Individualized Structured Eating Plans to Improve Glycemic Control in Adolescents with Type 1 Diabetes

1型糖尿病（T1D）继续造成相当大的公共卫生负担。2016年美国青年平均HbA1c为8.8%，远高于< 7.5%的标准临床目标，且自2011年以来显著恶化。血糖控制不足是导致高发的主要原因，但迄今为止研究的干预措施效果不一或有限。与目前的建议相关的是，尽管在过去二十年中胰岛素泵和连续血糖监测（CGM）的使用增加，但强调青年糖尿病患者饮食摄入的灵活模式显然与适当的血糖控制不一致。因此，对于哪些干预措施可以改善血糖控制，以及哪种饮食摄入模式可能有益，在知识上存在重大差距。一些主要的T1D临床实践指南明确建议使用结构化的饮食模式，包括国际儿科和青少年糖尿病协会（ISPAD），而美国糖尿病协会（ADA）的营养指南没有。值得注意的是，没有临床试验数据表明有组织的饮食模式对青少年T1D患者改善全天血糖控制的有效性。因此，我们的首要目标是严格测试个性化、结构化饮食模式在改善全天血糖控制方面的有效性，以便为T1D临床实践指南提供信息。我们已经完成了几项初步研究，支持个性化结构化饮食计划干预的可能接受性和有效性，我们称之为“我的计划”，其中包括合作开发个性化结构化饮食计划，以分散一天中碳水化合物和卡路里的摄入。在此，我们提出一项试点单臂临床试验，为未来在临床环境中增加个性化结构化饮食计划以进行糖尿病护理提供充分的实用试验。我们的具体目标是：评估40名青少年T1D患者对为期6个月的个性化结构化饮食干预（“我的计划”）的可接受性和依从性。我们将招募年龄在12-17岁、T1D病程至少1年、糖化血红蛋白(HbA1c)≥8%且<11%的青少年（共招募50人，以确保两个临床站点的40名积极参与者）参加为期6个月的MyPlan干预，该干预将指导参与者根据构成结构化饮食模式的5项原则设定行为目标。目标2。比较6个月MyPlan干预结束时和基线时青少年T1D患者的血糖控制情况。血糖控制措施将包括基于连续血糖监测和HbA1c的%范围内时间（TIR）。我们的团队已经合作多年，有能力开展这项重要的工作，为青少年T1D患者提供医疗营养治疗方法。

Type 1 diabetes mellitus (T1D) continues to impose a considerable public health burden. Average HbA1c among youth in the US in 2016 was 8.8%, considerably above the standard clinical target of < 7.5%, and had worsened significantly since 2011. Inadequate glycemic control is a major contributor to excess morbidity, yet interventions studied to date have mixed or limited effects. Relevant to the current proposal, the emphasis of the last two decades on flexible patterns of dietary intake for youth with T1D has clearly not corresponded with adequate glycemic control, despite increased use of insulin pumps and continuous glucose monitoring (CGM) in that time period. Thus, there are major gaps in knowledge about what interventions might achieve improved glycemic control, and what approach to patterns of dietary intake might be beneficial. Some major T1D clinical practice guidelines explicitly recommend use of structured eating patterns, including the International Society for Pediatric and Adolescent Diabetes (ISPAD), whereas the American Diabetes Association (ADA) nutrition guidelines do not. Remarkably, there are no clinical trial data on the effectiveness of structured eating patterns for youth with T1D to improve glycemic control throughout the day. Thus, our overarching goal is to rigorously test the effectiveness of individualized, structured eating patterns to improve glycemic control throughout the day, in order to inform T1D clinical practice guidelines. We have completed several preliminary studies that support the likely acceptability and effectiveness of an individualized structured eating plan intervention we called “MyPlan”, that includes collaborative development of the individualized structured eating plan to spread intake of carbohydrate and calories over the day. Here we propose a pilot single arm clinical trial to inform a future, fully powered pragmatic trial of the addition of individualized structured eating plans to ongoing diabetes care in clinical settings. Our Specific Aims are: Aim 1. Assess acceptability and adherence to a 6-month individualized structured eating intervention (“MyPlan”) among 40 youth with T1D. We will recruit adolescents, age 12-17 years, with T1D of at least 1-year duration and with HbA1c >8 % and <11% (total n=50 recruited to ensure n=40 active participants across two clinical sites) to participate in a 6-month MyPlan intervention, which will guide participants in setting behavioral goals in relation to five tenets that comprise a structured eating pattern. Aim 2. Compare glycemic control among adolescents with T1D at baseline and at the end of the 6-month MyPlan intervention. Measures of glycemic control will include % time in range (TIR) based on continuous glucose monitoring and HbA1c. Our team has worked together for many years and is well positioned to conduct this critical work that will inform how medical nutrition therapy is approached for youth with T1D.