CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 29 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.

Search/NCT00530023
NCT00530023Phase 4Completed

Pilot Study To Identify Effective Methods Of Training Pump Naïve Subjects To Use The Paradigm® 722 System And To Describe Clinical Effectiveness Compared To Subjects Continuing With Multiple Dose Injections (MDI) of Insulin

Medtronic MiniMed, Inc.·interventional·Posted Sep 17, 2007·Updated Jun 10, 2011

In Brief

A Phase 4 clinical trial evaluating MiniMed Paradigm REAL-Time System for Type 1 Diabetes. Completed, enrolled 29 participants across 2 sites.

Detailed Summary

Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus subjects continuing to administer insulin in multiple dose injections. Evaluate the educational materials and time required for training subjects naïve to continuous subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation for a large multi-center clinical trial

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 17, 2007
Enrollment StartFeb 1, 2006
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.8 years ago

Interventions

MiniMed Paradigm REAL-Time Systemdevice

MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink