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Continuous Glucose Monitoring for Neonatal Hypoglycemia
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
Must not have
Birth weight <2kg
Systemic sepsis, viral syndromes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 times per day for 1-7 days
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My birth weight was under 2kg.
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I do not have an ongoing infection or viral illness.
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My skin is healthy enough for medical device placement.
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I have a skin condition that could increase my risk, like severe blistering or peeling.
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I have a genetic or immune disease like severe immunodeficiency or a metabolic error.
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I have a skin infection like staph, strep, or herpes.
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I have a defect in my abdominal wall.
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My child has been diagnosed with a genetic disorder or severe birth defect.
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I have been diagnosed with brain damage due to lack of oxygen.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
Number of participants with adverse outcomes at the device site
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Continuous Glucose MonitoringExperimental Treatment1 Intervention
All participants will have the continuous glucose monitoring device placed.
Find a Location
Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
510 Previous Clinical Trials
2,796,374 Total Patients Enrolled
Children's Miracle NetworkOTHER
22 Previous Clinical Trials
1,689 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
144 Previous Clinical Trials
35,385 Total Patients Enrolled
2 Trials studying Neonatal Hypoglycemia
215 Patients Enrolled for Neonatal Hypoglycemia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My newborn is at risk and admitted to the nursery or NICU.You were born smaller than most babies.My skin is healthy enough for medical device placement.I have a skin condition that could increase my risk, like severe blistering or peeling.You were born prematurely between 34 to 36 weeks of pregnancy.I do not have an ongoing infection or viral illness.My newborn is being screened for low blood sugar as per the hospital's protocol.My birth weight was under 2kg.I have a genetic or immune disease like severe immunodeficiency or a metabolic error.You are unable to eat or drink normally.You were born to a mother with diabetes.The baby is bigger than most other babies at the same stage of development.I have a skin infection like staph, strep, or herpes.I have a defect in my abdominal wall.This criterion refers to people who have an increased risk of having a weakened immune system.My child has been diagnosed with a genetic disorder or severe birth defect.I have been diagnosed with brain damage due to lack of oxygen.Babies who are not expected to survive or are very sick.
Research Study Groups:
This trial has the following groups:- Group 1: Continuous Glucose Monitoring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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