Clinical Trial Results Of The Artificial Pancreas Project, Designed To Provide A Real Solution For Patients With Diabetes
A publication in the February 28th issue of the New England Journal of Medicine reports results of a clinical study with an automated artificial pancreas performed for the first time outside a hospital during a diabetes camp. In a prospective, randomized, multicenter, multinational clinical trial within the DREAM consortium 56 children, adolescents and young adults with insulin dependent type 1 diabetes were treated either with the current state of the art treatment with insulin pumps and glucose sensors or with the MD-Logic artificial pancreas system. The use of the MD-Logic artificial pancreas during the night resulted in significantly fewer events of hypoglycemia and shortened the time patients spent with glucose levels below the normal range as compared to the use of pumps and sensors (control group). Furthermore, the glucose concentration was maintained within the narrow near-normal range for significantly more time with the MD-Logic artificial pancreas as compared to the control without the need of patients' intervention.
The clinical trial was performed in three academic centers: Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood diabetes at the Schneider Children's Medical Center of Israel in Petah Tikva, Israel headed by Prof. Moshe Phillip, the Department of Pediatric Endocrinology, Diabetes and Metabolism headed by Prof. Tadej Battelino at the University Children's Hospital in Ljubljana, Slovenia, and the Department of Pediatric Endocrinology and Diabetes headed by Prof. Thomas Danne & Prof. Olga Kordonouri at the Kinderkrankenhaus AUF DER BULT in Hannover, Germany. Together, the three centers developed the DREAM (Diabetes Wireless Artificial Pancreas Consortium) project aiming at clinical development of the MD-Logic artificial pancreas for routine use by the people with insulin dependent diabetes.
"Night time is a sensitive period of the day during which people with diabetes are not able to consciously control their blood glucose levels and are therefore exposed to extreme fluctuations. Using the MD-Logic artificial pancreas system might change the patients' lives. The results of this study are crucial for further clinical development of a device that could be routinely used as a "Glucositter" at home", says the principal investigator Prof. Moshe Phillip of the Schneider Children's Medical Center of Israel ". Moreover, "the use of the MD-Logic artificial pancreas during the night time may, for the first time, bring some long desired relieve to patients and parents of people with insulin dependent diabetes" adds Prof. Tadej Battelino. "Clinical development of the MD-Logic artificial pancreas system will bring our patients the freedom of a more relaxed lifestyle at no cost to their glucose control" says Prof. Thomas Danne.
Millions of children, adolescents and adults suffer from insulin dependent diabetes which necessitates tight control of blood glucose concentration for preventing acute and long-term complications. Meticulous glycemic control is demanding and requires detailed planning of the diet, physical activity and insulin dosing. The MD-Logic artificial pancreas was developed by the Diabetes Technology Center at the National Center for Childhood Diabetes at Schneider Children's Medical Center of Israel to assist patients with diabetes in achieving the goal of good glycemic control without the burden it usually entails. The multidisciplinary team of doctors, engineers, nurses and dieticians developed the MD-Logic artificial pancreas algorithm which controls routinely available insulin pumps based on the measurements provided by approved subcutaneous continuous glucose sensors. The MD-Logic artificial pancreas algorithm processes the information received from the individual patient, learns her or his specific requirements and based on the glucose concentration commands the minute-to-minute amount of insulin injected into the body.
The National Center for Childhood diabetes at the Schneider Children's Medical Center of Israel cares for around 1600 children, adolescents and young adults with type 1 diabetes with some 150 new patients annually, and performs advanced basic and clinical research in the fields of diabetes and endocrinology. The Department of Pediatric Endocrinology, Diabetes and Metabolism at the University Children's Hospital in Ljubljana, Slovenia is the country's referral center for childhood-onset diabetes, endocrine and metabolic disorders and provides cutting-edge clinical and genetic investigations to these patient populations. The Department of Pediatric Endocrinology and Diabetes at the Kinderkrankenhaus AUF DER BULT in Hannover is the largest pediatric diabetes center in Germany and coordinates the European SWEET initiative to establish reference centers for pediatric diabetes aiming at better quality of care for young patients.