85: Real-time continuous glucose monitoring in gestational diabetic pregnancies: a randomized controlled trial

Abstract

To evaluate whether real-time continuous glucose monitoring (CGM) improves glycemic control over intermittent self-monitoring of blood glucose (SMBG) in gestational diabetes (GDM). This represented a randomized controlled trial at a single academic institution. Patients with GDM were randomized to use either real-time or blinded CGM. The blinded CGM group wore a CGM system that only collected, but did not display data. The real-time CGM group wore a CGM system that collected and displayed continuous glycemic feedback. Both groups also completed SMBG 4-7 times daily. The primary outcome was mean sensor glucose level during the fourth week of CGM use. Secondary outcomes included time spent in and out of a glycemic target of 70-140 mg/dL, polyhydramnios, macrosomia, and a composite of obstetric and neonatal outcomes. Sample size calculations were designed to detect a 20% decrease in mean glucose level with 80% power. From December 2017 through May 2018, a total of 374 patients diagnosed with GDM were referred to our practice. Of these, 40 met inclusion criteria and were enrolled. Twenty patients were randomized into the blinded CGM group and 20 into the real-time CGM group. Twelve (60%) patients in the blinded CGM group and 11 (55%) in the real-time CGM group completed 4 weeks of monitoring and were included in the final analysis. Demographic characteristics were similar between groups. There was no significant difference in mean sensor glucose level between the blinded CGM group (98.9+8.9 mg/dL) and the real-time CGM group (107.5+11.4 mg/dL) in the fourth week of CGM use. There were also no significant differences in time spent in glycemic target, maternal, or neonatal outcomes. An end of participation survey showed that all study patients would consider CGM to monitor glucose in a subsequent pregnancy and all patients in the real-time CGM group believed that the real-time feedback was helpful in managing their GDM. Our study showed that the feedback provided by real-time CGM did not significantly decrease mean glucose values compared to SMBG alone after four weeks of CGM use. All patients considered CGM an effective motivational tool for use in GDM.View Large Image Figure ViewerDownload Hi-res image Download (PPT)