Overnight MD-Logic
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Study design: Multicenter,randomized, prospective, open label, cross over, six segments,
      pilot trial to evaluate blood glucose control overnight under closed-loop insulin delivery
      with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes.

      on the first segment 15 eligible subjects will be enrolled from the three participating
      centers (5 patients at each center). All 15 patients will participate in the overnight closed
      loop session in the hospital settings.

      On the second segment, 54 eligible subjects will be enrolled (18 at each center). Each
      subject will participate in the two consecutive overnight sessions in diabetes camp settings,
      one under closed-loop with MDLAP and one under sensor augmented pump therapy.

      In the third segment,9-20 eligible patients will be enrolled at the Israeli center only.Each
      subject will participate in up to four consecutive overnight under closed loop with MDLAP and
      up to four additional overnight under regular sensor augmented pump therapy at home.

      On the fourth segment, 45-60 patients will be enrolled at the Israeli center only. This
      segment will be conducted at a diabetes camp and will consist of two main parts. In part 1,
      15-20 patients will be randomized to participate in one of the two groups: 2-4 nights under
      closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under
      closed loop control without activating the MD-Logic learning algorithm. In part 2 of the
      forth segment 30-40 patients will participate in two consecutive24-48 hours sessions,one
      under closed loop control and the second under sensor augmented pump therapy.

      On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center only.The
      first 10 patients will participate in a pilot session and data gathered at this pilot session
      will not be used at the final analysis.This segment will consist of two parts. At part 1 each
      subject will participate in 4weeks-1.5 months period of over nights either using closed-loop
      with MDLAP or using sensor augmented pump (SAP) therapy.At the end of the first 4 weeks-1.5
      months of the study, statistical analysis will be performed in order to decide whether to
      extend the study with an optional period of extra 4 weeks-1.5 months.In case it will be
      decided to extend the study, additional 4 weeks-1.5 months intervention period following
      completion of final visit activities will be offered to participants. Subjects that have
      participated in the control group (sensor augmented pump therapy) will be offered the
      opportunity to continue to 4 weeks-1.5 months of closed-loop control and the study group will
      be offered to switch to sensor augmented pump therapy. In segment 5 part 2, up to 40 patients
      will be enrolled. Each patient will participate in 3 months study period either using
      overnight closed loop under MDLAP or sensor augmented pump therapy.Participants in segment 5
      part 2 will be offered to participate in part 2A. At this part, sleep quality assessment will
      be made (by using actigraf and sleep questionnaire) At the end of this period an optional 3
      months extension period will be offered with the other arm (cross-over)

      Segment 6 will be consist of two main parts.In part 1, up to 40 eligible patients will be
      enrolled at the Israeli center only. Each subject will participate in up to 72 hours of
      closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy
      . The sequence of the treatment intervention will be randomly assigned. The sequence of the
      treatment intervention will be randomly assigned. In part 2 of this segment 40 eligible
      patients will enrolled at the Israeli center only. Each subject will participate in up to 2
      weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor augmented pump
      therapy. The sequence of the treatment intervention will be randomly assigned

      Objectives: The objective of this feasibility study is to evaluate the safety and efficacy of
      blood glucose control using the MD-Logic Artificial Pancreas System in individuals with type
      1 diabetes in the hospital settings,at a diabetes camp and finally at patient's home.
    

Detailed description: 
      In the last two decades, remarkable technological progress has been made with the development
      of continuous glucose sensors, miniature devices, implantable pumps and sensors and wireless
      communications, interest in the closed-loop insulin delivery was revived.

      Control trails that evaluate the clinical benefits of continuous glucose sensor have shown
      improved HbA1c with no significant increase in sever hypoglycemia, trend towards lower
      hypoglycemic episodes although not significant and no significant change in sever
      hypoglycemia. One of the main drawbacks of continuous glucose sensor is noncompliant of the
      patient, the flow of information and the need to act accordingly makes this devise a burden
      for some patients. Theoretically subcutaneous insulin pumps and glucose sensors attached to
      an artificial pancreas in a closed-loop system can mimic the activity of functioning
      pancreatic beta cells, with strict control of blood glucose levels. Such a system may also
      offer an opportunity to free the patients from the daily burden of dealing with their
      diabetes.

      We developed the MD-Logic Artificial Pancreas (MDLAP) which is based on a model which
      imitates the logic of diabetes care givers.

