Continuous Glucose Monitoring in Neonatal Hyperinsulinism

NCT06363929 | Terminated FDA Device

• 1 other identifier: 341-23
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperinsulinism; Hypoglycemia Neonatal

Outcome Measures

Primary Outcomes (1)

• Mean absolute relative difference (MARD)

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

  Through study completion, about 2 years

Secondary Outcomes (1)

• Mean absolute difference (MAD)

  Through study completion, about 2 years

Study Arms (1)

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

Interventions

Dexcom G6 continuous glucose monitor DEVICE

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

Neonates with hyperinsulinism

Eligibility Criteria

• Age: 24 Hours - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age: 0-90 days old
• Gestational Age: \> 28 weeks gestational age
• Diagnosis of hyperinsulinism based on critical sample and/or glucagon challenge

You may not qualify if:

• 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

Sponsors & Collaborators

• MemorialCare Health System: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Miller Children's Hospital

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Hyperinsulinism

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Erin L Okawa, MD

  Memorial Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: April 12, 2024
• Study Start: June 1, 2023
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)