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: 7502078
• 负责人: BRUCE A BUCKINGHAM
• 金额: $ 21.68万
• 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/7502078
• 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)：调查人员建议制定一项 评价儿童近连续型血糖传感器的系统方法 和青少年。这一方法可以用于评估当前的 传感器现已向公众开放，并适用于未来将成为 在此项目期间可用。准确度将使用NORMAL确定 对照组和患有糖尿病的儿童。最初的精度测量将是 在CRC中进行，使用实验室质量测量的葡萄糖。这个 然后在家庭环境中对传感器进行评估，以确定其 检测血糖水平变化和改善糖尿病的有用性 管理层。调查人员将收集食物摄入量的详细记录， 和连续的身体活动记录将使用 加速计以及心理评估。这些数据将是 综合评估导致低血糖的多种因素和 血糖水平的可变性，以及提供有效的工具 改善糖尿病管理。在未来，这些数据将在 开发将这些信息合并到一个闭环系统中的算法 胰岛素输送系统。目标1是确定以下各项的准确性 正常儿童的血糖监测仪近乎连续。这将允许 评估可能的生理影响，如睡眠和生理 活动对葡萄糖水平的影响。这些研究还将使我们能够确定 传感器读数在低血糖范围内的发生率，尽管正常 血糖水平。目标2是确定近连续的精度 糖尿病儿童的血糖传感器。我们会特别注意 用于检测低血糖，特别是夜间低血糖，以及 体力活动时传感器的准确性。目标3是评估低血糖 在使用NEAR的同期1型糖尿病儿童人群中 持续的血糖监测。这将是一项在家里进行的观察性研究 环境。目标4是评估NEAR的长期有效性 持续血糖监测对降低心绞痛发生频率和严重程度的作用 降糖反应，改善血糖控制。