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SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c (SWITCH)

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ClinicalTrials.gov Identifier: NCT00598663
Recruitment Status : Completed
First Posted : January 22, 2008
Last Update Posted : September 20, 2010
Information provided by:

Brief 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.

Condition or disease Intervention/treatment 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 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : January 2008
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
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
Other Names:
  • Paradigm Real-Time Insulin Pump System
  • Medtronic MMT-522 or MMT-722 + MMT7707WW
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.
Other Names:
  • Paradigm Real-Time insulin pump
  • Guardian Real-Time clinical
  • MMT-522 or MMT-722 + MMT7707WW + CSS7100

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in glycemic variability [ Time Frame: 6 months ]
  2. Change in occurrence of hypoglycemia [ Time Frame: 6 months ]
  3. Time spent in euglycaemia [ Time Frame: 6 months ]
  4. Change in postprandial glycaemia [ Time Frame: 6 months ]
  5. Quality of Life (paeds) and Treatment Satisfaction (adults) [ Time Frame: 6 months ]
  6. Severe hypo or Diabetic Ketoacidosis events [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598663

Hospital Hietzing
Vienna, Austria
Steno Diabetes Center
Copenhagen, Denmark
Glostrup Hospital
Glostrup, Denmark
Clinica Pediatrica, Policlinico Umberto I
Rome, Italy
Center Hospitalier de Luxembourg
Luxembourg, Luxembourg
Groene Hart Ziekenhuis
Gouda, Netherlands
University Children's Hospital
Ljubljana, Slovenia
Hospital Clinic i Universitari
Barcelona, Spain
Sponsors and Collaborators
Principal Investigator: Dr. T Battelino University Children's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hannah Gough / Severine Liabat, Medtronic
ClinicalTrials.gov Identifier: NCT00598663     History of Changes
Other Study ID Numbers: EUR03
First Posted: January 22, 2008    Key Record Dates
Last Update Posted: September 20, 2010
Last Verified: September 2010

Keywords provided by Medtronic:
Type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs