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，需要创新的方法来帮助他们实现更好的血糖控制和行为结果。连续血糖传感器(CGS)已经逐步改进，可以提供可接受的准确、几乎连续的血糖水平和趋势估计。这种增加的血糖数据的质量和数量可能是传统的血糖自我监测的一个很好的辅助工具，允许更多知情的糖尿病决策。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，但那些自我管理习惯极不稳定、血糖控制不佳的人可能不会轻易实现这些好处。我们假设，对于糖化血红蛋白(HbA1c)和糖化血红蛋白(GT；)为7.5%的年轻人，有针对性的、以家庭为中心的行为干预可以优化在T1 DM治疗中加入CGS的益处。将150名T1 DM和HbA1C在7.5%至10.0%的青少年作为多点样本，随机分为标准护理组(SC)，或使用CGS装置(CGS)或使用CGS装置并辅以靶向行为治疗干预(CGS+BT)的强化SC组。在研究期间，将获得血糖控制、血糖变异性和医疗保健使用的多种衡量标准，并将定期评估人口因素、糖尿病自我管理、家庭关系和心理调整。将涉及三个具体目标：1.评估CGS+BT是否比CGS或SC在血糖结果方面产生更大的改善；2.评估CGS+BT是否比CGS或SC在行为结果方面产生更大的改善；以及3.确定通过使用CGS设备来调节和适度提高血糖的行为变量。这项研究还将比较CGS和CGS+BT相对于SC的成本效益，并评估各种血糖变异性指数在年轻人中的预测效用。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果(HbA1C；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个月的持续阶段使用CGS设备。统计分析将基于个人增长建模技术。该应用程序利用了首席调查员先前和正在资助的关于T1 DM家庭管理的研究，包括以家庭为重点的行为干预试验、强化治疗方案和连续血糖传感器的临床评估。这项拟议的研究将确定有针对性的行为干预是否能改善以前血糖控制不足的青少年的CGS益处。这些结果可能表明，如果为以前糖尿病控制不佳的青少年提供专门的行为干预，他们可以从CGS的使用中获得多种好处。与公共健康相关：与传统的血糖自我监测相比，连续血糖传感器(CGS)提供了关于血糖水平、趋势和变异性的更好信息。这项研究的主要假设是，对1型糖尿病控制不佳的青少年如果接受旨在优化他们使用CGS的简短、有针对性的行为治疗干预，将更有可能从他们现有的糖尿病治疗方案中增加CGS的使用而受益。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，提高生活质量，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.