Monitoring glucose levels in newborns using continuous devices
Continuous Glucose Monitoring in Infants
This study tests if using a continuous glucose monitor can help keep track of blood sugar levels in newborns at risk for low blood sugar right after they are born.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 1 Hour to 2 Hours |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT04458649 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize continuous glucose monitoring technology to track glucose levels in newborn infants. Within two hours of birth, a continuous glucose monitor will be placed on the infant to record blood glucose values every five minutes. Additionally, standard heel stick blood glucose checks will be performed according to hospital protocols to ensure accurate monitoring. The goal is to better understand glucose profiles in infants at risk for neonatal hypoglycemia.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born appropriate for gestational age or large for gestational age, whose mothers are at least 18 years old.
Not a fit: Patients who may not benefit from this study include those born small for gestational age, with low birth weight, or those born before 38 weeks of gestation.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of glucose levels in newborns, reducing the risk of complications associated with neonatal hypoglycemia.
How similar studies have performed: Other studies utilizing continuous glucose monitoring in similar populations have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mother at least 18 years of age * Infants born either appropriate for gestational age (AGA) or large for gestational age (LGA) * Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin calipers Exclusion Criteria: * Infants born small for gestational age (SGA) * Infant birth weight \<2.5 kg * Infant BMI \<10th percentile on Olsen chart * Infants born \<38 weeks gestation * Infants with concern for intrauterine growth restriction (IUGR) and short femur length based on ultrasound * Mother is non-English speaking
Where this trial is running
La Jolla, California
- UCSD Medical Center — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Jane Kim, MD — University of California San Diego/Rady Children's Hospital
- Study coordinator: Valentina Stanley, BS
- Email: vstanley@health.ucsd.edu
- Phone: (858) 249-5985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.