INTENSIVE THERAPY FOR IDDM IN YOUTH--OUTCOME PREDICTIONS

糖尿病控制和并发症试验（DCCT）证明， 胰岛素依赖型糖尿病的强化治疗（IT） 靶向接近正常水平的药物可以延迟发病并减缓疾病的进展， 长期并发症。 DCCT只招收积极性高的成年人， 青少年，目前还不清楚这种成功是否可以复制， 更广泛的青年样本。 信息技术的成本阻碍了其推广; 需要更有效地交付IT的战略，以最大限度地提高 DCCT的公共卫生影响。 在每次DCCT评估中，大约25%的 常规治疗组青少年的HbA 1c水平低于8.0 %，而类似数量的IT患者没有。 因此，一些患者 CT可以接近正常值，而其他人甚至不能与IT。 区分这些患者的因素的规范可以优化 分配DCCT临床翻译的资源， 两种治疗方法都有好处。 这项建议建立在该团队的临床经验，以前的研究， 青少年胰岛素依赖性糖尿病的心理方面及其在 NIH资助的项目。 该应用程序基于一个概念模型， 认为发展适当的自我照顾自主性和胰岛素依赖型糖尿病 自我管理能力中介人口因素的影响， 家庭功能和心理压力对糖尿病控制的影响。 家庭 适度的自我管理能力被假设为 受益于IT。160名患有IDDM的青年及其父母的样本将 随机分配至IT组或继续接受常规治疗（UC;强化治疗 常规疗法）。 基线评估将包括相关的 人口、心理和家庭因素。 将进行评估 每季度进行一次，为期18个月，包括评估胰岛素依赖型糖尿病的自我护理自主性， 治疗依从性，家庭使用血糖数据，家庭相互作用 与卫生保健提供者，情感调整的胰岛素依赖型糖尿病和健康状况。 建议采取广泛的措施，以确保UC患者不会暴露于 由于参与研究而增加的风险。 UC和IT治疗的预测 将使用灵活的个体生长建模方法分析响应。 这项研究将详细说明调解IT的行为和心理因素 和UC反应，促进针对这些干预措施的发展 机制和充分验证的协议，选择患者， 了

DESCRIPTION: The Diabetes Control and Complications Trial (DCCT) proved that Intensive Therapy (IT) for insulin-dependent diabetes mellitus targeting near-normoglycemia delays the onset and slows the progression of long-term complications. The DCCT enrolled only highly motivated adults and adolescents and it is unclear if this success can be duplicated with a broader sample of youth. The cost of IT impedes its dissemination; strategies of delivering IT more efficiently are needed to maximize the DCCT's public health impact. At each DCCT assessment, about 25 percent of adolescents in the Conventional Therapy group had HbA1c levels less than 8.0 percent, while a similar number of IT patients did not. Thus, some patients may approach normoglycemia with CT and others may not even with IT. Specification of factors differentiating these patients could optimize resource allocation for clinical translation of the DCCT and maximize treatment benefits from either approach. This proposal builds on the team's clinical experience, previous studies of psychological aspects of IDDM in youth and their collaboration on an NIH-funded project. The application is based on a conceptual model which asserts that developmentally appropriate self care autonomy and IDDM self-management competence mediate the influence of demographic factors, family function and psychological stress on diabetic control. Families with moderate self management competence are hypothesized to accrue the most benefit from IT. A sample of 160 youth with IDDM and their parents will be randomized to either IT or to continue in their usual care (UC; intensified conventional therapy). Baseline assessment will include pertinent demographic, psychological and family factors. Evaluations will occur quarterly for 18 months, including assessment of IDDM self care autonomy, treatment adherence, family use of blood glucose data, family interactions with health care providers, affective adjustment to IDDM and health status. Extensive measures are proposed to ensure that UC patients are exposed to no added risks due to study participation. Prediction of UC and IT treatment response will be analyzed using flexible individual growth modeling methods. The study will specify behavioral and psychological factors that mediate IT and UC response, promoting the development of interventions targeting these mechanisms and of well validated protocols for the selection of patients for IT.