Yale Study of Closed-Loop Automated Glucose Control for Hypoglycemia Prevention

耶鲁大学闭环自动血糖控制预防低血糖的研究

• 批准号: 7323862
• 负责人: STUART ALAN WEINZIMER
• 金额: $ 23.1万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7323862
• 关键词: Achievement; Adolescent; Age; Anxiety; Blood Glucose; Blood Glucose Self-Monitoring; Carbohydrates; Child; Childhood; Clinic; Clinical; Clinical Research; Clinical Trials; Count; Cross-Sectional Studies; Daily; Diabetes Mellitus; Effectiveness; Event; Exercise; External Infusion Pumps; Frequencies; Fright; Future; Glucose; Glycosylated hemoglobin A; Grant; Guidelines; Health Personnel; Home environment; Hormones; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Infusion procedures; Injection of therapeutic agent; Inpatients; Insulin; Insulin-Dependent Diabetes Mellitus; Measurement; Methods; Neuropathy; Outcome; Parents; Patients; Pilot Projects; Prevention; Progress Reports; Protocols documentation; Pump; Randomized; Randomized Controlled Trials; Rate; Research; Research Design; Research Personnel; Resources; Risk; School-Age Population; Schools; Severities; Standards of Weights and Measures; Study Section; System; Testing; Time; Validation; Week; Youth; base; blood glucose regulation; glucose monitor; hypoglycemia unawareness; improved; monitoring device; prevent; prospective; response; subcutaneous; systems research; young adult

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.

描述（由申请人准备）：糖尿病控制的结果和 并发症 试验表明，大多数 1 型糖尿病 (T1DM) 患者 应接受强化治疗以降低微血管和 神经性并发症。事实证明，严格控制糖尿病可以 可以在患有 T1DM 的青少年中实现，但代价是难以接受的高 严重低血糖事件的发生频率，尤其是年轻患者。 此外，使用新型连续葡萄糖传感系统的试点研究 患有 T1DM 的青少年表明，许多血糖从高值到低值的波动是由于 无症状且未通过自我血糖监测 (SBGM) 检测到。 因此，研究人员正在提交申请，希望成为该中心的一个中心。 儿童 1 型糖尿病研究网络评估其效用 连续血糖监测设备可改善糖尿病控制和 预防青少年 T1DM 低血糖。作为第一步， 研究人员提议验证 MiniMed Continuous 的准确性 患有和不患有 T1DM 的儿童的血糖监测系统 (CGMS) 在住院诊所和研究中心频繁测量血糖 环境。接下来，CGMS 将用于一项大型横断面研究 描述并比较低血糖和高血糖的频率和严重程度 按年龄（学前、学龄、青少年）、胰岛素类型 治疗（注射与泵），以及 HbA1c 水平（目标内与 高于目标）。验证和横断面研究还将提供 测试当前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成分，以及 下午运动对夜间低血糖的影响。这 研究人员还提议进行一项随机、前瞻性临床试验 检查是否在 24 周内每六周重复使用一次 CGMS 与传统 SBGM 结合使用比单独使用 SBGM 更有效 改善糖尿病控制，降低低血糖风险，并减少 患者和家长？焦虑和对低血糖的恐惧。介绍 连续葡萄糖传感的新方法有望成为最重要的 近20年来T1DM治疗的进展。临床资源 研究和网络的专业知识也将使研究人员能够 评估当前和未来血糖对 T1DM 儿童的有用性 科学严谨、及时的传感系统。