Results of study published in The New England Journal of Medicine could redefine the standard of care for people with Type 1 diabetes
San Diego – The Scripps Whittier Diabetes Institute was one of 30 trial sites in the U.S. and Canada to participate in diabetes research which showed adult and pediatric patients with Type 1 diabetes achieved better blood sugar level 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 the average amount of glucose in the blood (A1C levels) observed in the Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) trial occurred without an increase in the rate of hypoglycemia (low blood sugar), which is the most prevalent clinical risk with intensive insulin management. Results from the STAR 3 trial were recently published online in The New England Journal of Medicine and presented at the American Diabetes Association 70th Scientific Sessions.
“As a leading diabetes care provider in Southern California and trial site for the STAR 3 study, the Scripps Whittier Diabetes Institute was able to offer patients with diabetes the latest in diabetes treatment technology,” said Dr. Athena Philis-Tsimikas, endocrinologist and corporate vice president of the Scripps Whittier Diabetes Institute. “Scripps Whittier continues to focus on improving quality of life for individuals with diabetes. This study shows that over time patients using sensor-augmented pump therapy will achieve a more consistent blood sugar level, helping to prevent serious complications associated with the disease.”
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 blood sugar levels can even lead to death. Carefully-controlled blood sugar levels are a goal of diabetes treatment and can improve patient health and long-term outcomes.
STAR 3 is the first study that confirms sensor-augmented insulin pump therapy provides superior blood sugar level 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 blood sugar control targets, compared to only 20 percent of patients in the multiple daily injection group.
In addition, the adult participants in the sensor-augmented insulin pump therapy arm experienced 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 serious complications (blindness, kidney disease and nervous system disease) 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. and conducted at 30 sites in the U.S. and Canada with participation from 485 patients (329 adult and156 pediatric subjects), ranging in age from 7 to 70.