NCT01726829

Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home

Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home, Pilot Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	MD-Logic Artificial Pancreas (MDLAP) system
PROCEDURE	sensor augmented pump therapy

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2012-11-15
• Last updated: 2016-04-08

Locations

3 sites across 3 countries: Germany, Israel, Slovenia