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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 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缓1型糖尿病(T1D)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，与成人T1D相比，青少年更难达到和维持目标血糖和HbA1c水平。与接受强化治疗的成年人相比，接受强化治疗的青少年HbA1c水平更高，严重低血糖的风险增加60%，肥胖率增加2倍。 尽管越来越多地使用胰岛素泵和多种注射方案，并推出了快速和长效的胰岛素类似物，但大多数T1D患者未能达到DCCT在12年前推荐的目标HbA1c水平。虽然自我监测血糖在达到目标HbA1c水平方面发挥了重要作用，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T1D患者中，通常也会观察到餐后高血糖和无症状的夜间低血糖。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，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中。 增加血糖监测的频率是改善DCCT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HbA1c水平)血糖控制的主要障碍。实时连续血糖监测(RT-CGM)提供了改善血糖控制的机会，包括减少而不是增加严重低血糖的发生率，因为控制是“严格的”。GLucoWatch传记是第一个可供患者日常使用的“实时”血糖传感器。不幸的是，人们对它没有很好的耐受性，很少有孩子发现它有长期的效用。最近，几种RT-CGM系统获得了FDA的批准：DexCom STS连续血糖监测系统(DexCom，Inc.)和Paradigm and Guardian实时连续血糖监测系统(美敦力迷你)。Paradigm和Guardian系统使用相同的传感器。因此，对于此协议，我们将Paradigm和Guardian设备视为同一设备。另一种RT-CGM系统，Freestyle Navigator连续血糖监测系统(雅培糖尿病护理公司)已经由儿童糖尿病研究网络(DirecNet)进行了评估，预计很快就会获得FDA的批准。 RT-CGM在T1D治疗中的作用尚未确定。RT-CGM技术的临床试验对于证明该技术是有效的并提供关于如何实施和使用该技术的信息至关重要。该研究的主要目的是确定RT-CGM是否能改善T1D儿童和成人的血糖控制和生活质量。此外，还将对RT-CGM的成本效益进行评估。

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.