NCT06363929

Continuous Glucose Monitoring in Neonatal Hyperinsulinism

A Study to Evaluate the Accuracy of Continuous Glucose Monitors in Neonates With Hyperinsulinism.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: MemorialCare Health System · Academic / Other
• Sex: All
• Age: 24 Hours – 3 Months
• Healthy volunteers: Accepted

Summary

The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly.

Conditions

• Hyperinsulinism
• Hypoglycemia Neonatal

Interventions

Type	Name	Description
DEVICE	Dexcom G6 continuous glucose monitor	Dexcom G6 continuous glucose monitor to be placed on neonates with hyperinsulinism for 10 days.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-09-22
• Completion: 2025-09-22
• First posted: 2024-04-12
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study