Use of Continuous Glucose Sensors in Adolescents with Inadequate Diabetic Control

连续血糖传感器在糖尿病控制不足的青少年中的使用

基本信息

批准号：
8386901
负责人：
Tim Wysocki
金额：
$ 39.44万
依托单位：
NEMOURS CHILDREN'S CLINIC
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-01-10 至 2015-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8386901
关键词：
Address Adolescent Adolescent Behavior Affect Behavior Therapy Behavioral Blindness Blood Glucose Blood Glucose Self-Monitoring Carbohydrates Caregivers Child Childhood Chronic Disease Clinical Communication Complications of Diabetes Mellitus Conflict (Psychology)Data Decision Making Demographic Factors Devices Diabetes Mellitus Empirical Research Exercise Family Family Relationship Feedback Frequencies Fright Funding Glucose Glycemic Index Glycosylated Hemoglobin Glycosylated hemoglobin A Growth Habits Health Healthcare Heart Diseases Hyperglycemia Hypoglycemia Individual Injection of therapeutic agent Insulin Insulin Infusion Systems Insulin-Dependent Diabetes Mellitus Intake Intervention Kidney Failure Measures Mediating Mediation Medical Methods Modeling Nerve Normal Range Outcome Outcome Measure Parents Phase Principal Investigator Psychological adjustment Psychosocial Influences Quality of life Randomized Reading Regimen Regulation Relative (related person)Research Risk Sampling Self Management Site Techniques Testing Therapeutic Time United States National Institutes of Health Work Youth abstracting base blood glucose regulation cost effectiveness diabetes control diabetes management diabetes mellitus therapy diabetic emerging adult family management glucose sensor glycemic control improved indexing innovation primary outcome psychologic randomized trial research clinical testing satisfaction secondary outcome standard care theories therapy design treatment adherence trend

项目摘要

Project Abstract Management of type 1 diabetes mellitus (T1DM) in adolescents is very difficult and innovative approaches are needed to help them achieve better glycemic control and behavioral outcomes. Continuous glucose sensors (CGS) have been refined progressively and provide acceptably accurate, nearly continuous estimates of glucose levels and trends. This increased quality and quantity of glucose data could be an excellent adjunct to conventional self-monitoring of blood glucose, permitting more informed diabetes decision-making. CGS could yield medical, educational and psychological benefits for adolescents with T1DM, but those with extremely variable self-management habits and suboptimal glycemic control may not realize these benefits readily. We hypothesize that a targeted, family-focused behavioral intervention could optimize benefit from adding CGS to T1DM therapy for youths with glycosylated hemoglobin (HbA1c) > 7.5%. A multi-site sample of 150 adolescents with T1DM and HbA1C of 7.5% to 10.0% will be randomized to either Standard Care for T1DM (SC), or to augmentation of SC with 9 months' use of a CGS device (CGS) or use of a CGS device supplemented with a targeted behavior therapy intervention (CGS+BT). Multiple measures of glycemic control, glycemic variability and health care use will be obtained during the study and there will be periodic assessments of demographic factors, diabetes self-management, family relations and psychological adjustment. Three specific aims will be addressed: 1. Evaluate whether CGS+BT yields more improvement in glycemic outcomes than CGS or SC; 2. Evaluate whether CGS+BT yields more improvement in behavioral outcomes than CGS or SC; and 3. Identify behavioral variables that mediate and moderate glycemic benefit from use of the CGS device. The study will also compare the cost effectiveness of CGS and CGS+BT relative to SC and evaluate the predictive utility of various indices of glycemic variability in youths. We hypothesize that, compared with SC and CGS, CGS+BT will yield significantly better biomedical outcomes (HbA1C; severe hypoglycemia; glycemic variability; proportion of glucose readings in the normal range) and behavioral outcomes (treatment adherence; parent adolescent teamwork; diabetes-related family conflict; quality of life; fear of hypoglycemia; and treatment satisfaction). After the 9 month randomized trial, all youths will be allowed to use the CGS device during an additional 3- month continuation phase. Statistical analyses will be based on individual growth modeling techniques. The application capitalizes on the Principal Investigator's prior and ongoing funded research on family management of T1DM, including trials of family-focused behavioral interventions, intensive therapy regimens, and clinical evaluations of continuous glucose sensors. The proposed study will determine whether a targeted behavioral intervention improves CGS benefits among adolescents with previously inadequate glycemic control. These results could demonstrate that adolescents with previously suboptimal diabetic control could realize multiple benefits from CGS use if they are provided with a specialized behavioral intervention.

项目摘要青少年中1型糖尿病（T1DM）的管理非常困难，创新的方法是需要帮助他们获得更好的血糖控制和行为结果。连续的葡萄糖传感器（CG）已逐步完善，并提供可接受的准确，几乎连续的估计值葡萄糖水平和趋势。这种增加的葡萄糖数据质量和数量可能是传统的对血糖的自我监控，可以使更多知情的糖尿病决策。 CGS可以为具有T1DM的青少年产生医学，教育和心理利益可变的自我管理习惯和次优血糖控制可能不会轻易意识到这些好处。我们假设有针对性的，以家庭为中心的行为干预可以优化从将CGS添加到糖基化血红蛋白（HBA1C）> 7.5％的年轻人的T1DM治疗。 150名青少年的多站点样本 T1DM和HBA1C为7.5％至10.0％，将随机分为T1DM（SC）的标准护理或使用CGS设备（CGS）或使用补充CGS设备的9个月使用SC的增强靶向行为疗法干预（CGS+BT）。血糖控制，血糖变异性多种测量在研究期间将获得医疗保健的使用，并将定期评估人群因素，糖尿病自我管理，家庭关系和心理调整。三个具体目标将是地址：1。评估CGS+BT是否比CGS或SC的血糖结局更有改善； 2。评估CGS+BT是否比CGS或SC的行为结果更有改善；和3。识别使用CGS设备可介导和中度血糖益处的行为变量。研究将还要比较CGS和CGS+BT相对于SC的成本效益，并评估了预测效用年轻人血糖变异性的各种指标。我们假设与SC和CGS相比，CGS+BT 将产生明显更好的生物医学结果（HBA1C；严重低血糖症；血糖变异性；比例在正常范围内的葡萄糖读数）和行为结果（治疗依从性；父子青少年团队合作；与糖尿病有关的家庭冲突；生活质量；害怕低血糖；和治疗满意度）。在进行9个月的随机试验后，所有年轻人将在额外3--中使用CGS设备。月延续阶段。统计分析将基于个体增长建模技术。这申请将主要研究人员的先前和正在进行的家庭管理研究研究 T1DM的of，包括以家庭为中心的行为干预，强化治疗方案和临床的试验连续葡萄糖传感器的评估。拟议的研究将确定是否有针对性的行为干预措施改善了先前血糖控制不足的青少年中的CGS益处。这些结果可以表明，先前具有次优糖尿病控制的青少年可以意识到多个如果CGS进行专门的行为干预，则使用CGS的益处。