NAVIGATOR: GLUCOSE SENSOR IN THE MANAGEMENT OF TYPE-1 DIABETES IN CHILDREN

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。假设：对频繁的血糖监测的抵抗是实现良好的(较低的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Navigator(TM)有助于更密切地监测血糖水平。我们预计，Navigator连续血糖监测仪将在儿童糖尿病的管理中发挥重要作用。因此，这项研究的结果可能对糖尿病儿童有利。我们假设，来自传感器的血糖信息以及为管理决策提供的说明将对受试者的糖尿病自我管理有用。这项初步研究将包括大约30名3至7岁的1型糖尿病患者，下午将完成中等强度的运动。这使得可以在运动期间评估导航器功能，并评估检测血糖变化的准确性。对于体重足以容纳所需血量的受试者，早餐后每10分钟测量一次血糖，持续一小时。这使得可以评估导航仪在血糖升高期间检测变化的准确性。回顾了入院前的导航仪、HGM和PUMP数据，并根据需要对糖尿病管理进行了更改。为受试者和家长提供广泛的教学，以使用协议开发的算法，以便在受试者离开GCRC后，根据导航器数据实时使用糖尿病管理的改变。每个主题都提供了下载导航器的说明。

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. Hypothesis: 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. As a result of 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(TM) by TheraSense has been developed to assist in closer monitoring of glucose levels. We expect that the Navigator continuous glucose monitor will have an important role in the management of diabetes in children. Therefore, the results of this study are likely to be beneficial for children with diabetes. We hypothesize that the blood sugar information from the sensor along with the instructions provided for management decisions will be useful for the subject's diabetes self-management. This pilot study will include approximately 30 subjects with Type-1 Diabetes aged 3 to 7 years old, an exercise session of moderate intensity is completed in the afternoon. This allows for assessment of Navigator function during exercise and assessment of the accuracy of detecting changes in blood glucose. For subjects of sufficient weight to accommodate the volume of blood required, blood glucose measurements are made every 10 min for one hr after breakfast. This allows for assessment of the accuracy of the Navigator in detecting change during a period of rising blood glucose. The pre-admission Navigator, HGM, and pump data are reviewed and changes are made to diabetes management as needed. Subjects and parents are provided with extensive teaching to use the protocol-developed algorithms for changes to diabetes management to be used in real time based on Navigator data after the subject leaves the GCRC. Each subject is provided with the instructions for downloading the Navigator.