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Randomized Controlled Trial
. 2016 May 3;10(3):754-61.
doi: 10.1177/1932296816642578. Print 2016 May.

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)

Marcus Lind  1 , William Polonsky  2 , Irl B Hirsch  3 , Tim Heise  4 , Jan Bolinder  5 , Sofia Dahlqvist  6 , Nils-Gunnar Pehrsson  7 , Peter Moström  8
Affiliations
Randomized Controlled Trial

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)

Marcus Lind et al. J Diabetes Sci Technol. .

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.

Keywords: CGM; glycemic control; quality of life; randomized trial; type 1 diabetes mellitus.

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Conflict of interest statement

Declaration of Conflicting Interests: ML has received research grants from AstraZeneca, Dexcom, and Novo Nordisk, been a consultant or received honoraria from Medtronic, Eli Lilly, Pfizer, Abbot Scandinavia, Bayer, Novo Nordisk, and Rubin Medical. ML has participated in advisory boards for Novo Nordisk. WP has served as a consultant for Dexcom and Abbott Diabetes Care. IBH has received research grants from Novo Nordisk, and been a consultant for Abbott Diabetes Care, Roche, and Becton Dickinson. TH has received research funds from Adocia, AstraZeneca, BD, Biocon, Boehringer Ingelheim, Dance Pharmaceuticals, Grünenthal, Eli Lilly, Medtronic, Novo Nordisk, Novartis, Sanofi, and Senseonics. TH has participated in advisory panels for Novo Nordisk and received speaker honoraria and travel grants from Eli Lilly, Mylan, and Novo Nordisk. JB has received honoraria for consulting and/or lecture fees from Abbott Diabetes Care, AstraZeneca, Integrity Applications, Eli Lilly, and Sanofi. SD, NGP, and PM have no conflicts of interest to declare.

Figures

Figure 1.
Figure 1.
Flow chart of design.
See this image and copyright information in PMC

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