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SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

NCT00598663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2019-09-16

Study results available
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Summary

The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump System with continuous glucose monitoring versus the Medtronic MiniMed Paradigm® REAL-Time Pump alone with Self Monitoring Blood Glucose (SMBG).Our null hypothesis is there is a 0% reduction in HbA1c from baseline compared to control group, after 6 months of treatment.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)

6 months of pump plus continuous glucose sensing in conjunction to SMBG

DEVICE

insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)

insulin pump with smbg to be worn for 6 months. 15 days in each 6 week period blinded continuous glucose sensing will be conducted.

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • Dr. T Battelino · University Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Austria
  • Denmark
  • Italy
  • Luxembourg
  • Netherlands
  • Slovenia
  • Spain

Study Locations

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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 NCT00598663 on ClinicalTrials.gov