Use of Real-time CGM prevents blood sugar swings in infants: Lancet Study

The study is published in The Lancet- Child and Adolescent Health Journal.

Hyperglycaemia and hypoglycaemia are common in preterm infants and has been associated with an increased risk of mortality and morbidity. Interventions to reduce the risk associated with these exposures are particularly challenging due to the infrequent measurement of blood glucose concentrations, with the potential of causing more harm instead of improving outcomes for these infants. Continuous glucose monitoring (CGM) is widely used in adults and children with diabetes to improve blood sugar control but has not been approved for use in neonates.

Hence, Kathryn Beardsall and colleagues from the Department of Paediatrics, University of Cambridge, UK conducted this study to evaluate the efficacy and safety of CGM in preterm infants requiring intensive care.

The authors carried out this international, open-label, randomized controlled trial in 13 neonatal intensive care units in the UK, Spain, and the Netherlands. Infants were included if they were within 24 h of birth, had a birth weight of 1200 g or less had a gestational age up to 33 weeks plus 6 days and had parental written informed consent.

A total of 182 infants were enrolled, 180 of whom were randomly assigned (85 to real-time CGM, 95 to standard care). 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.

Infants were randomly assigned (1:1) to real-time CGM or standard care (with masked CGM for comparison) using a central web randomization system, stratified by recruiting center and gestational age (<26 or ≥26 weeks). 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 hypoglycemia (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.

The key findings were-

1. 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% [SD 22] vs 94% [11]; adjusted mean difference 8·9% [95% CI 3·4–14·4]), equivalent to 13 h (95% CI 5–21).
2. 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).
3. There were no serious adverse events related to the use of the device or episodes of infection.

Hence, the authors concluded that "real-time CGM can reduce exposure to prolonged or severe hyperglycemia and hypoglycemia. Further studies using CGM are required to determine optimal glucose targets, strategies to obtain them, and the potential effect on long-term health outcomes."