SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

• Change in glycemic variability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Change in occurrence of hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Time spent in euglycaemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Change in postprandial glycaemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Quality of Life (paeds) and Treatment Satisfaction (adults) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Severe hypo or Diabetic Ketoacidosis events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

• Change in glycemic variability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Change in occurrence of hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Time spent in euglycaemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Change in postprandial glycaemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Quality of Life (paeds) and Treatment Satisfaction (adults) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
• Severe hypo or DKA events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.

• Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)
  6 months of pump plus continuous glucose sensing in conjunction to SMBG
  Other Names:

  • Paradigm Real-Time Insulin Pump System
  • Medtronic MMT-522 or MMT-722 + MMT7707WW
• Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)
  insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.
  Other Names:

  • Paradigm Real-Time insulin pump
  • Guardian Real-Time clinical
  • MMT-522 or MMT-722 + MMT7707WW + CSS7100

• Experimental: A
  Paradigm Real-Time system: insulin pump with continuous glucose sensing
  Intervention: Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)
• B
  Paradigm Real-Time insulin pump with self-monitoring blood glucose
  Intervention: Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)

Inclusion Criteria:

• Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
• Sub-optimal glycemic control (7.5%<HbA1c<9.5%).
• Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
• Patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent.
• Patient has no preliminary experience with the sensor function of the Paradigm REAL-Time or the Guardian® REAL-Time for the 4 months prior signature of informed consent.

Exclusion Criteria:

• Existing pregnancy or intention to conceive (as assessed by investigator).
• Hearing or vision impairment so that glucose display and alarms cannot be recognized.
• Three or more incidents in the last 12 months of severe hypoglycaemia with documented Blood Glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
• History of hypoglycemic unawareness as assessed by the investigator.
• Alcohol or drug abuse, other than nicotine.
• Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
• Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : Body Mass Index >35 and children Body Mass Index > 2 standard deviations. for age) as assessed by the investigator.
• Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
• For pediatric subjects: does not have a reliable support person.
• Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).
• Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.