ESPE2014 Plenary Lectures Closed-Loop System: Dream or Reality? (1 abstracts)
Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, Schneider Childrens Medical Center of Israel, National Center for Childhood Diabetes, Tel Aviv, Israel.
Despite the fact that patients with diabetes and medical staff are doing their best to achieve tight glycemic control, most patients all over the world do not achieve the goal. Good glycemic control is crucial to prevent diabetes related complications as well as hypoglycemic episodes, seizure, coma and death. The Diabetes wiREless Artificial Pancreas ConsortiuM (DREAM) was established by three diabetes centers in Slovenia, Germany and Israel, with a goal to reduce the risk of hypoglycemia while improving blood glucose control and reducing patients burden of diabetes management by using the MD-Logic system, which is a wireless fully automated closed-loop system based on a fuzz-logic theory algorithm, with a learning capability, a personalized system settings and safety alert module.
Since October 2010, in silico studies using the FDA approved UVA simulator (n=300 virtual patients) and clinical studies were conducted by the three centers with more than 200 children, adolescents and adults with T1D. After the successful conclusion of first feasibility in-hospital studies, a set of prospective randomized controlled, multicenter, multinational, cross-over studies were conducted in hospitals, at diabetes camps and at patients homes. We first targeted at the night time, with the GlucoSitter as a solution for need of nocturnal blood glucose control and recently a full 24 h closed-loop system was tested successfully at patients homes.
Studies results demonstrated the safety and efficacy of the MD-Logic system for overnight glucose control and during the day. In all studies, the MD-Logic system achieved significantly less hypoglycemia, tighter overnight glucose control compared to sensor augmented pump therapy.
The MD-Logic system may safely integrate into lives of people with diabetes, providing a potent tool to lower the rate of nocturnal hypoglycemia and improve overall glucose control. The DREAM consortium is now evaluating the MD-Logic system in a longer study period at patients homes.