Hyperglycemia, Very Low Birth Weight Infant, Very Preterm Maturity of Infant
Conditions
Keywords
Continuous glucose monitor, Neonates, Hyperglycemia, Hypoglycemia, Very low birth weight
Brief summary
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.
Interventions
DEVICEDexcom G6 sensor Continuous Glucose Monitor (CGM)
The device used as part of the study is to obtain results for glucose testing for research only and not for diagnostic purposes.
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of hypo- and hyperglycemia - CGM device | 10 days post placement of CGM | Proportion of CGM device readings that match blood glucose readings |
| Detection of hypo- and hyperglycemia - 60 mg/dL | 10 days post placement of CGM | % time below 60 mg/dL |
| Detection of hypo- and hyperglycemia - 180 mg/dL | 10 days post placement of CGM | % time above 180 mg/dL |
| Detection of hypo- and hyperglycemia - AEs | 10 days post placement of CGM | % of infants with adverse events secondary to CGM placement or wear |
Countries
United States
Outcome results
None listed