TerminatedNot Applicable

Continuous Glucose Monitoring in Neonatal Hyperinsulinism

Stopped: Principal investigator is leaving the study.

United States1 participantsStarted 2023-06-01

Plain-language 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.

Who can participate

Age range24 Hours – 3 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean absolute relative difference (MARD)

Timeframe: Through study completion, about 2 years

Trial details

NCT IDNCT06363929

SponsorMemorialCare Health System

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-22

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