RANDOMIZED COMPARISON OF METABOLIC CONTROL ACHIEVED BY INTRAPERITONEAL INSULIN INFUSION WITH IMPLANTABLE PUMPS VERSUS INTENSIVE SUBCUTANEOUS INSULIN THERAPY IN TYPE-I DIABETIC-PATIENTS

OBJECTIVE - To compare intraperitoneal implantable insulin infusion (IP) to subcutaneous (SC) intensive insulin therapy. RESEARCH DESIGN AND METHODS - Twenty-one insulin-dependent (type I) diabetic patients aged 24-61 yr underwent a 3-mo treatment optimization using multiple SC daily injections or external pumps. Patients were then randomized (time 0 mo) to IP infusion using Infusaid-programmable pumps or continuation on SC intensive insulin for 6 mo. RESULTS - No differences were noted between study and control group data. However, longitudinal within-group comparisons from baseline showed that glycosylated hemoglobin improved to near-normal in both groups: IP, 9.0 +/- 0.5 vs. 7.8 +/- 0.6% (P < 0.05) and SC, 8.4 +/- 0.5 vs. 7.5 +/- 0.3% (P < 0.05) at 0 and 4 mo, respectively (normal < 6.9%). The percentage of blood glucose tests > 11 mM at 0 and 6 mo was 28 +/- 5 vs. 16 +/- 4% in the IP group (P < 0.05) and 22 +/- 5 vs. 24 +/- 7% in the SC group (NS). At 0 and 6 mo, the standard deviation of blood glucose values, an index of glycemic fluctuations, was 4.3 +/- 0.4 vs. 3.2 +/- 0.5 mM in the IP group (P < 0.05) and 3.7 +/- 0.3 vs. 4.0 +/- 0.4 mM in the SC group (NS). Weight, insulin dosages, circulating lipid levels, and the frequency of severe hypoglycemic reactions and biochemical hypoglycemias were similar and did not change in the two groups.