BOSTON, Mass. – Clinical research conducted at 30 trial sites in the U.S. and Canada, including Joslin Diabetes Center, showed adult and pediatric patients with type 1 diabetes achieved better blood glucose control by using a sensor-augmented insulin pump compared to multiple daily insulin injections.
The significant improvement in blood glucose levels observed in the STAR 3 (Sensor-Augmented Pump Therapy for A1C Reduction) trial occurred without an increase in the rate of hypoglycemia (low blood glucose), the most prevalent clinical risk with intensive insulin management.
Results from the trial were published online in The New England Journal of Medicine on June 29 and presented at the American Diabetes Association 70th Scientific Sessions. The study was sponsored by Medtronic, Inc. and included participation from 485 patients ranging in age from 7 to 70.
STAR 3 is the first study that confirms that therapy combining insulin pumping with continuous glucose monitoring (CGM) provides superior glucose control compared with multiple daily insulin injections for children and adolescents. This age group 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. (A1C is a standard measurement reflecting average blood glucose levels for the past two to three months). Every percentage point drop in A1C blood test results (for example, from 8.0 percent to 7.0 percent) can reduce the risk of microvascular complications (diabetic eye, kidney and nerve disease) by 40 percent. Diabetes association guidelines recommend that most people with diabetes maintain A1C levels of 7.0 percent or below.
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). 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 demonstration of a significant 0.6% reduction in A1C for youth and adults in the STAR 3 trial is very encouraging,” commented Sanjeev Mehta, M.D., M.P.H., a STAR 3 investigator and Joslin staff physician and research associate. “The strong association between changes in A1C and adherence to sensor wear, however, reinforces the need to focus on resolving barriers to the sustained use of these devices for individuals with type 1 diabetes. We are encouraged by these findings and now look forward to opportunities to translate these benefits into the clinical care arena.”