Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: MiniMed Paradigm REAL-Time System
Intervention description: MiniMed Paradigm 722 insulin pump The transmitter The sensor Paradigm Link Glucose Meter The ComLink
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus
      subjects continuing to administer insulin in multiple dose injections. Evaluate the
      educational materials and time required for training subjects naïve to continuous
      subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation
      for a large multi-center clinical trial
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is between 18 - 70 years of age (inclusive)

          -  Subject is diagnosed with Type 1 Diabetes Mellitus as determined by the Investigator.

          -  Diabetes is diagnosed > (greater or equal to) six (6) months prior to study entry.

          -  A1C > 7.5% (greater than or equal to) as measured by the Central Laboratory at
             Screening Visit 1.

          -  Subject currently requires insulin administration by injection > (greater or equal to)
             three (3) times daily.

          -  Subject is currently (over past 3 months) performing an average of four (4) blood
             glucose measurements per day, as determined and documented by the investigator

          -  Subject has been treated in the investigator's practice or in a referring
             endocrinologist's practice for at least 6 months prior to the study

          -  Subject is fluent in speaking, understanding, and reading English.

          -  Subject is able and willing to perform the study procedures and agrees to wear sensors
             at least five (5) days per week (722 Arm only) during the study period.

          -  Subject is able to use the study devices (722 Arm only) as labeled

          -  Subject has reviewed and signed the Informed consent, HIPPA Authorization, and
             California Experimental Subject's Bill of Rights (California only).

          -  Subject has the capability to upload their insulin pumps or glucose meters every two
             weeks; access to the Internet and specific computer system requirements are necessary
             to participate in the study

        Exclusion Criteria:

          -  Subject is pregnant or planning to become pregnant during the course of the study.

          -  Subject has a history of tape allergies that have not been resolved.

          -  Subject self-reports any skin abnormality (i.e. psoriasis, rash, and staphylococcus
             infection).

          -  Subject has any additional condition(s) (medical, social, or psychosocial) that in the
             Investigator's opinion would warrant exclusion from the study or prevent the subject
             from completing or complying with the study requirements.

          -  Subject is currently or within past 4 weeks participated in an investigational study
             (drug or device).

        Subject has a history of tape allergies that have not been resolved.