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?

在英国，2型糖尿病(T2D)影响着410万人，许多人需要药物来帮助控制血糖，而那些患有晚期T2D的人需要每天注射胰岛素。胰岛素治疗与较差的生活质量和疾病进展导致的并发症风险增加有关。从长远来看，T2D与一系列破坏性并发症有关，包括失明、肾功能衰竭、下肢截肢和中风。最近的研究表明，这在很大程度上是可以通过减肥来预防的。90%的T2D超重/肥胖患者的体重减轻。COVID加剧了由T2D驱动的先前存在的健康不平等，需要新的治疗方法。直接临床试验显示，使用低热量饮食(约.每天800千卡)帮助人们减少甚至停止他们的糖尿病药物治疗12周，近一半的人能够使他们的T2D进入缓解(定义为正常血糖水平并停止所有糖尿病药物)。伦敦大学学院(UCL)的一项新研究对服用胰岛素的人使用了同样的低卡路里饮食，发现39%的参与者可以完全停止胰岛素，总胰岛素剂量减少75%。尽管有这一发现，但如今接受胰岛素治疗的人无法在NHS获得低卡路里饮食，NHS专员表示，他们需要更多证据，证明此类计划能够以他们负担得起的价格安全提供。伦敦大学学院和直接研究面临的挑战是，他们使用昂贵的面对面支持，这对人们来说也很难获得，需要休假或护理承诺，而且往往需要高昂的旅行成本。难于出席的预约可以使人们不太可能坚持节食并获得良好的结果。Oviva针对成年T2D患者的100%远程数字糖尿病缓解低卡路里饮食计划已经显示出比面对面模式更好地获得NHS患者的机会、结果和成本效益，但这还不支持胰岛素治疗患者。该项目旨在为接受胰岛素治疗的T2D成年人开发和测试一种新的低卡路里饮食计划(称为Oviva糖尿病缓解-Insulin)。Oviva将与伦敦大学学院合作设计这项计划，然后在与NHS赫尔大学教学医院的一项研究中对其进行评估。该计划包括：*整个过程中的专业营养师支持。*Oviva应用程序，参与者可以跟踪他们的食物、体重和健康，并访问12个月的体重预测图表，以保持他们的跟踪。*最新的血糖和体重监测技术，以确保参与者在脱离胰岛素后得到安全的支持。

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.