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NCT00417989 · ClinicalTrials.gov registry record · NA
Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy
A NA study of Type 1 Diabetes, sponsored by Medtronic Diabetes.
- Completed
- Registry status
- NA
- Development phase
- 485
- Enrollment target
- 20
- Study locations
NCT00417989: Completed NA study of Type 1 Diabetes, sponsored by Medtronic Diabetes.
NCT00417989 is a NA study of Type 1 Diabetes that has completed, run by Medtronic Diabetes. The registered enrollment target is 485 participants, below the 764-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00417989, a NA study of Type 1 Diabetes, has completed, sponsored by Medtronic Diabetes.
- COMPLETED
- Registry status
- NA
- Development phase
- 485 participants
- Enrollment target
- 20
- Study locations
Study 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)
Primary Outcome
Change is defined as A1c at Week 52 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.
Conditions Studied
Interventions
- DEVICE MiniMed Paradigm REAL-Time System
Study Locations (20)
North Carolina
- Mountain Diabetes & Endocrine Center - Asheville
- University of North Carolina at Chapel Hill - Chapel Hill
- Duke University Medical Center Diabetes Research Clinic - Durham
- Diabetes and Obesity Center, East Carolina University - Greenville
Minnesota
- Mayo Clinic - Rochester
- Minnesota International Diabetes Center - Saint Louis Park
- Children's Hospital of St. Paul - Saint Paul
California
- Scripps Institute - La Jolla
- Children's Hospital of Orange County (CHOC) - Orange
Colorado
- Barbara Davis Center, University of Colorado - Boulder
Connecticut
- Yale University - New Haven
Florida
- Diabetes Research Institute (DRI) - Miami
Georgia
- Endocrine Research Solutions, Inc. - Roswell
Idaho
- Rocky Mountain Diabetes and Osteoporosis Center - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 485 participants |
| Start Date | 2007-01 |
| Est. Completion | 2010-06 |
| Phase | NA |
What the finished NCT00417989 record still lists
NCT00417989 is an interventional study that assigns participants to a tested intervention. The registered 485 participants enrollment target is mid-sized for trials with a published cap, below the 764-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which MiniMed Paradigm REAL-Time System is the first listed.
NCT00417989 names 20 study sites across 14 states, led by North Carolina, Minnesota, California.
Frequently Asked Questions
What is clinical trial NCT00417989 about?
NCT00417989 is a clinical study titled "Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy". 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 th...
What is the current status of trial NCT00417989?
This trial is currently completed. It is a NA study. The enrollment target is 485 participants. The study started on 2007-01. Estimated completion is 2010-06.
What conditions does trial NCT00417989 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT00417989?
The interventions under investigation include: MiniMed Paradigm REAL-Time System (DEVICE).
Who is sponsoring clinical trial NCT00417989?
This trial is sponsored by Medtronic Diabetes, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00417989 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00417989's enrollment target sits among peer trials
485 18th of 198 higher than 181 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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