Glucose Sensors in Children with Type I Diabetes

描述(由申请人准备)：本申请的具体目的是 确定1型儿童是否可以安全地改善血糖控制 使用连续血糖监测(CGM)导致的糖尿病。在一个 初步可行性试验，将两种CGM装置的准确性进行比较 儿童GCRC患者的静脉血糖水平。患有和不患有糖尿病的儿童 将在GCRC度过24小时。这也将有助于对儿童进行分类 糖尿病患者(每30人中就有1人)对葡萄糖手表有过度皮肤反应， 或者不能忍受皮下CGM传感器的人。患有糖尿病的儿童 然后随机进行为期三个月的可行性试验，使用 GLucoWatch传记作者或MiniMed CGM或作为对照。 儿童将被选入可行性研究和为期两年的研究，他们是 要么使用强化糖尿病管理，要么致力于 向强化糖尿病管理迈进。他们必须至少愿意做 每天四次自我血糖监测(SBGM)。他们将会是 随机接受两年的治疗，包括使用四个月的六个月 每周(两天/两晚)GLucoWatch传记作者，使用 MiniMed CGMS，以及六个月的控制期。 主要终点将是HbA1c水平的变化和 低血糖症。HbA1c水平将初步确定，每三次 几个月，或可行性试验中的一个月和三个月，目标是 达到HbA1c值低于7%。ALL的发病率 将比较三组的低血糖事件和严重低血糖事件。 治疗组在三个月的可行性和两年较长的试验。 此外，在较长时间的试验中，每个人都将作为自己的对照 因为他们被随机分配到三个研究组中的每一个。二次端 积分将是酮症酸中毒发作、体重指数变化、感应器数量 使用，胰岛素剂量，使用胰岛素泵，使用碳水化合物计数， 每天进行SBGM测试的次数以及对低血糖和 生活质量调查问卷。生活质量与对低血糖的恐惧 问卷将被用来评估两个人的心理因素 可行性和为期两年的试验中的因素。

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.