Continuous Glucose Monitoring Use and Glucose Variability in Very Young Children with Type 1 Diabetes (VibRate): A Multinational Prospective Observational Real-World Cohort Study.

While data on the efficacy and safety of continuous glucose monitoring (CGM) exist across a broad age spectrum, it is limited in very young children with type 1 diabetes (T1D). We aimed to assess real-world data in this high-risk population, focusing on glycemic variability and metrics beyond HbA1c. A 12-month multi-national, prospective, observational, registry-based cohort study in children with T1D aged 1-7 years compared glucose control using real-time CGM and using fingerstick blood glucose monitoring (BGM) alone. The prespecified primary endpoint was a difference in coefficient of variation (CV) between the CGM users and BGM-only cohort. Among 227 individuals using insulin pumps (42% female, age 5.3 years), 175 were CGM and 52 were BGM-only users. The median (IQR) CV was 39.1% (36.6-41.9) among CGM and 46.8% (42.3-51.2) among BGM-only users (P<0.001). Time in range was 65.2% (56.2-73.0) among CGM and 49.1% (40.0-54.5) among BGM-only users with an estimated difference of 17.1% after adjusting for covariates (P<0.001). In summary, CGM use was associated with reduced glucose fluctuations and increased TIR, attributed to less time both above and below range, and approaching targeted glycemia. This article is protected by copyright. All rights reserved.