Safety and Efficacy of Medtronic Extended Mio 30 Infusion Set
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the Extended Mio 30 infusion set (EM30IS) 7-day
      functioning compared to the regular Mio 30 infusion set (M30IS) 3-day functioning. The study
      will be carried out in adult patients with type 1 diabetes.

      Secondary objective, to evaluate the differences in glucose control between the infusion set
      currently used by participants (Medtronic Quick set infusion sets) and the Medtronic Mio 30
      Infusion Set.
    

Detailed description: 
      This is a 1-center, prospective, open-label, cross-over controlled study with type 1 patients
      with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM).

      A total of up to 40 subjects will be enrolled in order to have 20 subjects meeting
      eligibility criteria. Eligible patients meeting the enrollment and randomization criteria
      will enter a run-in period of up to 1 month for device adaptation. After the run- in phase,
      The participants will enter the first study part; participants will be randomized into 2
      arms, each arm will undergo 2 phases. In each phase a different type of infusion set will be
      evaluated. Each evaluation will be for 1 month. The order will be determined by the
      randomization process:

      Arm A: Quick set infusion set- M30IS. First phase Quick set, second phase Mio 30.

      Arm B: M30IS- Quick set infusion set. First phase Mio 30, second phase Quick set infusion
      set.

      Trial Arm A: Subjects will be randomized to a group who will be using the Quick set infusion
      set for the initial Phase. All patients will be trained on the use of the Quick set infusion
      set by site staff and will be asked to demonstrate proficiency. All subjects will be
      instructed to change sets every 3 days or at set failure (replace with another Quick set
      infusion set).

      After 1 month, the patients will return to a visit, return all the extracted catheters sets
      and will switch to the M30IS, entering Phase 2. All patients will then be retrained on the
      use of the M30IS by site staff and demonstrate proficiency. All subjects will be instructed
      to change sets every 3 days or at set failure (replace with another M30IS). 1 month, the
      patients will return all the extracted catheters sets.

      Trial Arm B: Subjects will be randomized to a group who will be using the Mio 30 infusion set
      (M30IS) for the second Phase. All patients will be retrained on the use of the M30IS by site
      staff and will be asked to demonstrate proficiency. All subjects will be instructed to change
      sets every 3 days or at set failure (replace with another M30IS).

      After 1 month, the patients will return to a visit, return all the extracted catheters sets
      and will switch to the Quick set infusion set, entering Phase 2. All patients will be trained
      at this visit on the use of the Quick set infusion set by site staff and demonstrate
      proficiency in the use of the Quick set infusion set. All subjects will be instructed to
      change sets every 3 days or at set failure (replace with another Quick set infusion set). 1
      month, the patients will return all the extracted catheters sets

      After completing the first study part, participants will be randomized again into 2 arms,
      each arm will undergo 2 phases. In each phase a different type of infusion set will be
      evaluated. Each evaluation will be for 4 sets (up to 28 days). The order will be determined
      by the randomization process:

        -  Arm A: M30IS - EM30IS. First phase Mio 30, second phase Extended Mio 30.

        -  Arm B: EM30IS - M30IS. First phase Extended Mio 30, second phase Mio 30. Trial Arm A:
           Subjects will be randomized to a group who will be using the Mio 30 infusion set (M30IS)
           for the Phase 1. All patients will be retrained on the use of the M30IS by site staff
           and will be asked to demonstrate proficiency. All subjects will be instructed to change
           sets every 3 days or at set failure (replace with another M30IS).

      At day 12 or after using 4 sets (set used defined as a set that was used for more than 6
      hours), the patients will return to a visit, return all the extracted catheters sets and will
      switch to the Extended Mio 30 infusion set (EM30IS), entering Phase 2. All patients will be
      trained at this visit on the use of the EM30IS by site staff and demonstrate proficiency in
      the use of the EM30IS. All subjects will be instructed to change sets every 7 days or at set
      failure (replace with another EM30IS). After 28 days or after using 4 sets, the patients will
      return all the extracted catheters sets.

      Trial Arm B: Subjects will be randomized to a group who will be using the EM30IS for the
      initial Phase. All patients will be trained on the use of the EM30IS by site staff and will
      be asked to demonstrate proficiency. All subjects will be instructed to change sets every 7
      days or at set failure (replace with another EM30IS).

      At day 28 or after using 4 sets (set used defined as a set that was used for more than 6
      hours), the patients will return to a visit, return all the extracted catheters sets and will
      switch to the M30IS, entering Phase 2. All patients will then be retrained on the use of the
      M30IS by site staff and demonstrate proficiency. All subjects will be instructed to change
      sets every 3 days or at set failure (replace with another M30IS). After 12 days or after
      using 4 sets, the patients will all the extracted catheters sets.

      Each subject will wear MiniMed™ 780G/670G insulin system. Each subject will be given for the
      first study part: 11 infusion sets each to wear, each infusion set for at least the labelled
      use time (3 days for M30IS or 3 days for Quick set infusin set), or until infusion set
      failure if this occurs before 3 days.for the second part 4 infusion sets each to wear, each
      infusion set for at least the labelled use time (3 days for M30IS or 7 days for EM30IS), or
      until infusion set failure if this occurs before 3 days.
    

Intervention name(s): Medtronic Extended Mio 30 Infusion Set
Intervention type(s): Device
Intervention description(s): Safety and Efficacy of Medtronic Extended Mio 30 Infusion Set
Other intervention name(s): Medtronic Mio 30 Infusion Set; Medtronic Quick set infusion set
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment