LONG-TERM SAFETY AND EFFICACY OF PROGRAMMABLE IMPLANTABLE INSULIN DELIVERY SYSTEMS

Objectives: Since only short-term studies of continuous intraperitonea l insulin infusion (CIPII) therapy using implantable programmable insu lin delivery systems have been performed to show this method of diabet es therapy to be safe and efficacious, we have performed long-term stu dies to assess ifs safety and efficacy. Research design and methods: F or 78 patient-years of follow-up, we have longitudinally studied the i ncidence of diabetic ketoacidosis and severe hypoglycemia in 25 type I diabetic patients treated with CIPII. We also compared, cross-section ally, the long-term safety and efficacy of CIPII to intensive subcutan eous insulin therapy using intermittent injections or continuous subcu taneous insulin infusion. Finally, we examined the relationship betwee n glycated hemoglobin levels and the standard deviation of daily blood glucose excursion. Results: Cross-sectional analysis revealed similar degrees of metabolic control accompanied by significantly decreased r ates of both ketoacidosis (0.013 events/patient/year) and severe hypog lycemia (0.05 events/patient/year) during CIPII compared to intermitte nt injections and continuous subcutaneous insulin infusion therapy. A four-fold decrease in the rate of severe hypoglycemia was observed dur ing longitudinal comparison of pre- and postimplantation complication rates. A relationship was also shown between decreased levels of mean glycated hemoglobin and the standard deviation of blood glucose excurs ions during CIPII therapy. Conclusions: Our data demonstrate that long -term therapy with CIPII is as effective as other methods in achieving near-normal levels of glycated hemoglobin, which in CIPII is associat ed with a decreased standard deviation of blood glucose excursions. Fu rther, CIPII using implantable programmable insulin delivery systems i s the safest method described for intensive insulin therapy in home bl ood glucose monitoring type I diabetic patients.