Continuous Glucose Monitoring for Neonatal Hypoglycemia

Overseen By Kerry Deitrick, LPN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Birth weight <2kg, Hypoxic-ischemic encephalopathy, Chromosomal abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores an easier method to monitor blood sugar in newborns at risk of low levels, which can affect their development. Instead of multiple needle sticks throughout the day, a small sensor on the baby's thigh continuously tracks glucose levels using the Dexcom G6 system. The trial aims to determine if this method is safe and effective while reducing pain and missed low blood sugar episodes. Newborns who might qualify include those born to diabetic mothers, those larger or smaller than average for their age, or those born slightly early. Parents of participating newborns will complete a short survey about their experience with this device. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance newborn care.

Will I have to stop taking my current medications?

The trial does not specify whether participants must stop taking their current medications. However, it mentions that newborns of mothers taking certain medications like oral hypoglycemic agents, beta-blockers, or systemic steroids within 7 days before delivery are included in the study.

What prior data suggests that this continuous glucose monitoring method is safe for newborns?

Research has shown that the Dexcom G6 continuous glucose monitoring (CGM) system is generally safe for people of all ages, from infants to adults. Studies have found it accurate and safe for pregnant women with diabetes, suggesting potential safety for newborns as well. The system eliminates the need for frequent finger pricks, reducing needle-related pain. While some research highlights concerns about accuracy in certain situations, overall, it is considered a safe and effective method for managing blood sugar levels. Using the device in newborns could decrease the number of painful procedures required for glucose monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Dexcom G6 for neonatal hypoglycemia because it offers continuous glucose monitoring, which is a game-changer compared to the usual blood sugar tests that require frequent blood samples. This method provides real-time data, enabling immediate adjustments to care, which is crucial for managing low blood sugar in newborns. Unlike traditional monitoring that only gives snapshots of glucose levels, the Dexcom G6 allows for a more comprehensive understanding of glucose trends, potentially improving outcomes and reducing stress for both babies and caregivers.

What evidence suggests that continuous glucose monitoring is effective for neonatal hypoglycemia?

Research has shown that the Dexcom G6 Continuous Glucose Monitoring (CGM) system provides accurate blood sugar readings compared to regular blood tests. Studies have found that CGM systems effectively detect low blood sugar in infants and children, with a success rate of 65.4%, meaning they catch many low sugar events. In this trial, all participants will have the continuous glucose monitoring device placed. The system also reduces the need for frequent needle pricks, helping to lessen pain for newborns. Continuous monitoring tracks sugar levels more consistently, reducing the chances of missing any drops in sugar levels. ^{1 2 3 4 5}

Who Is on the Research Team?

Jeffrey R. Kaiser, MD, MA

Principal Investigator

Penn State Health Milton S Hershey Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My newborn is at risk and admitted to the nursery or NICU.

You were born smaller than most babies.

You were born prematurely between 34 to 36 weeks of pregnancy.

Exclusion Criteria

My skin is healthy enough for medical device placement.

I have a skin condition that could increase my risk, like severe blistering or peeling.

I do not have an ongoing infection or viral illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 days

Device Placement and Monitoring

Continuous glucose monitoring device (Dexcom G7) is placed on the participant's thigh and glucose levels are recorded continuously for analysis after discharge.

1-7 days

Continuous monitoring with at least 3 evaluations per day

Data Collection and Analysis

Data collected from participant's and mother's medical records, including glucose values, treatments, and NICU admission data. Parents complete a survey about their experience with the device.

After discharge

Follow-up

Participants are monitored for any adverse outcomes at the device site and overall safety of the CGM device.

1-7 days

What Are the Treatments Tested in This Trial?

Interventions

• Dexcom G6

Trial Overview 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.

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring Experimental Treatment 1 Intervention

All participants will have the continuous glucose monitoring device placed.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Children's Miracle Network

Collaborator

Trials

23

Recruited

1,800+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

The Dexcom G6 continuous glucose monitoring system demonstrated acceptable accuracy during elective abdominal surgery, with a mean absolute relative difference of 12.7% between sensor readings and reference glucose values, based on 1207 data pairs from 20 adults.

No clinically significant adverse events were reported, indicating that the Dexcom G6 is a safe option for peri-operative glucose management in patients with (pre)diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a factory-calibrated, real-time continuous glucose monitoring system during elective abdominal surgery. Tripyla, A., Herzig, D., Joachim, D., et al.[2021]

The Dexcom G4 Platinum with Software 505 algorithm (SW505) demonstrated significantly better accuracy and performance compared to the original G4 Platinum system (G4P) in youth with diabetes, with a mean absolute relative difference (MARD) of 10% for SW505 versus 17% for G4P when compared to reference measurements.

