NCT02179281

Prevention of Hypoglycaemia With Predictive Insulin Suspend Using Sensor Augmented Insulin Pump in Children

Prevention of Hypoglycaemia With Predictive Insulin Suspend Using Medtronic MiniMed™ 640G Sensor Augmented Insulin Pump in Children - The SportGuard Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Ljubljana, Faculty of Medicine · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to prove whether the use of the SmartGuard feature of the MiniMed system significantly reduces hypoglycemic excursions and thus provide proactive protection to the user.

Detailed description

This is randomized two-arm parallel controlled open label study that will be conducted at two sites, in Slovenia and Israel. It is an investigator initiated pediatric clinical study. Study will be conducted on pediatric population during two weeks, following a 3 day Run-in period that will allow the patients to get familiar with study device and CGM (SmartGuard OFF). Patients will be asked to continuously wear the study device for 14 days, which will be set up by study staff according to randomization in the specific group. They will be provided with a diary for entering their daily activity, food consumption (carb count) and eventual adverse events.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Medtronic MiniMed™ 640G system	The MiniMed™ 640G system is indicated for the continuous delivery of insulin, for continuous or periodic monitoring of glucose levels in the fluid under the skin, with a feature for a prediction of low or high glucose episodes.

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-07-01
• Last updated: 2015-03-10

Locations

2 sites across 2 countries: Israel, Slovenia