Abstract
Identifying hyperglycaemia during postoperative period is essential for neonates. The objective of the study was to analyse the accuracy and reliability of continuous glucose monitoring (CGM) device for detecting hyperglycaemia during postoperative period in neonates. In this prospective study, hourly glucose recordings by CGM device and six hourly by glucometer glucose (GG-reference test for patient management) were collected in ten surgical neonates during first three postoperative days. Mean absolute relative difference (MARD) and proportion of CGM values within ± 15%/15 mg/dL, ± 20%/20 mg/dL, and ± 30%/30 mg/dL of GG, were analysed from matched pair CGM and GG recordings. The diagnostic performance of CGM for neonatal hyperglycaemia (> 150 mg/dL) was expressed as sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV); and the clinical reliability was assessed in Clarke Error Grid Analysis. A total of 720 CGM glucose readings, 120 matched -paired glucose readings by CGM –-GG, and 37 episodes were hyperglycaemia by GG. The MARD was 10.76 %; the percentages of glucose readings within 15%/15 mg/dL, 20%/20 mg/dL, and 30%/30 mg/dL were 94.6%, 97.3% and 100% during the hyperglycaemia period. The sensitivity, specificity, PPV and NPV to detect hyperglycaaemia by CGM device were 100%, 93.9%, 88% and 100 % respectively. In Clarke Error Grid Analysis, 97.3 % points were in zone A and B during the hyperglycaemia period.
Conclusion: CGM device can be a clinically reliable tool for hyperglycaemia management during postoperative period in neonates.
What is Known: • Neonates are vulnerable for hyperglycaemia during post-operative period and bed side glucometers are used for frequent glucose monitoring in them. • Continuous glucose monitor(CGM) devices are used for the glucose monitoring in adult and paediatric diabetes care. | |
What is New: • For the first time, this study analysed the accuracy and clinical reliability of FreeStyle Libre (CGM device) for identifying hyperglycaemia during post-operative period in neonates. • CGM device has very good accuracy for detecting hyperglycaemia in neonates, it may help the clinician for better glucose stability during post-operative period. |
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The data that support the findings of this study are available and can be provided by the corresponding author, based upon reasonable request.
References
Arsenault D, Brenn M, Kim S, Gura K, Compher C, Simpser E (2012) American Society for Parenteral and Enteral Nutrition Board of Directors, Puder M. A.S.P.E.N. Clinical Guidelines: hyperglycemia and hypoglycemia in the neonate receiving parenteral nutrition. JPEN J Parenter Enteral Nutr 36(1):81–95. https://doi.org/10.1177/0148607111418980
Funtanilla VD, Candidate P, Caliendo T, Hilas O (2019) Continuous glucose monitoring: a review of available systems. P T 44(9):550–553
Wu Y, Pei J, Yang XD, Cheng ZD, Zhao YY, Xiang B (2013) Hyperglycemia and its association with clinical outcomes for patients in the pediatric intensive care unit after abdominal surgery. J Pediatr Surg 48(4):801–805. https://doi.org/10.1016/j.jpedsurg.2012.10.003
Bischoff AR, Grass B, Fan CS, Tomlinson C, Lee KS (2021) Risk factors for postoperative hyperglycemia in neonates. J Neonatal Perinatal Med 14(2):183–191. https://doi.org/10.3233/NPM-200535
Wasiq MA, Behura SS, Sahoo S, Panda SK (2022) Comparison of continuous real time blood glucose measurement with venous laboratory blood glucose level in neonates during perioperative period. Indian Pediatr 59(8):620–622
Bailey T, Bode BW, Christiansen MP, Klaff LJ, Alva S (2015) The performance and usability of a factory-calibrated flash glucose monitoring system. Diabetes Technol Ther 17(11):787–794. https://doi.org/10.1089/dia.2014.0378
Şimşek DG, Ecevit A, Hatipoğlu N, Çoban A, Arısoy AE, Baş F, Mutlu GY, Bideci A, Özek E (2018) Neonatal hyperglycemia, which threshold value, diagnostic approach and treatment? Turkish Neonatal and Pediatric Endocrinology and Diabetes Societies consensus report. Turk Pediatri Ars 53(Suppl 1):S234–S238. https://doi.org/10.5152/TurkPediatriArs.2018.01821
Nishimura E, Oka S, Ozawa J, Tanaka K, Momose T, Kabe K, Namba F (2021) Safety and feasibility of a factory-calibrated continuous glucose monitoring system in term and near-term infants at risk of hypoglycemia. Turk Arch Pediatr 56(2):115–120. https://doi.org/10.5152/TurkArchPediatr.2020.20183
Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH et al (2017) International consensus on use of continuous glucose monitoring. Diabetes Care 40(12):1631–1640. https://doi.org/10.2337/dc17-1600
Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL (1987) Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care 10(5):622–628. https://doi.org/10.2337/diacare.10.5.622
Parkes JL, Slatin SL, Pardo S, Ginsberg BH (2000) A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 23(8):1143–1148. https://doi.org/10.2337/diacare.23.8.1143
Mondal H (2021) Clarke Error Grid Analysis Template, figshare. Online resource. https://doi.org/10.6084/m9.figshare.17166620.v1
Beardsall K, Thomson L, Elleri D et al (2020) Feasibility of automated insulin delivery guided by continuous glucose monitoring in preterm infants. Arch Dis Child Fetal Neonatal Ed 105:279–284. https://doi.org/10.1136/archdischild-2019-316871
Nava C, Modiano Hedenmalm A, Borys F, Hooft L, Bruschettini M, Jenniskens K (2020) Accuracy of continuous glucose monitoring in preterm infants: a systematic review and meta-analysis. BMJ Open 10(12):e045335. https://doi.org/10.1136/bmjopen-2020-045335
Iglesias Platas I, Thio Lluch M, Pociello Alminana N et al (2009) Continuous glucose monitoring in infants of very low birth weight. Neonatology 95:217–223. https://doi.org/10.1159/000165980
Tomotaki S, Toyoshima K, Shimokaze T et al (2019) Reliability of real-time continuous glucose monitoring in infants. Pediatr Int 61:1001–1006. https://doi.org/10.1111/ped.13961
Galderisi A, Bruschettini M, Russo C et al (2020) Continuous glucose monitoring for the prevention of morbidity and mortality in preterm infants. Cochrane Database Syst Rev 2020:2. https://doi.org/10.1002/14651858
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S. K. P.: conceptualization, critical inputs to manuscript writing and supervision; M. A. W.: principal investigator, data collection and writing manuscript; S. S. B.: analysis and vital inputs to manuscript writing; S. S.: data collection and manuscript writing. All authors approved the final version of the manuscript and are accountable for all aspects related to the study.
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The Institutional Ethics Committee of the Kalinga Institute of Medical Sciences, KIIT University, has approved the study (KIMS/KIIT/IEC/799/2022). The patient identity is not exposed in this study; hence, individual patient consent was not taken for publication.
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Communicated by Daniele De Luca
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Wasiq, M.A., Behura, S.S., Sahoo, S. et al. Accuracy to detect neonatal hyperglycaemia using real-time continuous glucose monitoring during postoperative period. Eur J Pediatr 182, 1083–1087 (2023). https://doi.org/10.1007/s00431-022-04777-1
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DOI: https://doi.org/10.1007/s00431-022-04777-1