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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hypoglycemia
• Neonatal Hypoglycemia

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.