Monitoring blood sugar levels in newborns with hyperinsulinism
A Study to Evaluate the Accuracy of Continuous Glucose Monitors in Neonates With Hyperinsulinism.
This study is testing how well a continuous glucose monitor works for tracking blood sugar levels in newborns with hyperinsulinism to help manage their condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 24 Hours to 3 Months |
| Sex | All |
| Sponsor | MemorialCare Health System Academic / other |
| Locations | 1 site (Long Beach, California) |
| Trial ID | NCT06363929 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the accuracy of the Dexcom G6 continuous glucose monitor in infants diagnosed with hyperinsulinism at Miller Children's Hospital Neonatal Intensive Care Unit. Participants will wear the device on their thigh for 10 days, during which blood sugar levels will be monitored both continuously and through glucometer checks. The study aims to correlate the readings from the continuous glucose monitor with those from the glucometer, especially during instances of low blood sugar alarms. This approach seeks to improve the management of blood sugar levels in affected newborns.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 0-90 days with a diagnosis of hyperinsulinism and a gestational age greater than 28 weeks.
Not a fit: Patients who may not benefit from this study include those with severe skin conditions, multi-drug resistant infections, or those expected to stay in the NICU for less than 24 hours.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring and management of blood sugar levels in newborns with hyperinsulinism, leading to better health outcomes.
How similar studies have performed: While continuous glucose monitoring has been explored in other populations, this specific application in neonatal hyperinsulinism is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Long Beach, California
- Miller Children's Hospital — Long Beach, California, United States (Recruiting)
Study contacts
- Study coordinator: Erin Okawa, MD
- Email: eokawa@mednet.ucla.edu
- Phone: 310-825-6244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.