Continuous Glucose Monitoring in Infants

NCT04458649 | Recruiting FDA Device

• 1 other identifier: 191263
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neonatal Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

No increased risk of hypoglycemia

Infants born with no obvious risk factors for hypoglycemia in the neonatal period.

Device: Dexcom continuous glucose monitor

Increased risk of hypoglycemia

Infants considered at increased risk for hypoglycemia after birth including the following criteria: * Infant born to a diabetic mother * Very large for gestational age (VLGA) infant with weight \>97%

Device: Dexcom continuous glucose monitor

Interventions

Dexcom continuous glucose monitor DEVICE

Measurement of interstitial glucose

Increased risk of hypoglycemia; No increased risk of hypoglycemia

Eligibility Criteria

• Age: 1 Hour - 2 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• DexCom, Inc.: collaborator

Study Sites (1)

UCSD Medical Center

La Jolla, California, 92037, United States

RECRUITING

Related Publications (3)

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

  PMID: 28364046 BACKGROUND

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

  PMID: 26780301 BACKGROUND

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

  PMID: 19952738 BACKGROUND

Study Officials

• Jane Kim, MD

  University of California San Diego/Rady Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Stanley, BS

CONTACT

(858) 249-5985; vstanley@health.ucsd.edu

Jane Kim, MD

CONTACT

(858) 966-4032

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)