Real-time Continuous Glucose Monitoring in Infants With Hypoxic-ischaemic Encephalopathy: a Pilot Randomized Controlled Trial

What this Trial Is About

Researchers are studying whether continuous glucose monitoring (CGM) can improve glucose control in newborns with moderate or severe hypoxic ischemic encephalopathy (HIE) after perinatal asphyxia. The study aims to see if using CGM increases the time glucose levels stay within the target range and to assess secondary outcomes including mean glucose levels, glucose variability, and the time spent in high or low glucose ranges. This is a randomized controlled trial involving neonates with specific birth weight and gestational age criteria. Neonates weighing over 1.8 kg, born after 35 weeks gestation, and less than 6 hours old are randomly assigned to receive either real-time CGM data to guide glucose management or standard care with blinded CGM data collection for 72 hours. All babies will have a Dexcom ONE+ CGM sensor placed on their thigh for continuous glucose measurement, and glucose and insulin infusions will be adjusted based on CGM data following a shared protocol. In the control group, glucose monitoring and management follow standard intermittent blood sampling without access to real-time CGM data. Participants will be closely monitored for glucose control during the first 72 hours after birth, with CGM data calibrated twice daily and downloaded using specialized software. Researchers will track the time glucose levels remain in the target range, occurrences of hypoglycemia and hyperglycemia, glucose variability, and any adverse events related to CGM insertion up to 10 days after birth. The study involves informed parental consent and careful clinical management throughout the monitoring period.

Continuous Glucose Monitoring in HIE