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?

SAFE-LCD：连续血糖监测和数字化低热量饮食计划相结合能否使接受胰岛素治疗的患者安全且安全地缓解 2 型糖尿病？

• 批准号: 10036336
• 金额: $ 60.73万
• 依托单位: OVIVA UK LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10036336
• 关键词: SAFE; LCD; combination; continuous; glucose

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.

2型糖尿病（T2 D）影响着英国410万人，其中许多人需要药物来帮助控制血糖，而那些患有晚期T2 D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引起的并发症风险增加有关。长期来看，T2 D与一系列毁灭性并发症有关，包括失明、肾衰竭、下肢截肢和中风。最近的研究表明，对于90%的超重/肥胖的T2 D患者，通过减肥，这在很大程度上是可以预防的。COVID加剧了由T2 D驱动的先前存在的健康不平等，需要新的治疗方法。800千卡/天），帮助人们减少甚至停止糖尿病药物治疗，几乎一半的T2 D患者能够缓解病情（定义为血糖水平正常并停止所有糖尿病药物治疗）。来自伦敦大学学院（UCL）的新研究使用相同的低热量饮食给胰岛素治疗的人，发现39%的参与者可以完全停用胰岛素，胰岛素总剂量减少75%。尽管有这一发现，接受胰岛素治疗的人在今天的NHS中无法获得低热量饮食，NHS专员表示，他们需要更多证据证明这些计划可以以他们负担得起的价格安全地提供。UCL和DireCT研究的挑战是，他们使用了昂贵的亲自支持，这对人们来说也很难获得，需要休假或护理承诺，并且通常需要高昂的旅行费用。难以参加的预约可能会使人们不太可能坚持节食并取得良好的结果。Oviva为T2 D成人提供的100%远程数字糖尿病缓解低热量饮食计划显示，与面对面模式相比，NHS患者具有上级访问，结果和成本效益，但这还不支持胰岛素治疗的患者。该项目旨在为接受胰岛素治疗的T2 D成人开发和测试一种新的低热量饮食计划（称为Oviva糖尿病缓解胰岛素）。Oviva将与伦敦大学学院合作设计该计划，然后与NHS船体大学教学医院进行研究评估。该计划包括：* 全程专业营养师支持。* Oviva应用程序可让参与者跟踪他们的食物、体重和健康状况，并访问12个月的体重预测图表，让他们保持正常。最新的血糖和体重监测技术，确保参与者在停用胰岛素时得到安全支持。