Accuracy of continuous glucose monitoring in preterm infants: a systematic review and meta-analysis

Abstract

Background and objectivesContinuous 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 sourcesA 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 extractionRisk 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.ResultsAmong 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.ConclusionsCGM devices demonstrated low sensitivity for detecting hypoglycaemia in preterm infants, however, provided high accuracy for detection of hyperglycaemia.PROSPERO registration numberCRD42020152248.

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Should continuous glucose monitoring be used to manage neonates at risk of hypoglycaemia?

“…Furthermore, of the neonates who did develop hypoglycaemia (BG < 2.6 mmol/L, 47 mg/dl) 25% spent at least 5 h with SG < 2.6 mmol/L (47 mg/dl), and nearly a quarter of neonates who were considered to have normal BG levels by routine monitoring had episodes of clinically silent hypoglycaemia. Developments however are needed to provide diagnostic accuracy at the thresholds for hypoglycaemia in neonates which are significantly lower than those used in adults, to provide confidence in their use at this time ( 34 ). The potential to support proactive monitoring of such at-risk neonates to prevent hypoglycaemia vs. the potential to increase unnecessary interventions and maternal and neonate separation requires further evaluation.…”

“…The MARD score for hypoglycaemic values (2.8–3.9 mmol/L, 50–70 mg/dl) is often higher than in euglycaemic values in patients with diabetes ( 48 , 49 ). A recent systematic review concluded that the sensitivity of CGM for detecting hypoglycaemia was low ( 34 ). This may partly be due to the increased rate of change during episodes of hypoglycaemia.…”

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“…They used a bivariate model to summarize the receiver operating characteristic curve (ROC) curve and extract the area under the curve (AUC). According to their findings, CGM systems have low sensitivity for detecting hypoglycemia in preterm newborns but good accuracy for identifying hyperglycemia [ 4 ]. As a result, new approaches are continually being developed, and minimally invasive glucose monitoring technologies have sparked a lot of interest in this field.…”