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

个体化结构化饮食计划可改善 1 型糖尿病青少年的血糖控制

• 批准号: 10322740
• 负责人: Sarah Collins Couch
• 金额: $ 15.19万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10322740
• 关键词: Address; Adherence; Adolescent; Age; American; Australia; Behavior Therapy; Behavioral; Calories; Carbohydrates; Caring; Child; Childhood; Childhood diabetes; Clinic; Clinical; Clinical Practice Guideline; Clinical Trials; Consensus; Counseling; Data; Development; Diabetes Mellitus; Dietary Practices; Dietary intake; Disease; Eating; Effectiveness; Elements; Endocrinology; Ensure; Feasibility Studies; Frequencies; Future; Glycosylated hemoglobin A; Goals; Guidelines; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Intake; International; Intervention; Intervention Studies; Knowledge; Life Style; Measurable; Measures; Medical Nutrition Therapy; Medical center; Morbidity - disease rate; North Carolina; Outcome; Parents; Participant; Patients; Pattern; Pediatric Hospitals; Persons; Positioning Attribute; Public Health; Randomized Clinical Trials; Risk; Role; Societies; Structure; Subgroup; Testing; Time; Universities; Work; Youth; adolescent patient; arm; base; clinical practice; clinical research site; design; diabetes management; diabetes self-management; dietary; effectiveness testing; feeding; flexibility; glucose monitor; glycemic control; improved; improved outcome; interest; nutrition; pragmatic trial; preference; primary outcome; programs; psychologic; recruit; willingness

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.

1型糖尿病（T1 D）继续造成相当大的公共卫生负担。2016年，美国年轻人的平均HbA 1c为8.8%，远高于<7.5%的标准临床目标，自2011年以来显著恶化。血糖控制不充分是导致发病率过高的主要因素，但迄今为止研究的干预措施具有混合或有限的效果。与当前提案相关的是，过去20年来，尽管胰岛素泵和动态血糖监测（CGM）的使用增加，但强调T1 D青年灵活的饮食摄入模式显然与充分的血糖控制不一致。因此，关于什么样的干预措施可以改善血糖控制，以及什么样的饮食摄入模式可能是有益的，在知识上存在重大差距。一些主要的T1 D临床实践指南明确建议使用结构化饮食模式，包括国际儿科和青少年糖尿病学会（ISPAD），而美国糖尿病协会（ADA）营养指南没有。值得注意的是，没有关于结构化饮食模式对T1 D青少年改善全天血糖控制的有效性的临床试验数据。因此，我们的首要目标是严格测试个性化，结构化饮食模式的有效性，以改善全天的血糖控制，以告知T1 D临床实践指南。我们已经完成了几项初步研究，这些研究支持我们称为“MyPlan”的个性化结构化饮食计划干预的可能可接受性和有效性，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量。在这里，我们提出了一个试点单臂临床试验，以告知未来，充分有力的务实试验，增加个性化的结构化饮食计划，以持续的糖尿病护理在临床环境中。我们的具体目标是：目标1。评估40名T1 D青少年对6个月个性化结构化饮食干预（“MyPlan”）的可接受性和依从性。我们将招募12-17岁的青少年，T1 D持续时间至少1年，HbA 1c> 8%且<11%（共招募n=50名，以确保两个临床研究中心的n=40名活跃参与者）参与为期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五个原则设定行为目标。目标2.比较基线和6个月MyPlan干预结束时T1 D青少年的血糖控制。血糖控制指标将包括基于持续血糖监测和HbA 1c的范围内时间（TIR）%。我们的团队已经合作多年，并且已经准备好进行这项关键工作，这将为T1 D青少年的医学营养治疗提供信息。