Continuous Glucose Monitoring in Neonatal Hyperinsulinism

NCT ID: NCT06363929

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperinsulinism Hypoglycemia Neonatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neonates with hyperinsulinism

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

Dexcom G6 continuous glucose monitor

Intervention Type DEVICE

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

Interventions

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Dexcom G6 continuous glucose monitor

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

24 Hours

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role collaborator

MemorialCare Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin L Okawa, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Health Services

Locations

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Miller Children's Hospital

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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341-23

Identifier Type: -

Identifier Source: org_study_id

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