At a glance
ClinicalIndex Comparison RecordN/ACompleted· 115 enrolled
Drug / intervention
Minimed paradigm Real Time Sytem +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Minimed paradigm Real Time Sytem and Minimed Paradigm 512/712 Insulin pump for Type 1 Diabetes. Completed, enrolled 115 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesFrance
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2006
First PostedFeb 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedFeb 28, 2007
Enrollment StartJun 1, 2006
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.3 years ago
Interventions
Minimed paradigm Real Time Sytemdevice
Minimed paradigm Real Time Sytem
Minimed Paradigm 512/712 Insulin pumpdevice
Minimed Paradigm 512/712 Insulin pump