DIABETES CONTROL AND COMPLICATIONS TRIAL

这项拨款提案是对NIH RFA参与一项 合作20中心研究，其最终目标是 确定血糖控制水平是否为胰岛素依赖型 糖尿病患者是糖尿病发展的一个主要因素 这个特别的应用程序只关注 这一长期项目的可行性试验阶段。具体目标 这一阶段的目的是确定是否有可能(1)随机化 胰岛素依赖型糖尿病患者分为两组，一组为 一组为常规治疗组，一组为强化治疗组。 (2)加大教育力度，控制饮食，控制胰岛素治疗， 锻炼等，有没有可能显著改善代谢控制， 尤指血液波动的正常化或接近正常化 葡萄糖。(3)能否以合理的成本安全、有效地完成这项工作？ 病人能接受吗？(4)有这样的副作用吗？ 作为情绪障碍，这可能是强化治疗的结果？ 我们希望招募10名典型的胰岛素缺乏型糖尿病患者 我们匹兹堡儿童医院的糖尿病门诊人群 在大学健康中心，将他们随机分成两组， 保持传统疗法于一体，并提供越来越多的关注， 改善代谢控制的教育、指导和刺激 第二组。患者将被纳入临床研究 初始评估中心，非常完整的评估，这将在以下时间再次完成 这项研究的完成。干预性入院治疗将是 视需要而安排的。代谢控制的详细观察 还将进行心理评估，包括 入场时将进行认知评估和情感评估 和终结者。终端确定也将记录在 外周视网膜血管改变的进入和终止观察 血管改变，周围神经功能和详细的评估 肾功能和骨钙化。

This grant proposal is a response to an NIH RFA to participate in a collaborative 20 center study, the ultimate objective of which is to determine whether the level of blood glucose control in insulin-dependent diabetic patients is a major factor in the development of "diabetic complications." This particular application focuses solely on the feasibility trial phase of this long term project. The specific objectives of this phase are to determine whether it is possible to (1) Randomize insulin dependent diabetic patients into two treatment groups, one a conventional treatment group and the other an intensive treatment group. (2) By increasing the intensity of education, diet control insulin therapy, exercise, etc., is it possible to significantly improve metabolic control, particularly normalization or near normalization of fluctuations in blood glucose. (3) Can this be done safely, effectively, and at reasonable cost and is it acceptable to the patients? (4) Are there adverse effects such as emotional distrubance which may be a consequence of intensive therapy? We expect to recruit 10 classical insulin-deficient diabetic patients from our diabetic clinic populations at the Children's Hospital of Pittsburgh and at the University Health Center, randomize them into two groups, maintaining conventional therapy in one and providing increasing attention, education, direction, and stimulation for improving metabolic control in the second group. The patients will be admitted to the Clinical Research Centers for inital, very complete evaluation and this will be done again at the completion of the study. Intervening hospital admissions will be arranged as deemed necessary. Detailed observations on metabolic control will be carried out in addition, psychological evaluation including cognitive assessment and emotional assessment will be carried out at entry and termination. Endpoint determinations also will be documented with entry and termination observations on retinal vascular changes, peripheral vascular alterations, peripheral nerve function, and detailed assessment of renal function and bone calcification.