Accuracy of continuous glucose monitoring in preterm infants: a systematic review and meta-analysis
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Transcutaneous Microcirculatory Imaging in Preterm Neonates
Published on: December 31, 2015
Chiara Nava1, Astrid Modiano Hedenmalm2, Franciszek Borys3
1Neonatal Intensive Care Unit, Ospedale Alessandro Manzoni, Lecco, Lecco, Italy.
Insights
Continuous glucose monitoring (CGM) shows low sensitivity for detecting hypoglycemia in preterm infants but high accuracy for hyperglycemia. Further research is needed to improve CGM device performance for this vulnerable population.
Area of Science:
- Neonatal Medicine
- Medical Devices
- Diagnostic Accuracy
Background:
- Preterm neonates are at risk for glycemic instability.
- Continuous glucose monitoring (CGM) offers potential for real-time glucose assessment in this population.
Purpose of the Study:
- To systematically review and meta-analyze the diagnostic accuracy of CGM devices compared to intermittent blood glucose testing in preterm infants.
- To evaluate CGM device performance against established accuracy standards.
Main Methods:
- Systematic literature search and inclusion of 11 studies.
- Individual patient data (IPD) meta-analysis using logistic mixed-effects models.
- Assessment of sensitivity, specificity, Mean Absolute Relative Difference (MARD), and Area Under the Curve (AUC).
Main Results:
- None of the studied CGM devices met European Union ISO 15197 accuracy requirements.
- Pooled sensitivity for hypoglycemia was 0.39 (AUC 0.70), and for hyperglycemia was 0.87 (AUC 0.86).
- Evidence certainty was rated as low to moderate due to study limitations.
Conclusions:
- CGM devices exhibit low sensitivity in detecting hypoglycemia in preterm neonates.
- CGM devices demonstrate high accuracy for detecting hyperglycemia in this population.
- Current CGM technology requires improvement for reliable use in preterm infants.
Background And Objectives:
Continuous glucose monitoring (CGM) could be a valuable instrument for measurement of glucose concentration in preterm neonate. We undertook a systematic review and meta-analysis to compare the diagnostic accuracy of CGM devices to intermittent blood glucose evaluation methods for the detection of hypoglycaemic or hypoglycaemic events in preterm infants.
Data Sources:
A structured electronic database search was performed for studies that assessed the accuracy of CGM against any intermittent blood glucose testing methods in detecting episodes of altered glycaemia in preterm infants. No restrictions were used. Three review authors screened records and included studies.
Data Extraction:
Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. From individual patient data (IPD), sensitivity and specificity were determined using predefined thresholds. The mean absolute relative difference (MARD) of the studied CGM devices was assessed and if those satisfied the accuracy requirements (EN ISO 15197). IPD datasets were meta-analysed using a logistic mixed-effects model. A bivariate model was used to estimate the summary receiver operating characteristic curve (ROC) curve and extract the area under the curve (AUC). The overall level of certainty of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation.
Results:
Among 4481 records, 11 were included. IPD datasets were obtained for five studies. Only two of the studies showed an MARD lower than 10%, with none of the five CGM devices studied satisfying the European Union (EU) ISO 15197 requirements. Pooled sensitivity and specificity of CGM devices for hypoglycaemia were 0.39 and 0.99, whereas for hyperglycaemia were 0.87 and 0.99, respectively. The AUC was 0.70 and 0.86, respectively. The certainty of the evidence was considered as low to moderate. Limitations primarily related to the lack of representative population, reference standard and CGM device.
Conclusions:
CGM devices demonstrated low sensitivity for detecting hypoglycaemia in preterm infants, however, provided high accuracy for detection of hyperglycaemia.
Prospero Registration Number:
CRD42020152248.
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