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Published on: December 31, 2015
Continuous Glucose Monitoring in Very Preterm Infants: A Randomized Controlled Trial
Alfonso Galderisi1,2, Andrea Facchinetti3, Garry M Steil4
1NICU, Departments of Women's and Child's Health and alfonso.galderisi@yale.edu.
Insights
Continuous glucose monitoring (CGM) significantly improved glucose control in very preterm infants. CGM-guided glucose titration increased time in the target range, reduced hypoglycemia, and minimized glucose variability compared to standard care.
Area of Science:
- Neonatalogy
- Endocrinology
- Medical Devices
Background:
- Impaired glucose control in very preterm infants is linked to adverse outcomes.
- Previous insulin titration strategies have shown limited success in achieving euglycemia without increasing hypoglycemia.
- Effective glucose management is critical for improving survival and neurologic outcomes in vulnerable preterm neonates.
Purpose of the Study:
- To evaluate the efficacy of continuous glucose monitoring (CGM) for guiding glucose administration in very preterm infants.
- To compare CGM-guided glucose titration with standard blood glucose monitoring for maintaining euglycemia.
- To assess the impact of CGM on hypoglycemia, hyperglycemia, and glucose variability.
Main Methods:
- A randomized controlled trial involving 50 newborns with gestational age ≤32 weeks or birth weight ≤1500 g.
- Infants were assigned to either computer-guided glucose infusion rate (GIR) with unblinded CGM or standard care with blinded CGM.
- The primary outcome was the percentage of time spent within the euglycemic range (72-144 mg/dL).
Main Results:
- The unblinded CGM group spent significantly more time in the euglycemic range (84% vs. 68%, P < .001).
- CGM use led to reduced time spent in both mild and severe hypoglycemia and severe hyperglycemia.
- Glycemic variability was significantly decreased in the CGM group (SD: 21.6 vs. 27 mg/dL, P = .01).
Conclusions:
- Continuous glucose monitoring-guided glucose titration is effective in very preterm infants.
- CGM significantly increases time spent in the euglycemic range during the first week of life.
- CGM reduces hypoglycemia and minimizes glucose variability, contributing to better glucose control.
Background And Objectives:
Impaired glucose control in very preterm infants is associated with increased morbidity, mortality, and poor neurologic outcome. Strategies based on insulin titration have been unsuccessful in achieving euglycemia in absence of an increase in hypoglycemia and mortality. We sought to assess whether glucose administration guided by continuous glucose monitoring (CGM) is more effective than standard of care blood glucose monitoring in maintaining euglycemia in very preterm infants.
Methods:
Fifty newborns ≤32 weeks' gestation or with birth weight ≤1500 g were randomly assigned (1:1) within 48-hours from birth to receive computer-guided glucose infusion rate (GIR) with or without CGM. In the unblinded CGM group, the GIR adjustments were driven by CGM and rate of glucose change, whereas in the blinded CGM group the GIR was adjusted by using standard of care glucometer on the basis of blood glucose determinations. Primary outcome was percentage of time spent in euglycemic range (72-144 mg/dL). Secondary outcomes were percentage of time spent in mild (47-71 mg/dL) and severe (<47 mg/dL) hypoglycemia; percentage of time in mild (145-180 mg/dL) and severe (>180 mg/dL) hyperglycemia; and glucose variability.
Results:
Neonates in the unblinded CGM group had a greater percentage of time spent in euglycemic range (median, 84% vs 68%, P < .001) and decreased time spent in mild (P = .04) and severe (P = .007) hypoglycemia and in severe hyperglycemia (P = .04) compared with the blinded CGM group. Use of CGM also decreased glycemic variability (SD: 21.6 ± 5.4 mg/dL vs 27 ± 7.2 mg/dL, P = .01; coefficient of variation: 22.8% ± 4.2% vs 27.9% ± 5.0%; P < .001).
Conclusions:
CGM-guided glucose titration can successfully increase the time spent in euglycemic range, reduce hypoglycemia, and minimize glycemic variability in preterm infants during the first week of life.
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