SAFE-LCD: Can the combination of continuous glucose monitoring and a digital low calorie diet programme make Type 2 diabetes remission achievable and safe in people on insulin therapy?

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Type 2 diabetes (T2D) affects 4.1 million people in the UK, with many requiring medication to help control their blood sugars, and those with advanced T2D requiring daily insulin injections. Insulin treatment is linked to poorer quality of life and increased risk of complications due to disease progression.Longer-term, T2D is associated with a range of devastating complications including blindness, kidney failure, lower limb amputation and stroke. Recent research shows this is largely preventable with weight loss for the 90% of people with T2D who are overweight/obese.COVID has exacerbated pre-existing health inequalities driven by T2D, and new treatments are needed.The DiRECT clinical trial showed substantial weight loss (of 10-15kg) using a low-calorie diet (approx. 800kcal/day) for 12-weeks helps people reduce or even stop their diabetes medications, with nearly half able to put their T2D into remission (defined as normal blood sugar levels and stopped all diabetes medications).New research from University College London (UCL) used the same low-calorie diet for people on insulin and found that 39% of participants could stop insulin completely and overall insulin doses reduced by 75%. Despite this finding, people treated with insulin don't have access to low-calorie diets in the NHS today, with NHS commissioners stating they need more evidence such programmes can be delivered safely at a price they can afford.The challenge with the UCL and DiRECT studies was they used expensive in-person support, which is also hard for people to access, requiring time off work or care commitments and often high travel costs. Hard-to-attend appointments can make people less likely to stay on the diet and achieve a good outcome.Oviva's 100% remote, digital Diabetes Remission low-calorie diet programme for adults with T2D has shown superior access, outcomes and cost-effectiveness for NHS patients than in-person models, but this does not yet support insulin-treated patients.This project aims to develop and test a new low-calorie diet programme for adults with T2D who are insulin-treated (called Oviva Diabetes Remission-Insulin). Oviva will work with UCL to design the programme and then evaluate it in a research study with NHS Hull University Teaching Hospitals.The programme includes:* Specialist dietitian support throughout.* The Oviva app for participants to track their food, weight and health, and access a 12-month weight prediction chart to keep them on track.* The latest sugar and weight monitoring technology to ensure participants are safely supported as they come off their insulin.