RT Journal Article
SR Electronic
T1 Strict glycaemic control in very low birthweight infants using a continuous glucose monitoring system: a randomised controlled trial
JF Archives of Disease in Childhood - Fetal and Neonatal Edition
JO Arch Dis Child Fetal Neonatal Ed
FD BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
SP 26
OP 31
DO 10.1136/archdischild-2020-320540
VO 107
IS 1
A1 Alessandro Perri
A1 Eloisa Tiberi
A1 Lucia Giordano
A1 Annamaria Sbordone
A1 Maria Letizia Patti
A1 Rossella Iannotta
A1 Teresa Pianini
A1 Francesco Cota
A1 Luca Maggio
A1 Giovanni Vento
YR 2022
UL http://fn.bmj.com/content/107/1/26.abstract
AB Objective To evaluate the efficacy of a strict glycaemic control protocol using a continuous glucose monitoring (CGM) in infants at high risk of dysglycaemia with the aim of reducing the number of dysglycaemic episodes.Design Randomised controlled trial.Setting Neonatal intensive care unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome.Patients All infants <1500 g fed on parental nutrition (PN) since birth were eligible. A total of 63 infants were eligible and 48 were randomised.Intervention All participants wore a CGM sensor and were randomised in two arms with alarms set at different cut-off values (2.61–10 mmol/L (47–180 mg/dL) vs 3.44–7.78 mmol/L (62–140 mg/dL)), representing the operative threshold requiring modulation of glucose infusion rate according to an innovative protocol.Main outcome measures The primary outcome was the number of severe dysglycaemic episodes (<2.61 mmol/L (47 mg/dL) or >10 mmol/L (180 mg/dL)) in the intervention group versus the control group, during the monitoring time.Results We enrolled 47 infants, with similar characteristics between the two arms. The number of dysglycaemic episodes and of infants with at least one episode of dysglycaemia was significantly lower in the intervention group (strict group): respectively, 1 (IQR 0–2) vs 3 (IQR 1–7); (p=0.005) and 12 (52%) vs 20 (83%); p=0.047. Infants managed using the strict protocol had a higher probability of having normal glycaemic values: relative risk 2.87 (95% CI 1.1 to 7.3). They spent more time in euglycaemia: 100% (IQR 97–100) vs 98% (IQR 94–99), p=0.036. The number needed to treat to avoid dysglycaemia episodes is 3.2 (95% CI 1.8 to 16.6).Conclusion We provide evidence that CGM, combined with a protocol for adjusting glucose infusion, can effectively reduce the episodes of dysglycaemia and increase the percentage of time spent in euglycaemia in very low birthweight infants receiving PN in the first week of life.Data are available upon reasonable request. The data that support the findings of this study are available on request from the corresponding author AP. Reuse is not permitted.