Continuous Glucose Monitoring in Infants

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

Study Overview

• Status: Recruiting
• Conditions: Neonatal Hypoglycemia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Valentina Stanley, BS; Phone Number: (858) 249-5985; Email: vstanley@health.ucsd.edu
• Study Contact Backup: Name: Jane Kim, MD; Phone Number: (858) 966-4032

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • Ucsd Medical Center
      • Contact: Valentina Stanley, BS; Phone Number: 858-966-4032; Email: vstanley@health.ucsd.edu
      • Contact: Jane Kim, MD; Phone Number: 858-966-4032

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 hours (Child)
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Jane Kim, MD, University of California San Diego/Rady Children's Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: 191263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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