STAR 3 randomized controlled trial to compare sensor-augmented insulin pump therapy with multiple daily injections in the treatment of type 1 diabetes: research design, methods, and baseline characteristics of enrolled subjects.
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BACKGROUND: Sensor-augmented pump therapy (SAPT) integrates real-time continuous glucose monitoring (RT-CGM) with continuous subcutaneous insulin infusion (CSII) and offers an alternative to multiple daily injections (MDI). Previous studies provide evidence that SAPT may improve clinical outcomes among people with type 1 diabetes. Sensor-Augmented Pump Therapy for A1c Reduction (STAR) 3 is a multicenter randomized controlled trial comparing the efficacy of SAPT to that of MDI in subjects with type 1 diabetes. METHODS: Subjects were randomized to either continue with MDI or transition to SAPT for 1 year. Subjects in the MDI cohort were allowed to transition to SAPT for 6 months after completion of the study. SAPT subjects who completed the study were also allowed to continue for 6 months. The primary end point was the difference between treatment groups in change in hemoglobin A1c (HbA1c) percentage from baseline to 1 year of treatment. Secondary end points included percentage of subjects with HbA1c < or =7% and without severe hypoglycemia, as well as area under the curve of time spent in normal glycemic ranges. Tertiary end points include percentage of subjects with HbA1c < or =7%, key safety end points, user satisfaction, and responses on standardized assessments. RESULTS: A total of 495 subjects were enrolled, and the baseline characteristics similar between the SAPT and MDI groups. Study completion is anticipated in June 2010. CONCLUSIONS: Results of this randomized controlled trial should help establish whether an integrated RT-CGM and CSII system benefits patients with type 1 diabetes more than MDI.
Diabetes Mellitus, Type 1
Insulin Infusion Systems
Published Version (Please cite this version)10.1089/dia.2009.0145
Publication InfoBattelino, T; Davis, SN; Horton, ES; Rubin, RR; Schulman, Kevin Alan; & Tamborlane, WV (2010). STAR 3 randomized controlled trial to compare sensor-augmented insulin pump therapy with multiple daily injections in the treatment of type 1 diabetes: research design, methods, and baseline characteristics of enrolled subjects. Diabetes Technol Ther, 12(4). pp. 249-255. 10.1089/dia.2009.0145. Retrieved from https://hdl.handle.net/10161/3233.
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Adjunct Professor in the Department of Medicine
Kevin A. Schulman, MD, MBA, is a professor of medicine and the Gregory Mario and Jeremy Mario Professor of Business Administration (2010 - 2016) at Duke University. He is a visiting professor of business administration at Harvard Business School. He holds several leadership appointments at Duke. He is an associate director of the Duke Clinical Research Institute in the School of Medicine, the country's largest academic clinical research organization. In Duke's Fuqua School of Business, he s
This author no longer has a Scholars@Duke profile, so the information shown here reflects their Duke status at the time this item was deposited.