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SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
This study is ongoing, but not recruiting participants.
First Received: December 5, 2007   Last Updated: April 16, 2009   History of Changes
Sponsored by: Medtronic
Information provided by: Medtronic
ClinicalTrials.gov Identifier: NCT00598663
  Purpose

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
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

MedlinePlus related topics: Diabetes Diabetes Type 1
Drug Information available for: Insulin Dextrose
U.S. FDA Resources
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

Further study details as provided by Medtronic:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in glycemic variability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in occurrence of hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time spent in euglycaemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in postprandial glycaemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of Life (paeds) and Treatment Satisfaction (adults) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Severe hypo or Diabetic Ketoacidosis events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
A: Experimental
Paradigm Real-Time system: insulin pump with continuous glucose sensing
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
B
Paradigm Real-Time insulin pump with self-monitoring blood glucose
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.

  Eligibility

Ages Eligible for Study:   6 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
  • Sub-optimal glycemic control (7.5%<HbA1c<9.5%).
  • Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
  • Patient treated within the practice of the investigator's center at least 6 months prior signature of informed consent.
  • Patient has no preliminary experience with the sensor function of the Paradigm REAL-Time or the Guardian® REAL-Time for the 4 months prior signature of informed consent.

Exclusion Criteria:

  • Existing pregnancy or intention to conceive (as assessed by investigator).
  • Hearing or vision impairment so that glucose display and alarms cannot be recognized.
  • Three or more incidents in the last 12 months of severe hypoglycaemia with documented Blood Glucose below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.
  • History of hypoglycemic unawareness as assessed by the investigator.
  • Alcohol or drug abuse, other than nicotine.
  • Documented cutaneous allergy or disease (allergy to sensor or components of the sensor, psoriasis, staphylococcus, exanthema etc.).
  • Any documented concomitant chronic disease known to affect diabetes control (e.g. altered renal function, active cancer undergoing treatment, Crohn's disease, ulcerative colitis, Mb Addison disease) or any concomitant pharmacological treatment that might modify glycemic values (e.g chronic corticosteroid therapy), eating disorders and morbid obesity (defined as adults : Body Mass Index >35 and children Body Mass Index > 2 standard deviations. for age) as assessed by the investigator.
  • Any other medical, social or psychological condition that, in the investigator's opinion, makes the patient unable to comply with the study protocol and all study procedures.
  • For pediatric subjects: does not have a reliable support person.
  • Plans to travel for extended periods (3+ weeks) where the devices cannot be supplied or replaced and/or medical support is limited (eg. exotic countries, remote places).
  • Participation in another clinical study, on-going or completed less than 3 months prior to signature of Patient Informed Consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598663

Locations
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
Sponsors and Collaborators
Medtronic
Investigators
Principal Investigator: Dr. T Battelino University Children's Hospital
  More Information

No publications provided

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

Keywords provided by Medtronic:
Type 1 diabetes

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009