Yale Center in The Children's Glucose Sensor Network

描述（由申请人编写）：糖尿病控制和 1型糖尿病（T1DM）患者的饮食习惯有哪些？ 应接受强化治疗，以降低微血管和 神经性并发症事实证明，严格的糖尿病控制可以 在青年T1DM患者中实现，但代价是不可接受的高 严重低血糖事件的频率，尤其是在年轻患者中。 此外，使用新的连续葡萄糖传感系统的试点研究， 患有T1DM的年轻人表明，许多葡萄糖从高值到低值的波动， 无症状且未被自我血糖监测（SBGM）检测到。 因此，研究人员提交了一份申请， 儿童1型糖尿病研究网络评估的效用 持续葡萄糖监测设备，用于改善糖尿病控制， 预防青年T1DM患者的低血糖。作为第一步 研究者建议验证MiniMed连续 血糖监测系统（CGMS）在儿童和非T1DM， 在住院诊所和研究中心频繁测量血糖 设置.接下来，CGMS将用于一项大型横断面研究， 描述和比较低血糖和高血糖的频率和严重程度 按年龄（学龄前vs学龄vs青少年）、胰岛素类型 治疗（注射vs泵）和HbA1c水平（目标内vs 高于目标）。验证和横断面研究也将提供 测试现行管理准则有效性的机会 关于碳水化合物的计算和睡前零食的组成，以及 下午锻炼对夜间低血糖的影响。的 研究人员还提出了一项随机前瞻性临床试验， 检查是否重复使用CGMS每六周一次，持续24周， 与常规SBGM结合比单独SBGM更有效， 改善糖尿病控制，降低低血糖风险， 病人？s和父母？焦虑和对低血糖的恐惧。引入 新的连续葡萄糖传感方法有望成为最重要的 综述了近20年来T1DM的治疗进展。临床资源 网络中的研究和专业知识也将使调查人员能够 评估当前和未来血糖对T1DM儿童的有用性 以科学严谨和及时的方式检测系统。

DESCRIPTION (prepared by applicant): Results of the Diabetes Control and Complications Trial indicate that most patients with type 1 diabetes (T1DM) should receive intensive treatment to lower the risk of microvascular and neuropathic complications. It has been shown that strict diabetes control can be achieved in youth with T1DM but at the expense of unacceptably high frequency of severe hypoglycemic events, especially in younger patients. Moreover, pilot studies using new continuous glucose sensoring systems in youth with T1DM indicate that many glucose swings from high to low values are asymptomatic and are not detected by self blood glucose monitoring (SBGM). Thus the investigators are submitting an application to be a center in the Type 1 Diabetes in Children Research Network to evaluate the utility of continuous glucose monitoring devices in improving diabetes control and preventing hypoglycemia in youth with T1DM. As a first step, the investigators are proposing to validate the accuracy of the MiniMed Continuous Glucose Monitoring System (CGMS) in children with and without T1DM against frequent blood glucose measurements in an inpatient Clinic and Research Center setting. Next, the CGMS will be used in a large, cross-sectional study to characterize and compare the frequency and severity of hypo and hyperglycemia by age (pre-school versus school age versus adolescents), type of insulin treatment (injections versus pump), and by HbA1c level (within target versus above target). Validation and cross-sectional studies will also provide the opportunity to test the effectiveness of current management guidelines regarding carbohydrate counting and the composition of bedtime snacks, as well as the impact of afternoon exercise on nocturnal hypoglycemia. The investigators are also proposing a randomized, prospective clinical trial to examine whether repeated use of the CGMS every six weeks for 24 weeks in conjunction with conventional SBGM is more effective than SBGM alone in improving diabetes control, lowering the risk for hypoglycemia, and reducing patient?s and parents? anxiety and fears of hypoglycemia. The introduction of new methods of continuous glucose sensoring promises to be the most important advance in therapy of T1DM in the past 20 years. The resources for clinical research and the expertise in the Network will also allow the investigators to assess the usefulness for children with T1DM of current and future glucose sensoring systems in a scientifically rigorous and timely manner.