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Continuous glucose monitoring in neonates at risk of hypoglycaemia: a feasibility study
Katrine Engen1, Kari Holte2, Mads Nikolaj Holten-Andersen3,4
1Department of Pediatric and Adolescent Medicine, Innlandet Hospital Trust, Brumunddal, Norway kateng@me.com.
Insights
Continuous glucose monitoring (CGM) in at-risk neonates showed feasibility, detecting silent hypoglycaemic events. Further research is needed for approved neonatal CGM devices.
Area of Science:
- Neonatal Medicine
- Endocrinology
- Medical Devices
Background:
- Hypoglycaemia is a common neonatal condition with potential for long-term neurodevelopmental impairment.
- Early detection and management of neonatal hypoglycaemia are crucial for preventing adverse outcomes.
- Continuous glucose monitoring (CGM) offers potential for real-time glucose surveillance.
Purpose of the Study:
- To assess the feasibility of utilizing continuous glucose monitoring (CGM) in high-risk neonates.
- To evaluate the accuracy and performance of a CGM device in a neonatal population.
- To identify silent hypoglycaemic episodes in at-risk infants.
Main Methods:
- An observational feasibility study was conducted in a Level 2 neonatal unit in Norway.
- Twenty-five infants at risk (maternal diabetes or large for gestational age) were included.
- A blinded CGM device was applied to the neonate's thigh, recording tissue glucose, with comparison to capillary blood glucose measurements.
Main Results:
- Tissue glucose readings were higher than blood glucose, with decreasing discrepancy over time (1.0 to 0.5 mmol/L).
- Lowest tissue glucose levels were observed around 50 hours postnatal age.
- CGM detected 49 silent hypoglycaemic events in 10 infants from 28 hours postnatal age; no significant skin harm was observed.
Conclusions:
- CGM accuracy improved over time compared to capillary blood glucose, though the device had limitations below 2.2 mmol/L.
- Hypoglycaemia occurred later than anticipated, with lowest glucose levels around 50 hours postnatal age.
- CGM shows promise as a supplementary tool for neonatal glucose monitoring, highlighting the need for specifically approved neonatal devices.
Objective:
Hypoglycaemia is common in neonates. Repeated hypoglycaemic episodes impose a risk of subsequent neurodevelopmental impairment. We aimed to assess the feasibility of using continuous glucose monitoring (CGM) in a group of infants at risk of hypoglycaemia.
Design:
Observational feasibility study.
Settings:
Level 2 neonatal unit, Norway.
Patients:
Infants of mothers with diabetes or infants born large for gestational age.
Interventions:
A blinded CGM-device was applied on the upper lateral thigh of the neonate shortly after birth to record tissue glucose during the infant's admission at the postnatal ward. Capillary blood glucose screening samples were analysed by oxidase method.
Main Outcomes:
Accuracy of tissue glucose values. Tissue glucose variations during the first 3 days after birth. Number of silent hypoglycaemic events.
Results:
We included 25 infants. Tissue glucose values were higher than blood glucose values but estimated discrepancy decreased from 1.0 mmol/L at 6 hours to 0.5 mmol/L at 18 hours of age. The lowest tissue glucose values were observed around 50 hours postnatal age. From 28 hours postnatal age until discharge, CGM detected 49 silent hypoglycaemic events in 10 infants. We observed no significant harm from the devices on skin or subcutaneous tissue.
Conclusion:
Accuracy of tissue glucose increased with time in comparison to capillary blood glucose, but the device could not detect glucose values <2.2 mmol/L. Tissue glucose levels were lowest at ~50 hours postnatal age and hypoglycaemia occurred later than expected. CGM may be a feasible supplement, but approved CGM-devices for neonates are called for.
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