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Pilot study of a model-based approach to blood glucose control in very-low-birthweight neonates
Aaron J Le Compte1, Adrienne M Lynn, Jessica Lin
1Department of Mechanical Engineering, University of Canterbury, Christchurch, New Zealand. aaron.lecompte@canterbury.ac.nz
Insights
A computer model safely managed hyperglycemia in very-low-birthweight infants, achieving better blood glucose control without increasing hypoglycemia risk. This method offers effective neonatal glucose management.
Area of Science:
- Neonatalogy
- Medical Informatics
- Pediatric Endocrinology
Background:
- Hyperglycemia is common in premature, very low birthweight infants (VLBW) due to immature regulatory systems and physiological stress.
- Neonatal hyperglycemia is associated with increased morbidity and mortality, particularly in lower birthweight infants.
- Current insulin management for neonatal hyperglycemia carries a significant risk of hypoglycemia.
Purpose of the Study:
- To assess the efficacy of a computer metabolic system model for determining insulin infusion rates in VLBW infants.
- To evaluate the safety and effectiveness of computer-guided glycemic control compared to traditional methods.
Main Methods:
- Short-term (24-hour) and long-term (several days) trials were conducted on VLBW infants with hyperglycemia.
- Blood glucose control was compared to a retrospective cohort using insulin infusions determined by sliding scales and clinician intuition.
- The study involved 8 infants in short-term trials and 22 in long-term trials, with median birthweights around 750g and gestational ages of 25.4 weeks.
Main Results:
- Hyperglycemia was safely reduced to the target glucose band in all infants during short-term trials, with no hypoglycemic episodes.
- The computer model achieved a lower median blood glucose concentration (6.6 mmol/L) compared to the retrospective cohort (8.0 mmol/L, p < 0.01).
- The percentage of blood glucose readings within the target range (4.0-8.0 mmol/L) increased by 41% (68.4% vs 48.4%, p < 0.01) without a significant difference in hypoglycemia incidence.
Conclusions:
- A computer model accurately simulating neonatal metabolism provides safe and effective blood glucose control.
- This model can manage neonatal hyperglycemia without increasing the risk of hypoglycemia.
- The study demonstrates a significant improvement in glycemic control for VLBW infants using a computer-based system.
Background:
Hyperglycemia often occurs in premature, very low birthweight infants (VLBW) due to immaturity of endogenous regulatory systems and the stress of their condition. Hyperglycemia in neonates has been linked to increased morbidities and mortality and occurs at increasing rates with decreasing birthweight. In this cohort, the emerging use of insulin to manage hyperglycemia has carried a significant risk of hypoglycemia. The efficacy of blood glucose control using a computer metabolic system model to determine insulin infusion rates was assessed in very-low-birth-weight infants.
Methods:
Initial short-term 24-hour trials were performed on 8 VLBW infants with hyperglycemia followed by long-term trials of several days performed on 22 infants. Median birthweight was 745 g and 760 g for short-term and long-term trial infants, and median gestational age at birth was 25.6 and 25.4 weeks respectively. Blood glucose control is compared to 21 retrospective patients from the same unit who received insulin infusions determined by sliding scales and clinician intuition. This study was approved by the Upper South A Regional Ethics Committee, New Zealand (ClinicalTrials.gov registration NCT01419873).
Results:
Reduction in hyperglycemia towards the target glucose band was achieved safely in all cases during the short-term trials with no hypoglycemic episodes. Lower median blood glucose concentration was achieved during clinical implementation at 6.6 mmol/L (IQR: 5.5 - 8.2 mmol/L, 1,003 measurements), compared to 8.0 mmol/L achieved in similar infants previously (p < 0.01). No significant difference in incidence of hypoglycemia during long-term trials was observed (0.25% vs 0.25%, p = 0.51). Percentage of blood glucose within the 4.0 - 8.0 mmol/L range was increased by 41% compared to the retrospective cohort (68.4% vs 48.4%, p < 0.01).
Conclusions:
A computer model that accurately captures the dynamics of neonatal metabolism can provide safe and effective blood glucose control without increasing hypoglycemia.
Trial Registration:
ClinicalTrials.gov registration NCT01419873.
