Type 1 Diabetes Clinical Trial
Official title:
Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home, Pilot Study.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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