Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type I diabetic patients on intensified treatment: A randomized study

Abstract

OBJECTIVE - To compare the efficacy of 2 intensified insulin regimens, continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI), by using the short-acting insulin analog lispro in type 1 diabetic patients. RESEARCH DESIGN AND METHODS - A total of 41 C-peptide-negative type 1 diabetic patients (age 43.5 ± 10.3 years; 21 men and 20 women, BMI 24.0 ± 2.4 kg/m2, diabetes duration 20.0 ± 11.3 years) on intensified insulin therapy (MDI with regular insulin or lispro, n = 9; CSII with regular insulin, n = 32) were included in an open-label randomized crossover study comparing two 4-month periods of intensified insulin therapy with lispro: one period by MDI and the other by CSII. Blood glucose (BG) was monitored before and after each of the 3 meals each day. RESULTS - The basal insulin regimen had to be optimized in 75% of the patients during the MDI period (mean number of NPH injections per day = 2.65). HbA(1c) values were lower when lispro was used in CSII than in MDI (7.89 ± 0.77 vs. 8.24 ± 0.77%, P < 0.001). BG levels were lower with CSII (165 ± 27 vs. 175 ± 33 mg/dI, P < 0.05). The SD of all the BG values (73 ± 15 vs. 82 ± 18 mg/dI, P < 0.0l) was lower with CSII. The frequency of hypoglycemic events, defined as BG levels <60 mg/dI, did not differ significantly between the 2 modalities (CSII 3.9 ± 4.2 per 14 days vs. MDI 4.3 ± 3.9 per 14 days). Mean insulin doses were significandy lower with CSII than with MDI (38.5 ± 9.8 vs. 47.3 ± 14.9 U/day, respectively, P < 0.0001). CONCLUSIONS - When used with external pumps versus MDI, lispro provides better glycemic control and stability with much lower doses of insulin and does not increase the frequency of hypoglycemic episodes.