Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia

Study of Minimed 640G Insulin Pump With SmartGuard in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia

The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1 diabetic adults with an increased risk of hypoglycemia.

The study should show:

• A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a reduction in the time spent in hypoglycemia six months in any group compared to Baseline.
• A complete prevention of severe and not severe hypoglycemia in the pump group Minimed 640G + Enlite sensor with SmartGuard activation

Inclusion Criteria:

• Type 1 or insulin-dependent diabetic patients
• Patients treated with subcutaneous insulin pump with at least 2 episodes of severe hypoglycemia within 12 months before the study enrollment
• Affiliation to the french social security system or equivalent
• People who signed the consent form

Exclusion Criteria:

• Patient who have difficulty to understand the French language
• Patient can not be raised to the use of an insulin pump, or a glucose sensor
• Patient visually impaired
• Patient hard of hearing
• Pregnant woman or woman having a project of pregnancy within 6 months
• Persons referred to in Articles L1121-5 to L1121-8 CSP: pregnant woman, woman in labor, breastfeeding women, persons deprived of their liberty by judicial or administrative decision, person under a legal protection measure.