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

BACKGROUND: Self-monitoring of blood glucose represents the standard for glycemic monitoring in gestational diabetes mellitus, while the role of continuous glucose monitoring remains uncertain. OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: ; 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). CONCLUSION: 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.