CGM may help prevent blood sugar swings in preterm infants in ICU: Lancet
UK: The use of real-time Continuous glucose monitoring (CGM) in preterm infants requiring intensive care can aid earlier detection and prevention of exposures to the extremes of both hypoglycemia and hyperglycemia, show results from REACT trial.
The findings of the study were published in The Lancet Child & Adolescent Health.
Low (hypoglycemia) and high blood sugar levels (hyperglycemia) are common in preterm infants and are associated with an increased risk of morbidity and mortality. Owing to the infrequent measurement of blood sugar concentrations, interventions to reduce the risk associated with these exposures are particularly challenging with the potential of causing more harm than doing good.
Continuous glucose monitoring (CGM) is widely used for improving blood sugar control in adults and children with diabetes but has not been approved for use in neonates. Considering this, Kathryn Beardsall, Department of Paediatrics, University of Cambridge, Cambridge, UK, and colleague aimed to evaluate the efficacy and safety of CGM in preterm infants requiring intensive care (REACT trial).
For this purpose, the researchers performed an international, open-label, randomized controlled trial across 13 neonatal intensive care units in the UK, Spain, and the Netherlands. It included infants who were within 24 h of birth, had a birthweight of 1200 g or less, had a gestational age up to 33 weeks plus 6 days, and had parental written informed consent. 180 of whom were randomly assigned in the ratio of 1:1 to real-time CGM (n=85) or standard care (n=95) (with masked CGM for comparison).
70 infants in the real-time CGM intervention group and 85 in the standard care group had CGM data and were included in the primary analysis.
The primary efficacy outcome was the proportion of time sensor glucose concentration was 2·6–10 mmol/L for the first week of life. Safety outcomes related to hypoglycaemia (glucose concentrations <2·6 mmol/L) in the first 7 days of life. All outcomes were assessed on the basis of intention to treat in the full analysis set with available data.
70 infants in the real-time CGM intervention group and 85 in the standard care group had CGM data and were included in the primary analysis.
Key findings of the study include:
- Compared with infants in the standard care group, infants managed using CGM had more time in the 2·6–10 mmol/L glucose concentration target range (mean proportion of time 84% vs 94%; adjusted mean difference 8·9%), equivalent to 13 h.
- More infants in the standard care group were exposed to at least one episode of sensor glucose concentration of less than 2·6 mmol/L for more than 1 h than those in the intervention group (13 [15%] of 85 vs four [6%] of 70).
- There were no serious adverse events related to the use of the device or episodes of infection.
"Real-time CGM can reduce exposure to prolonged or severe hyperglycaemia and hypoglycaemia," wrote the authors. "Further studies using CGM are required to determine optimal glucose targets, strategies to obtain them, and the potential effect on long-term health outcomes."
Reference:
The study titled, "Real-time continuous glucose monitoring in preterm infants (REACT): an international, open-label, randomised controlled trial," is published in The Lancet Child & Adolescent Health.
DOI: https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(20)30367-9/fulltext
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