy diets to induce diabetes remission. The general approach of aiming to achieve remission in nearly all people with newly diagnosed type 2 diabetes is intended to become the first and best treatment option for people with newly diagnosed diabetes and this programme aims to be one of the treatment options. The modelling will estimate the long-term impact on health and healthcare expenditure and thus the cost-effectiveness of the intervention. We will work with Oxford Innovations to support long-term adoption by the NHS.
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