Use of an Automated Insulin Delivery System Compared to Sensor Augmented Pump at Patients With Type 1 Diabetes (T1D)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Title: An open-label, three-center, randomized, cross-over study to evaluate the safety and
      efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery
      system compared to sensor augmented pump therapy at patients with type 1 diabetes at home
      Indication: Type 1 Diabetes mellitus using an insulin pump therapy and continues glucose
      sensors The objective of this pilot study is to evaluate the safety and efficacy of 60 hours
      blood glucose control, using the MD-Logic System in individuals with type 1 diabetes at
      patient's home.

      The duration of study participation for one subject is 28-56 days and the overall duration of
      the study is 6 months The participants of the study are patients ≥ 10 years until 65 years
      with Type 1 Diabetes mellitus using and insulin pump therapy and continuous glucose sensors.

      Sample Size n = 45
    

Detailed description: 
      Up to 45 eligible patients will be enrolled to participate in two crossover sessions of 60
      hours of consecutive days, with closed-loop or sensor-augmented pump therapy (Minimed
      ®Paradigm). The sequence of the sessions will be randomly assigned. The randomization will be
      blocked randomization (1:1). Patients will be assigned to one of the following arm: Group A:
      60 hours under closed-loop control and then 60 hours of sensor augmented pump therapy and
      Group B: 60 hours using sensor augmented pump therapy and then 60 hours under closed-loop
      control.

      Subjects will be enrolled according to the following schedule/ successive phases:

      Phase 1: 5 Adult subjects: After all adult subjects have completed the study the 2nd
      enrollment phase starts.

      Phase 2: 5 Adolescent subjects aged 14-18. After these subjects have completed the study the
      3rd enrollment phase starts.

      Phase 3: 5 Children aged 10-14 will be enrolled.

      The enrollment of phase 2 and phase 3 will not be started before all participants of the
      previous phase completed the study and the safety and efficacy of the system has been
      analyzed based on the occurrence of (serious) adverse Events (AE) or any other issue relevant
      for patient's safety. If the observed AEs or device problems do not exceed the amount or
      severity of the risks expected during a regular diabetes therapy and the recruitment of the
      next age category is considered reasonable from the medical point of view, the next
      enrollment phase will be started.Screening Failures will be replaced to get a total of 45
      completed patients.The average duration of study participation for subjects completing the
      study is estimated to be approximately 28-56 days. The estimated duration of the total study
      is 6 months.In this study 45 patients will be included, 15 are planned to be enrolled in
      Germany.

      The study will consist of 5 visits (3 clinical visits and 2 visits will be done by phone) as
      followed:

        -  Visit 1: Screening, eligibility, enrolment and sensor and diabetes guidelines training.
           (Day - 21)

        -  Run-in period

        -  Visit 2: Randomization and preparation visit for the outpatient period. (Day 0)

        -  Intervention session 1 (same weekdays as Intervention session 2)

        -  Visit 3: Phone call visit between arms. (Day 4)

        -  Washout period

        -  Visit 4: Phone call visit before session 2 (Day 18)

        -  Intervention session 2 (same weekdays as Intervention session 1)

        -  Visit 5: Final visit. (Day 21)

      There is no follow up visit or observation planned after the end of the study or after a
      subject discontinued study participation. In case of a Serious Adverse Event (SAE) a follow
      up period until this SAE is resolved/ recovered is planned.
    

Intervention name(s): MD-Logic-Automated Insulin Delivery System; MiniMed Paradigm® Veo™ System
Intervention type(s): Device; Device
Intervention description(s): Subjects will undergo 60 hours at home under MD-Logic control and continuing with their regular routine life. At evening of the first intervention day patients will switch to MD-Logic control. Patients will be asked to connect study sensor and pump to the computer using the MD-Logic software. After the activation of the MD-Logic system, basal insulin dosing and correction boluses will be fully automated and controlled by the MD-Logic system except to meal boluses. Patients will be encouraged to measure capillary blood glucose at least 4 times a day, before each meal and before bed time. After the third night the patient will turn the closed-loop controller "OFF", this will automatically save the log file. The patient will return to his regular insulin treatment.; Subjects use 60 hours at home their conventional insulin pump and continuing with their regular Routine life. During this therapy the Insulin pump operating separately and are not controlled by the MD-Logic System.
Other intervention name(s): Closed loop; sensor augmented continuous subcutaneous insulin infusion
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment