Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This is a randomized prospective single blind 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, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia
      and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will
      participate in four consecutive over nights under closed-loop with MDLAP, and four additional
      over nights under regular sensor augmented pump therapy at home with a washout period of 10 ±
      3 days between arms.
    

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.

      Study Objectives are to determine the safety and efficacy of using the MDLAP system to
      automatically control overnight blood glucose in type 1 diabetic patients. Overnight glucose
      control time defined as the time range between bedtime (21:00-23:00 PM) and awaking time
      (7:00 AM).

      This is a randomized prospective single blind 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, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia
      and Hannover, Germany; 75 eligible patients will be enrolled.Each subject will participate in
      four consecutive over nights under closed-loop with MDLAP, and four additional over nights
      under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days
      between arms.
    

Intervention name(s): MD-Logic Artificial Pancreas (MDLAP) system; sensor augmented pump therapy
Intervention type(s): Device; Procedure
Other intervention name(s): four consecutive outpatients overnight sessions at home under closed loop MD-Logic Artificial Pancreas (MDLAP) system; four consecutive outpatients overnight sessions at home under standard treatment with sensor augmented pump therapy
Intervention MeSH terms: Pancrelipase; Pancreatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Artificial Pancreas; Closed Loop