Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00598663
Recruitment Status : Completed
First Posted : January 22, 2008
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

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) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010


Arm Intervention/treatment
Experimental: Off/On

6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]

4 month wash out period

6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]

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

Experimental: On/Off

6 month-Period On: Continuous Subcutaneous Insulin Infusion (CSII) + personal continuous glucose monitoring (personal CGM) [Device: Paradigm® Real-Time pump with Sensor On feature continuously]

4 month wash out period

6 month-Period Off: Continuous Subcutaneous Insulin Infusion (CSII) and Self Monitoring Blood Glucose [Device: Paradigm® Real-Time pump with Sensor Off feature]

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 at 6 Month [ Time Frame: 6 months ]
    The end of period difference in HbA1c after 6 months of treatment


Secondary Outcome Measures :
  1. Glycemic Variability [ Time Frame: 6 months ]
    24 h SD of glucose values (mg/dl)

  2. Number of Severe Hypoglycemia Events [ Time Frame: 6 months ]
  3. Daily Min Spent in Euglycaemia (3.9-10.0 mmol/l) [ Time Frame: 6 months ]
  4. Postprandial Glycaemia [ Time Frame: 6 months ]
    Breakfast Postprandial glycaemia

  5. Pediatric Quality of Life Inventory (Vers 4.0; PedsQL) [ Time Frame: 6 months ]

    This questionnaire is a validated assessment of health-related quality of life in children developed by J.W. Varni, (1998).

    Scores are transformed on a scale from 0 to 100. higher values represent a better outcome


  6. Diabetic Ketoacidosis Events [ Time Frame: 6 months ]
    A diabetic ketoacidosis event (DKE) is defined as a hyperglycemia (blood glucose >250 mg/dL) with either low serum bicarbonate (<15 mEq/L) and/or low pH (<7.3) and either ketonemia or ketonuria and requiring treatment within a health-care facility.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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


Locations
Layout table for location information
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 Diabetes
Investigators
Layout table for investigator information
Principal Investigator: Dr. T Battelino University Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00598663    
Other Study ID Numbers: EUR03
ISRCTN09806152
First Posted: January 22, 2008    Key Record Dates
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019
Last Verified: August 2019
Keywords provided by Medtronic Diabetes:
Type 1 diabetes
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs