REAL-TIME CONTINUOUS GLUCOSE MONITORING IN THE MANAGEMENT OF TYPE 1 DIABETES

实时连续血糖监测在 1 型糖尿病治疗中的应用

• 批准号: 7604925
• 负责人: EVA TSALIKIAN
• 金额: $ 0.12万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604925
• 关键词: Adolescent; Adult; Blood Glucose; Blood Glucose Self-Monitoring; Caring; Child; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Daily; Devices; Diabetes Mellitus; Diabetic Angiopathies; Evaluation; Event; Frequencies; Fright; Funding; Glucose; Glycosylated hemoglobin A; Grant; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Incidence; Individual; Injection of therapeutic agent; Institution; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Long-Acting Insulin; Measures; Monitor; Obesity; Parents; Patients; Play; Protocols documentation; Quality of life; Rate; Research; Research Personnel; Resistance; Resources; Risk; Role; Sleep; Source; System; Technology; Time; Treatment Protocols; United States Food and Drug Administration; United States National Institutes of Health; Weight Gain; analog; blood glucose regulation; cost; cost effectiveness; glucose monitor; glucose sensor; glycemic control; improved; prevent; sensor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Diabetes Control and Complications Trial (DCCT) clearly demonstrated the importance of glycemic control in preventing and delaying the microvascular complications of type 1 diabetes (T1D) but at the cost of a 3-fold increase in the frequency of severe hypoglycemia and a 2-fold increase in the frequency of excessive weight gain. The DCCT also demonstrated that achieving and maintaining target glucose and HbA1c levels was more difficult in adolescents than adults with T1D. Compared with intensively treated adults, intensively treated adolescents in the DCCT had higher HbA1c levels, a 60% increase in the risk of severe hypoglycemia, and the same 2-fold increase in the rate of obesity. Despite increased use of insulin pumps and multiple injection regimens and the introduction of rapid and long-acting insulin analogs, the majority of individuals with T1D fail to achieve target HbA1c levels recommended by the DCCT more than 12 years ago. While self-monitoring of blood glucose plays an important role in achieving target HbA1c levels, most patients measure glucose levels infrequently immediately after meals and during the overnight period. Consequently, post-prandial hyperglycemia and asymptomatic nocturnal hypoglycemia are commonly oberved even in well-controlled individuals with T1D. In addition, the fear of hypoglycemia by patients, and for children's parents, is a major obstacle to successful intensive insulin therapy, and the lack of overnight monitoring is a problem since more than 50% of severe hypoglycemic events occur during sleep. Increasing the frequency of glucose monitoring was an important aspect of attaining improved glucose control in the DCCT. However, resistance to frequent blood glucose monitoring is a major impediment to attaining good (lower HbA1c level) glucose control. Real-time continuous glucose monitoring (RT-CGM) offers the opportunity to improve glycemic control, including reducing rather than increasing the incidence of severe hypoglycemia as control is "tightened". The GlucoWatch Biographer was the first "real-time" glucose sensor made available for daily use by patients. Unfortunateily, it was not tolerated well and few children found it to have long-term utility. Recently, several RT-CGM systems were approved by the FDA: the DexCom STS Continuous Glucose Monitoring System (DexCom, Inc.) and the Paradigm and Guardian REAL-Time Continuous Glucose Monitoring Systems (Medtronic Minimed). The same sensor is used by the Paradigm and Guardian systems. Therefore, for this protocol we are considering the Paradigm and Guardian devices as the same device. An additional RT-CGM system, the FreeStyle Navigator Continuous Glucose Monitoring System (Abbott Diabetes Care, Inc.) has been evaluated by the Diabetes Research in Children Network (DirecNet) and is expected to receive FDA approval shortly. The proper role of the RT-CGM in the management of T1D has not been determined. Clinical trials of RT-CGM technology are critically important to demonstrate that this technology is effective and to provide information on how it should be implemented and used. The primary objective of the study is to determine if RT-CGM can imporve glycemic control and quality of life in children and adults with T1D. In addition, an evaluation of the cost-effectiveness of RT-CGM will be conducted.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 糖尿病控制和并发症试验（DCCT）清楚地证明了血糖控制在预防和延迟1型糖尿病（T1 D）微血管并发症方面的重要性，但代价是严重低血糖的频率增加了3倍，体重过度增加的频率增加了2倍。 DCCT还表明，青少年T1 D患者达到和维持目标血糖和HbA 1c水平比成人T1 D患者更困难。 与强化治疗的成人相比，DCCT中强化治疗的青少年具有更高的HbA 1c水平，严重低血糖的风险增加60%，肥胖率增加2倍。 尽管胰岛素泵和多次注射方案的使用增加，并引入了快速和长效胰岛素类似物，但大多数T1 D患者未能达到DCCT在12年前推荐的目标HbA 1c水平。 虽然自我血糖监测在达到目标HbA 1c水平方面发挥着重要作用，但大多数患者在餐后立即和过夜期间很少测量血糖水平。 因此，即使在控制良好的T1 D患者中，餐后高血糖和无症状夜间低血糖也很常见。 此外，患者和儿童父母对低血糖的恐惧是成功强化胰岛素治疗的主要障碍，并且缺乏过夜监测是一个问题，因为超过50%的严重低血糖事件发生在睡眠期间。 增加血糖监测频率是DCCT中实现改善血糖控制的一个重要方面。 然而，对频繁血糖监测的抵抗是实现良好（较低的HbA 1c水平）血糖控制的主要障碍。 实时动态血糖监测（RT-CGM）提供了改善血糖控制的机会，包括在控制“收紧”时减少而不是增加严重低血糖的发生率。 GlucoWatch Biographer是第一款可供患者日常使用的“实时”葡萄糖传感器。 不幸的是，它的耐受性不好，很少有孩子发现它有长期的效用。 最近，FDA批准了几种RT-CGM系统：DexCom STS持续葡萄糖监测系统（DexCom，Inc.）以及Paradigm和Guardian实时动态葡萄糖监测系统（Medtronic Minimed）。 Paradigm和Guardian系统使用相同的传感器。 因此，对于本方案，我们将Paradigm和Guardian器械视为同一器械。 另一种RT-CGM系统，FreeStyle Navigator动态葡萄糖监测系统（Abbott Diabetes Care，Inc.）已由儿童糖尿病研究网络（DirecNet）进行评估，预计不久将获得FDA批准。 尚未确定RT-CGM在T1 D管理中的适当作用。 RT-CGM技术的临床试验对于证明该技术的有效性并提供如何实施和使用该技术的信息至关重要。 本研究的主要目的是确定RT-CGM是否可以改善T1 D儿童和成人的血糖控制和生活质量。 此外，还将对实时CGM的成本效益进行评价。