Optimizing CGM Use and Metabolic Outcomes in Youth with Type 1 Diabetes

描述（由申请人提供）：连续血糖监测（CGM）技术的可用性为1型糖尿病（T1D）患者提供了实现目标血红蛋白A1c （A1c）水平的机会。直到有一个完全自动化的闭环胰岛素输送系统，人的动机和耐力的实施和持续使用CGM装置是必要的。青少年糖尿病研究基金会（JDRF） CGM研究组最近发表的一项研究表明，与标准血糖监测相比，使用CGM的成年患者的A1c有显著改善，而低血糖发生率没有增加。年轻的T1D患者被随机分配到CGM并没有获得与成年人随机分配到CGM相同的益处。然而，持续使用CGM的儿科患者在A1c方面的改善与成人相同。不幸的是，最大的不遵守CGM发生在8-17岁。在本应用中，我们试图实现CGM在改善8-17岁青少年T1D患者代谢控制和降低严重低血糖的益处。在一项前瞻性、随机、对照临床试验中，我们将120名持续时间为>=1年的T1D青年分配到两组中的一组：(1)根据标准治疗实施的CGM （CGM- sc）或(2)采用手动的、以家庭为中心的团队干预实施的CGM，使用动机性访谈技术来克服公认的CGM使用障碍（CGM- tw）。这项为期2年的临床试验将提供一个机会来评估CGM在儿科T1D患者中的长期使用及其相关的代谢和行为结果。该试验的完成将提供以前无法获得的关于CGM的长期疗效和有效性的数据，这些数据涉及是否采用以家庭为中心的行为团队干预，以鼓励CGM的实施和持续使用。在这个题为“优化青少年1型糖尿病患者的CGM使用和代谢结果”的应用中，总体目标是改善T1D儿童和青少年的代谢控制并保持行为健康/心理结果。

DESCRIPTION (provided by applicant): The availability of continuous glucose monitoring (CGM) technologies provides opportunities to achieve target hemoglobin A1c (A1c) levels for persons with type 1 diabetes (T1D). Until there is a fully automated closed- loop insulin delivery system, human motivation and stamina for implementation and sustained use of CGM devices are necessary. The recently published study by the Juvenile Diabetes Research Foundation (JDRF) CGM Study Group demonstrated significant improvements in A1c without an increase in hypoglycemia in adult patients using CGM compared to standard BG monitoring. Young persons with T1D randomized to CGM did not experience the same benefits as adults randomized to CGM. However, pediatric patients who used CGM consistently did experience the same improvements in A1c as adults. Unfortunately, the greatest non- adherence to CGM occurred in 8-17 year olds. In this application, we seek to realize the benefits of CGM for improving metabolic control and reducing severe hypoglycemia in youth ages 8-17 with T1D. In a prospective, randomized, controlled clinical trial, we will assign 120 youth with T1D of duration >=1 year to 1 of 2 groups: (1) CGM implemented according to standard care (CGM-SC) or (2) CGM implemented with a manualized, family- focused teamwork intervention administered using motivational interviewing techniques to overcome recognized barriers to CGM use (CGM-TW). The 2-year clinical trial will provide an opportunity to evaluate longer-term use of CGM and its associated metabolic and behavioral outcomes in pediatric patients with T1D. Completion of this trial will provide previously unavailable data regarding the longer-term efficacy and effectiveness of CGM implemented with and without a family-focused, behavioral teamwork intervention that encourages CGM implementation and sustained use. The overall aim is to improve metabolic control and preserve behavioral health/psychological outcomes in children and adolescents with T1D in this application entitled, "Optimizing CGM Use and Metabolic Outcomes in Youth with Type 1 Diabetes". PUBLIC HEALTH RELEVANCE: Continuous glucose monitoring (CGM) improves glycemic control without increasing hypoglycemia in adults with type 1 diabetes (T1D); youth with T1D do not experience equivalent benefit. This application will design, implement, and evaluate a family-focused behavioral intervention to encourage sustained CGM use in pediatric patients with T1D in order for them to realize the glycemic benefits afforded to adult patients using this technology. The current application will evaluate the long-term acceptability and durability of CGM, and assess the metabolic outcomes and behavioral impact of CGM on pediatric patients with T1D and their families.