Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes The DREAMED Trail
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well
      as reduce glycemic variability.

      Several groups around the world investigate efforts in developing closed-loop systems.
      Investigators combined two closed-loop systems with different mode of operation in order to
      enhance the closed-loop system. The two systems are Hybrid closed-loop system and the
      MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was
      tested 'In silico' and was proved to be safe and effective. The next step is to test the
      system in a clinical study in a supervised environment in a camp.

      The two systems were tested separately in several clinical studies and were proven to be safe
      and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system
      for overnight use "the GlucoSitter" has a CE mark.

      The purpose of this study is to collect data on the feasibility of the HLCL system in a camp
      setting.
    

Detailed description: 
      Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well
      as reduce glycemic variability.

      Several groups around the world investigate efforts in developing closed-loop systems.
      Investigators combined two closed-loop systems with different mode of operation in order to
      enhance the closed-loop system. The two systems are Hybrid closed-loop system and the
      MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was
      tested 'In silico' and was proved to be safe and effective. The next step is to test the
      system in a clinical study in a supervised environment in a camp.

      The two systems were tested separately in several clinical studies and were proven to be safe
      and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system
      for overnight use "the GlucoSitter" has a CE mark.

      The primary objective of the study is to characterize the overall management of the glycemic
      control using this system including Safety. The data collected in this study will be used to
      confirm/develop the HLCL System further.

      Secondary objectives of this study include evaluation of the HLCL system in a monitored
      setting (camp) with the following stresses:Exercise, high carbohydrate and high fat meals

      This study is a single-arm, single-center, in clinic Investigation in subjects with type 1
      diabetes on insulin pump therapy.

      Run-in Period:

      A total of up to 10 subjects will be enrolled (age 18-40). A minimum of 6 days run-in period
      with sensor augmented pump will be used to collect sensors and insulin data and to allow the
      subject to become familiar.

      Study Period - Camp:

      Following the run-in period subjects will participate in a 5 day, 4 night study period in a
      camp setting during which the HLCL feature will be studied.
    

Intervention name(s): HLCL- Hybrid Logic Closed Loop System
Intervention type(s): Device
Intervention description(s): All subjects wearing the HLCL System and using it with the closed loop algorithm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment