title: Design and Methods of a Randomized Trial of Continuous Glucose Monitoring in Persons With Type 1 Diabetes With Impaired Glycemic Control Treated With Multiple Daily Insulin Injections (GOLD Study).
abstract: The majority of individuals with type 1 diabetes today have glucose levels exceeding guidelines. The primary aim of this study was to evaluate whether continuous glucose monitoring (CGM), using the Dexcom G4 stand-alone system, improves glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections (MDI).
  
  
  
  Individuals with type 1 diabetes and inadequate glycemic control (HbA1c ≥ 7.5% = 58 mmol/mol) treated with MDI were randomized in a cross-over design to the Dexcom G4 versus conventional care for 6 months followed by a 4-month wash-out period. Masked CGM was performed before randomization, during conventional treatment, and during the wash-out period to evaluate effects on hypoglycemia, hyperglycemia, and glycemic variability. Questionnaires were used to evaluate diabetes treatment satisfaction, fear of hypoglycemia, hypoglycemia confidence, diabetes-related distress, overall well-being, and physical activity during the different phases of the trial. The primary endpoint was the difference in HbA1c at the end of each treatment phase.
  
  
  
  A total of 205 patients were screened, of whom 161 were randomized between February and December 2014. Study completion is anticipated in April 2016.
  
  
  
  It is expected that the results of this study will establish whether using the Dexcom G4 stand-alone system in individuals with type 1 diabetes treated with MDI improves glycemic control, reduces hypoglycemia, and influences quality-of-life indicators and glycemic variability.
authors.affiliation: Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden Department of Medicine, NU Hospital Group, Uddevalla, Sweden lind.marcus@telia.com.
authors.forename: Marcus
authors.initials: M
authors.lastname: Lind
authors.affiliation: University of California San Diego, San Diego, CA, USA.
authors.forename: William
authors.initials: W
authors.lastname: Polonsky
authors.affiliation: University of Washington, School of Medicine, Seattle, WA, USA.
authors.forename: Irl B
authors.initials: IB
authors.lastname: Hirsch
authors.affiliation: Profil, Neuss, Germany.
authors.forename: Tim
authors.initials: T
authors.lastname: Heise
authors.affiliation: Department of Medicine, Karolinska University Hospital Huddinge, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Bolinder
authors.affiliation: Department of Medicine, NU Hospital Group, Uddevalla, Sweden.
authors.forename: Sofia
authors.initials: S
authors.lastname: Dahlqvist
authors.affiliation: Statistiska Konsultgruppen, Gothenburg, Sweden.
authors.forename: Nils-Gunnar
authors.initials: NG
authors.lastname: Pehrsson
authors.affiliation: Department of internal medicine, Alingsås Hospital, Alingsås, Sweden.
authors.forename: Peter
authors.initials: P
authors.lastname: Moström
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D017060:Patient Satisfaction; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: CGM; glycemic control; quality of life; randomized trial; type 1 diabetes mellitus