One hundred youth ages 14-30 will test each system for three months. Study co-PI's Drs. Phillip and Bergenstal are excited to have the trial conducted at seven clinical sites in the US and abroad, including Minneapolis (IDC- Drs. Anders L. Carlson and Amy Criego), New Haven (Yale - Dr. Stuart Weinzimer), Boston (Joslin - Dr. Lori Laffel), Gainesville (U. of Florida - Drs. Desmond Schatz and Michael Haller), Israel (Petah Tikva, Schneider Children's - Dr. Revital Nimri), Germany (Hannover - Dr. Thomas Danne), Slovenia (Ljubljana - Dr. Tadej Battelino). Dr. Korey Hood at Stanford will assess quality of life and patient adjustment to the new technology and Dr. Beck and J. Sibayan at the Jaeb Center for Health Research, Inc. in Tampa will coordinate the trial.
"We are hopeful this next-generation closed-loop technology will not only further improve blood glucose levels in a safe manner but actually let these teens and young adults focus on living their lives to the fullest," said Dr. Phillip.
"After a decade of algorithm development and successful clinical studies, we are excited to be able to test our unique MD-Logic Technology combined with Medtronic's PID algorithm in this multinational clinical study," said Dr. Revital Nimri , which was part of the Glucositter algorithm development team, from Schneider Children's.
This is one of four separate projects funded by the NIDDK designed to move these advanced closed-loop systems toward regulatory approval for commercial use. A successful, fully automated, closed-loop system (also referred to as artificial pancreas technology) would be a life-changing advancement for many people with type 1 diabetes.
A closed-loop system is an integrated sensor-augmented insulin pump system that monitors blood glucose levels continually and signals the pump to deliver the amount of insulin needed to help keep glucose levels in a safe range, not too high or too low.
"These studies aim to collect the data necessary to bring artificial pancreas technology to the people who need it," said Dr. Guillermo Arreaza-Rubin, director of NIDDK's Diabetes Technology Program. "Results from these studies could change and save lives."
This hybrid closed loop clinical trial (NIH grant DK108611) will begin in late 2017. Learn more: NCT03040414.
About Schneider Children's Medical Center, Israel: Schneider Children's Medical Center of Israel is the only comprehensive, tertiary care hospital of its kind in the country and in the Middle East, offering the full range of pediatric disciplines under one roof to all children from 0-18. Since its establishment in 1991, Schneider Children's has revolutionized the practice of pediatric medicine in the country and been recognized as one of the leading pediatric institutions in the world. The Institute of Endocrinology and Diabetes at Schneider Children's is a national referral center and the first to introduce a comprehensive multidisciplinary approach to diabetic patients in Israel. The Institute treat children and youth who suffer from hormone and growth disorders and follows 1700 type 1 diabetic patients. The Institute has gained international recognition through the development of new approaches to the care of diabetes in children, and is leading projects in diabetes technology including artificial pancreas and decision support system that will revolutionize the treatment of diabetes in the future http://www.schneider.org.il/eng
About DreaMed Diabetes: DreaMed Diabetes was established in 2014 to empowering patients with diabetes using insulin and their care providers with innovative and patient-centric digital decision support technologies in order to improve health, treatment and quality of life. The Company's first product, GlucoSitter™, was developed for closed-loop insulin therapy, was licensed to Medtronic and will be used in this study. The Company also develop the Advisor™ portfolio, a system for the optimization of patient specific intensive insulin therapy decisions. For more information please visit http://www.dreamed-diabetes.com.
About IDC and HealthPartners Institute
Founded in 1967 the IDC provides world-class diabetes care, education, publications and research that meet the needs of people with diabetes and their families. It includes more than 70 health care professionals involved in research and education, along with the collaboration of professionals across the HealthPartners and Park Nicollet care system to ensure patients receive the best possible diabetes care. IDC is part of HealthPartners Institute. One of the largest medical research and education centers in the Midwest, the Institute conducts more than 450 research studies annually; trains medical residents, fellows and students; and provides continuing medical education, patient education and clinical quality improvement. For more information, visit http://www.healthpartnersinstitute.org or http://www.internationaldiabetescenter.org .
Riva Shacked, Schneider Children's MC Spokesperson
SOURCE Schneider Children’s Medical Center