CGM Use in Preterm Infants

Study Overview
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Brief Summary
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Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. The low alarm threshold will be set at 60 mg/dL or 80mg/dL (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. A suggestion will be made to the clinical team to draw a blood glucose to correlate with CGM values ≤60 mg/dL and the infant will be treated according to Neonatal Intensive Care Unit (NICU) protocol for corroborating blood glucose levels. Infants will also be monitored per current NICU protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. Clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.

Official Title
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Improving Growth and Neurodevelopmental Outcomes in Preterm Infants Experiencing Hyperglycemia

Conditions
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Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Hyperglycemia

Intervention / Treatment
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* Device: Dexcom G6 sensor Continuous Glucose Monitor (CGM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit written informed consent can be secured from a parent within 96 hours of birth. Exclusion Criteria: Infants born at ≥31 weeks GA infants with a prenatally diagnosed clinical or genetic condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development children experiencing severe birth asphyxia, children enrolled in another nutritional study, children likely to be transferred out of the NICU

Ages Eligible for Study
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Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexcom G6 sensor Continuous Glucose Monitor (CGM)<br>All participants will be assigned to use the continuous glucose monitor | Device: Dexcom G6 sensor Continuous Glucose Monitor (CGM)<br>* The device used as part of the study is to obtain results for glucose testing for research only and not for diagnostic purposes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of hypo- and hyperglycemia - CGM device | Proportion of CGM device readings that match blood glucose readings | 10 days post placement of CGM | 
| Detection of hypo- and hyperglycemia - 60 mg/dL | % time below 60 mg/dL | 10 days post placement of CGM | 
| Detection of hypo- and hyperglycemia - 180 mg/dL | % time above 180 mg/dL | 10 days post placement of CGM | 
| Detection of hypo- and hyperglycemia - AEs | % of infants with adverse events secondary to CGM placement or wear | 10 days post placement of CGM | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous glucose monitor, Neonates, Hyperglycemia, Hypoglycemia, Very low birth weight