NAVIGATOR CONTINUOUS GLUCOSE SENSOR TO MANAGE PEDIATRIC TYPE 1 DIABETES

用于管理儿童 1 型糖尿病的 NAVIGATOR 连续血糖传感器

• 批准号: 7377060
• 负责人: EVA TSALIKIAN
• 金额: $ 1.82万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377060
• 关键词: NAVIGATOR; CONTINUOUS; GLUCOSE; SENSOR; MANAGE

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。对频繁血糖监测的抵制是实现良好（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”血糖控制）可降低糖尿病眼、肾和神经并发症的可能性。增加血糖监测频率是 DCCT 中改善血糖控制的一个重要方面。 DCCT 的结果是，许多医生试图对儿童和成人进行非常“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 无法使用安全实施严格血糖控制的工具。 TheraSense 开发的 Navigator 旨在帮助更密切地监测血糖水平。 Navigator 在儿童 1 型糖尿病管理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 Navigator 与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，我们将进行一项试点研究，受试者将在其家庭环境中使用导航器。