IMPLANTABLE INSULIN PUMP THERAPY

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。植入式胰岛素输注泵（IIP）是一种胰岛素输注系统，包括一个手术植入的圆盘形器械，直径约3”，厚0.75”。原型最初是在JHU/APL设计的，P.I.自1986年以来，在约翰霍普金斯的人体研究中使用了IIP。IIP在法国使用最广泛。最后一轮植入是在1999年左右完成的，考虑到3年的电池寿命，所有14名植入的受试者此时都使用了无功能、电池耗尽的泵。 本研究将重新植入之前参与的研究受试者，将其旧胰岛素泵更换为电池寿命为8年的新（2007型）胰岛素泵。该研究旨在测试与常规治疗相比，接受IIP治疗的受试者的血糖控制是否有所改善。由于2007型与之前的2000型的主要区别在于其预期电池寿命，因此没有理由预期其将实现比之前植入期间更好的控制。因此，假设在常规控制下，前一个IIP周期和新的IIP周期都将优于中间周期。将收集数据，比较既往胰岛素泵使用期间、当前常规治疗期间和使用新胰岛素泵治疗期间的不良反应。将随机选择植入1个月基线期或3个月基线期，以检验研究效果。在植入前3天和植入后定期通过下载自我监测的血糖结果、血红蛋白A1 c和使用连续血糖监测仪检测血糖。这些方法将允许比单独的自我监测更密切地观察血糖变化。数据收集期计划为植入后一年。在此之后，我们预计将对一般临床研究中心（GCRC）的患者进行常规随访，直到器械获得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器械的支持。

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.