We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Continuous Glucose Monitoring in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458649
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : May 15, 2023
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Dr Jane Kim, University of California, San Diego

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.

Condition or disease Intervention/treatment
Neonatal Hypoglycemia Device: Dexcom continuous glucose monitor

Detailed 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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Glucose Monitoring in Infants
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Dextrose

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
No increased risk of hypoglycemia
Infants born with no obvious risk factors for hypoglycemia in the neonatal period.
 Device: Dexcom continuous glucose monitor
Measurement of interstitial glucose
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
Measurement of interstitial glucose


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time spent with glucose <40 mg/dL [ Time Frame: 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. ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Hour to 2 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458649


Contacts
Layout table for location contacts
Contact: Valentina Stanley, BS (858) 249-5985 vstanley@health.ucsd.edu
Contact: Jane Kim, MD (858) 966-4032

Locations
Layout table for location information
United States, California
UCSD Medical Center Recruiting
La Jolla, California, United States, 92037
Contact: Valentina Stanley, BS    858-966-4032    vstanley@health.ucsd.edu   
Contact: Jane Kim, MD    858-966-4032      
Sponsors and Collaborators
University of California, San Diego
DexCom, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jane Kim, MD University of California San Diego/Rady Children's Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Dr Jane Kim, Professor of Pediatrics, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04458649    
Other Study ID Numbers: 191263
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases