IMPLANTABLE INSULIN PUMP THERAPY

植入式胰岛素泵治疗

• 批准号: 7378844
• 负责人: CHRISTOPHER D. SAUDEK
• 金额: $ 0.58万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378844
• 关键词: IMPLANTABLE; INSULIN; PUMP; THERAPY

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.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。植入式胰岛素输注泵（IIP）是一种用于胰岛素输送的系统，它包括一个手术植入的、直径约3英寸的圆盘状装置。75年“厚。原型最初是在JHU/APL设计的，自1986年以来，pi一直在约翰霍普金斯大学的人类研究中使用IIP。IIP在法国使用最为广泛。最后一轮植入是在1999年左右完成的，由于电池寿命为3年，所有14名被植入的受试者此时都有无功能的、电池耗尽的泵。目前的研究将重新植入先前参与研究的受试者，将他们的旧泵换成新的（2007型）泵，该泵具有8年的电池寿命。该研究旨在测试与常规治疗相比，IIP治疗是否能改善受试者的血糖控制。由于2007型与之前的2000型的不同主要在于预期的电池寿命，因此没有理由期望它会比之前的植入期实现更好的控制。因此，假设在常规控制下，前一个IIP期和新的IIP期都将优于中期。将收集数据，比较先前使用泵、当前常规治疗和新泵治疗期间的血糖。植入物将随机选择在1个月的基线期或3个月的基线期进行，以测试研究效果。血糖将通过下载自我监测的血糖结果、血红蛋白A1c进行检测，并在植入前3天和植入后定期使用连续血糖监测仪。这些方法可以比单独的自我监测更密切地观察血糖变化。数据采集周期为植入后1年。在此之后，我们预计在普通临床研究中心（GCRC）定期跟踪患者，直到设备获得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，或制造商终止对设备的支持。