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According to the results of the Diabetes Control and Complications Trial (DCCT) (1), intensive diabetes management should be proposed for most type 1 diabetic patients to prevent long-term complications. However, the ideal insulin regimen should simultaneously achieve 2 goals: maintenance of near-euglycemia and avoidance of frequent and severe hypoglycemia.Several studies have suggested that continuous subcutaneous insulin infusion (CSII) could provide better glycemic control (2-4) with a lower risk of hypoglycemia (5,6) than multiple daily injections (MDI). But very few of these studies were randomized, and all used regular insulin. We and others (7-9) also reported that, when used in external pumps, the shortacting insulin analog lispro provided better glycemic control than regular insulin without increasing the frequency of hypoglycemic episodes.However, to the best of our knowledge, the benefits of lispro use in CSII and MDI have never been compared. Therefore, the aim of the present work was to compare the efficacy on glycemic control and hypoglycemia frequency of 2 new intensified insulin regimens, CSII and MDI, with insulin lispro in a randomized study. RESEARCH DESIGN AND METHODS -The study protocol was approved by the Ethics Committee of Toulouse, and all of the patients gave written consent. PatientsA total of 41 type 1 diabetic patients between 21 and 65 years of age participated in the study. At enrollment, 32 were treated by CSII with regular insulin and 9 by MDI with regular insulin or insulin lispro. The inclusion criteria were HbA 1c Ͻ10.0%, negative C-peptide, and experience of intensified Comparison of Continuous Subcutaneous Insulin Infusion and Multiple Daily Injection Regimens Using Insulin Lispro in Type 1 Diabetic Patients on Intensified TreatmentA randomized study O R I G I N A L A R T I C L EOBJECTIVE -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/m 2 , 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 Ͻ 0.001). BG levels were lower with CSII (165 ± 27 vs. 175 ± 33 mg/dl, P Ͻ 0.05). The SD of all the BG values (73 ± 15 vs. 82 ± 18 mg/dl, P Ͻ 0.01) was lower with CSII. The frequency of...

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