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Obtain a Good Blood Glucose Control With the Paradigm Real Time System

NCT00441129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2018-12-05

Study results available
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Summary

In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.

Conditions

Interventions

DEVICE

Minimed paradigm Real Time Sytem

Minimed paradigm Real Time Sytem

DEVICE

Minimed Paradigm 512/712 Insulin pump

Minimed Paradigm 512/712 Insulin pump

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • denis Raccah, professor · DCCT Group, Effect of Intensive Treatment of diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. NJEM 1993; 329/977-986

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00441129 on ClinicalTrials.gov