Improving Metabolic Stability in Preterm Infants Using Continuous Glucose Monitoring: A Randomized Study

Background: Preterm infants are particularly susceptible to glycemic instability, which has been associated with enhanced risks of morbidity and adverse neurodevelopmental outcomes. Continuous glucose monitoring (CGM) may offer advantages in minimizing glycemic fluctuations. Study aim is to determine whether real-time CGM improves glycemic control and neurodevelopmental outcomes compared to standard care in preterm infants. Methods: this single-centre, prospective, randomized trial was conducted in our NICU between January 2022 and August 2023. Infants were randomly allocated within six hours of life to either a real-time CGM group or a control group with blinded CGM. In the intervention group, glycemic management was guided by CGM data; in the control group, it was based on intermittent blood glucose measurements. Primary outcomes included the frequency and duration of hypoglycemic (<47 mg/dL) and hyperglycemic (>180 mg/dL) episodes. Neurodevelopment was assessed at two years of corrected age using the Griffiths Scales of Child Development. Results: 53 infants were included (CGM group: n=26; control group: n=27). Infants in the real-time CGM group demonstrated significantly fewer episodes of both hypoglycemia and hyperglycemia during the first week of life (hypoglycemia:339 vs 934, p=0.0001; hyperglycemia: 145 vs 830, p = 0.0001 ) and at 32 weeks of postmenstrual age (hypoglycemia:260 vs 785, p=0.0001; hyperglycemia: 1 vs 38, p = 0.0001). No significant differences were observed in neurodevelopmental outcomes. Conclusions: use of CGM allows therapeutic metabolic strategies to be employed the enhance glycaemic control in preterm during the early neonatal period. The trial protocol was registered under EudraCT number 2020-005739-65 (protocol code PN-CGM)