Continuous Glucose Monitoring in Neonatal Hyperinsulinism

MemorialCare Health System1 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hyperinsulinism Hypoglycemia Neonatal

Interventions

Dexcom G6 continuous glucose monitorDEVICE

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

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean absolute relative difference (MARD)

Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses.

Time frame: Through study completion, about 2 years

Secondary Outcomes

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.