Continuous Glucose Monitoring in At-Risk Newborns

Launched by MILTON S. HERSHEY MEDICAL CENTER · May 9, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor blood sugar levels in newborns who are at risk for a condition called hypoglycemia, which means low blood sugar. Newborns who might be eligible for this study include those born to diabetic mothers, babies who are either larger or smaller than expected for their age, and late preterm infants. The trial aims to see if a special device called a continuous glucose monitor (CGM) can safely and accurately track blood sugar levels with less discomfort than the usual method, which requires several painful needle pricks.

If a baby is enrolled in the study, a small sensor will be placed on their thigh to continuously check their blood sugar levels for up to seven days. During this time, the baby will still receive the standard care, which includes regular blood sugar checks and treatments if needed. Parents will also be asked to share their thoughts about using the CGM device once it's removed. The trial is designed to improve the way we monitor blood sugar in newborns and reduce the pain associated with frequent needle sticks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * At-risk newborns (\<48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria:
• • 1. Infant of a diabetic mother (IDM, pre-existing or gestational diabetes)
• • 2. Large for gestational age (LGA, \>90th percentile \[sex-specific\])
• • 3. Small for gestational age (SGA, \<10th percentile \[sex-specific\])
• • 4. Late preterm (LPT, 34 0/7 to 36 6/7 weeks' gestation)
• • Any newborn undergoing routine blood glucose screening in the newborn nursery per the Neonatal Hypoglycemia protocol (includes newborns of mothers taking oral hypoglycemic agents, beta-blocker medications, or systemic steroids within 7 days before delivery; and newborns with clinical manifestations of hypoglycemia)
• Exclusion Criteria:
• • Birth weight \<2kg
• • hypoxic-ischemic encephalopathy
• • a contraindication to oral feeding
• • abnormal skin that will preclude placement of the CGM (e.g., skin on the thigh that is not intact)
• • chromosomal abnormalities or severe congenital anomalies identified ante- or postnatally
• • infants who are not expected to survive or who are in extremis
• * additional risk of immunocompromise, including:
• • 1. Skin infections, such as staphylococcus or streptococcus skin infections and herpes (skin, eye, and mouth disease) infection
• • 2. Skin diseases that add additional risk, such as epidermolysis bullosa, ichthyosis, peeling skin syndrome, and hemangiomas
• • 3. Systemic sepsis, viral syndromes
• • 4. Immune diseases such as severe combined immunodeficiency, cancer, T-cell or B-cell deficiencies, inborn errors of metabolism, chromosomal abnormalities, glycogen storage diseases, genetic diseases
• • 5. Abdominal wall defects