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DOI: 10.1055/s-0039-1678733
Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial
Funding Medtronic (Northridge, CA) provided investigator-initiated research support for this project through a scientific research grant (MDT ID# NERP17–006). The grant allowed for discounted pricing on medical devices used in this study. Medtronic had no part in the design, execution, or analysis of this project, or on the composition or editing of this manuscript. Medtronic has reviewed the manuscript prior to submission to ensure the correct nomenclature of its products. All authors have adhered to the Good Publication Practice (GPP3) for manuscripts that are supported by medical device companies.Publication History
11 January 2019
11 January 2019
Publication Date:
28 February 2019 (online)
Abstract
Objective To evaluate whether real-time continuous glucose monitoring improves glycemic control over intermittent self-monitoring of blood glucose in gestational diabetes.
Study Design We performed a single-institution randomized controlled trial. Patients with gestational diabetes were randomized to use either real-time or blinded continuous glucose monitoring. The primary outcome was mean sensor glucose level during the fourth week of continuous glucose monitoring use. Secondary outcomes included glycemic control and a composite of obstetric and neonatal outcomes.
Results Of the 40 enrolled patients, 12 (60%) patients in the blinded continuous glucose monitoring group and 11 (55%) in the real-time continuous glucose monitoring group completed 4 weeks of monitoring and were included in the final analysis. There was no significant difference in mean sensor glucose level between the blinded continuous glucose monitoring group (98.9 ± 8.9 mg/dL) and the real-time continuous glucose monitoring group (107.5 ± 11.4 mg/dL). There were also no significant differences in the time spent in glycemic target, maternal, or neonatal outcomes.
Conclusion Our study shows that the use of continuous glucose monitoring with real-time feedback did not significantly decrease mean glucose values compared with intermittent self-monitoring of blood glucose after 4 weeks of continuous glucose monitoring use.
Keywords
gestational diabetes - diabetes - pregnancy - continuous glucose monitoring - glucose monitoringClinical Trials Registry
ClinicalTrials.gov #NCT03326232. Date of registration: October 31, 2017. Date of initial enrollment: December 1, 2017. Available at https://clinicaltrials.gov/ct2/show/NCT03326232?cond=continuous+glucose+monitoring+in+gestational+diabetes&rank=2.
Note
The findings of this study have been presented as an oral presentation at the 39th annual Society for Maternal–Fetal Pregnancy Medicine meeting, February 11–16, 2019, in Las Vegas, Nevada.
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