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Strict glycaemic control in very low birthweight infants using a continuous glucose monitoring system: a randomised
Alessandro Perri1, Eloisa Tiberi2, Lucia Giordano2
1Child Health Area, University Hospital Agostino Gemelli Department of Woman and Child Health Sciences, Rome, Lazio, Italy alessandro.perri@policlinicogemelli.it.
Insights
A strict glycaemic control protocol using continuous glucose monitoring (CGM) significantly reduced dysglycaemic episodes in high-risk infants. This approach also increased the time infants spent in normal blood glucose ranges, improving overall metabolic stability.
Area of Science:
- Neonatal Medicine
- Endocrinology
- Clinical Trial Research
Background:
- Infants at high risk of dysglycaemia, particularly those born very low birth weight and receiving parenteral nutrition (PN), face significant metabolic challenges.
- Effective glycaemic control is crucial in this vulnerable population to prevent adverse outcomes associated with blood glucose fluctuations.
Purpose of the Study:
- To assess the efficacy of a stringent glycaemic control protocol, utilizing continuous glucose monitoring (CGM), in minimizing dysglycaemic episodes among high-risk neonates.
- To determine if this protocol enhances the time infants spend within the euglycaemic range.
Main Methods:
- A randomized controlled trial was conducted in a neonatal intensive care unit.
- Eligible infants (<1500 g) receiving PN were randomized into two groups with different CGM alarm cut-offs.
- A strict protocol guided glucose infusion rate adjustments based on CGM readings.
Main Results:
- The intervention group, managed with the strict protocol, experienced significantly fewer dysglycaemic episodes (1 vs 3; p=0.005) and a lower incidence of infants with at least one episode (52% vs 83%; p=0.047).
- Infants in the strict group showed a higher probability of maintaining normal glycaemic values (RR 2.87) and spent more time in euglycaemia (100% vs 98%; p=0.036).
- The number needed to treat to avoid dysglycaemia episodes was 3.2.
Conclusions:
- Continuous glucose monitoring (CGM) integrated with a protocol for adjusting glucose infusion effectively reduces dysglycaemia in very low birth weight infants on PN.
- This strategy significantly increases the duration of euglycaemia, highlighting its clinical utility in neonatal metabolic management.
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.
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