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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Diabetes, Type 1

Intervention / Treatment
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* Device: Minimed 640G with smartguard activated
* Device: Minimed 640G with smartguard off


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimed 640G with smartguard activated<br>Group SmartGuard On: Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640G insulin pump with SmartGuard activation | Device: Minimed 640G with smartguard activated<br>* Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation<br>* Other names: Minimed 640G insulin Pump with Smartguard activation;|
| Active Comparator: Minimed 640G with smartguard off<br>Group SmartGuard Off Patients will be equipped with a sensor augmented pump (SAP) therapy Minimed 640 insulin pump without SmartGuard activation | Device: Minimed 640G with smartguard off<br>* Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation<br>* Other names: Minimed 640G insulin Pump without activated Smartguard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Minimed 640G insulin pump with Smartguard activation in preventing the number of severe and non-severe hypoglycaemia in patients with diabetes type 1 at risk of severe hypoglycemia | Number of events of hypoglycemia (severe and non-severe) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Improving of overall glycemic control with SmartGuard activation in type 1 diabetic patients at risk of severe hypoglycemia | Comprehensive metabolic evaluation data and evaluation data of severe hypoglycaemic risk | 6 months | 
| Assessment of the quality of life of patients with smartguard activation | Quality of Life Questionnaire | 6 months | 
| Assessment of the number of adverse events | Assessment of the safety of the sensor augmented pump therapy with the Mimimed 640G insulin pump coupled with a 640G Minimed Enlite sensor with Smart Guard as compare to sensor augmented pump therapy with the Mimimed 640G insulin pump coupled with a 640G Minimed Enlite sensor without Smart Guard activation (Decompensated ketoacidosis, Hospitalization related to severe hypoglycemia or frequent hypoglycemia or moderate decompensation, Materiovigilance data, Collection and monitoring of serious adverse events and non-serious) | 6 months | 
| Study of average cost per patient for each therapeutic strategy supported from the point of view of society | An average cost per patient will be calculated for each strategy. The horizon time is 6 months from randomization of the patient. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Type 1, Hypoglycemia, Insulin Infusion Systems