Using continuous glucose monitoring to help at-risk newborns

Continuous Glucose Monitoring in At-Risk Newborns: A Feasibility Study

This study is testing if a small sensor that continuously checks blood sugar levels can help at-risk newborns, like those born to diabetic mothers, avoid painful needle tests and improve their care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 1 Minute to 2 Weeks
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Locations: 1 site (Hershey, Pennsylvania)
• Trial ID: NCT04386005 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility, safety, and precision of continuous glucose monitoring (CGM) in at-risk newborns, such as those born to diabetic mothers or with abnormal growth patterns. By using a small sensor placed in the thigh, the study aims to reduce the number of painful needle sticks required for blood glucose testing while providing continuous glucose level data. The goal is to determine if CGM can decrease missed episodes of hypoglycemia and improve overall care for these vulnerable infants.

Who should consider this trial

Good fit: Ideal candidates include at-risk newborns under 48 hours old, such as infants of diabetic mothers, large or small for gestational age infants, and late preterm infants.

Not a fit: Patients who may not benefit include those with birth weights under 2kg or those with conditions like hypoxic-ischemic encephalopathy.

Why it matters

Potential benefit: If successful, this approach could significantly reduce pain and improve monitoring of blood glucose levels in at-risk newborns.

How similar studies have performed: While continuous glucose monitoring is widely used in other populations, this specific application in newborns is novel and has not been extensively tested.

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

Where this trial is running

Hershey, Pennsylvania

• Penn State Health Milton S Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Jeffrey R. Kaiser, MD, MA — Penn State Health Milton S Hershey Medical Center
• Study coordinator: Jeffrey R. Kaiser, MD, MA

Conditions Neonatal Hypoglycemia; blood glucose; continuous glucose monitor