A year-long clinical trial by Yale University and other institutions showed that treatment with sensor-augmented insulin pumps, which include a system of continuous glucose monitoring, leads to significantly greater control of type 1 diabetes than a daily regimen of multiple insulin injections. Results of the STAR 3 trial were presented at the annual meeting of the American Diabetes Association, and appear online in the New England Journal of Medicine (http://content.nejm.org/).
The multicenter, randomized and controlled trial compared the efficacy of both methods in 485 adult and child patients. At one year, average plasma glucose concentrations – which indicate blood sugar control in type 1 diabetes – were significantly lower for both adults and children in the pump-therapy group, compared with the injection-therapy group.
Improved glycemic control can reduce the complications associated with type 1 diabetes, but maintaining that control is challenging, particularly for children. William Tamborlane, M.D., professor and section chief of pediatric endocrinology at Yale School of Medicine and Yale-New Haven Children’s Hospital, a member of the steering committee of the study and second author on the paper, said, “This technology of combining insulin pumps and continuous glucose monitoring can help patients safely reach their goal of glycemic control, while minimizing the risk of severe hypoglycemia and weight gain.”
Recent studies on the effectiveness of using insulin pumps or continuous glucose monitoring devices alone showed that among adults, they improve blood sugar levels better than daily injections. But results in children have been inconsistent. In this new study by Yale and other institutions, sensor-augmented pump therapy, which integrates the two technologies and allows patients and doctors to monitor treatment and response through internet-based software, benefited children as significantly as adults.
“Sensor-augmented pump therapy will be helpful to all patients with type 1 diabetes who were until now unable to effectively control their blood sugar levels, but it will be particularly beneficial for younger patients,” said Dr. Jennifer Sherr, M.D., who, along with Stuart A. Weinzimer, M.D. and Lori Carria, of the Department of Pediatrics, Yale School of Medicine, were the other Yale investigators involved in the study.
Other authors are Richard M. Bergenstal, M.D. of the International Diabetes Center; Andrew Ahmann, M.D. of Oregon Health and Science University; John B. Buse, M.D., Ph.D. of the University of North Carolina School of Medicine; George Daily, M.D. of the Scripps Institute; Stephen N. Davis, M.D. of the University of Maryland School of Medicine; Carol Joyce, M.D. of Memorial University of Newfoundland, Health Science Center; Tim Peoples, M.A. and John B. Welsh, M.D., Ph.D. of Medtronic; Bruce A. Perkins, M.D., M.P.H., of Toronto General Hospital; Steven M. Willi, M.D. of Children’s Hospital of Philadelphia; and Michael A. Wood, M.D. of Helen DeVos Children’s Hospital.
The study was supported by Medtronic, Novo Nordisk, LifeScan, Bayer Healthcare and Becton Dickinson. It was also partly funded by the Yale Clinical and Translational Science Award (CTSA) grant from the National Center for Research Resources at the National Institutes of Health.
Dr. Tamborlane reports receiving consulting fees from Medtronic Diabetes as a member of the Diabetes Advisory Board.
NOTE ABOUT WILLIAM TAMBORLANE, M.D.: The American Diabetes Association (ADA) has honored William Tamborlane, M.D., a world-renowned pioneer in the understanding and treatment of childhood diabetes and innovator of the insulin pump, as its Outstanding Physician Clinician for 2010. This is one of the highest honors bestowed by the ADA each year.
Dr. Tamborlane, a member of Yale Medical Group, is chief of pediatric endocrinology at Yale School of Medicine and Yale-New Haven Children’s Hospital. His major achievements have included pioneering work in the development of insulin pump therapy, continuous glucose monitoring, sensor-augmented pumps, closed loop systems and development of an artificial pancreas. He also demonstrated the role of insulin resistance in pediatric metabolic disorders, including obesity and type 2 diabetes.
“Yale has one of the top children’s diabetes treatment programs in the world,” Dr. Tamborlane said. “Being honored with this award is a testament to all the wonderful physicians, nurse practitioners, dieticians, social workers and clinical research staff members who have dedicated their careers to helping our patients and their families.”
Late last year, Dr. Tamborlane was honored with the Diabetes Technology Leadership award for his extraordinary lifetime accomplishments in diabetes research and technology.