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Continuous blood glucose measurement in neonates (Continuous blood glucose measurement in neonates)

Continuous blood glucose measurement in neonates (Continuous blood glucose measurement in neonates)

20

Baseline Characteristics Total included case: 20. Female 6 : Male 14. Gestational age ; 38.1+-0.9 weeks, Birth weight 2987.3+-295.6 g. Normal vaginal delivery; 7, Caesarean section; 13.

Participant flow Enrollment was somewhat poor, with consent obtained in 27 cases. The number of enrolled and conducted cases was 20, of which 18 were terminated. The study was terminated in 2 cases, one due to worsening respiratory status and the other due to the development of hypoglycemia.

Adverse events The total number of events was 3 (all minor). There were four cases of induration of the puncture site, one case of erythema of the puncture site, and one case of micro subcutaneous hemorrhage of the avulsion site.

<Primary outcome> It was safely installed except for minor and reversible side reactions. <Secondary outcome> There was a good correlation between scan values and blood glucose values.

For term neonates, the Libre was safely placed immediately after birth and up to 6 hours. Only slight induration and redness at the sensor puncture site were observed, which resolved spontaneously. Bland-Altmann Analysis and Clarke Error Grid studies showed good correlation between blood glucose levels and libre scan data. It was clarified that the scan value fluctuated and dissociated after the blood sugar level during the phases of rapid blood sugar drop and rise.

Mar. 31, 2023

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs042180045

Ohishi Akira

Hamamatsu University School of Medicine

1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka

a-ohishi@hama-med.ac.jp

Ohishi Akira

Hamamatsu University School of Medicine

1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka

+81-53-435-2312

a-ohishi@hama-med.ac.jp

Complete

May. 11, 2018

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

A pregnant woman scheduled to deliver at the Hamamatsu School of Medicine's perinatal maternal and child centers, who got consent from a custodial person in advance and who is born at 37 to 47 weeks of gestation and has no complications in particular

Neonate with inborn diagnosis of congenital anomaly
Neonate who entered the neonatal intensive care unit due to premature birth or complications
Infants judged inappropriate by doctor's judgment

Both

N/A

Attach a continuous blood glucose monitoring device to the thigh of a newborn baby,soon after birth for 6 hours.

Safety of continuous blood glucose monitoring device in neonate

Accuracy of continuous blood glucose monitoring device in neonate

+81-53-435-2680

Jan. 18, 2019

Not applicable