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Continuous Glucose Monitoring in Infants

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ClinicalTrials.gov Identifier: NCT04458649
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Dr Jane Kim, University of California, San Diego

Tracking Information
First Submitted Date July 1, 2020
First Posted Date July 7, 2020
Last Update Posted Date November 4, 2020
Actual Study Start Date October 1, 2020
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 2, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Continuous Glucose Monitoring in Infants
Official Title Continuous Glucose Monitoring in Infants
Brief Summary The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care.
Condition Neonatal Hypoglycemia
Intervention Device: Dexcom continuous glucose monitor
Measurement of interstitial glucose
Study Groups/Cohorts
  • No increased risk of hypoglycemia
    Infants born with no obvious risk factors for hypoglycemia in the neonatal period.
    Intervention: 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%
    Intervention: Device: Dexcom continuous glucose monitor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 2, 2020)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2022
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Hours   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Beth Gottesman, MD 858-966-4032 bgottesman@rchsd.org
Contact: Jane Kim, MD 858-966-4032 janekim@health.ucsd.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04458649
Other Study ID Numbers 191263
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr Jane Kim, University of California, San Diego
Study Sponsor University of California, San Diego
Collaborators DexCom, Inc.
Investigators
Principal Investigator: Jane Kim, MD University of California San Diego/Rady Children's Hospital
PRS Account University of California, San Diego
Verification Date November 2020