| Outcome Measures: |
Primary: Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion, Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason. Pump infusion set occlusion defined by at least one of the following items: * pump occlusion alarm, * patient observation of an occlusion, spontaneously or because of elevated blood glucose value., over 13 weeks of each treatment period | Secondary: Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion, Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason. Pump infusion set occlusion defined by at least one of the following items: * pump occlusion alarm, * patient observation of an occlusion, spontaneously or because of elevated blood glucose value., over 13 weeks of each treatment period|Percentage of Patients With at Least One Unexplained Hyperglycemia, Unexplained hyperglycemia defined as blood glucose value above 300 mg/dL (16.7 mmol/L) with no apparent medical dietary, insulin dosage or pump failure reason., over 13 weeks of each treatment period|Monthly Rate of Unexplained Hyperglycemia, over 13 weeks of each treatment period|Percentage of Patients With at Least One Confirmed Infusion Set Occlusion, Pump infusion set occlusion defined by at least one of the following items: * pump occlusion alarm, * patient observation of an occlusion, spontaneously or because of elevated blood glucose value., over 13 weeks of each treatment period|Monthly Rate of Confirmed Infusion Set Occlusion, over 13 weeks of each treatment period|Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis, Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria). Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and \>1.5 mmol/l, over 13 weeks of each treatment period|Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis, Diabetic ketoacidosis (DKA) is preceded by an increase in ketone production, resulting in blood ketone value increase (hyperketonemia) and later in ketone urine value (hyperketonuria). Significant hyperketonemia and risk level for impending diabetic ketoacidosis (DKA) are reported respectively as a blood ketone value from 0.6 to 1.5 mmol/L and \>1.5 mmol/l, over 13 weeks of each treatment period|Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year, Symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration., over 13 weeks of each treatment period|Rate of Severe Symptomatic Hypoglycemia Per Patient-year, Severe symptomatic hypoglycemia is defined as an event with clinical symptoms that are considered to results from hypoglycemia in which the patient required assistance of another person and one of the following: * the event was associated with a measured blood glucose level below 36 mg/dL * or event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration., over 13 weeks of each treatment period|Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year, Nocturnal Symptomatic hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia (confirmed or not by a glucose measurement) and associated with prompt recovery after oral carbohydrate administration which occurs while the patient is asleep, after bedtime and before getting up in the morning., over 13 weeks of each treatment period|Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site, Infection: local reaction at the infusion site requiring local or systemic antibiotherapy, or local drainage as per Investigator judgment. Site inflammation or erythema: local reaction at the infusion site with no need for local or systemic antibiotherapy as per Investigator judgment. Pruritis at injection site: presence of pruritis at the infusion site without any symptom of inflammation or erythema and/or infection. Isolated pain at injection site: presence of pain at the infusion site without any symptom of inflammation or erythema and/or infection., over 13 weeks of each treatment period|Time Interval Between Infusion Set Changes: All Changes, Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event). "All changes" include all the changes whatever the reason such as routine or requested by occurrence of events., over 13 weeks of each treatment period|Time Interval Between Infusion Set Changes in Routine, Patients treated with insulin pump have to change their infusion set regularly (i.e.change was recommended every 48h). The patients were asked to report any change of their infusion set and the reason for change (routine basis or because of occurrence of a specific event such as occlusion, unexplained hyperglycemia or adverse event). Changes in routine correspond to interval between changes according to patient use., over 13 weeks of each treatment period|Glycosylated Hemoglobin: HbA1c, Glycolysated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow-up in diabetic patients. This parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c \<7%, over 13 weeks of each treatment period|Total Daily Basal Insulin Infusion, dose of the basal insulin regimen administered throughout the 24-hour period, over 13 weeks of each treatment period|Total Daily Bolus Insulin Dose, dose of every increment administered for example before meals, over 13 weeks of each treatment period
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| Locations: |
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States|Sanofi-Aventis Administrative Office, Macquarie Park, Australia|Sanofi-Aventis Administrative Office, Vienna, Austria|Sanofi-Aventis Administrative Office, Paris, France|Sanofi-Aventis Administrative Office, Budapest, Hungary|Sanofi-Aventis Administrative Office, Natanya, Israel|Sanofi-Aventis Administrative Office, Milan, Italy|Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of|Sanofi-Aventis Administrative Office, PE Gouda, Netherlands|Sanofi-Aventis Administrative Office, Barcelona, Spain|Sanofi-Aventis Administrative Office, Bromma, Sweden|Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom
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