Continuous Glucose Monitoring in Neonatal Hyperinsulinism

Recruiting

• Conditions: Hypoglycemia Neonatal; Hyperinsulinism
• Interventions: Device: Dexcom G6 continuous glucose monitor

• Registration Number: NCT06363929
• Lead Sponsor: MemorialCare Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2023-12-20
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-10
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Age: 0-90 days old
• Gestational Age: > 28 weeks gestational age
• Diagnosis of hyperinsulinism based on critical sample and/or glucagon challenge

Exclusion Criteria

• Diffuse skin disease such that placement of a Dexcom G6 sensor would be difficult to secure
• Infants colonized or infected with multi-drug resistant organisms (i.e. MRSA, VRE, ESBL producing bacteria)
• Infants on hypothermic protocols
• Infants expected to remain in the NICU <24 hours
• Infants enrolled in a competing clinical trial
• Family/team have decided to limit or redirect from aggressive NICU technological support
• Ward of the state

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonates with hyperinsulinism	Dexcom G6 continuous glucose monitor	Neonates with a diagnosis of hyperinsulinism will wear a Dexcom G6 continuous glucose monitor placed for 10 days.

Primary Outcome Measures

Name	Time	Method
Mean absolute relative difference (MARD)	Through study completion, about 2 years	Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses.

Secondary Outcome Measures

Name	Time	Method
Mean absolute difference (MAD)	Through study completion, about 2 years	MAD between Dexcom G6 glucoses and the point of care blood or plasma glucoses and the percentage of Dexcom G6 glucose values within 15 mg/dL, 20 mg/dL and 30 mg/dL of point of care blood or plasma glucose values when they are \<100 mg/dL.

Trial Locations

Locations (1)

Miller Children's Hospital; 🇺🇸 Long Beach, California, United States