The development of implanted insulin pumps remains a complicated and difficult enterprise. Dr. Saudek remains the lead investigator in the U.S.A., collaborating with a number of investigators in Europe. Studies utilize the in-patient GCRC extensively, as his work (like that of the Europeans) remains his own, free from the restraints that would accompany an industry-initiated study. Dr. Saudek continues to publish and present independently, and was in this grant period Secretary General of the International Study Group on Innovative Insulin Delivery (ISGIID). Throughout this grant period, we were struggling with an insulin crystalization problem that was first recognized in 1994, due to a change in manufacturing technique by Hoechst AG. Continuation of the implanted pumps required development of new pump-rinsing procedures. Most important, a side-port catheter was introduced that allowed simpler installation of alkali rinse solution, in a procedure that now takes about 1.5 - 2 hours rather than the previous overnight stay and 4 hour procedure. We developed a research procedure to measure the pump outlet pressure in real time, using a recording manometer needle during a test command. We defined various patterns of pressure build-up in the catheter, and are working on the correlation of the pressure patterns to clinical status. In addition to the refills and pressure measurement procedures, we performed re-implantations and catheter changes. There was one pump pocket infection, the 3rd in our 11 year experience, that appeared to occur remote to the post-operative enough that it seemed unlikely to be surgically related. In summary, the year was one of maintaining as many of our implanted insulin pump patients as possible, through use of new approaches to rinsing the pumps and collecting data on pump outlet pressure tracings. By the end of the year, a new insulin variant became available that has promise of considerably improved longevity in the pump.
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