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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 1 型糖尿病 (T1DM) 的管理非常困难，需要创新方法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、近乎连续的估计血糖水平和趋势。葡萄糖数据质量和数量的提高可能是一个很好的辅助手段传统的自我血糖监测，可以做出更明智的糖尿病决策。中国地质调查局可以为患有 T1DM 的青少年带来医疗、教育和心理方面的益处，但那些患有极度糖尿病的青少年多变的自我管理习惯和次优的血糖控制可能无法轻易实现这些益处。我们假设有针对性的、以家庭为中心的行为干预可以优化添加 CGS 的益处针对糖化血红蛋白 (HbA1c) > 7.5% 的青少年的 T1DM 治疗。 150 名青少年的多地点样本 T1DM 且 HbA1C 为 7.5% 至 10.0% 的患者将被随机分配至 T1DM 标准护理 (SC) 或通过使用 CGS 设备 (CGS) 9 个月或使用 CGS 设备补充 SC 来增强 SC 针对性行为治疗干预（CGS+BT）。血糖控制、血糖变异性的多重测量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数据因素、糖尿病自我管理、家庭关系及心理调节。将实现三个具体目标解决： 1. 评估 CGS+BT 是否比 CGS 或 SC 更能改善血糖结果； 2. 评估 CGS+BT 是否比 CGS 或 SC 能带来更多的行为结果改善； 3. 识别介导和调节使用 CGS 设备带来的血糖益处的行为变量。该研究将还比较了 CGS 和 CGS+BT 相对于 SC 的成本效益，并评估了预测效用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 将产生显着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；糖尿病相关的家庭冲突；生活质量；担心低血糖；和治疗满意度）。经过 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。这应用程序利用了首席研究员之前和正在进行的家族管理资助研究 T1DM 的研究，包括以家庭为中心的行为干预、强化治疗方案和临床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可改善先前血糖控制不足的青少年的 CGS 益处。这些结果可以证明，以前糖尿病控制不佳的青少年可以实现多种目标如果为他们提供专门的行为干预，他们将从 CGS 的使用中受益。