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（T1D）继续施加相当大的公共卫生伯恩。 2016年美国青年中的平均HBA1C为8.8％，高于标准临床目标<7.5％，自2011年以来大大恶化。血糖控制不足是超过发病率的主要原因，但迄今为止研究果断的干预措施具有混合或有限的影响。与当前的建议相关，最近二十年的重点是T1D青年饮食摄入的柔性模式，显然与足够的血糖控制，期望增加胰岛素泵的使用和连续的葡萄糖监测（CGM）在那个时间段内。这就是了解哪些干预措施可能会改善血糖控制的主要差距，以及饮食摄入模式的哪种方法可能是有益的。一些主要的T1D临床实践指南明确建议使用结构化饮食模式，包括国际小儿和青少年糖尿病学会（ISPAD），而美国糖尿病协会（ADA）营养指南则没有。值得注意的是，没有关于T1D青年在一天中改善血糖控制的结构化饮食模式有效性的临床试验数据。这就是我们的总体目标是严格测试个性化的结构化饮食模式的有效性，以全天改善血糖控制，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，这些研究支持我们称为“ Myplan”的个性化结构性饮食计划干预措施的可能可接受性和有效性，其中包括对个性化结构性饮食计划的协作开发，以在一天中传播碳水化合物和卡路里的摄入量。在这里，我们提出了一项飞行员单臂临床试验，以告知未来，全功率的务实试验，以在临床环境中添加个性化结构性饮食计划为正在进行的糖尿病护理中。我们的具体目的是：目标1。评估40名T1D青年对6个月的个性化结构性饮食干预措施（“ Myplan”）的可接受性和依从性。我们将招募12-17岁的青少年，T1D至少为1年，HBA1C> 8％> 8％和<11％（总计n = 50招募，以确保n = 40个跨两个临床部位的活跃参与者）参加了6个月的Myplan干预，这将指导参与者与5个手段相关的五个手段，以使五个手段构成五个型号的饮食。 AIM 2。比较基线时T1D的青少年和6个月Myplan干预结束时的血糖控制。基于连续的葡萄糖监测和HBA1C，血糖控制的度量将包括范围（TIR）的百分比。我们的团队已经共同努力了多年，并且在进行这项关键工作方面有好处，该工作将为T1D青少年提供医疗营养疗法。