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). (May 2016)

• Record Type: Journal Article
• Authors: Lind, Marcus; Polonsky, William; Hirsch, Irl B.; Heise, Tim; Bolinder, Jan; Dahlqvist, Sofia; Pehrsson, Nils-Gunnar; Moström, Peter
• Is Part Of: Journal of diabetes science and technology. Volume 10:Number 3(2016:May)
• Page Start: 754
• Page End: 761
• Publication Date: 2016-05
• Subjects: type 1 diabetes mellitus -- CGM -- randomized trial -- glycemic control -- quality of life; Diabetes -- Periodicals; Medical technology -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1177/1932296816642578
• Languages: English
• ISSNs: 1932-2968

Abstract

Background: 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). Methods: 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. Results: A total of 205 patients were screened, of whom 161 were randomized between February and December 2014. Study completion is anticipated in April 2016. Conclusions: 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.