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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 is a NA study of Type 1 Diabetes that has completed, run by Medtronic Diabetes. The registered enrollment target is 485 participants, below the 822-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (41% lower). The trial reports 20 study locations across 14 states.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00417989
The ClinicalTrials.gov registry entry for NCT00417989 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 485 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 822-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (41% lower). The listed sponsor is Medtronic Diabetes, which has 9 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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