Continuous blood glucose measurement in neonates

Phase 2

• Conditions: /A

• Registration Number: JPRN-jRCTs042180045
• Lead Sponsor: Ohishi Akira

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-08
• Study Completion: 2022-02-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of continuous blood glucose monitoring device in neonate

Secondary Outcome Measures

Name	Time	Method
Accuracy of continuous blood glucose monitoring device in neonate