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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.

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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

FieldValue
Enrollment Target 485 participants
Start Date 2007-01
Est. Completion 2010-06
Phase NA

Sponsor

Medtronic Diabetes

9 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.