Continuous Glucose Monitoring in Neonatal Hyperinsulinism

Last updated: September 26, 2025
Sponsor: MemorialCare Health System
Overall Status: Terminated

Phase

N/A

Condition

Hormone Deficiencies

Diabetes (Pediatric)

Primary Insulin Hypersecretion

Treatment

Dexcom G6 continuous glucose monitor

Clinical Study ID

NCT06363929
341-23
  • Ages 24-3
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Diffuse skin disease such that placement of a Dexcom G6 sensor would be difficult tosecure

  • 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 technologicalsupport

  • Ward of the state

Study Design

Total Participants: 1
Treatment Group(s): 1
Primary Treatment: Dexcom G6 continuous glucose monitor
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
September 22, 2025

Connect with a study center

  • Miller Children's Hospital

    Long Beach, California 90806
    United States

    Site Not Available

  • Miller Children's Hospital

    Long Beach 5367929, California 5332921 90806
    United States

    Site Not Available

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