At a glance
ClinicalIndex Comparison RecordN/ACompleted· 485 enrolled
Drug / intervention
MiniMed Paradigm REAL-Time Systemdevice
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.
The STAR 3 Study - A Prospective, Randomized, Two-Arm Study to Compare the Efficacy of the MiniMed Paradigm REAL-Time System Versus Multiple Daily Injections (MDI) in Subjects Naïve to Insulin Pump Therapy
In Brief
A clinical study evaluating MiniMed Paradigm REAL-Time System for Type 1 Diabetes. Completed, enrolled 485 participants across 30 sites in 2 countries.
Detailed Summary
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group". Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic variability, Area Under the Curve (AUC); Quality of Life; and Health Economic Outcomes (MRU)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedJan 2007
Primary CompletionDec 2009
Study CompletionJun 2010
TodayJul 2026
First PostedJan 4, 2007
Enrollment StartJan 1, 2007
Primary CompletionDec 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.5 years ago
Interventions
MiniMed Paradigm REAL-Time Systemdevice
Paradigm 722 insulin pump Paradigm REAL-Time Transmitter Sensor ComLink Paradigm Link glucose meter