Intensive insulin therapy with insulin lispro - A randomized trial of continuous subcutaneous insulin infusion versus multiple daily insulin injection

OBJECTIVE - To evaluate glycemic control, hypoglycemic events, and quality of life in patients treated with continuous subcutaneous insulin infusion ( CSII) and multiple daily insulin injection (MDI), with insulin lispro as th e principal insulin. RESEARCH DESIGN AND METHODS - This clinical trial enrolled 27 patients With type 1 diabetes. They were randomly assigned to CSII (n = 13) or MDI (n = 14) treatment regimens. Glycemic control (HbA(1c) level) was the primary ou tcome and was measured monthly for 9 months. Secondary outcomes were patien t reports of hypoglycemic events (recorded monthly for 9 months) and qualit y of life assessed at 9 months using the Diabetes Quality of Life (DQOL) qu estionnaire. RESULTS - A significant decrease in HbA(1c) from baseline was shown for bot h groups. However, the overall treatment effect (CSII - MDI) for HbA(1c) wa s +0.08% (95% CI -0.23 to +039, P > 0.10). This was significantly less than the a priori limit of +/-0.5% (P = 0.004). The relative treatment effect ( [CSII - MDI]/MDI) for the overall number of hypoglycemic events Was +9% (95 % Cl -37 to +87, P > 0.10). There were no Statistically significant differe nces between treatment groups for any of the DQOL subscales. CONCLUSIONS - No statistically significant differences in glycemic control, reported hypoglycemic events, or quality of life were found in this study, Furthermore, a clinically significant difference of more than +/-0.5% HbA( 1c) between the two regimens can be confidently ruled out. We conclude that the choice of intensive insulin therapy should be a matter of patient pref erence, Consistent With lifestyle.