title: Sensor-augmented pump and multiple daily injection therapy in the United States and Canada: post-hoc analysis of a randomized controlled trial.
abstract: OBJECTIVE
  Effectiveness of advanced technologies for diabetes management may differ depending on national healthcare models or population characteristics. In the setting of a cross-national trial, we aimed to compare efficacy of sensor-augmented pump (SAP) therapy in the United States (US) and Canada.
  
  
  METHODS
  In the clinical trial Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3), 329 adults with type 1 diabetes were randomly allocated to either SAP or glargine-based multiple daily injection (MDI) therapy at 26 US sites (n=271) and 4 Canadian sites (n=58). A bootstrap analysis was performed to confirm significant differences in baseline characteristics. For the primary analysis, we compared the baseline to 1-year change in glycated hemoglobin (A1C) between Canadian and US subjects.
  
  
  RESULTS
  At baseline, compared with US subjects, Canadian subjects were more likely to be students (19% vs. 7%, p<0.01) and to consume alcohol (91% vs. 63%, p<0.01). Although Canadian subjects had greater A1C reductions from baseline compared with US subjects (p=0.02), the incremental benefit of SAP was similar in the US (SAP compared with MDI, -0.93%±0.73% vs. -0.31%±0.81%, p<0.001) and Canada (-1.14%±0.72% vs. -0.67%±0.71%, p<0.001). Mean sensor use was significantly higher in Canada than in the US (79% vs. 68% of the time, p<0.001).
  
  
  CONCLUSIONS
  Despite differences in baseline characteristics and sensor adherence, SAP efficacy was similar between US and Canadian participants. As long as the intervention is administered with a similar level of expertise as was conducted in the trial, it is likely to be applicable in diverse clinical practice settings.
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: bperkins@mtsinai.on.ca.
authors.forename: Bruce A
authors.initials: BA
authors.lastname: Perkins
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Elise M
authors.initials: EM
authors.lastname: Halpern
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Andrej
authors.initials: A
authors.lastname: Orszag
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Alanna
authors.initials: A
authors.lastname: Weisman
authors.affiliation: Division of Endocrinology and Metabolism, Queen's University, Kingston, Ontario, Canada.
authors.forename: Robyn L
authors.initials: RL
authors.lastname: Houlden
authors.affiliation: International Diabetes Centre at Park Nicollet, Minneapolis, Minnesota, USA.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Bergenstal
authors.affiliation: Memorial University of Newfoundland, St. John's, Newfoundland, Canada.
authors.forename: Carol
authors.initials: C
authors.lastname: Joyce
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002170:Canada; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007267:Injections; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use*; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D012959:Socioeconomic Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D006442:Glycated Hemoglobin; D007328:Insulin
keywords: clinical trial; diabète de type 1; essai clinique; multi-injections quotidiennes; multicentre; multiple daily injections; pump therapy; traitement par pompe; type 1 diabetes