Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type 1 diabetic patients on intensified treatment - A randomized study

OBJECTIVE - To compare the efficacy of 2 intensified insulin regimens, cont inuous subcutaneuus insulin infusion (CSII) and multiple daily injections ( MDI),by using the short-acting insulin analog lispro in type 1 diabetic pat ients. RESEARCH DESIGN END METHODS - A total of 41 C-peptide-negative type 1 diabe tic patients (age 43.5 +/- 10.3 years; 21 men and 20 women, BMI 24.0 +/- 2. 4 kg/m(2), diabetes duration 20.0 +/- 11.3 years) on intensified insulin th erapy (MDI with regular insulin or lispro, n = 9; CSII with regular insulin , n = 32) were included in an open-label randomized crossover study compari ng two 4-month periods of intensified insulin therapy with lispro: one peri od by MDI and the other by CSII. Blood glucose (BG) was monitored before an d after each of the 3 meals each day. RESULTS - The basal insulin regimen had to be optimized in 75% of the patie nts during the MDI period (mean number of NPH injections per day = 2.65). H bA(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/dl, P < 0.05). The SD of all the BG values (73 +/- 15 vs. 82 +/- 18 mg/dl, P < 0.01) was lower with CSII. The frequency of hyp oglycemic events, defined as BG levels <60 mg/dl, did not differ significan tly 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 significantly lower with CSII tha n 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 be tter glycemic control and stability with much lower doses of insulin and do es not increase the frequency of hypoglycemic episodes.