Prevention of Hypoglycemia and Associated Complications in Type 1 Diabetes

预防 1 型糖尿病的低血糖及相关并发症

• 批准号: 7932067
• 负责人: EVA TSALIKIAN
• 金额: $ 32.51万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7932067
• 关键词: Address; Adolescent; Affect; Age; Anatomy; Area; Blood Glucose; Brain; Broca' s area; Carbohydrates; Characteristics; Child; Childhood; Cognitive; Cross-Sectional Studies; Detection; Diabetes Mellitus; Diet; Dietary Intervention; Dietary intake; Dose; Education; Exercise; Frequencies; Funding; Glucose; Home environment; Human Resources; Hypoglycemia; Image; Incidence; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Intake; Intervention; Language Disorders; Lead; Left; Life Style; Measurement; Motor; Neurocognitive; Neurocognitive Deficit; Neurologic; Parietal; Patient Recruitments; Patients; Pattern; Physical activity; Play; Prevention; Prophylactic treatment; Protocols documentation; Randomized Controlled Trials; Recording of previous events; Reporting; Research; Risk; Role; Severities; Short-Term Memory; System; Techniques; Time; Training and Infrastructure; United States National Institutes of Health; Verbal Learning; Visuospatial; blood glucose regulation; executive function; flexibility; frontal lobe function; glucose monitor; neuroimaging; prevent; response; standard of care; tool; young adult

DESCRIPTION (provided by applicant): Intensive therapy is now accepted as the current standard of care in diabetes. However, intensive therapy is frequently complicated by hypoglycemia, which then becomes a limiting factor in maintaining glucose control. During intensive treatment, hypoglycemia occurs in patients with diabetes due to excess insulin, 'excess glucose utilization (e.g. exercise) or inadequate carbohydrate intake. Young children and adolescents have many lifestyle characteristics that make them particularly prone to hypoglycemia. In addition, frequent hypoglycemia may lead to neurological sequelae. With current home glucose monitoring capabilities it is difficult to accurately define the true incidence, duration and severity of hypoglycemia. Continuous glucose monitoring (CGM) has recently become available as a tool to more closely examine glucose patterns and defining characteristics of hypoglycemia, so that measures for prevention of hypoglycemia can be devised. Recent neurocognitive and neuro-imaging studies show that the developing brain may be particularly vulnerable to hypoglycemia. The understanding of specific neurocognitive deficits requires further studies in children and young adults. Optimal prevention of hypoglycemia and its sequelae requires near-continuous recognition and response to prevailing blood glucose concentrations. Hence, our major objective is to use CGM to detect the frequency, severity and duration of hypoglycemia and then carry out a randomized controlled trial (RCT) to determine the ability of real-time CGM to minimize the risk of hypoglycemia in young patients with type 1 diabetes (T1DM) ages 7-24. In addition we will examine added variables of intervention with activity assessment, diet or both, to determine if further reductions in hypoglycemia are achievable. At baseline, we will compare rates of hypoglycemia frequency, severity and duration and other factors, such as age at onset or duration of diabetes, with neurocognitive and neuroimaging parameters in a cross-sectional study. We will characterize neuroanatomical differences in children and young adults with T1 DM, vs. normal controls. Our center has participated in the Diabetes Research in Children Network (DirecNet), a successful, NIH funded consortium of 5 pediatric diabetes centers and a coordinating center established to study hypoglycemia in children with T1 DM. We have excellent infrastructure, trained personnel, a highly efficient system of patient recruitment, and successful history of efficient protocol completion.

描述（由申请人提供）：现在接受强化治疗是糖尿病中当前的护理标准。然而，低血糖症通常会使强化疗法复杂化，这成为维持葡萄糖控制的限制因素。在强化治疗过程中，由于过量的胰岛素，葡萄糖的利用过多（例如运动）或碳水化合物摄入不足而导致糖尿病患者发生低血糖。幼儿和青少年具有许多生活方式特征，使他们特别容易出现低血糖症。另外，频繁的低血糖可能导致神经后遗症。使用当前的家居葡萄糖监测功能，很难准确地定义低血糖的真实发生率，持续时间和严重程度。连续葡萄糖监测（CGM）最近已成为一种工具，可以更仔细地检查葡萄糖模式和降低性低血糖特征，因此可以设计预防低血糖的措施。最近的神经认知和神经模仿研究表明，发育中的大脑可能特别容易受到低血糖的影响。对特定神经认知缺陷的理解需要对儿童和年轻人进行进一步的研究。最佳预防低血糖及其后遗症需要几乎连续的识别和对流行血糖浓度的反应。因此，我们的主要目标是使用CGM检测低血糖的频率，严重程度和持续时间，然后进行随机对照试验（RCT）来确定实时CGM最小化1型糖尿病患者低血糖风险的能力，年龄为1型糖尿病（T1DM）7-24岁。此外，我们将检查通过活动评估，饮食或两者兼而有之的干预变量，以确定是否可以实现低血糖的进一步减少。在基线时，我们将比较低血糖频率，严重程度和持续时间以及其他因素（例如发病时代或糖尿病持续时间）与神经认知和神经影像学参数的速度。我们将表征T1 DM的儿童和年轻人的神经解剖学差异，与正常对照相比。我们的中心参加了儿童网络（DireCnet）的糖尿病研究，这是一个成功的NIH资助的5个小儿糖尿病中心的财团，并建立了一个协调中心，该中心旨在研究T1 DM儿童的降血症。我们拥有出色的基础设施，受过训练的人员，高效的患者招聘系统以及成功完成协议的成功历史。