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Sponsored by: |
Medtronic |
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Information provided by: | Medtronic |
ClinicalTrials.gov Identifier: | NCT00598663 |
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.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 1 |
Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System) Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump) |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment |
Official Title: | Randomized, Cross Over, Controlled, Multi-Centric Study to Assess Whether Type 1 Diabetic Patients in Sub-Optimal Glycemic Control Can Improve Using the Continuous Glucose Values of the MiniMed Paradigm REAL-Time Insulin Pump System Versus the MiniMed Paradigm Insulin Pump |
Enrollment: | 154 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Paradigm Real-Time system: insulin pump with continuous glucose sensing
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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
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B
Paradigm Real-Time insulin pump with self-monitoring blood glucose
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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.
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Ages Eligible for Study: | 6 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Hospital Hietzing | |
Vienna, Austria | |
Denmark | |
Steno Diabetes Center | |
Copenhagen, Denmark | |
Glostrup Hospital | |
Glostrup, Denmark | |
Italy | |
Clinica Pediatrica, Policlinico Umberto I | |
Rome, Italy | |
Luxembourg | |
Center Hospitalier de Luxembourg | |
Luxembourg, Luxembourg | |
Netherlands | |
Groene Hart Ziekenhuis | |
Gouda, Netherlands | |
Slovenia | |
University Children's Hospital | |
Ljubljana, Slovenia | |
Spain | |
Hospital Clinic i Universitari | |
Barcelona, Spain |
Principal Investigator: | Dr. T Battelino | University Children's Hospital |
Responsible Party: | Medtronic ( Hannah Gough / Severine Liabat ) |
Study ID Numbers: | EUR03, ISRCTN09806152 |
Study First Received: | December 5, 2007 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00598663 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety; Austria: Ethikkommission; Austria: Federal Ministry for Health and Women; Austria: Federal Office for Safety in Health Care; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: National Board of Health; Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: The Ministry of the Interior and Health; Italy: Ethics Committee; Italy: Ministry of Health; Italy: National Bioethics Committee; Italy: National Institute of Health; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Italy: The Italian Medicines Agency; Netherlands: Independent Ethics Committee; Netherlands: Dutch Health Care Inspectorate; Netherlands: Medical Ethics Review Committee (METC); Netherlands: Medicines Evaluation Board (MEB); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Slovenia: Agency for Medicinal Products - Ministry of Health; Slovenia: Ministry of Health; Spain: Comité Ético de Investigación Clínica; Spain: Ethics Committee; Spain: Ministry of Health; Spain: Ministry of Health and Consumption; Spain: Spanish Agency of Medicines |
Type 1 diabetes |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 Physiological Effects of Drugs |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |