PILOT ST -EVAL NAVIGATOR CONTINUOUS GLUCOSE SENSOR IN MANGMT OF TYPE1 DIABETES

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。TheraSense开发的导航器旨在帮助更密切地监控血糖水平。在这项由美国国立卫生研究院资助的试点研究中，将研究使用导航仪的可行性及其准确性，为随机临床试验做准备。将在5个临床中心招募30名患有1型糖尿病的儿童(3至17岁，包括3岁至17岁)。每个受试者将在注册时接受使用导航器的培训，并将在家中佩戴导航器约1周。受试者将输入信息，但对血糖水平视而不见。在本周末，受试者将在临床研究中心度过24小时，佩戴两个导航器设备。所有受试者都将进行频繁的血液采样和膳食诱导的高血糖测试。7岁以上的受试者将完成一项跑步机运动测试。在出院前，受试者将被给予一套剂量算法，这些算法将指导他们如何使用导航器数据来改变他们的糖尿病治疗方案。受试者将在入院后1、3、7和13(+1)周进行随访，并在入院后3天(+1天)进行电话联系，然后在入院后2、4、8和10周(+1周)进行电话联系。访问和电话的目的将是审查他们的糖尿病管理，并评估对算法使用的遵守情况。每周，受试者都会被要求下载导航器并通过电子邮件发送结果。在为期13周的访问中，受试者可以自愿再使用导航器13周。在此期间，不会有调查人员发起的联系，但家属可以自由联系研究人员。

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. The Navigator¿ by TheraSense has been developed to assist in closer monitoring of glucose levels. In this pilot study funded by the NIH, feasibility of using the Navigator and its accuracy will be studied in preparation for a randomized clinical trial. 30 children (ages 3 to 17 years, inclusive) with type 1 diabetes will be enrolled across 5 clinical centers. Each subject will be trained to use the Navigator at enrollment and will wear it at home for approximately 1 week. The subjects will enter information but be blinded to the glucose levels. At the end of the week, subjects will spend 24 hours in the clinical research center wearing two Navigator devices. All subjects will have frequent blood sampling and a meal-induced hyperglycemia test. Subjects over the age of seven will complete a treadmill exercise test. Prior to discharge, subjects will be given a set of dosing algorithms, which will instruct them how to use the Navigator data to make changes to their diabetes regimen. Subjects will have follow-up visits at 1, 3, 7, and 13 (+1) weeks after the CRC admission and phone contacts at 3 days (+1 day), then at 2, 4, 8, and 10 weeks (+1 week) post CRC admission. The purpose of the visits and calls will be to review their diabetes management and assess compliance with use of the algorithms. Each week subjects will be asked to download the Navigator and email the results. At the 13-week visit, subjects may volunteer to use the Navigator for another 13 weeks. There will be no investigator-initiated contact during this time, but families may contact study personnel freely.