Flash glucose monitoring addition to self-monitoring of blood glucose and perinatal outcomes in gestational diabetes: a randomized controlled trial.

Abstract

Self-monitoring of blood glucose represents the standard for glycemic monitoring in gestational diabetes mellitus, while the role of continuous glucose monitoring remains uncertain. To assess whether adjunctive flash glucose monitoring improves achievement of established self-monitored glucose targets compared with self-monitoring alone and to examine maternal and neonatal outcomes. We conducted an open-label, single-center, randomized controlled trial comparing adjunctive flash glucose monitoring plus self-monitoring of blood glucose with self-monitoring of blood glucose alone. The prespecified primary outcome was the percentage of self-monitored glucose measurements within the established target range. Secondary outcomes included maternal and neonatal outcomes. Analyses followed the intention-to-treat principle. A total of 205 women (median age, 32 years; median prepregnancy body mass index, 23.5 kg/m²; median gestational age, 27 weeks) were randomized (102 to adjunctive flash glucose monitoring and 103 to self-monitoring alone). The percentage of self-monitored glucose measurements within target range was lower in the adjunctive flash monitoring group (89.5% vs 92.6%, P=.04). Median fasting and 1-hour postprandial self-monitored glucose concentrations were comparable between groups and within recommended targets. The incidence of large-for-gestational-age infants was lower in the flash monitoring group (3% vs 11%; P=.05; odds ratio, 0.27; 95% confidence interval, 0.07-0.99). Adjunctive flash glucose monitoring did not improve glycemic outcome in this low-risk gestational diabetes population. However, it was associated with fewer large-for-gestational-age neonates, a secondary outcome that should be interpreted cautiously given the sample size and number of events.