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

基本信息

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
项目类别：
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

项目摘要

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) 给公共健康带来了相当大的负担。 2016 年，美国青少年的平均 HbA1c 为 8.8%，显着高于 < 7.5% 的标准临床目标，并且自 2011 年以来显着恶化。血糖控制不足是导致发病率过高的一个主要原因，但迄今为止研究的干预措施的效果好坏参半或有限，与当前的提案相关，过去二十年强调灵活。尽管在该时期胰岛素泵和连续血糖监测 (CGM) 的使用有所增加，但 T1D 青少年的饮食摄入模式显然与充分的血糖控制不相符。因此，对于哪些干预措施可以改善血糖，人们在认识上存在重大差距。一些主要的 T1D 临床实践指南明确建议使用结构化饮食模式，包括国际儿童和青少年糖尿病协会 (ISPAD)，而美国糖尿病协会 (ADA) 的营养指南。值得注意的是，目前还没有关于 1 型糖尿病青少年结构化饮食模式能否有效改善全天血糖控制的临床试验数据，因此，我们的首要目标是严格测试个性化、结构化饮食模式对改善血糖的有效性。全天血糖控制，为了为 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”的个性化结构化饮食计划干预措施的可能可接受性和有效性，其中包括协作开发个性化结构化饮食。计划在这里，我们建议进行一项试点单臂临床试验，为未来在临床环境中持续糖尿病护理中添加个性化结构化饮食计划提供信息。 1. 评估 40 名患有 T1D 的青少年对为期 6 个月的个体化结构化饮食干预（“MyPlan”）的可接受性和依从性我们将招募年龄为 12-17 岁、至少患有 T1D 的青少年。持续 1 年，HbA1c >8 % 和 <11%（总共招募 50 名参与者，以确保临床两个中心的 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设定行为目标目标 2. 比较患有 T1D 的青少年在基线和 6 个月 MyPlan 干预结束时的血糖控制情况。基于连续血糖监测和 HbA1c 的时间范围 (TIR) 我们的团队已经合作多年，完全有能力开展这项关键工作，为患有 T1D 的青少年提供医学营养治疗的信息。