Both systems were found to be safe, with no serious adverse events reported, but the improved accuracy of SW505 has the potential to enhance glucose management and glycemic outcomes in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. Laffel, L.[2018]

A continuous glucose monitoring system (CGMS) using factory-calibrated sensors was tested on 21 neonates at risk of hypoglycemia, showing a good correlation with blood glucose measurements (R=0.67, p<0.01).

While the CGMS is a safe and feasible option for glucose monitoring, it tends to overestimate blood glucose levels, particularly within the first 3 hours after placement, indicating that caution is needed when interpreting its readings in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of a factory-calibrated continuous glucose monitoring system in term and near-term infants at risk of hypoglycemia. Nishimura, E., Oka, S., Ozawa, J., et al.[2022]

Continuous glucose monitoring (CGM) in a rooming-in setting for newborns is safe and effectively identifies cases of hypoglycemia, with only three out of 44 infants showing verified low glucose levels.

At 24 months, infants monitored with CGM did not show any significant neurodevelopmental issues, as indicated by Bayley scale scores, suggesting that CGM does not negatively impact cognitive, language, or motor development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Continuous Glucose Monitoring in Infants at Risk of Hypoglycemia in a Rooming-in Setting. Tabery, K., Doležalová, L., Černý, M., et al.[2022]

In a pilot study involving 10 children with congenital hyperinsulinism, continuous glucose monitoring (CGM) detected 26 hypoglycemic events in 60% of participants, highlighting its effectiveness in identifying undetected hypoglycemia.

CGM provided valuable data on blood glucose trends, particularly during early morning hours when point of care testing is typically not performed, leading to medication dose adjustments in 30% of the participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of CGM to identify hypoglycemia and glycemic patterns in congenital hyperinsulinism. Gariepy, M., Yoosefi, N., Silva, C., et al.[2023]

The continuous glucose monitoring system (CGMS) effectively detected hypoglycemic episodes in infants and children, with a sensitivity of 65.4% and specificity of 90.6%, based on a study involving five patients over 57 days.

CGMS serves as a valuable tool for diagnosing and evaluating hypoglycemia, helping to document normal blood sugar levels after treatment, despite a relatively high false positive rate of 42.9%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a continuous glucose monitoring system in hypoglycemic disorders. Conrad, SC., Mastrototaro, JJ., Gitelman, SE.[2022]

Continuous glucose monitoring (CGM) devices showed low sensitivity (39%) for detecting hypoglycaemia in preterm infants, indicating they may not be reliable for identifying low blood sugar events.

However, CGM devices demonstrated high accuracy for detecting hyperglycaemia, with a sensitivity of 87% and specificity of 99%, suggesting they are effective for monitoring high blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of continuous glucose monitoring in preterm infants: a systematic review and meta-analysis. Nava, C., Modiano Hedenmalm, A., Borys, F., et al.[2021]

The Dexcom G6 continuous glucose monitoring (CGM) system demonstrated a mean absolute relative difference (MARD) of 7.7% in accuracy when compared to laboratory blood glucose measurements, indicating high reliability for monitoring glucose levels in children and adolescents with type 1 diabetes.

With 96.2% of estimated glucose values falling within 20% of the reference values, the G6 system's accuracy supports its potential to enhance glycemic control and encourage consistent use among young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. Welsh, JB., Zhang, X., Puhr, SA., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7757524/

Performance of the Dexcom G6 Continuous Glucose ... This study demonstrated that the Dexcom G6 CGM System provided accurate readings in comparison to reference YSI blood glucose values and that sensors were well ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9900115/

Continuous glucose monitoring for children with ... In this state of the art review, we critically analyse the updated evidence for use of CGM in non-diabetic childhood hypoglycaemia disorders since 2020.

3. withpower.com withpower.com/trial/phase-hypoglycemia-7-2021-133ac

Continuous Glucose Monitoring for Neonatal Hypoglycemia The continuous glucose monitoring system (CGMS) effectively detected hypoglycemic episodes in infants and children, with a sensitivity of 65.4% and specificity ...

4. dexcom.com dexcom.com/en-us/g6-cgm-system

Dexcom G6 CGM System | No Fingersticks, No Scanning Dexcom CGM is clinically proven to lower A1C, reduce hyper- and hypoglycemia, and increase time in range. ... The more time you spend in range, the better you may ...

5. diabetesjournals.org diabetesjournals.org/care/article/47/12/2062/157410/Consensus-Considerations-and-Good-Practice-Points

Consensus Considerations and Good Practice Points for Use ... CGM systems can help prevent dysglycemia during the perioperative period, though further study is needed on their reliability during procedures ...