Show simple item record Davis, SN Horton, ES Battelino, T Rubin, RR Schulman, KA Tamborlane, WV
dc.coverage.spatial United States 2011-04-15T16:46:24Z 2010-04
dc.identifier.citation Diabetes Technol Ther, 2010, 12 (4), pp. 249 - 255
dc.description.abstract 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.
dc.format.extent 249 - 255
dc.language eng
dc.language.iso en_US en_US
dc.relation.ispartof Diabetes Technol Ther
dc.relation.isversionof 10.1089/dia.2009.0145
dc.subject Adolescent
dc.subject Adult
dc.subject Aged
dc.subject Child
dc.subject Diabetes Mellitus, Type 1
dc.subject Humans
dc.subject Hypoglycemic Agents
dc.subject Injections
dc.subject Insulin
dc.subject Insulin Infusion Systems
dc.subject Middle Aged
dc.subject Research Design
dc.subject Young Adult
dc.title 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.
dc.type Journal Article
dc.description.version Version of Record en_US 2010-4-0 en_US
duke.description.endpage 255 en_US
duke.description.issue 4 en_US
duke.description.startpage 249 en_US
duke.description.volume 12 en_US
dc.relation.journal Diabetes Technology & Therapeutics en_US
pubs.issue 4
pubs.organisational-group /Duke
pubs.organisational-group /Duke/Institutes and Provost's Academic Units
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/Initiatives
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/Initiatives/Duke Science & Society
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/University Institutes and Centers
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/University Institutes and Centers/Global Health Institute
pubs.organisational-group /Duke/School of Medicine
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Medicine
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Medicine/Medicine, General Internal Medicine
pubs.organisational-group /Duke/School of Medicine/Institutes and Centers
pubs.organisational-group /Duke/School of Medicine/Institutes and Centers/Duke Cancer Institute
pubs.organisational-group /Duke/School of Medicine/Institutes and Centers/Duke Clinical Research Institute
pubs.publication-status Published
pubs.volume 12
dc.identifier.eissn 1557-8593

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