Use of Continuous Glucose Sensors in Adolescents with Inadequate Diabetic Control

描述（由申请人提供）：青少年1型糖尿病（T1 DM）的管理非常困难，需要创新方法来帮助他们实现更好的血糖控制和行为结局。连续葡萄糖传感器（CGS）已逐步完善，并提供可接受的准确性，几乎连续的葡萄糖水平和趋势的估计。这种提高质量和数量的葡萄糖数据可能是传统的自我血糖监测的一个很好的辅助手段，允许更明智的糖尿病决策。CGS可以为T1 DM青少年带来医疗、教育和心理方面的益处，但那些自我管理习惯极其多变和血糖控制欠佳的青少年可能不会轻易意识到这些益处。我们假设，有针对性的、以家庭为中心的行为干预可以优化糖化血红蛋白（HbA 1c）> 7.5%的青少年在T1 DM治疗中加入CGS的益处。将150例HbA 1C为7.5%-10.0%的T1 DM青少年的多中心样本随机分配至T1 DM标准治疗（SC）组，或使用CGS器械（CGS）或使用CGS器械补充靶向行为治疗干预（CGS+BT）的SC增强组。研究期间将获得血糖控制、血糖变异性和医疗保健使用的多项指标，并将定期评估人口统计学因素、糖尿病自我管理、家庭关系和心理调整。将讨论三个具体目标：1。评估CGS+BT是否比CGS或SC更能改善血糖结局; 2.评估CGS+BT是否比CGS或SC产生更多的行为结果改善;和3.确定使用CGS器械可介导和调节血糖获益的行为变量。该研究还将比较CGS和CGS+BT相对于SC的成本效益，并评估青年血糖变异性的各种指标的预测效用。我们假设，与SC和CGS相比，CGS+BT将产生显著更好的生物医学结局（HbA 1C;严重低血糖;血糖变异性;血糖读数在正常范围内的比例）和行为结局（治疗依从性;父母青少年团队合作;糖尿病相关的家庭冲突;生活质量;对低血糖的恐惧;和治疗满意度）。在9个月的随机试验后，所有青少年将被允许在另外3个月的持续阶段使用CGS设备。统计分析将基于个体生长建模技术。该申请利用了主要研究者之前和正在进行的关于T1 DM家庭管理的资助研究，包括以家庭为中心的行为干预试验、强化治疗方案和动态葡萄糖传感器的临床评价。这项拟议的研究将确定是否有针对性的行为干预改善CGS的好处，青少年与以前的血糖控制不足。这些结果可以证明，如果为青少年提供专门的行为干预，那么先前糖尿病控制不佳的青少年可以从CGS的使用中实现多种益处。公共卫生相关性：动态葡萄糖传感器（CGS）提供的血糖水平、趋势和变异性信息比传统的血糖自我监测更好。本研究的主要假设是，1型糖尿病控制欠佳的青少年如果接受旨在优化CGS使用的简短、有针对性的行为治疗干预，将更有可能从将CGS使用添加到其现有糖尿病治疗方案中获益。如果这是有效的，糖尿病控制不佳的青少年可以实现更好的短期健康，改善生活质量，并可能减少糖尿病的长期并发症，如肾衰竭，失明，神经损伤和心脏病。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: Continuous glucose sensors (CGS) provide better information about blood glucose levels, trends and variability than is feasible with conventional self-monitoring of blood glucose. The main hypothesis of this study is that adolescents with suboptimal control of type 1 diabetes mellitus will be more likely to realize benefits from adding CGS use to their existing diabetes regimens if they receive a brief, targeted behavior therapy intervention designed to optimize their use of CGS. If this is effective, adolescents with suboptimal control of diabetes could achieve better short-term health, improved quality of life and possible reduction in long-term complications of diabetes such as kidney failure, blindness, nerve damage and heart disease.