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

PILOT ST -EVAL NAVIGATOR 连续血糖传感器用于治疗 1 型糖尿病

• 批准号: 7374389
• 负责人: H PETER CHASE
• 金额: $ 1.35万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-24 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7374389
• 关键词: aging; blood; blood glucose; children; clinical research; clinical trials; exercise; family; glucose; hyperglycemia; insulin dependent diabetes mellitus; literature survey; patient monitoring device; training

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.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。TheraSense开发的Navigator用于协助更密切地监测血糖水平。在这项由NIH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。将在5个临床中心入组30名1型糖尿病儿童（3 - 17岁，含）。 每例受试者将接受入组时使用Navigator的培训，并将在家中佩戴约1周。受试者将输入信息，但对葡萄糖水平不知情。在一周结束时，受试者将在临床研究中心度过24小时，佩戴两个Navigator设备。所有受试者将频繁采血并进行餐后高血糖试验。7岁以上的受试者将完成跑步机运动测试。出院前，将为受试者提供一组给药算法，指导他们如何使用Navigator数据来改变其糖尿病治疗方案。受试者将在CRC入院后1、3、7和13（+1）周接受随访访视，并在CRC入院后3天（+1天）、2、4、8和10周（+1周）进行电话联系。访视和电话的目的是审查他们的糖尿病管理并评估使用算法的依从性。每周将要求受试者下载导航器并通过电子邮件发送结果。 在第13周访视时，受试者可自愿再使用Navigator 13周。在此期间，将不会有监护人发起的联系，但家属可以自由联系研究人员。