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: 8008761
• 负责人: Tim Wysocki
• 金额: $ 58.98万
• 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/8008761
• 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; 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

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）：青少年中1型糖尿病（T1DM）的管理非常困难，需要创新的方法来帮助他们获得更好的血糖控制和行为结果。连续的葡萄糖传感器（CGS）已逐步完善，并提供了可接受的准确，几乎连续的葡萄糖水平和趋势估计。葡萄糖数据的质量和数量增加可能是对血糖的常规自我监测的出色辅助手段，从而允许更多知情的糖尿病决策。 CGS可以为具有T1DM的青少年带来医学，教育和心理利益，但是那些具有极高的自我管理习惯和次优血糖控制的人可能不会轻易意识到这些好处。我们假设，针对性的，以家庭为中心的行为干预措施可以优化为糖基化血红蛋白（HBA1C）> 7.5％的年轻人添加CGS的T1DM治疗。由T1DM和HBA1C为7.5％至10.0％的150名青少年的多站点样本将被随机分配给T1DM（SC）的标准护理，或使用CGS设备（CGS）使用9个月的SC增强SC，或者使用CGS设备使用CGS设备，并补充了针对性的行为治疗治疗治疗治疗治疗疗法干预（CGS）。在研究期间将获得多种血糖控制，血糖变异性和医疗保健使用的方法，并将定期评估人口统计学因素，糖尿病自我管理，家庭关系和心理调整。将解决三个具体目标：1。评估CGS+BT是否比CGS或SC的血糖结局更有改善； 2。评估CGS+BT是否比CGS或SC的行为结局更有改善； 3。确定使用CGS设备介导和中等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，并评估年轻人血糖变异性各种指标的预测效用。我们假设，与SC和CG相比，CGS+BT将产生更好的生物医学结果（HBA1C；严重的低血糖；血糖差异；血糖差异；正常范围内的葡萄糖读数比例）和行为上的结果和行为上的结果（治疗依从性；父母的青少年团队；糖尿病的糖尿病家庭；糖尿病家庭的兴奋剂和糖尿病；在进行9个月的随机试验后，所有年轻人将在3个月的延续阶段额外使用CGS设备。统计分析将基于个体增长建模技术。该申请将资本利用主要研究者的先前和正在进行的T1DM家庭管理研究，包括以家庭为中心的行为干预措施，强化治疗方案以及连续葡萄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中的CGS益处。这些结果可能表明，如果提供专门的行为干预，则具有先前次优糖尿病控制的青少年可以从CGS使用中实现多种益处。公共卫生相关性：连续葡萄糖传感器（CGS）提供了有关血糖水平，趋势和可变性的更好信息，而不是对血糖的常规自我监测。这项研究的主要假设是，如果旨在优化旨在优化CGS使用的简短，有针对性的行为疗法干预措施，那么对1型糖尿病的次优型糖尿病的青少年就会更有可能实现其现有糖尿病方案的好处。如果这是有效的，那么对糖尿病次优的青少年可以获得更好的短期健康，改善的生活质量以及可能减少糖尿病的长期并发症，例如肾衰竭，失明，神经损伤和心脏病。