An observational study in Hyperinsulinism and Hypoglycemia Neonatal, sponsored by MemorialCare Health System. Terminated at 1 site in United States. Open to participants aged 24 Hours to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by MemorialCare Health System · Observational
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.
112 studies on the registry are indexed under Hyperinsulinism; 24 are open to participants now.
This study's enrollment of 1 is below the median of 90 across 18 observational studies indexed under Hyperinsulinism.
Browse Hyperinsulinism studies →MemorialCare Health System is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
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Neonates with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit
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Exclusion Criteria:
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.
Mean absolute relative difference (MARD)
Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses.
Time frame: Through study completion, about 2 years
Mean absolute difference (MAD)
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.
Time frame: Through study completion, about 2 years
Ran from Jun 2023 to primary completion in Sep 2025, 27 months.
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This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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MemorialCare Health System