Glucose Sensors and Hypoglycemia in Children with DM

描述（由申请人提供）：目前接受强化治疗 作为标准治疗，以降低长期并发症的风险， 所有年龄段的糖尿病患者。然而，强化治疗经常 并发低血糖与成人、幼儿和 青少年有更多的生活方式特征，使他们更容易 低血糖，然后成为一个危险的并发症和主要限制 强化治疗和良好的糖尿病控制因素。目前的家 葡萄糖监测能力，很难准确定义真正的 糖尿病儿童低血糖的发生率、持续时间和严重程度。 连续葡萄糖监测系统（CGMS）最近变得可用， 一个更仔细地检查血糖模式的工具，通过记录高达288 每天进行864次葡萄糖测量（72小时内的864次葡萄糖读数）。的 本研究的目的是阐明低血糖的程度， 导致儿童低血糖的因素， 糖尿病 在这项描述性研究中，将研究四个年龄组的儿童： 定义为2-6岁、6-10岁、10-14岁和14-18岁的儿童。按年龄分类 将确保不同年龄的儿童的适当样本，以及 大规模青春期前队列。18名糖尿病儿童将被纳入 每个年龄组共72例糖尿病患者。九个孩子 将作为每个年龄组的对照， 正常生理葡萄糖变异性。在四年的数据中， 收集，受试者将参与一到三年，具体取决于 注册时间。他们将在三天内安装CGMS， 每季度、每隔一周和周末间隔。数据将于 孩子呢患者的病史、血糖水平、基因分型和饮食 摄入活动将通过加速度计进行监测。认知功能， 学校表现、行为和对糖尿病的适应将被测量为 导致低血糖风险的潜在因素。总之，CGMS 将提供关于低血糖的有价值的信息 频率和严重程度，以及与此严重 儿童糖尿病强化管理的并发症。

DESCRIPTION (provided by applicant): Intensive therapy is currently accepted as the standard of care to reduce the risk of long term complication in patients with diabetes of all ages. However, intensive therapy is frequently complicated by hypoglycemia. In comparison to adults, young children and adolescents have even more lifestyle characteristics that make them prone to hypoglycemia, which then becomes a dangerous complication and a major limiting factor of intensive treatment and good diabetes control. With current home glucose monitoring capabilities it is difficult to accurately define the true incidence, duration, and severity of hypoglycemia in children with diabetes. A continuous glucose monitoring system (CGMS) has recently become available as a tool to more closely examine blood glucose patterns, by recording up to 288 glucose measurements a day (864 glucose readings over a 72 hour period). The purpose of the proposed study is to elucidate the extent of hypoglycemia and the factors that contribute to hypoglycemia in children with and without diabetes. In this descriptive study, four age groups of children will be studied: defined by children 2-6, 6-10, 10-14, and 14-18 years of age. Grouping by age will assure an appropriate sample of children of different ages, as well as a large prepubertal cohort. Eighteen children with diabetes will be included in each age group for a total of 72 patients with diabetes. Nine children without diabetes will serve as controls for each age group in order to study the normal physiologic glucose variability. During the four years of data collection, subjects will participate for one to three years, depending on the time of enrollment. They will be fitted with the CGMS for three days, quarterly, alternating week, and weekend intervals. Data will be obtained on the child?s medical history, blood glucose levels, genotyping, and dietary intake. Activity will be monitored by accelerometry. Cognitive functioning, school performance, behavior, and adjustment to diabetes will be measured as potential factors contributing to the risk of hypoglycemia. In summary, CGMS in children with diabetes will provide valuable information on hypoglycemia frequency and severity, and the risk factors associated with this serious complication of intensive diabetes management in children.