Use of Continuous Glucose Sensors in Adolescents with Inadequate Diabetic Control

项目摘要 青少年1型糖尿病(T1 DM)的管理非常困难，创新的方法是 需要帮助他们实现更好的血糖控制和行为结果。连续式血糖传感器 (CGS)已逐步完善，并提供了可接受的准确、几乎连续的 血糖水平和趋势。这种增加的质量和数量的葡萄糖数据可能是一个很好的补充 常规的血糖自我监测，允许更知情的糖尿病决策。CGS可以 为患有T1 DM的青少年带来医疗、教育和心理上的好处，但那些患有极端糖尿病的青少年 可变的自我管理习惯和次优的血糖控制可能不会轻易实现这些好处。我们 假设有针对性的、以家庭为中心的行为干预可以优化将CGS添加到 使用糖化血红蛋白(HbA1c)和GT治疗年轻人的T1 DM；7.5%。150名青少年的多点抽样 T1 DM和HbA1C为7.5%至10.0%的患者将随机分为T1 DM标准护理组(SC)或 通过使用CGS装置(CGS)9个月或使用CGS装置并补充 靶向行为治疗干预(CGS+BT)。血糖控制的多种测量，血糖变异性 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 因素、糖尿病自我管理、家庭关系和心理调适。三个具体目标将是 解决：1.评估CGS+BT是否比CGS或SC更能改善血糖结果； 评估CGS+BT在行为结果方面是否比CGS或SC产生更大的改善；以及3.确定 调节和中度血糖升高的行为变量受益于CGS设备的使用。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数。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果(HbA1C；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；与糖尿病相关的家庭冲突；生活质量；对低血糖的恐惧；以及治疗满意度)。 在9个月的随机试验后，所有青少年将被允许在另外3-3个月内使用CGS设备 月延续阶段。统计分析将基于个人增长建模技术。这个 应用利用首席调查员先前和持续资助的关于家庭管理的研究 包括以家庭为中心的行为干预试验、强化治疗方案和临床试验 连续血糖传感器的评价。拟议的研究将确定是否有针对性的行为 干预改善了既往血糖控制不充分的青少年的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 如果为CGS提供了专门的行为干预，则可从CGS使用中获益。

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.