Safety and feasibility of a factory-calibrated continuous glucose monitoring system in term and near-term infants at risk of hypoglycemia

Objective: Hypoglycemia increases the risk of adverse neurological outcomes in neonates. Adequate glucose monitoring requires repetitive and painful blood sampling. We aimed to evaluate the feasibility and accuracy of a continuous glucose monitoring system (CGMS) using factory-calibrated sensors to improve glucose monitoring and decrease the frequency of blood samples in neonates.

Material and Methods: A methodological study was conducted to investigate a correlation of CGMS values with blood glucose measurements.

Results: Factory-calibrated CGMS sensors were placed on 21 infants at risk of hypoglycemia after delivery. CGMS values were compared with blood glucose concentrations. Thirty-seven pairs of CGMS and blood glucose values were obtained. There was a good correlation between CGMS and blood glucose values (R=0.67, p<0.01) with a mean difference (2 standard deviations) of 9.78 (−24.68 to 44.25) mg/dL. The mean differences at <3 hours and ≥3 hours after sensor placement were 17.35 (−4.54 to 39.21) mg/dL and 0.88 (−37.62 to 39.38) mg/dL, respectively. CGMS values were significantly higher than blood glucose concentration at <3 hours after sensor placement (p<0.01), whereas no significant differences in glucose values were observed between the CGMS and blood glucose values at ≥3 hours after sensor placement (p=0.852).

Conclusion: The factory-calibrated CGMS was a safe and feasible modality for glucose monitoring. However, it has a tendency to overestimate the blood glucose concentrations. Therefore, this system should be used cautiously for neonates at risk of hypoglycemia, especially within 3 hours after sensor placement.

Cite this article as: Nishimura E, Oka S, Ozawa J, et al. Safety and feasibility of a factory-calibrated continuous glucose monitoring system in term and near-term infants at risk of hypoglycemia. Turk Arch Pediatr 2021; 56(2): 115-20.