Prevention of Nocturnal Hypoglycemia: Effect on Neurologic Outcome in Toddlers

预防夜间低血糖：对幼儿神经系统结果的影响

• 批准号: 7323928
• 负责人: BRUCE A BUCKINGHAM
• 金额: $ 22.12万
• 依托单位: STANFORD 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/7323928
• 关键词: 5 year old; Adolescent; Age; Age-Years; Aged, 80 and over; Alder plant; Algorithms; Anesthesia procedures; Anisotropy; Area; Area Under Curve; Attention; Auditory; Beds; Blood Glucose; Brain; Brain imaging; Cerebrum; Child; Child Development; Classification; Clinical Trials; Cognitive; Cognitive deficits; Control Groups; Data; Detection; Development; Diabetes Mellitus; Diffusion Magnetic Resonance Imaging; Eating; Effectiveness; Episodic memory; Evaluation; Event; Exposure to; Frequencies; Fright; Future; Gender; Glucose; Glycosylated hemoglobin A; Goals; Hippocampus (Brain); Home environment; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Imaging Techniques; Incidence; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Knowledge; Laboratories; Longitudinal Studies; MRI Scans; Magnetic Resonance Imaging; Measurement; Measures; Memory; Monitor; Neurocognitive; Neurologic; Neurological outcome; Neuropsychological Tests; Numbers; Observational Study; Outcome; Outcome Measure; Parents; Patients; Physical activity; Physiological; Population; Prevention; Principal Investigator; Protocols documentation; Publishing; Quality of life; Randomized; Randomized Controlled Clinical Trials; Range; Reactive hypoglycemia; Reading; Relative (related person); Research Personnel; Risk; Role; Score; Security; Seizures; Severities; Short-Term Memory; Siblings; Sleep; Standards of Weights and Measures; Structure; System; Testing; Time; Toddler; Unconscious State; United States National Institutes of Health; Upper arm; Visual; age group; clinically significant; cognitive function; design; diabetes management; diabetic; early onset; executive function; frontal lobe function; glucose monitor; glucose sensor; glycemic control; gray matter; improved; indexing; lifetime risk; neurocognitive test; neuropsychological; non-diabetic; prevent; processing speed; prospective; psychologic; sensor; sex; skills; tool; vigilance; white matter

DESCRIPTION (prepared by applicant): The investigators propose to develop a systematic approach to evaluating near continuous glucose sensors in children and adolescents. This approach can be used in the assessment of current sensors now available to the public, and for future sensors that become available during this project. Accuracy will be determined using normal controls and children with diabetes. Initial accuracy measurements will be performed in a CRC using a laboratory quality measurement of glucose. The sensors will then be assessed in the home environment to determine their usefulness in detecting changes in blood glucose levels and improving diabetes management. The investigators will collect detailed record of food intake, and a continuous record of physical activity will be obtained using an accelerometer as well as psychological assessments. These data will be integrated to evaluate the multiple factors leading to hypoglycemia and variability in blood glucose levels, as well as provide effective tools for improving diabetes management. In the future these data will be valuable in developing algorithms that incorporate this information into a closed loop insulin delivery system. Aim 1 is to determine the accuracy of near-continuous glucose monitors in normal children. This will allow assessment of the possible physiologic effects, such as sleep and physical activity on glucose levels. These studies will also allow determination of the incidence of sensor readings in the hypoglycemic range despite normal blood glucose levels. Aim 2 is to determine the accuracy of near-continuous glucose sensors in children with diabetes. Particular attention will be given to the detection of hypoglycemia, especially nocturnal hypoglycemia, and the accuracy of sensors during physical activity. Aim 3 is to assess hypoglycemia in a contemporaneous population of children with Type 1 diabetes using near continuous glucose monitoring. This will be an observational study in a home environment. Aim 4 is to assess the long-term effectiveness of near continuous glucose monitoring on decreasing the frequency and severity of hypoglycemic reactions, and improving glycemic control.

描述（由申请人准备）：研究人员建议开发一种 评估儿童近连续血糖传感器的系统方法 和青少年。该方法可用于评估当前 传感器现在可供公众使用，并且未来的传感器将成为 在此项目期间可用。准确度将使用正常值来确定 对照组和患有糖尿病的儿童。初始精度测量将是 在 CRC 中使用实验室葡萄糖质量测量进行。这 然后将在家庭环境中评估传感器以确定其 在检测血糖水平变化和改善糖尿病方面有用 管理。研究人员将收集食物摄入量的详细记录， 并且将使用以下方法获得身体活动的连续记录 加速度计以及心理评估。这些数据将 综合评估导致低血糖的多种因素 血糖水平的变异性，并提供有效的工具 改善糖尿病管理。未来这些数据将具有价值 开发将这些信息合并到闭环中的算法 胰岛素输送系统。目标 1 是确定 正常儿童的近乎连续的血糖监测仪。这将允许 评估可能的生理影响，例如睡眠和身体 对葡萄糖水平的活动。这些研究还将确定 尽管正常，但传感器读数处于低血糖范围的发生率 血糖水平。目标 2 是确定近连续的精度 糖尿病儿童的葡萄糖传感器。将给予特别关注 检测低血糖，特别是夜间低血糖，以及 身体活动期间传感器的准确性。目标 3 是评估低血糖情况 在同期患有 1 型糖尿病的儿童群体中，使用近 连续血糖监测。这将是一项在家中进行的观察性研究 环境。目标 4 是评估近期的长期有效性 连续血糖监测可降低糖尿病的发生频率和严重程度 低血糖反应，改善血糖控制。