NCT02657213

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Diabetes, Type 1

Interventions

Type	Name	Description
DEVICE	Minimed 640G with smartguard activated	Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
DEVICE	Minimed 640G with smartguard off	Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-01-15
• Last updated: 2017-10-18

Locations

2 sites across 1 country: France