Hyperinsulinism, Hypoglycemia Neonatal
Conditions
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.
Interventions
Dexcom G6 continuous glucose monitor to be placed on neonates with hyperinsulinism for 10 days.
Sponsors
DexCom, Inc.
MemorialCare Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
24 Hours to 3 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute relative difference (MARD) | Through study completion, about 2 years | Mean absolute relative difference (MARD) between Dexcom G6 glucoses and point of care blood or plasma glucoses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute difference (MAD) | Through study completion, about 2 years | 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. |
Countries
United States
Outcome results
None listed