Avtor/Urednik     Davis, Stephen N; Horton, Edward S; Battelino, Tadej; Rubin, Richard R; Schulman, Kevin A; Tamborlane, William V
Naslov     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
Tip     članek
Vir     Diabetes Technol Ther
Vol. in št.     Letnik 12, št. 4
Leto izdaje     2010
Obseg     str. 249-55
Jezik     eng
Abstrakt     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.
Deskriptorji     DIABETES MELLITUS, INSULIN-DEPENDENT
INSULIN
INFUSION PUMPS, IMPLANTABLE
INJECTIONS, INTRAMUSCULAR
RANDOMIZED CONTROLLED TRIALS
MULTICENTER STUDIES