NCT00441129

Obtain a Good Blood Glucose Control With the Paradigm Real Time System

To Assess Whether Type 1 Diabetic Patients Treated With M D I and in Poor Metabolic Control Can Improve Using the Paradigm® Real Time System Compared to Self-Monitoring Blood Glucose and Continuous Subcutaneous Insulin Infusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Accepted

Summary

In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.

Detailed description

The long-term clinical benefit of tight glycemic control in people with diabetes is well known . HbA1c generally assesses the average/long term quality of glycemic control, it has been clearly demonstrated that a target of HbA1c at 7.0% or less has benefits for diabetic patients

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Minimed paradigm Real Time Sytem	Minimed paradigm Real Time Sytem
DEVICE	Minimed Paradigm 512/712 Insulin pump	Minimed Paradigm 512/712 Insulin pump

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-02-28
• Last updated: 2018-12-05
• Results posted: 2018-12-05

Locations

8 sites across 1 country: France