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

优化 1 型糖尿病青少年的 CGM 使用和代谢结果

基本信息

批准号：
8538952
负责人：
LORI M LAFFEL
金额：
$ 63.24万
依托单位：
JOSLIN DIABETES CENTER
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-30 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8538952
关键词：
17 year old Address Adherence Adolescent Adult Age Anxiety Artificial Pancreas Behavior Therapy Behavioral Blood Glucose Blood Vessels Calibration Child Childhood Clinical Trials Complications of Diabetes Mellitus Data Diabetes Mellitus Dose Drops Effectiveness Epidemiology Face Family Foundations Frequencies Fright Future Glucose Glycosylated hemoglobin A Goals Growth Growth and Development function Human Hypoglycemia Insulin Insulin-Dependent Diabetes Mellitus Intervention Investigation Measures Metabolic Metabolic Control Modeling Monitor Motivation Outcome Patients Persons Physiological Population Puberty Publishing Pump Randomized Randomized Controlled Clinical Trials Reporting Research Risk Risk Reduction Self Efficacy System Techniques Technology Therapeutic Weight Gain Youth analog behavioral health beta cell replacement burnout cost depressive symptoms design diabetes control evidence base experience follow-up glucose monitor glycemic control health related quality of life improved loris monitoring device motivational enhancement therapy primary outcome prospective psychologic psychological outcomes public health relevance response sensor standard care trend

项目摘要

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.

描述（由申请人提供）：动态血糖监测（CGM）技术的可用性为1型糖尿病（T1 D）患者提供了达到目标血红蛋白A1 c（A1 c）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的CGM设备是必要的。青少年糖尿病研究基金会（JDRF）CGM研究小组最近发表的研究表明，与标准BG监测相比，使用CGM的成人患者的A1 c显著改善，而低血糖症没有增加。随机分配至CGM的T1 D年轻患者未体验到与随机分配至CGM的成人相同的获益。然而，持续使用CGM的儿科患者确实与成人一样经历了A1 c的改善。不幸的是，最大的不遵守CGM发生在8-17奥尔兹。在本申请中，我们寻求实现CGM改善代谢控制和减少8-17岁T1 D青年严重低血糖的益处。在一项前瞻性、随机、对照临床试验中，我们将120名T1 D持续时间>=1年的青少年分配至2组之一：（1）根据标准治疗实施CGM（CGM-SC）或（2）通过使用动机访谈技术进行手动、以家庭为中心的团队干预实施CGM，以克服CGM使用的公认障碍（CGM-TW）。这项为期2年的临床试验将提供一个机会，以评估长期使用CGM及其相关的代谢和行为结果的儿科患者与T1 D。本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，这些数据是在有和没有以家庭为中心的行为团队干预的情况下实施的，这些干预鼓励CGM的实施和持续使用。总体目标是改善代谢控制，并保持T1 D儿童和青少年的行为健康/心理结果，该申请题为“优化CGM使用和1型糖尿病青年的代谢结果”。公共卫生相关性：动态血糖监测（CGM）可改善1型糖尿病（T1 D）成人患者的血糖控制，而不会增加低血糖; T1 D青少年患者未获得同等益处。该应用程序将设计、实施和评价以家庭为中心的行为干预，以鼓励T1 D儿科患者持续使用CGM，从而使他们实现使用该技术为成人患者提供的血糖获益。本申请将评价CGM的长期可接受性和耐久性，并评估CGM对T1 D儿科患者及其家人的代谢结局和行为影响。