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

• 批准号: 7578405
• 负责人: Tim Wysocki
• 金额: $ 61.19万
• 依托单位: NEMOURS CHILDREN'S CLINIC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-01-10 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7578405
• 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; Randomized Controlled Clinical Trials; Reading; Regulation; Relative (related person); Research; Risk; Sampling; Self Management; Site; Techniques; Testing; Therapeutic; Time; Treatment Protocols; United States National Institutes of Health; Work; Youth; 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; public health relevance; research clinical testing; satisfaction; secondary outcome; standard care; theories; therapy design; treatment adherence; trend

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.

描述（由申请人提供）：青少年 1 型糖尿病 (T1DM) 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果。连续葡萄糖传感器 (CGS) 已逐步完善，可提供可接受的准确度、近乎连续的葡萄糖水平和趋势估计。血糖数据质量和数量的提高可以成为传统血糖自我监测的绝佳辅助手段，从而可以做出更明智的糖尿病决策。 CGS 可以为患有 T1DM 的青少年带来医疗、教育和心理方面的益处，但那些自我管理习惯差异极大且血糖控制不佳的人可能不容易意识到这些益处。我们假设，针对糖化血红蛋白 (HbA1c) > 7.5% 的青少年，有针对性的、以家庭为中心的行为干预可以优化在 T1DM 治疗中添加 CGS 的益处。 150 名患有 T1DM 且 HbA1C 为 7.5% 至 10.0% 的青少年的多地点样本将被随机分配到 T1DM 标准护理 (SC) 组，或使用 CGS 设备 (CGS) 增强 SC 组 (CGS) 或使用 CGS 设备辅以针对性行为治疗干预 (CGS+BT)。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，并对人口因素、糖尿病自我管理、家庭关系和心理调整进行定期评估。将解决三个具体目标： 1. 评估 CGS+BT 是否比 CGS 或 SC 能更好地改善血糖结果； 2. 评估 CGS+BT 是否比 CGS 或 SC 更能改善行为结果； 3. 确定通过使用 CGS 装置调节和调节血糖益处的行为变量。该研究还将比较 CGS 和 CGS+BT 相对于 SC 的成本效益，并评估青少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 将产生显着更好的生物医学结果（HbA1C；严重低血糖；血糖变异性；正常范围内的血糖读数比例）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）。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。该应用程序利用了首席研究员之前和正在进行的 T1DM 家庭管理研究，包括以家庭为中心的行为干预试验、强化治疗方案以及连续血糖传感器的临床评估。拟议的研究将确定有针对性的行为干预是否可以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，如果为之前糖尿病控制不佳的青少年提供专门的行为干预，他们可以从使用 CGS 中获得多种益处。公共健康相关性：与传统的自我血糖监测相比，连续血糖传感器 (CGS) 可以提供更好的有关血糖水平、趋势和变异性的信息。这项研究的主要假设是，如果 1 型糖尿病控制不佳的青少年接受旨在优化 CGS 使用的简短、有针对性的行为治疗干预，他们将更有可能意识到在现有糖尿病治疗方案中添加 CGS 的好处。如果这一方法有效，糖尿病控制不佳的青少年可以实现更好的短期健康状况，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。