Continuous Glucose Monitoring in Neonatal Hyperinsulinism

Launched by MEMORIALCARE HEALTH SYSTEM · Apr 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well the Dexcom G6 continuous glucose monitor works in babies with a condition called hyperinsulinism, which can cause dangerously low blood sugar levels. The trial is taking place at Miller Children's Hospital Neonatal Intensive Care Unit. Babies who are between 0 and 90 days old and have been diagnosed with hyperinsulinism will wear the glucose monitor on their thigh for 10 days. During this time, doctors will regularly check the babies' blood sugar levels using a standard blood test to see how accurate the monitor is. If the monitor alerts for low blood sugar, the doctors will confirm it with a blood test and provide treatment if necessary.

To be eligible for this study, babies must be older than 28 weeks gestational age and diagnosed with hyperinsulinism. However, some babies won't be able to participate, such as those with certain skin conditions or infections, those who are expected to leave the NICU soon, or those in other competing studies. Families of eligible babies can expect close monitoring and support during the trial, helping researchers learn more about managing blood sugar levels in newborns with this condition.

Gender

ALL

Eligibility 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