NCT00598663

SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

Randomized, Cross Over, Controlled, Multi-centric Study to Assess Whether Type 1 Diabetic Patients in Sub-optimal Glycemic Control Can Improve Using the Continuous Glucose Values of the MiniMed Paradigm REAL-Time Insulin Pump System Versus the MiniMed Paradigm Insulin Pump

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 6 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-01-22
• Last updated: 2019-09-16
• Results posted: 2019-09-16

Locations

8 sites across 7 countries: Austria, Denmark, Italy, Luxembourg, Netherlands, Slovenia, Spain