Continuous Glucose Monitoring in Neonatal Hyperinsulinism

MemorialCare Health System

Status: Terminated

Conditions: Hyperinsulinism; Hypoglycemia Neonatal

Treatments: Device: Dexcom G6 continuous glucose monitor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06363929

341-23

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 24 hours to 3 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1 participants in 1 patient group

Neonates with hyperinsulinism

Description:

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

Treatment:

Device: Dexcom G6 continuous glucose monitor