Continuous Glucose Monitoring in Infants

• ClinicalTrials.gov Identifier: NCT04458649
• Recruitment Status: Recruiting
• First Posted: July 7, 2020
• Last Update Posted: November 4, 2020
• Sponsor: University of California, San Diego
• 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
• 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 *

• Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063. Review.
• Adamkin DH. Neonatal hypoglycemia. Curr Opin Pediatr. 2016 Apr;28(2):150-5. doi: 10.1097/MOP.0000000000000319. Review.
• Straussman S, Levitsky LL. Neonatal hypoglycemia. Curr Opin Endocrinol Diabetes Obes. 2010 Feb;17(1):20-4. doi: 10.1097/MED.0b013e328334f061. Review.

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

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