Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the study is to compare two closed-loop strategies in terms of glycemic
      control in Type 1 Diabetes during a camp setting.

      The proposed study is a four-segment feasibility study. One segment is a proof of concept
      study (with two parts) conducted as in-patient clinic study ,the second segment is two-arms,
      cross-over, randomized and single-center and the third segment is four-arms, parallel,
      randomized and single-center, in diabetes camp study in subjects with type 1 diabetes on
      insulin pump therapy and the forth segment is a single arm feasibility in a diabetes camp
      setting followed by a 3 weeks period at home.

      Segment 1 will be divided into two parts: part 1 is a single arm pilot study aim to asses
      logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim
      to evaluate glucose performance using closed-loop control. Part 2-is a randomized cross-over
      (two arms) in-patient study: A total of 12 patients will participate in this part of the
      study. Following the run-in period subjects will be randomized to participate in two periods
      of closed-loop treatment, each period will last 36 hours in hospital setting. During the
      first period, glycemic control will be controlled by the Hybrid closed-loop system and during
      the second period by Hybrid Logic closed-loop system. The sequence of treatment first period
      HCL therapy than AHCL or vice versa will be randomly assigned.

      Segment 2 is a randomized cross-over (two arms) Camp Study including up to 30 patients.
      Following the run-in period subjects will be randomized to participate in two periods of
      closed-loop treatment, each period will last 2days in a camp setting, the total duration of
      the camp will be up to 6 days. In one period, glycemic control will be controlled by the
      Hybrid closed-loop system and another period by Hybrid Logic closed-loop system. The sequence
      of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned.

      Segment 3 is a randomized, parallel (four arm) Camp Study including up to 80 patients.
      Following the run-in period subjects will be randomized to participate in one of 4
      intervention arms of closed-loop treatment in camp settings. The duration of the camp will be
      12 days in which glycemic control will be controlled by one of 4 versions of closed-loop
      system: Hybrid Closed Loop (HCL) or one of 3 versions of Advanced Hybrid Closed Loop (AHCL).

      Segment 4 is a single arm, feasibility study in a diabetes camp setting followed by a three
      week period at home. After the completion of segments 1-3, the AHCL system will be optimized
      and a new version of the system will be created for use in segment 4. Up to 20 subjects will
      participate in this part of the study. Following a minimum of 5 days run-in period, subjects
      will be placed in a camp setting and closed loop will be initiated. Subjects will remain in
      closed loop for 5 days and will have 3 days of challenges, including missed meal bolus, late
      meal bolus and moderate-intensity exercise. At the conclusion of the camp, subjects will
      continue to use the system at home in Auto Mode for a period of 21 days.
    


Intervention name(s): Advanced Hybrid Closed Loop System; Hybrid Closed Loop System
Intervention type(s): Device; Device
Other intervention name(s): AHCL; HCL
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: segment 1 part 1 is a single arm study, segment 1 part 2 is a is a crossover study, segment 2 is a randomized crossover study , segment 3 is a parallel study and segment 4 is a single arm study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closed Loop; Artificial Pancreas