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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June 11Case Consultation
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June 21Above the Bias Panel
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June 22Using CGM in Diabetes Self-Care
At the American Diabetes Association’s 85th Scientific Sessions (Chicago, IL), Dr. Polonsky, BDI President, will be speaking on Tell Me Why—Using CGM to Drive Changes in Diabetes Self-Care. He also serves a co-author on six poster presentations on that day:
June 23EMBARK
At the American Diabetes Association’s 85th Scientific Sessions (Chicago, IL), Dr. Fisher, BDI Research Director, will present Reducing Diabetes Distress Leads to Positive Glycemic Change—Results from the EMBARK Trial
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August 8 – 10. Taking Control of Your Diabetes (TCOYD) will be hosting the in-person ONE event, an amazing weekend experience here in San Diego for more than 500 people with type 1 diabetes and their loved ones. Dr. Polonsky is honored to be one of the presenters, and we will hope to see many of you there. There are still a few spaces left, so if you’d like to know more, please visit: