Use of Continuous Glucose Sensors in Adolescents with Inadequate Diabetic Control

工程摘要 青少年1型糖尿病（T1 DM）的管理非常困难， 需要帮助他们实现更好的血糖控制和行为结果。连续葡萄糖传感器 (CGS)已逐步完善，并提供可接受的准确，几乎连续的估计， 葡萄糖水平和趋势。这种增加的葡萄糖数据的质量和数量可能是一个很好的辅助， 传统的自我血糖监测，允许更明智的糖尿病决策。CGS可以 为T1 DM青少年提供医疗、教育和心理方面的益处， 可变的自我管理习惯和次优的血糖控制可能不容易实现这些益处。我们 假设有针对性的，以家庭为中心的行为干预可以优化增加CGS的益处， 糖化血红蛋白（HbA 1c）> 7.5%的青年T1 DM治疗。150名青少年的多中心样本 HbA 1C为7.5%-10.0%的T1 DM患者将随机接受T1 DM标准治疗（SC）或 使用CGS器械（CGS）9个月或使用CGS器械补充 目标行为治疗干预（CGS+BT）。血糖控制、血糖变异性的多种措施 在研究期间将获得医疗保健使用情况，并将定期评估人口统计学 影响因素、糖尿病自我管理、家庭关系及心理调适。三个具体目标将是 处理的问题：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.识别 行为变量介导和适度的血糖受益于使用CGS设备。这项研究将 还比较了CGS和CGS+BT相对于SC的成本效益，并评估了 青少年血糖变异性的各种指标。我们假设，与SC和CGS相比，CGS+BT 将产生显著更好的生物医学结局（HbA 1C;严重低血糖;血糖变异性;比例 血糖读数在正常范围内）和行为结果（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个月内使用CGS设备， 月延续阶段。统计分析将基于个体生长建模技术。的 应用程序利用首席研究员以前和正在进行的家庭管理资助研究 包括以家庭为中心的行为干预试验、强化治疗方案和临床 连续葡萄糖传感器的评价。这项拟议中的研究将确定是否有针对性的行为 干预改善了先前血糖控制不佳的青少年的CGS益处。这些 结果表明，以前糖尿病控制不佳的青少年可以实现多个 使用CGS的好处，如果他们提供了专门的行为干预。

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.