Clinical Trial Results of the Artificial Pancreas Project, Designed to Provide a Real Solution for Patients with Diabetes, Published Today in the new Issue of the Journal New England Journal of Medicine
PETACH TIKVAH, Israel, February 28, 2013 /PRNewswire/ –
The clinical trial was performed in three academic centers: the Schneider
Children’s Medical Center of Israel, the University Children’s Hospital in Slovenia and
the Kinderkrankenhaus AUF DER BULT in Germany.
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
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.
Contact: Riva Shacked Spokeperson Tel: +972-3-9253208 Schneider Children's Medical Center of Israel firstname.lastname@example.org http://www.schneider.org.il/eng [file://\\lonpivdocs\Documents and Settings\racheln\Local Settings\Documents and Settings\LiNORN\Local Settings\Temporary Internet Files\Local Settings\racheln\Local Settings\Temporary Internet Files\rshaked\Local Settings\Temporary Internet Files\Content.Outlook\KJINZY6H\www.schneider.org.il\eng ]
SOURCE Schneider Children’s Medical Center of Israel