United Kingdom User Evaluation, MiniMed Paradigm® X54 System
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Intervention: X54 insulin pump with low suspend feature
Intervention description: Change from current insulin pump to new X54 pump
Intervention MeSH terms: Insulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The user evaluation is to assess user acceptance and the quality of training materials for
      the MiniMed Paradigm® X54 System (X54 System) in preparation for commercial distribution of
      the new system.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are current 512/712, 515/715 or 522/722 MiniMed Paradigm Insulin Pump users, with or
             without CGM experience, and have at least three months experience with any one of
             these devices;

          -  Have signed an Informed Consent and are willing to comply with the user evaluation
             procedures;

          -  Have an HbA1c value less than 9.0% recorded at the time of their last test (if no
             HbA1c value is available within three months of enrollment, an HbA1c should be
             performed prior to entry to verify inclusion criteria);

          -  Are willing to use the Bolus Wizard feature;

          -  Agree to complete a diary for the duration of the study;

          -  Agree to complete a questionnaire at the conclusion of the study;

          -  Have been diagnosed with Type 1 Diabetes Mellitus by appropriate fasting or non
             fasting lab blood glucose values, c-peptide, insulin antibodies, prior documented DKA
             or good clinical picture at least six months prior to study start;

          -  Are 18 - 65 years of age;

          -  Have access to the internet and agree to upload the device per protocol

        Exclusion Criteria:

          -  Is pregnant or planning to become pregnant during the course of the user evaluation.
             Pregnancy screening will be completed during the routine office visit prior to
             evaluation for the study. If a woman becomes pregnant during participation, she will
             be withdrawn;

          -  Suffers from a chronic debilitating condition;

          -  Has serious or unstable medical or psychological conditions (e.g., eating disorders,
             clinical depression, anxiety disorder) which, in the opinion of the Investigator,
             would compromise the subject's safety or successful participation in the study;

          -  Has impaired vision or hearing problems that could compromise the handling of the
             device;

          -  Has a history of tape allergies or skin conditions that could interfere with continued
             use of the system;

          -  Has the potential for lack of compliance or any other issue, in the opinion of the
             Investigator, that may preclude the subject from satisfactory participation in the
             study;

          -  Has travel plans which would make it difficult for the subject to attend on-site study
             visits as scheduled;

          -  Is currently participating in an investigational study (drug or device).