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NCT04458649 Clinical Trial

Continuous Glucose Monitoring in Infants

Neonatal Hypoglycemia Clinical Trial

Official title:
Continuous Glucose Monitoring in Infants

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04458649
Other study ID # 191263
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date September 30, 2024

Study information
Verified date May 2023
Source University of California, San Diego
Contact Valentina Stanley, BS
Phone (858) 249-5985
Email vstanley@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.

Description:

We will place a continuous glucose monitor on the infant within 2 hours of birth and record blood glucose values every 5 minutes via the monitor; in addition, the infant will receive blood glucose checks via heel stick according to the standard hospital glucose monitoring protocol.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Hour to 2 Hours
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dexcom continuous glucose monitor
Measurement of interstitial glucose

Locations
Country Name City State
United States UCSD Medical Center La Jolla California

Sponsors (2)
Lead Sponsor Collaborator
University of California, San Diego DexCom, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Adamkin DH. Neonatal hypoglycemia. Curr Opin Pediatr. 2016 Apr;28(2):150-5. doi: 10.1097/MOP.0000000000000319. — View Citation

Straussman S, Levitsky LL. Neonatal hypoglycemia. Curr Opin Endocrinol Diabetes Obes. 2010 Feb;17(1):20-4. doi: 10.1097/MED.0b013e328334f061. — View Citation

Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time spent with glucose <40 mg/dL The Dexcom continuous glucose monitors measure interstitial fluid glucose values every 5 minutes. Data obtained from the Dexcom tracings will allow us to quantify how much time both infants with no risk for hypoglycemia (defined here as <40 mg/dL) and those with risk factors for hypoglycemia spend at a blood glucose of <40 mg/dL. The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal.
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