FEASIBILITY OF INTRAPERITONEAL INSULIN THERAPY WITH PROGRAMMABLE IMPLANTABLE PUMPS IN IDDM - A MULTICENTER STUDY

OBJECTIVE - To report the overall French experience, obtained through the collaboration of seven centers (EVADIAC [Evaluation dans le Diabet e du Traitement par Implants Actifs] register), on the safety, feasibi lity, and efficacy of intraperitoneal insulin therapy by programmable implantable pumps, using three different devices. RESEARCH DESIGN AND METHODS - This is a multicenter prospective study involving 224 type I diabetic patients implanted with a programmable implantable pump (cum ulative follow-up: 353 patient-years; mean duration: 1.5 +/- 0.9 years [mean +/- SD]). The Infusaid and the Promedos devices are equipped wi th a side port and refilled with U100 insulin (Hoechst 21 PH); the Min imed pump is not equipped with a side port and is refilled with U400 i nsulin (Hoechst 21 PH). Metabolic data and adverse events were recorde d in a central register run by EVADIAC. RESULTS - A total of 29 local pump-pocket events (8/100 patient-years) and 9 pump failures (2.5/100 patient-years) occurred. The major technical problems were 1) pump flo w rate reduction related to insulin aggregates, reversible after alkal ine rinsing of the pump, and 2) 47 catheter obstructions requiring lap aroscopic or conventional surgery. Pump therapy was abandoned in only 11 patients. HbA(1c) (7.4 +/- 1.8 vs. 6.8 +/- 1.0%, P < 0.001), mean g lycemia (8.7 +/- 1.5 vs. 7.8 +/- 1.0 mmol/l, P < 0.001), and blood glu cose SDs (3.8 +/- 0.8 vs. 3.3 +/- 0.8 mol/l, P < 0.001) decreased sign ificantly after 6 months and remained lower than baseline thereafter. CONCLUSIONS - Intraperitoneal insulin infusion using an implantable pr ogrammable pump is a feasible and relatively safe technique that may i mprove metabolic control and glycemic stability. Long-term studies, ho wever, are needed to demonstrate whether or not the improvement in gly cemic control could be sustained for several years.