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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

December 5, 2007
September 17, 2010
January 2008
July 2010   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00598663 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 DKA events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Diabetes Mellitus, Type 1
  • 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
  • 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
  • Experimental: A
    Paradigm Real-Time system: insulin pump with continuous glucose sensing
    Intervention: Device: insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System)
  • B
    Paradigm Real-Time insulin pump with self-monitoring blood glucose
    Intervention: Device: insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)
Battelino T, Conget I, Olsen B, Schütz-Fuhrmann I, Hommel E, Hoogma R, Schierloh U, Sulli N, Bolinder J; SWITCH Study Group. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia. 2012 Dec;55(12):3155-62. doi: 10.1007/s00125-012-2708-9. Epub 2012 Sep 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
6 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Denmark,   Italy,   Luxembourg,   Netherlands,   Slovenia,   Spain
 
NCT00598663
EUR03, ISRCTN09806152
No
Hannah Gough / Severine Liabat, Medtronic
Medtronic
Not Provided
Principal Investigator: Dr. T Battelino University Children's Hospital
Medtronic
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP