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)

Authors: Lind M, Polonsky W, Hirsch IB, Heise T, Bolinder J, Dahlqvist S, Pehrsson NG, Moström P.

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.

Source: https://pubmed.ncbi.nlm.nih.gov/27081191/

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BDI Monthly Events

March 12Case Consultation Meeting
March 12: BDI hosts the San Diego-wide, monthly case consultation meeting (for mental health professionals working in the field of diabetes). Contact us at [email protected] if you are in the greater San Diego area and would like further information about this program.
March 19-22International Conference
18th International Conference for ATTD (Advanced Technologies and Treatments for Diabetes) in Amsterdam, Dr. Polonsky (BDI President) has three presentations.
March 19Type 2 Presentation
On March 19, Dr. Polonski will present CGM is Wonderful, But… at the Roche-sponsored symposium, “Translating the Power of Prediction into Diabetes Management”, and Insulin Therapy Experience: Considering the Needs of People Living with Diabetes (with Professor Cukierman-Yaffe) at the Sanofi-sponsored symposium, Confidence and Simplicity in Diabetes Management”. https://attd.kenes.com/
March 20Type 2 Presentation
On March 20, Dr. Polonski will present Improved Patient- and Physician-Reported Outcomes with IGlarLixi When Switching From Premixed Insulin in People with Type 2 Diabetes: The Soli-Switch Study. https://cslide.ctimeetingtech.com/attd25/attendee/confcal/session/calendar/2025-03-20