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Continuous Glucose Monitoring for Neonatal Hypoglycemia

Q: Am I eligible to be a participant in this clinical research?

This research project is searching for up to 100 participants aged between one minute and two weeks who present with hypoglycemia. In addition, prospective patients must be classified as late preterm (34 0/7 to 36 6/7 weeks' gestation) or a newborn undergoing routine blood glucose screening per the Neonatal Hypoglycemia protocol (e.g., if mother has been taking oral hypoglycemic agents, beta-blockers, or systemic steroids in the week before delivery).

Q: Is this research endeavor still recruiting participants?

As reported on clinicaltrials.gov, recruitment for this medicinal trial is in progress. The original listing of the study was dated August 9th 2021 with a recent update to its details occurring June 1st 2022.

Q: Does the age restriction for this research trial extend beyond 45 years of age?

This clinical trial is designated for those between 1 minute and 2 weeks of age. There are 13 studies targeting patients under 18 years old, while 59 trials cater to persons over 65 years old.

Q: What is the upper limit for participants in this experiment?

Affirmative. According to clinicaltrials.gov, this experiment is in the process of locating suitable participants; it was first posted on August 9th 2021 and most recently updated on June 1st 2022. 100 individuals from one location are needed for enrollment purposes.

N/A

Recruiting

Led By Jeffrey R. Kaiser, MD, MA

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 times per day for 1-7 days

Awards & highlights

Study Summary

This trial will test the feasibility, safety, and precision of a continuous glucose monitor in at-risk newborns to see if it decreases the amount of painful procedures and episodes of hypoglycemia missed by intermittent sampling.

Who is the study for?

This trial is for newborns under 48 hours old who are at risk of low blood sugar and admitted to the Newborn Nursery or NICU. This includes babies born to diabetic mothers, those larger or smaller than average for their gestational age, late preterm infants, or any undergoing routine glucose screening. Babies with certain skin diseases, immune disorders, severe congenital anomalies, very low birth weight (<2kg), systemic infections, or in critical condition cannot participate.Check my eligibility

What is being tested?

The study tests a Continuous Glucose Monitoring Device (Dexcom G7) placed on the thigh of at-risk newborns to continuously record glucose levels. It aims to reduce pain from frequent heel sticks used in current standard care and improve detection of hypoglycemia. The device will be worn up to 7 days alongside regular medical care procedures.See study design

What are the potential side effects?

Potential side effects include irritation, infection, bleeding at the site where the CGM device is attached. These will be monitored by nurses multiple times daily for safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 times per day for 1-7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 times per day for 1-7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 times per day for 1-7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Agreement of blood glucose concentrations from CGM vs intermittent monitoring

Difference in number of episodes of hypoglycemia diagnosed with CGM vs intermittent glucose monitoring

Difference in number of needle sticks with CGM vs intermittent glucose monitoring

+1 more

Secondary outcome measures

Number of participants with adverse outcomes at the device site

Trial Design

1Treatment groups

Experimental Treatment

Group I: Continuous Glucose MonitoringExperimental Treatment1 Intervention

All participants will have the continuous glucose monitoring device placed.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

495 Previous Clinical Trials

2,798,774 Total Patients Enrolled

Children's Miracle NetworkOTHER

22 Previous Clinical Trials

1,739 Total Patients Enrolled

DexCom, Inc.Industry Sponsor

137 Previous Clinical Trials

29,745 Total Patients Enrolled

2 Trials studying Neonatal Hypoglycemia

215 Patients Enrolled for Neonatal Hypoglycemia

Media Library

Continuous Glucose Monitoring Device Clinical Trial Eligibility Overview. Trial Name: NCT04386005 — N/A

Neonatal Hypoglycemia Research Study Groups: Continuous Glucose Monitoring

Neonatal Hypoglycemia Clinical Trial 2023: Continuous Glucose Monitoring Device Highlights & Side Effects. Trial Name: NCT04386005 — N/A

Continuous Glucose Monitoring Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT04386005 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be a participant in this clinical research?

"This research project is searching for up to 100 participants aged between one minute and two weeks who present with hypoglycemia. In addition, prospective patients must be classified as late preterm (34 0/7 to 36 6/7 weeks' gestation) or a newborn undergoing routine blood glucose screening per the Neonatal Hypoglycemia protocol (e.g., if mother has been taking oral hypoglycemic agents, beta-blockers, or systemic steroids in the week before delivery)."

Answered by AI

Is this research endeavor still recruiting participants?

"As reported on clinicaltrials.gov, recruitment for this medicinal trial is in progress. The original listing of the study was dated August 9th 2021 with a recent update to its details occurring June 1st 2022."

Answered by AI

Does the age restriction for this research trial extend beyond 45 years of age?

"This clinical trial is designated for those between 1 minute and 2 weeks of age. There are 13 studies targeting patients under 18 years old, while 59 trials cater to persons over 65 years old."

Answered by AI

What is the upper limit for participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is in the process of locating suitable participants; it was first posted on August 9th 2021 and most recently updated on June 1st 2022. 100 individuals from one location are needed for enrollment purposes."

Answered by AI

Recent research and studies

PediatricsJournal

Postnatal Glucose Homeostasis in Late-preterm and Term Infants

Adamkin, David H., and Committee on Fetus and Newborn. 2011. “Postnatal Glucose Homeostasis in Late-preterm and Term Infants”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2010-3851.

JAMA PediatricsJournal

Association Between Transient Newborn Hypoglycemia and Fourth-grade Achievement Test Proficiency

Kaiser, Jeffrey R., Shasha Bai, Neal Gibson, Greg Holland, Tsai Mei Lin, Christopher J. Swearingen, Jennifer K. Mehl, and Nahed O. ElHassan. 2015. “Association Between Transient Newborn Hypoglycemia and Fourth-grade Achievement Test Proficiency”. JAMA Pediatrics. American Medical Association (AMA). doi:10.1001/jamapediatrics.2015.1631.

Plos OneJournal

Real-time Continuous Glucose Monitoring Reduces the Duration of Hypoglycemia Episodes: A Randomized Trial in Very Low Birth Weight Neonates

Uettwiller, Florence, Aude Chemin, Elisabeth Bonnemaison, Géraldine Favrais, Elie Saliba, and François Labarthe. 2015. “Real-time Continuous Glucose Monitoring Reduces the Duration of Hypoglycemia Episodes: A Randomized Trial in Very Low Birth Weight Neonates”. Edited by Martin Chalumeau. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0116255.

Acta PaediatricaJournal