- April 20, 2021
“Continuous glucose monitoring is widely used in adults and children with diabetes to improve glucose control, but has not been approved for use in neonates,” wrote the study Investigators. Led by Kathryn Beardsall, MD, Department of Pediatrics, University of Cambridge, UK, the international, open-label, randomized controlled trial was conducted across 13 neonatal intensive care centers in the UK, Spain, and the Netherlands. They included infants who were born within 24 hours, had a birthweight of ≤1200 g (less than or equal to 2.645547 pounds), and a gestational age of 33 weeks plus 6 days.
Continuous Glucose Monitoring in Infants
The team enrolled participants between July 4, 2016 and January 27, 2019 and randomly assigned 180 of them to either real-time CGM (n = 85) or standard care (n = 95). However, 70 in the real-time CGM cohort and 85 in the standard of care cohort had CGM data that were included in the analysis.
The primary outcome sought by the investigators was the proportion of time sensor glucose concentration between 2.6-10 mmol/L for the first week of life. They also evaluated safety outcomes related to hypoglycemia—defined as glucose concentrations <2·6 mmol/L—in the first 7 days since birth. “Clinical staff were advised to read and record the sensor glucose data hourly and were provided with a specifically designed guideline to aid the management of glucose control on the basis of the CGM data,” the Beardsall and colleagues wrote in reference to the intervention group. “This included modification of the rate of dextrose infusion or use of supplementary insulin.” they continued.
Thus, infants using CGM were found to have more time in the 2.6–10 mmol/L glucose concentration target range (mean proportion of time, 94%) than those in the standard of care group (mean proportion of time, 84%; adjusted mean difference, 8.9% [95% CI, 3.4.-14.4], equivalent to 13 hours).
They also indicated that 15% of infants in the standard of care group were exposed to at least 1 episode of sensor glucose concentration of <2.6 mmol/L for more than 1 hour — compared with 6% (4 of 70) in the intervention group. Additionally, the team noted no serious adverse events or infections that were related to the use of the CGM device. “This study supports previous single-center studies using real-time CGM in newborn infants but is unique in allowing clinicians to use the CGM data to optimize nutritional delivery as well as providing guidance on using insulin,” the team wrote.
Beardsall and colleagues acknowledged that their study was not powered enough to show the clinical effect of the difference in hyperglycemia.
Furthermore, they suggested that the trial intervention placed an increased burden on clinical nursing and staff, considering their requirement to learn new technology and to act on the data (and modify neonatal care) in a time-sensitive manner. As such, this may be a consideration in implementation of the technology. “In summary, the use of CGM allowed earlier detection of and prevention of exposure to the extremes of both hypoglycemia and hyperglycemia in preterm infants,” the Investigators concluded. “Lessons learned during the trial will support advances in CGM for these babies.”
The study, “Real-time continuous glucose monitoring in preterm infants (REACT): an international, open-label, randomised controlled trial,” was published online in The Lancet: Child & Adolescent Health.
REFERENCE: HCP Live; 10 FEB 2021; Jonathan Alicea