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Neonates with hyperinsulinism for Hyperinsulinemia

N/A
Recruiting
Research Sponsored by MemorialCare Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, about 2 years
Awards & highlights

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.

Eligible Conditions
  • Hyperinsulinemia
  • Neonatal Hypoglycemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, about 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, about 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean absolute relative difference (MARD)
Secondary outcome measures
Mean absolute difference (MAD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neonates with hyperinsulinismExperimental Treatment1 Intervention
Neonates with a diagnosis of hyperinsulinism will wear a Dexcom G6 continuous glucose monitor placed for 10 days.

Find a Location

Who is running the clinical trial?

MemorialCare Health SystemLead Sponsor
20 Previous Clinical Trials
2,540 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
137 Previous Clinical Trials
29,830 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Continuous Glucose Monitoring in Neonatal Hyperinsulinism
2023. "Continuous Glucose Monitoring in Neonatal Hyperinsulinism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06363929.
All > Anaheim > Paid Studies Ventura
~8 spots leftby Jun 2025
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