NAVIGATOR CONTINUOUS GLUCOSE SENSOR TO MANAGE PEDIATRIC TYPE 1 DIABETES

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 对频繁血糖监测的抵抗是实现良好(较低HbA1c水平)血糖控制的主要障碍。糖尿病控制和并发症试验(DCCT)令人信服地证明，血糖控制接近正常范围(“严格的”血糖控制)可降低糖尿病眼、肾和神经并发症的可能性。增加血糖监测的频率是改善DCCT血糖控制的一个重要方面。作为DCCT的结果，许多医生试图让儿童和成年人保持非常严格的血糖控制。不幸的是，DCCT研究还显示，强化治疗组的严重低血糖发生率是标准治疗组的三倍。DCCT无法获得安全实施严格血糖控制的工具。TheraSense公司开发的导航仪有助于更密切地监测血糖水平。 导航仪在儿童1型糖尿病治疗中的适当作用尚未确定。我们正在计划一项随机临床试验(RCT)，以比较使用导航仪和标准护理对血糖控制、低血糖和生活质量的影响。作为RCT的前奏，我们将进行一项试验性研究，受试者将在他们的家庭环境中使用导航器。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Resistance to frequent blood glucose monitoring is a major impediment to attaining good (lower HbA1c level) glucose control. The Diabetes Control and Complications Trial (DCCT) convincingly proved that glucose control closer-to-normal range ("tight" glycemic control) reduced the likelihood of the eye, kidney, and nerve complications of diabetes. Increasing the frequency of glucose monitoring was an important aspect of attaining improved glucose control in the DCCT. As a result of the the DCCT, many physicians have attempted to keep children and adults in very "tight" glucose control. Unfortunately, the DCCT study also showed that the incidence of severe hypoglycemia was three times higher in the intensively treated group compared with the standard treatment group. The tools to safely implement tight glycemic control were not available to the DCCT. The Navigator by TheraSense has been developed to assist in closer monitoring of glucose levels. The proper role of the Navigator in the management of type 1 diabetes in children has not been determined. We are planning a randomized clinical trial (RCT) to compare the effect on glycemic control, hypoglycemia, and quality of life of using a Navigator versus standard care. As a prelude to the RCT, we will conduct a pilot study in which subjects will use the Navigator in their home environment.