Conditions: Diabetes Mellitus, Type 1
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 289
Healthy volunteers: no

Brief summary:
Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion.

Main Secondary objectives:

To compare insulin glulisine, insulin aspart and insulin lispro on:

* Unexplained hyperglycemia
* Infusion set occlusion
* Hypoglycemic episodes,7-point blood glucose profiles
* Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis
* Time to change the infusion set
* HbA1c (Glycosylated hemoglobin)
* Overall safety: incidence of adverse events

Detailed description:
The maximal duration of the study participation for patients was 41 weeks and one day, split in:

* a 2-week screening period,
* a 39-week treatment period: 3 treatment periods of 13 weeks with a crossover alternative regimen, including a dose adjustment period of 1 week at the beginning of each period (sequence1: insulin glulisine, then insulin aspart, then insulin lispro; sequence2: insulin aspart, then insulin lispro, then insulin glulisine; sequence 3: insulin lispro, then insulin glulisine, then insulin aspart)
* and a follow-up period of 24 hours.

Arms:
arm 1: sequence 1: insulin glulisine / insulin aspart / insulin lispro. arm 2: Sequence 2: insulin aspart / insulin lispro / insulin glulisine arm 3: Sequence 3: insulin lispro / insulin glulisine / insulin aspart

Interventions: intervention 1: Insulin glulisine intervention 2: Insulin lispro intervention 3: Insulin aspart
Intervention descriptions: intervention 1: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump intervention 2: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump intervention 3: 100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

Protocol document: