Clinical efficacy of coordinated boluses in type 1 diabetic patients treated with insulin pumps: a multicentric, randomised, cross over study (COBOL study).

INTERVENTION: Trade Name: APIDRA Pharmaceutical Form: Solution for injection Trade Name: HUMALOG Pharmaceutical Form: Solution for injection Trade Name: NOVORAPID Pharmaceutical Form: Solution for injection CONDITION: Therapeutic area: Diseases [C] ‐ Nutritional and Metabolic Diseases [C18] type 1 diabetic patients ; MedDRA version: 18.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 ‐ Metabolism and nutrition disorders PRIMARY OUTCOME: Main Objective: To compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion. Primary end point(s): The primary outcome is the mean of 2 hours postprandial glycaemia measured by SMBG. Secondary Objective: ‐ to compare efficacy and safety of coordinated boluses with normal boluses on total and postprandial glycaemic control of patients. this will be evaluate using clinical, biological parameters and capillary glyceamia and glucose continue mesurement; ‐ to bring better comprehension on coordinated boluses action's mechanism Timepoint(s) of evaluation of this end point: 2 hours postprandial SECONDARY OUTCOME: Secondary end point(s): ‐ Clinical parameters : adverse events, severe hypoglycaemia frequency, insulin doses (basal rate and boluses) ; ‐ Data from SMBG : mean glyceamia, standard deviation, frequency of glycaemia =60mg/dl, between 61‐140mg/dl, and >140mg/dl ; ‐ Data from CGM : mean glucose level, standard deviation, time spent within glucose ranges: =60mg/dl, between 61‐140mg/dl, and >140mg/dl ; ‐ Biological parameter: fructosamine ; Timepoint(s) of evaluation of this end point: during postprandials periods and during the day. INCLUSION CRITERIA: ‐ Type 1 diabetes mellitus ‐ with confirmed Negative C‐peptide or diabetes duration>5 years ‐ Treated by external insulin pump Medtronic Paradigm Real‐Time or VEO and rapid insulin analog ‐ Educated to and practicing functional insulin treatment and carbohydrate counting ‐ Able to use the “basal temp” and “glycaemia reminder” functions of their pump ‐ Basal infusion rate = 0.5U/h ‐ SMBG frequency > 4/days ‐ Aware of hypoglycaemia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21