      We aimed to evaluate blood glucose control overnight under closed- loop insulin delivery with
      MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes in the hospital
      settings,at diabetes camp settings and finally at patient's home .

      Study Objectives To determine the safety and efficacy of using the MDLAP system to
      automatically control blood glucose in type 1 diabetic patients.

      Study Scope This is a three center, prospective pilot trail to evaluate blood glucose control
      under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in
      patients with type 1 diabetes, being conducted in: Tel Aviv, Israel;Ljubljana, Slovenia and
      Hannover, Germany

      Study will be consist from six segments:

      In segment 1, 15 eligible patients will be enrolled for the pilot study. 5 patients will be
      recruited at each center.Data generated from the first patient at each center will not be
      included at the final statistical analysis and will be used to assess logistical and training
      issues only.

      On the second segment, 54 eligible subjects will be enrolled (18 at each center). Each
      subject will participate in the two consecutive overnight sessions in diabetes camp settings,
      one under closed-loop with MDLAP and one under sensor augmented pump therapy. Staying at a
      camp, can represent the home setting, but has on site the support of a medical team trained
      in diabetes. A remote safety and control diabetes management system will be utilized at this
      segment to enable the supervising personnel to alert the patient and intervene in cases of
      impending hypoglycemia, long standing hyperglycemia and technical faults of any component of
      the AP system.

      In the third segment,9-20 eligible patients will be enrolled at the Israeli center only.Each
      subject will participate in up to four consecutive overnight under closed loop with MDLAP and
      up to four additional overnight under regular sensor augmented pump therapy at home.In
      similar to segment 2, we will use also at segment 3 the remote safety and control diabetes
      management system which enable the supervising personnel to alert the patient or parents and
      intervene in cases of impending hypoglycemia, long standing hyperglycemia and technical
      faults of any component of the AP system.

      On the fourth segment, 45-60 patients will be enrolled at the Israeli center only, This
      segment will be conducted at a diabetes camp and will consist of two main parts. In part 1,
      15-20 patients will be randomized to participate in one of the two groups: 2-4 nights under
      closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under
      closed loop control without activating the MD-Logic learning algorithm. In part 2 of the
      forth segment 30-40 patients will participate in two consecutive 24-48 hours sessions,one
      under closed loop control and the second under sensor augmented pump therapy.

      On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center only and
      will be conducted at patient's home. This segment will consist of two main parts .The first
      10 patients will participate in a pilot session and data gathered at this pilot session will
      not be used at the final analysis. At part 1 each subject will participate in 4 weeks-1.5
      months period of over nights either using closed-loop with MDLAP or using sensor augmented
      pump (SAP) therapy.At the end of the first 4 weeks-1.5 months of the study, statistical
      analysis will be performed in order to decide whether to extend the study with an optional
      period of extra 4 weeks-1.5 months.In case it will be decided to extend the study, additional
      4 weeks-1.5 months intervention period following completion of final visit activities will be
      offered to participants. Subjects that have participated in the control group (sensor
      augmented pump therapy) will be offered the opportunity to continue to 4 weeks-1.5 months of
      closed-loop control and the study group will be offered to switch to sensor augmented pump
      therapy. In segment 5 part 2, up to 40 patients will be enrolled. Each patient will
      participate in 3 months study period either using overnight closed loop under MDLAP or sensor
      augmented pump therapy. Participants in segment 5 part 2 will be offered to participate in
      part 2A. At this part, sleep quality assessment will be made (by using actigraf and sleep
      questionnaire). At the end of this period an optional 3 months extension period will be
      offered with the other arm (cross-over).

      Segment 6 will be consist of two main parts.In part 1 up to 40 eligible patients will be
      enrolled at the Israeli center only. Each subject will participate in up to 72 hours of
      closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy
      . The sequence of the treatment intervention will be randomly assigned. In part 2 of this
      segment 40 eligible patients will enrolled at the Israeli center only. Each subject will
      participate in up to 2 weeks of closed loop with MDLAP at home and up to 2 weeks under
      regular sensor augmented pump therapy. The sequence of the treatment intervention will be
      randomly assigned
    

Intervention name(s): MD-logic Artificial Pancreas (MDLAP); Standard treatment with insulin pump
Intervention type(s): Device; Device
Intervention description(s): Treatment with the closed loop MD-logic Artificial Pancreas(MDLAP)System; Standard treatment with sensor augmented pump therapy
Intervention MeSH terms: Pancrelipase
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Closed loop; Artificial Pancreas