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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。TheraSense公司开发的Navigator™是为了帮助更密切地监测血糖水平。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Navigator的可行性及其准确性，为随机临床试验做准备。30名患有1型糖尿病的儿童（3至17岁，含）将在5个临床中心入组。每个受试者将在注册时接受使用导航器的培训，并在家中佩戴大约1周。受试者将输入信息，但不知道血糖水平。在一周结束时，受试者将佩戴两个Navigator设备在临床研究中心度过24小时。所有受试者将进行频繁的血液采样和餐源性高血糖测试。七岁以上的受试者将完成一项跑步机运动测试。出院前，受试者将获得一套给药算法，这将指导他们如何使用Navigator数据来改变他们的糖尿病治疗方案。受试者将在CRC入院后1、3、7和13（+1）周进行随访，并在CRC入院后3天（+1天）、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和评估遵守使用的算法。每周受试者将被要求下载Navigator并通过电子邮件发送结果。在13周的访问中，受试者可以自愿使用导航器再使用13周。在此期间不会有研究者发起的联系，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.