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 availability statement
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.
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Contributors AP conceptualised and designed the study, designed the data collection instruments, enrolled patients, collected data, analysed the data, contributed to the interpretation of the results, drafted the initial manuscript, and reviewed and revised the manuscript. ET conceptualised and designed the study, enrolled patients, contributed to the interpretation of the results, and reviewed and revised the manuscript. LG and RI enrolled patients and reviewed and revised the manuscript. AS designed the data collection instruments, enrolled patients, collected data, analysed the data and drafted the initial manuscript. MLP designed the data collection instruments, enrolled patients, collected data and drafted the initial manuscript. TP enrolled patients, collected data and drafted the initial manuscript. FC contributed to the interpretation of the results and reviewed and revised the manuscript. LM contributed to the interpretation of the results and critically revised the manuscript. GV contributed to the interpretation of the results and critically revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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