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STAR 3: Sensor-augmented insulin pump bested multiple daily injections for glucose control
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ADA 70th Scientific Sessions
ORLANDO — Adding a continuous blood glucose level sensor to insulin pump therapy led to better blood glucose control compared with multiple daily insulin injections in children and adults with uncontrolled type 1 diabetes, according to findings from the STAR 3 trial.
At 1 year, baseline HbA1c levels decreased from 8.3% to 8.1% in patients assigned to multiple daily insulin injections vs. a decrease from 8.3% to 7.5% in patients assigned to sensor-augmented insulin pump therapy (P<.001). Further, the decrease did not increase the rate of severe hypoglycemia in either group (13.31 cases per 100 person-years vs. 13.48 per 100 person-years; P=0.58).
“We have shown that sensor-augmented insulin pump therapy had significant reductions in HbA1c for all age groups,” Richard M. Bergenstal, MD, president of medicine and science at the American Diabetes Association and executive director of the International Diabetes Center at Park Nicollet, Minn., said during the late-breaking clinical trial symposium here.
“More adults and children [assigned to sensor-augmented insulin pump therapy] reached our target goals and improvements in HbA1c were not associated with more hypoglycemia or diabetic ketoacidosis. These are some of the lowest rates in HbA1c ever seen in a large, randomized controlled trial,” he said.
For the randomized controlled trial, researchers compared the use of sensor-augmented insulin pump therapy (n=244) with multiple daily injections (n=241) in children (n=156) and adults (n=329) aged 7 to 70. Follow-up data were obtained at 3, 6, 9 and 12 months.
The absolute mean HbA1c reduction for adults was 1% with sensor-augmented insulin pump therapy vs. 0.4% with multiple daily insulin injections (P<.001). There was a similar trend among children, with an absolute HbA1c reduction of 0.4% with pump therapy vs. an increase of 0.2% with multiple injections (P<.001).
The proportion of patients who reached the HbA1c target of 7% or less was also greater in the sensor-augmented insulin pump group compared with the injection group.
The researchers reported two hospital admissions for cellulitis related to insertion-site infections in the pump therapy group and one death related to sudden cardiac arrest in the injection group.
“This type of therapy needs to be considered in those who do are unable to achieve adequate control on other therapy approaches,” Bergenstal said. “Integrating pumps and sensors is really one step along the way to our ultimate goal of getting an artificial pancreas.”
The sensor-augmented insulin pump therapy group utilized an integrated system that incorporated an insulin pump, continuous glucose monitor and self-management software.
The results were published simultaneously in The New England Journal of Medicine.
For more information:
- Bergenstal RM.Late breaking clinical studies. Presented at: American Diabetes Association 70th Scientific Sessions; June 25-29, 2010; Orlando.
- Bergenstal RM. N Engl J Med. 2010;doi:10.1056/NEJMoa1002853.
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