Artificial pancreas systems hold great promise for significantly improving glucose control and relieving the burden of disease management among individuals with T1D and are a key research and development priority for JDRF. Dr. Moshe Phillip and colleagues have reported the results of a multisite, international outpatient study testing the short-term safety and effectiveness of an artificial pancreas system to control night-time glucose levels. The study compared the use of an artificial pancreas system to the use of a sensor-augmented pump (Paradigm Veo system from Medtronic) in a group of children with T1D (ages 10 to 18) at three diabetes camps located in Israel, Slovenia and Germany. The diabetes camp setting was chosen because it combines real-life elements with the availability of an on-site healthcare team. Each child in the study was randomly assigned to use either the artificial pancreas system or the sensor-augmented pump on the first night and then switched to the other treatment the next night. CGM sensor data was collected on both nights and used for evaluating the performance of each system. The team found that use of the artificial pancreas system resulted in significantly fewer hypoglycemic events (7 on artificial pancreas vs. 22 on pump), as well as less time in the hypoglycemic range. In addition to improvements in several other measures of glucose control and variability, the use of the artificial pancreas resulted in more time in the 70-140 mg/dl range (median time 4.4 hours for artificial pancreas vs. 2.8 hours for pump). There was not a significant between-treatment difference in the median overnight glucose levels, in the number of hypoglycemia alarms or in subsequent carbohydrate interventions.
A YouTube video by the research team at the Israeli diabetes camp can be seen at the following link: http://www.youtube.com/watch?v=9HMx8yy2nVw
Ramifications for Individuals with T1D:
Children who wore the experimental artificial pancreas system in this test experienced significant improvements in glucose control and reduced hypoglycemia. These results demonstrate the feasibility and value of such systems to individuals with T1D and strongly support the continued research and development of artificial pancreas systems. This study also highlights the feasibility of conducting artificial pancreas research in diabetes camps as a ‘real life’ but medically-supervised intermediate setting on the path to pediatric studies in the free-living, home environment. Other JDRF-supported researchers are planning or have launched artificial pancreas studies in the diabetes camp setting including Dr. Bruce Buckingham’s group at Stanford and Dr. Ed Damiano’s group at Boston University.
JDRF did not provide funding for this study; however Dr. Phillip’s group is part of the European AP @ Home study group and are involved with the JDRF APP Consortia, and has recently been awarded a grant to develop and refine an automated bolus tool for the artificial pancreas system used in this study.
Investigators and Institutions:
Moshe Phillip1,2, Tadej Battelino3, Eran Atlas1, Olga Kordonouri4, Natasa Bratina3, Shahar Miller1, Torben Biester4, Magdalena Avbelj Stefanija3, Ido Muller1, Revital Nimri1, and Thomas Danne4
1Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s Medical Center of Israel, Petah, and 2Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv— both in Israel; the 3Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Center-University Children’s Hospital, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia and the 4Diabetes Center for Children and Adolescents, Auf der Bult, Kinder- und Jugendkrankenhaus, Hannover, Germany
Phillip M, Battelino T, and others. Nocturnal Glucose Control with an Artificial Pancreas at a Diabetes Camp. N Engl J Med 2013; 368:824-833February 28, 2013 DOI: 10.1056/NEJMoa1206881