Am J Perinatol 2019; 36(09): 891-897
DOI: 10.1055/s-0039-1678733
SMFM Fellowship Series Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial

Andrew S. Lane
1   Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia
,
Malgorzata A. Mlynarczyk
1   Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia
,
Margarita de Veciana
1   Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia
,
Lauren M. Green
2   Healthcare Analytics and Delivery Science Institute, Eastern Virginia Medical School, Norfolk, Virginia
,
Dana I. Baraki
3   Eastern Virginia Medical School, Norfolk, Virginia
,
Alfred Z. Abuhamad
1   Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virginia
› Author Affiliations
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.
Further Information

Publication History

11 January 2019

11 January 2019

Publication Date:
28 February 2019 (online)

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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.

Clinical 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.