IMPLANTABLE INSULIN PUMP THERAPY

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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.