SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c

This study has been completed.
Sponsor:
Information provided by:
Medtronic
ClinicalTrials.gov Identifier:
NCT00598663
First received: December 5, 2007
Last updated: September 17, 2010
Last verified: September 2010
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


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
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Other Names:
  • Paradigm Real-Time insulin pump
  • Guardian Real-Time clinical
  • MMT-522 or MMT-722 + MMT7707WW + CSS7100

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Medtronic

Additional 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, ISRCTN09806152
Study First Received: December 5, 2007
Last Updated: September 17, 2010
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

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
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014