Glucose Sensors in Children with Type I Diabetes

说明（由申请人准备）：本申请的具体目的是 以确定是否可以安全地改善1型糖尿病儿童的血糖控制， 糖尿病是由于使用连续葡萄糖监测（CGM）。中 在初步可行性试验中，将比较两种CGM设备的准确性， 儿科GCRC中的静脉葡萄糖水平。有糖尿病和无糖尿病的儿童 将在GCRC待上24小时这也将有助于梳理儿童 对GlucoWatch有过度皮肤反应的糖尿病患者（1/30）， 或无法耐受皮下CGM传感器的患者。糖尿病儿童 然后将被随机分配到一个为期三个月的可行性试验中， GlucoWatch Biographer或MiniMed CGMS或作为对照。 儿童将被选为可行性和为期两年的研究谁是 无论是使用密集的糖尿病管理，还是致力于移动 强化糖尿病管理。他们必须至少愿意 每天进行四次自我血糖监测（SBGM）。他们将 随机分配到两年的治疗，包括六个月的使用四 每周（两天/两晚），使用GlucoWatch Biographers六个月 MiniMed CGMS和6个月的对照期。 主要终点将是HbA1c水平的变化和 低血糖HbA1c水平将在最初和每三个 一个月，或在一个和三个月的可行性试验，目标是 HbA1c值低于7%。所有的发病率 低血糖事件和严重低血糖将进行比较， 治疗组在三个月的可行性和两年更长的试验。 此外，每个人将在较长的试验中作为自己的对照 因为他们被随机分配到三个研究组。次级端 点将是酮症酸中毒发作、BMI变化、传感器数量 使用的胰岛素、胰岛素剂量、胰岛素泵的使用、碳水化合物计数的使用， 每天进行的SBGM测试次数以及对低血糖的恐惧和 生活质量标准。生活质量和对抑郁症的恐惧 问卷将被用来评估心理因素， 可行性和两年试验的因素。

DESCRIPTION (prepared by applicant): The specific aim of this application is to determine if glucose control can be safely improved in children with type 1 diabetes as a result of using continuous glucose monitoring (CGM). In an initial feasibility trial, accuracy of the two CGM devices will be compared to venous glucose levels in a Pediatric GCRC. Children with and without diabetes will spend 24 hours in the GCRC. This will also help to sort out children with diabetes (1 in 30) who have excessive skin reactions to the GlucoWatch, or who cannot tolerate subcutaneous CGM sensors. The children with diabetes will then be randomized to a feasibility three-month trial of either using the GlucoWatch Biographer or the MiniMed CGMS or serving as a control. Children will be selected for the feasibility and the two-year study who are either using intensive diabetes management or who are committed to moving toward intensive diabetes management. They must be willing to do at least four self-blood glucose monitoring (SBGM) tests each day. They will be randomized to two years of treatment, including six months of using four GlucoWatch Biographers per week (two day/two night), six months of using the MiniMed CGMS, and a six month control period. Primary end points will be change in HbA1c levels and the incidence of hypoglycemia. HbA1c levels will be determined initially and every three months, or at one and three months in the feasibility trial, with a goal of achieving HbA1c values less than seven percent. The incidence of all hypoglycemic events and of severe hypoglycemia will be compared for the three treatment groups in the three-month feasibility and the two-year longer trial. In addition, each person will serve as their own control in the longer trial as they are randomized to each of the three study groups. Secondary end points will be episodes of ketoacidosis, change in BMI, numbers of sensors used, insulin dose, use of an insulin pump, use of carbohydrate counting, number of SBGM tests done per day and changes in Fear of Hypoglycemia and Quality of Life Questionnaires. Quality of Life and Fear of Hypoglycemia Questionnaires will be used to evaluate psychological factors in both the factors in both the feasibility and the two-year trials.