Continuous Glucose Monitoring in Neonatal Hyperinsulinism

September 26, 2025 updated by: MemorialCare Health System

A Study to Evaluate the Accuracy of Continuous Glucose Monitors in Neonates With Hyperinsulinism.

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Miller Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Neonates with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neonates with hyperinsulinism
Neonates with a diagnosis of hyperinsulinism will wear a Dexcom G6 continuous glucose monitor placed for 10 days.
Device: Dexcom G6 continuous glucose monitor
Dexcom G6 continuous glucose monitor to be placed on neonates with hyperinsulinism for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean absolute relative difference (MARD)
Time Frame: Through study completion, about 2 years
Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses.
Through study completion, about 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean absolute difference (MAD)
Time Frame: Through study completion, about 2 years
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.
Through study completion, about 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MemorialCare Health System

Collaborators

DexCom, Inc.

Investigators

  • Principal Investigator: Erin L Okawa, MD, Memorial Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

September 22, 2025

Study Completion (Actual)

September 22, 2025

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 341-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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