Results of study published in The New England Journal of Medicine could redefine the standard of care for people with type 1 diabetes
AURORA, Colo. (June 29, 2010) –Diabetes research conducted at 30 trial sites in the U.S. and Canada, including the only site in Colorado, the University of Colorado Anschutz Medical Campus, showed adult and pediatric patients with type 1 diabetes achieved better glucose control by using a sensor-augmented insulin pump compared to the most common approach to care today – multiple daily insulin injections.
The significant decrease in A1C levels observed in the Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) trial occurred without an increase in the rate of hypoglycemia, which is the most prevalent clinical risk with intensive insulin management. (The A1C test measures average blood glucose control for the past two to three months. In some ways, the A1C test is like a baseball player's season batting average—it gives a person's overall success.)
Uncontrolled glucose levels in patients with diabetes can lead to short- and long-term complications, including shakiness, confusion, fainting, blindness, kidney failure and limb amputation. Although very rare, low glucose levels can even lead to death. Carefully-controlled glucose levels are a goal of diabetes treatment and can improve patient health and long-term outcomes.
“As the longest and largest study of its kind, STAR 3’s outcomes could redefine what should be the standard of care for diabetes management,” said Robert Slover, MD, associate professor at the University of Colorado School of Medicine.
Results from the STAR 3 trial in which the University of Colorado Anschutz Medical Campus participated were recently published online in The New England Journal of Medicine and presented at the American Diabetes Association 70th Scientific Sessions.
STAR 3 is the first study that confirms sensor-augmented insulin pump therapy provides superior glucose control for children and adolescents, an age group that is particularly challenging to treat due to the social and physiological changes due to growth and maturation. In STAR 3, nearly 44 percent of pediatric patients using sensor-augmented insulin pump therapy achieved the American Diabetes Association’s age-specific glucose control targets, compared to only 20 percent of patients in the multiple daily injection group.
In addition, for the adult participants in the sensor-augmented insulin pump therapy arm, there was a full one percent reduction in their A1C levels. Every percentage point drop in A1C blood test results (e.g., from 8.0 percent to 7.0 percent) can reduce the risk of microvascular complications (eye, kidney, and nerve diseases) by 40 percent. Diabetes association guidelines recommend that most people with diabetes maintain A1C levels of seven percent or below in order to live healthier and more productive lives.
STAR 3 also showed patients on sensor-augmented insulin pump therapy demonstrated a reduction in mean A1C (levels that was four times greater than the multiple daily injection group (0.8 percent study vs. 0.2 percent control (p<.001). The mean A1C decrease was from a baseline of 8.3 percent to 7.5 percent in the sensor-augmented pump therapy group, compared to only 8.3 percent to 8.1 percent in the daily injection group.
The results demonstrated a strong link between increased sensor use and increased benefit. Patients who used the sensor with the insulin pump more than 81 percent of the time reduced their A1C levels by 1.2 percent.
The study was sponsored by Medtronic, Inc., with participation from 485 patients (329 adult and156 pediatric subjects), ranging in age from 7 to 70.
About the Anschutz Medical Campus
The Anschutz Medical Campus is the largest academic health center between Chicago, Texas and the West Coast. The campus is home to the health sciences programs of the University of Colorado as well as University of Colorado Hospital, the University of Colorado Cancer Center and the Barbara Davis Center for Childhood Diabetes. The University of Colorado Anschutz Medical Campus researchers have a proven record of success and expertise in innovation, discovery and commercialization of therapies, drugs and medical devices. Research accomplishments of being “the first” include the development of a classification and numbering system for human chromosomes, the identification of a genetic factor that converts normal cells into cancer cells, discovering that lymphocytes are preprogrammed to respond to antigens, the foundation of modern immunology, how a human cancer gene functions, and first to identify that naturally occurring proteins in the blood prevent the AIDS virus from reproducing and spreading to healthy cells. The Anschutz Medical Campus stands as a model across the nation for a successful redevelopment of a decommissioned army base.
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