Safety and feasibility of a factory-calibrated continuous glucose monitoring system in term and near-term infants at risk of hypoglycemia

Nishimura, Eri; Oka, Shuntaro; Ozawa, Junichi; Tanaka, Kosuke; Momose, Taichi; Kabe, Kazuhiko; Namba, Fumihiko

doi:10.5152/turkarchpediatr.2020.20183

Cited by 4 publications

(3 citation statements)

References 30 publications

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“…In a similar study of at-risk neonates by Nishimura et al, the accuracy of CGM devices was analyzed separately for the period within 3 h after birth and later, and they assumed that poor CGM accuracy due to sensor instability led to large dissociations within 3 h after birth. 16 In contrast, we performed hourly CGM scanning and blood-sample readings, and found that the CGM values tended to be low at 120 min and high at 60 min after birth compared to the blood sampling values. This suggests that the dissociation of CGM and blood sampling values observed in early post-natal period was caused by rapid changes in blood glucose which were not reflected in interstitial concentration, and not by sensor instability.…”

Section: Strengthsmentioning

confidence: 87%

“…In a similar study of at‐risk neonates by Nishimura et al, the accuracy of CGM devices was analyzed separately for the period within 3 h after birth and later, and they assumed that poor CGM accuracy due to sensor instability led to large dissociations within 3 h after birth 16 . In contrast, we performed hourly CGM scanning and blood‐sample readings, and found that the CGM values tended to be low at 120 min and high at 60 min after birth compared to the blood sampling values.…”

Section: Discussionmentioning

confidence: 99%

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Safety and accuracy of neonatal continuous glucose monitoring

Ohishi,

Ueno,

Fujita

et al. 2023

Pediatrics International

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BackgroundHypoglycemia is a significant problem for all neonates and requires minimally invasive and reliable monitoring. The primary objective of this study was to verify the safety and accuracy of the continuous glucose monitoring (CGM) of full‐term neonates using Freestyle Libre, a flash glucose monitoring (FGM) device.MethodsThe study was conducted on 20 neonates. Shortly after birth, we placed the FGM sensor on the outside of the neonates' thighs. We scanned the CGM values at 60, 120, 180, and 360 min after birth and simultaneously obtained blood glucose values with plantar capillaries by heel puncture. The neonates wore the sensors for up to 6 h and then they were removed.ResultsOf the 75 data points to be measured, 65 points (86.7%) were obtained by scan. There was no change in the sensor attachment site in 12 of 18 completed cases in this study but we observed slight induration in four cases (22.2%) and slight redness in one case (5.5%) at the sensor puncture site. A moderate correlation was observed between the CGM and blood glucose values. The CGM values tended to be low at 120, 180, and 360 min after birth, and tended to be high only at 60 min after birth.ConclusionsThe CGM device was safe to wear on the neonate and the CGM data correlated well with blood glucose levels. There was dissociation between CGM data and blood glucose levels in the acute period soon after birth when the blood glucose levels changed rapidly.

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Section: Strengthsmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Safety and accuracy of neonatal continuous glucose monitoring

Ohishi,

Ueno,

Fujita

et al. 2023

Pediatrics International

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“…The accuracy of the FreeStyle Libre® was evaluated in neonates, and the CGM values were significantly higher particularly in the first 3 h post-insertion. However, only 37 pairs of glucose values were available, and the MARD score was not reported ( 47 ). Assuming that the accuracy of factory calibrated CGM systems can be improved and validated for the neonate, they would be preferred, as they would reduce the frequency of blood samples and the workload of the clinical team.…”

Section: What Are the Device Limitations For Use In The Neonate?mentioning

confidence: 99%

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

2023

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The National Institute for Clinical Excellence (NICE) now recommends that continuous glucose monitoring (CGM) be offered to adults and children with diabetes who are at risk from hypoglycaemia. Hypoglycaemia is common in the neonatal period, and is a preventable cause of poor neurodevelopmental outcome, but is CGM helpful in the management of neonates at risk of hypoglycaemia? Neonatal studies have shown that CGM can detect clinically silent hypoglycaemia, which has been associated with reduced executive and visual function in early childhood. Intervention trials have further shown CGM can support the targeting of glucose levels in high-risk extremely preterm neonates. In spite of significant advances in technology, including smaller sensors, better accuracy and factory calibration, further progress and adoption into clinical practice has been limited as current devices are not designed nor have regulatory approval for the specific needs of the newborn. The use of CGM has the potential to support clinical management, and prevention of hypoglycaemia but must be set within its current limitations. The data CGM provides however also provides an important opportunity to improve our understanding of potential risks of hypoglycaemia and the impact of clinical interventions to prevent it.

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