IMPLANTABLE INSULIN PUMP THERAPY

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。植入式胰岛素输注泵(IIP)是一种胰岛素输送系统，它包括一个直径约3“、厚0.75”的外科植入盘状装置。该原型最初是在JHU/APL设计的，自1986年以来，P.I.一直在约翰·霍普金斯大学的人体研究中使用IIP。IIP在法国使用最广泛。上一轮植入是在1999年完成的，考虑到3年的电池寿命，所有14名植入的受试者在这一点上都没有功能，电池耗尽。本研究将重新植入以前参与的研究对象，将他们的旧泵换成新的(2007型)泵，新泵的电池寿命为8年。这项研究旨在测试与传统治疗相比，服用IIP的受试者的血糖控制是否有所改善。由于2007型与之前的2000型的主要不同之处在于其预期的电池寿命，因此没有理由期望它将实现比前一植入期间更好的控制。因此，假设前一个IIP周期和新的IIP周期在常规控制下都会好于中期。将收集数据，比较以前使用泵、目前的常规治疗和使用新泵治疗期间的血糖。植入物将随机选择为1个月的基准期或3个月的基准期，以测试研究效果。血糖将通过下载自我监测的血糖结果、糖化血红蛋白，并在植入前和植入后定期使用连续血糖监测仪进行测试。这些方法将允许比单独使用自我监测更密切地观察血糖变化。数据采集期计划为植入后一年。在此之后，我们预计在综合临床研究中心(GCRC)对患者进行常规跟踪，直到该设备获得FDA批准，之后将成为标准临床护理，受试者选择退出研究，泵故障，或制造商终止对该设备的支持。

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 implantable insulin infusion pump (IIP) is a system for insulin delivery that includes a surgically implanted, disk-shaped device ~ 3" diameter and .75" thick. The prototype was originally designed at JHU/APL, and the P.I. has used IIP in research studies in humans at Johns Hopkins since 1986. IIP is most extensively used in France. The last round of implantations was done in ~1999, and given the 3-year battery life, all 14 subjects who are implanted have non-functional, battery-depleted pumps at this point. The present study will re-implant previously participating research subjects, exchanging their old pump for a new (Model 2007) pump, which has an 8-year battery life. The study is designed to test whether glycemic control improves in subjects who are on IIP, compared with conventional therapy. Since the Model 2007 differs from the previous Model 2000 mainly in its expected battery life, there is no reason to expect that it will achieve better control than seen in the previous implantation period. Therefore, the hypothesis is that the both the previous IIP period and the new IIP period will be better than the middle period on conventional control. Data will be gathered comparing glycemia during prior pump use, current conventional therapy, and during treatment with the new pump. Implants will be randomly chosen to occur with a 1 month baseline period or a 3 month baseline period, to test for study effect. Glycemia will be tested with downloading of self-monitored blood glucose results, hemoglobin A1c, and use of a continuous blood glucose monitor for 3 days before and periodically after implantation. These methods will allow closer observation of glycemic variance than is possible with self-monitoring alone. The data collection period is planned for one year after implantation. Following this, we anticipate following patients on the General Clinical Research Center (GCRC) routinely until the device is approved by the FDA, after which it would be standard clinical care, the subjects chooses to withdraw from the study, the pump malfunctions, or the manufacturer ends support of the device.