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）：连续葡萄糖监测（CGM）技术的可用性为1型糖尿病患者（T1D）的患者提供了实现目标血红蛋白A1C（A1C）水平的机会。在有一个完全自动化的闭环胰岛素输送系统之前，必须进行人类动机和耐力，以实施和持续使用CGM设备。与标准的BG监测相比，使用CGM的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，使用CGM的成年患者的低血糖率有显着改善，而成年患者的低血糖率有所增加。 T1D随机分配给CGM的年轻人与随机分配给CGM的成年人没有相同的好处。但是，使用CGM的小儿患者始终如一地在A1C中与成年人相同的改善。不幸的是，对CGM的最大依从性发生在8-17岁的孩子中。在此应用中，我们试图实现CGM在改善代谢控制和减少T1D年龄8-17岁青年的严重低血糖症方面的好处。 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).这项为期两年的临床试验将提供一个机会，以评估CGM的长期使用及其在T1D儿科患者中的代谢和行为结果。该试验的完成将提供以前无法获得的数据，这些数据涉及以有或没有以家庭为中心的行为团队干预的CGM的长期疗效和有效性，这鼓励CGM实施和持续使用。总体目的是改善具有T1D的儿童和青少年的行为健康/心理结局，并保留T1D的行为健康/心理结局，标题为“优化1型糖尿病青少年的CGM使用和代谢结果”。公共卫生相关性：连续的葡萄糖监测（CGM）可改善血糖控制，而不增加1型糖尿病（T1D）成人低血糖；具有T1D的青年没有同等的利益。该应用将设计，实施和评估以家庭为中心的行为干预措施，以鼓励在T1D儿科患者中持续使用CGM，以便他们意识到使用该技术的成年患者提供的血糖益处。当前的应用将评估CGM的长期可接受性和耐用性，并评估CGM对T1D及其家人儿科患者的代谢结果和行为影响。