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Paradigm 722 sensor/pump clinical trials

Discussion in 'General Discussion' started by Ellen, Mar 9, 2006.

  1. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
    Messages:
    8,240
    http://www.clinicaltrials.gov/ct/show/NCT00211510;jsessionid=E6D7F606C7251

    Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes

    This study is currently recruiting patients.
    Verified by Medtronic Diabetes September 2005

    Sponsored by: Medtronic Diabetes
    Information provided by: Medtronic Diabetes
    ClinicalTrials.gov Identifier: NCT00211510


    Purpose

    The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only.
    Condition Intervention Phase
    Type 1 Diabetes
    Device: Paradigm 722 Sensor-augmented pump
    Phase III


    MedlinePlus related topics: Diabetes Type 1


    Study Type: Interventional
    Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

    Official Title: "The Seven Center Study" - Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-Center, Randomized Controlled Trial

    Further study details as provided by Medtronic Diabetes:
    Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (26 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (715) Group".
    Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic instability; Glucose sensor accuracy; User Acceptance (QoL + User Eval); Severe adverse events and device-related adverse events
    Expected Total Enrollment: 140
    Study start: June 2005


    Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.

    Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).

    Eligibility

    Ages Eligible for Study: 12 Years - 80 Years, Genders Eligible for Study: Both
    Criteria
    Inclusion Criteria:

    Age 12 - 80 years
    Type 1 Diabetes Mellitus diagnosed at least 1 year ago
    Using insulin infusion pump for past 6 months minimum
    Performing minimum 4 blood glucose tests per day
    Agree to treat to A1c targets
    Read and understand English
    Exclusion Criteria:

    Pregnant or planning pregnancy
    History of unresolved tape allergy or skin conditions
    Location and Contact Information

    Please refer to this study by ClinicalTrials.gov identifier NCT00211510


    California
    Stanford University, Stanford, California, 94305, United States; Recruiting
    Bruce A. Buckingham, MD 650-723-5791
    Bruce A. Buckingham, MD, Principal Investigator


    Children's Hospital of Los Angeles, Los Angeles, California, 90027, United States; Recruiting
    Mary Halvorson, RN 323-669-4606
    Francine R. Kaufman, MD, Principal Investigator


    Georgia
    Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States; Recruiting
    Bruce Bode, MD 404-355-4393
    Bruce W. Bode, MD, Principal Investigator


    Massachusetts
    Joslin Diabetes Center, Boston, Massachusetts, 02215, United States; Recruiting
    Howard A. Wolpert, MD 617-732-2665
    Howard A. Wolpert, MD, Principal Investigator


    New York
    The Endocrine Group, Albany, New York, 12206, United States; Recruiting
    Jill Ableseth, MD 518-489-4704
    Jill Abelseth, MD, Principal Investigator


    Texas
    Diabetes and Glandular Diabetes Research Associates, San Antonio, Texas, 78229, United States; Recruiting
    Sherwyn L Schwartz, MD 210-614-8612
    Sherwyn L Schwartz, MD, Principal Investigator
    Jerome Fischer, MD, Sub-Investigator


    Washington
    University of Washington, Seattle, Washington, 98195, United States; Recruiting
    Irl B. Hirsch, MD 206-598-4882
    Irl B. Hirsch, MD, Principal Investigator

    More Information

    Study ID Numbers: CEP 178/Z25/A2
    Last Updated: December 8, 2005
    Record first received: September 12, 2005
    ClinicalTrials.gov Identifier: NCT00211510
    Health Authority: United States: Food and Drug Administration
    ClinicalTrials.gov processed this record on 2006-03-09
     
  2. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
    Messages:
    8,240
    Sorry that page hasn't been updated since September 2005 and the trials are closed for participation.
     

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