Yale Center in The Children's Glucose Sensor Network

描述(由申请人准备)：糖尿病控制和治疗结果 并发症试验表明，大多数1型糖尿病(T1 DM)患者 应接受强化治疗，以降低微血管和 神经性并发症。已有研究表明，严格控制糖尿病可以 在患有T1 DM的年轻人中实现，但代价是高得令人无法接受 严重低血糖事件的频率，特别是在较年轻的患者中。 此外，使用新的连续血糖传感系统的试点研究 患有T1 DM的年轻人表明，许多血糖从高到低的波动是 无症状，自身血糖监测(SBGM)检测不到。 因此，调查人员正在提交一份申请，希望成为 1型糖尿病在儿童研究网络中的应用 连续血糖监测设备在改善糖尿病控制和治疗中的作用 预防青年T1 DM患者的低血糖。作为第一步， 调查人员提议验证MiniMed连续测试的准确性 1型糖尿病与非1型糖尿病儿童血糖监测系统的对比研究 住院患者临床和研究中心的频繁血糖测量 布景。接下来，将在一项大型横断面研究中使用CGMS 描述并比较低血糖和高血糖的频率和严重程度 按年龄(学龄前与学龄与青少年)、胰岛素类型 治疗(注射与泵)和HbA1c水平(在目标范围内与 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 关于碳水化合物计数和睡前零食的组成 以及下午锻炼对夜间低血糖的影响。这个 研究人员还提议进行一项随机、前瞻性的临床试验，以 检查是否在24周内每六周重复使用CGMS 与传统的SBGM联合使用比单独使用SBGM更有效 改善糖尿病控制，降低低血糖风险，减少 病人？S和父母？对低血糖的焦虑和恐惧。介绍了 连续血糖传感的新方法有望成为最重要的 近20年来T1 DM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T1 DM儿童的有效性 以科学严谨和及时的方式对传感系统进行检测。

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.