Safety and Efficacy of 7-day Wear Infusion Set vs. Control Infusion Set.
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the Extended Wear (EW) infusion set seven day
      functioning in patients with Type 1 diabetes compared to the Quick-set infusion set. The
      study will be carried out in adults with type 1 diabetes.
    

Detailed description: 
      This is a 1-center, prospective, open label randomized, crossover controlled study.

      40 patients will be using 4 infusion sets (a total of 160 sets) that will serve as an
      exploratory pilot study to assess the SD of 7 day use for future study design.

      Eligible patients meeting the enrollment and randomization criteria 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 for4 sets (up to 28 days). The order will be determined by
      the randomization process:

        -  Arm 1: Quick-EWIS. First phase Quickset, second phase EWIS.

        -  Arm 2: EWIS-Quick. First phase EWIS, second phase Quickset.

      Following screening and informed consenting to the trial, a randomized procedure will define
      the subject trial arm:

        -  Trial Arm A: Subjects will be randomized to a group who will be using the Quickset
           infusion system for the Phase 1. All patients will be retrained on the use of the
           Quickset infusion set 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 Quick-set). 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 X infusion set, entering Phase 2. All
           patients will be trained at this visit on the use of the X EW infusion set by site staff
           and demonstrate proficiency in the use of the EW infusion set. 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 EWIS set
           infusion system for the initial Phase. All patients will be trained on the use of the
           EWIS infusion set 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 Quick-set). 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 Quickset infusion set, entering Phase 2.
           All patients will then be retrained on the use of the Quickset infusion set by site
           staff and demonstrate proficiency. After 28 days or after using 4 sets, the patients
           will all the extracted catheters sets .

      An extension phase for additional one month (4 sets) will be conducted as a single arm to
      assess the seven day durability of sets.
    

Intervention name(s): 7 day infusion set
Intervention type(s): Device
Intervention description(s): 7 days survival of the sets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment