Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Medtronic MiniMed Implantable Pump Human Recombinant Insulin; Medtronic MiniMed Implantable Pump System; Aventis HOE21PH U400
Intervention description: 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.; The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.; 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Diabetes; Implantable Insulin Pump; Intraperitoneal Insulin Delivery

Summary:

      The purpose of this study is to evaluate the effectiveness of insulin delivered in the
      peritoneum (abdomen)by an implantable pump in Type 1 diabetics.
    

Eligibility criteria:

        -  Type 1 diabetes mellitus (American Diabetes Association definition)

          -  HbA1c greater than or equal to 7.5%

          -  Intensive insulin treatment for at least 3 months

          -  Physical and intellectual ability to operate MIP system

          -  Subject has been under the routine care of the investigator for at least two months
             prior to enrollment

          -  Subject has a reliable support person (defined as a person who has daily contact with
             the subject and knows whom to contact in the event of an emergency).

          -  Capability and willingness to perform self-monitoring of blood glucose at least four
             times daily for 9 months of the study and 7 times daily for 3 months of the study

          -  Physical and intellectual ability to operate the MIP system and to comply with the
             data reporting requirements of the study.

          -  Subject is willing to sign the informed consent form (approved by local Institutional
             Review Board and Medtronic MiniMed)

        Exclusion Criteria:

          -  The subject's insulin usage exceeds 66 units per day.

          -  Severe complications such as advanced autonomic neuropathy, legal blindness, or
             symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the
             last six months

          -  Reside at or plan to travel to elevations above 8000 feet during the study period
             (commercial airline travel is acceptable)

          -  Subject who is pregnant, of childbearing potential or lactating and is neither
             surgically sterile, using contraceptives (devices, oral or implanted) nor other
             physician approved contraceptive

          -  The subject has any major concomitant disease or any physical or psychological
             disorder within the last five years, which might be considered life threatening, or
             which might confound the collection or interpretation of the study data

          -  The subject has previously enrolled in or participated in an investigational drug or
             device study within the preceding 4 weeks

          -  The subject has any condition that precludes him/her from completing the study
             requirements

          -  Has plans for activities which require them to go 25 feet below sea level