Real-time continuous glucose monitoring in preterm infants (REACT): an international, open-label, randomized controlled trial
Hyperglycaemia, hypoglycemia, and glycaemic instability are commonly associated with an increased risk of mortality and morbidity in preterm infants. The current interventions cause more difficulties instead of improving outcomes due to infrequent, intermittent blood glucose measurement. It suggests that improving early glucose control could be an important modifiable risk factor in preterm infants. The author Kathryn Beardsall and colleague (2021) conducted a study titled “Real-time continuous glucose monitoring in preterm infants (REACT): an international, open-label, randomized controlled trial” published in The Lancet Child & Adolescent Health journal. The summary of the findings is below:
Objective:
To investigate the use of real-time CGM to provide guidelines for the clinical management of glycaemic control and the use of insulin in preterm infants.
Method:
This international, open-label, randomized controlled trial was conducted in 13 neonatal intensive care units in Spain, UK, and the Netherlands. The study included infants if they were within 24 h of birth, had a gestational age up to 33 weeks + 6 days, had a birth weight of less than or equal to 1200g and had written informed consent from parents. Using a central web randomization system, infants were stratified by recruiting centre and gestational age (<26 or ≥26 weeks). They were randomly assigned in 1:1 to real-time CGM or standard care (with masked CGM). The proportion of time sensor glucose concentration of 2.6–10 mmol/L for the first week of life was the primary efficacy outcome. Safety outcomes were related to hypoglycemia in the first 7 days of life. All outcomes were evaluated to treat in the full analysis set with available data.
Findings:
The study concludes that intervention with real-time CGM can improve glucose control in preterm infants. There was reduced exposure to elongated or severe hyperglycemia and hypoglycemia, a lesser number of infant deaths, less insulin resistance, and a lower rate of necrotizing enterocolitis in the real-time CGM intervention group. Without the risk of hypoglycemia, hyperglycemia can be prevented with variable insulin sensitivity, high energy, and nutritional requirement in preterm infants. Additionally, insulin treatment has been related to lower mortality in infants with hyperglycemia. The CGM data revealed that numerically more babies in the standard care group experienced one or more episodes of hypoglycemia for more than 1 h compared with those in the intervention group.
Real-time CGM was found to be safe for use in these preterm infants.
Limitation:
Several limitations acknowledged by the author include bias potential recruitment resulting from a short recruitment window, loss of data due to technical difficulties with sensor insertion, repeated calibrations and sensor shutting off, and potentially unnecessary sensor replacement. Additionally, the pointing accuracy of CGM is controversial. Lastly, the study was not powered to investigate the clinical effect of the difference in hyperglycemia.
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