Continuous Glucose Monitoring in Neonatal Hyperinsulinism

Hyperinsulinism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363929
• Other study ID #: 341-23
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: MemorialCare Health System
• Contact: Erin Okawa, MD
• Phone: 310-825-6244
• Email: eokawa[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Hours to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Hyperinsulinism
• Hypoglycemia
• Hypoglycemia Neonatal

Intervention

Device:
• Dexcom G6 continuous glucose monitor
Dexcom G6 continuous glucose monitor to be placed on neonates with hyperinsulinism for 10 days.

Locations

Country	Name	City	State
United States	Miller Children's Hospital	Long Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
MemorialCare Health System	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean absolute relative difference (MARD)	Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses.	Through study completion, about 2 years
Secondary	Mean absolute difference (MAD)	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.	Through study completion, about 2 years