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

Trial Summary

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 data supports the effectiveness of the treatment Dexcom G6, Dexcom G6 CGM System, Dexcom G6 Professional CGM System for neonatal hypoglycemia?

Research shows that continuous glucose monitoring (CGM) systems like Dexcom G6 can improve glucose control and reduce the frequency of low blood sugar episodes in children with type 1 diabetes and other hypoglycemic disorders. Additionally, studies indicate that using CGM in newborns at risk of low blood sugar is safe and can help detect hypoglycemia without frequent blood tests. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for use in humans?

Research shows that the Dexcom G6 continuous glucose monitoring system is generally safe for use in humans, including adults undergoing surgery and infants at risk of low blood sugar. No significant adverse events were reported in these studies, and the system was found to be safe from both clinical and developmental perspectives. ^{2 3 4 6 7}

How does continuous glucose monitoring differ from other treatments for neonatal hypoglycemia?

Continuous glucose monitoring (CGM) for neonatal hypoglycemia is unique because it uses sensors to continuously track glucose levels, reducing the need for frequent and painful blood samples. This approach allows for better glucose control and comfort for newborns and parents, unlike traditional intermittent blood sampling methods. ^{2 3 4 5 8}

What is the purpose of this trial?

Hypoglycemia (low blood glucose) is a very common problem in newborns, and has been associated with poor neurodevelopment, cognition, and school performance. At-risk newborns (infants of diabetic mothers \[IDM\], large \[LGA\] and small \[SGA\] for gestational age infants, and late preterm \[LPT\] infants) undergo a hypoglycemia screening protocol that involves numerous intermittent needle sticks to test glucose levels on bedside glucometers; however, continuous glucose monitoring (CGM, currently not approved for clinical use in babies), via a small sensor placed in the thigh (only 1 needle stick), would likely decrease pain while providing continuous glucose levels. This study will evaluate the feasibility, safety, and precision of CGM in at-risk newborns, and determine if this method would decrease the amount of painful procedures and episodes of hypoglycemia missed by intermittent sampling. As part of regular medical care, participants will undergo intermittent blood glucose screening with heel sticks as per the current hospital standard of care protocol. Regular medical care involves checking the participant's blood glucose via heel stick every few hours using a bedside glucometer, with another heel stick to confirm low values in the laboratory. If the participant has low values, he/she may be treated with oral glucose gel, feedings of breast milk or formula, or intravenous (IV) fluids in the Neonatal Intensive Care Unit (NICU). This research study involves placing a CGM device in addition to undergoing the current blood glucose screening protocol and treatment. As soon as possible after birth, a continuous glucose monitoring device (Dexcom G7) will be placed on the participant's thigh by a research team member, and will blindly continuously record glucose levels that will be analyzed after discharge. Everyone who agrees to participate in this study will have placement of this experimental device. The investigational device will stay in place for the same amount of time that a participant is undergoing blood glucose monitoring as per the current standard of care protocol, for a maximum of 7 days. A participant may need to have his/her blood glucose checked after 7 days for regular medical care (and not for research), because his/her glucose concentrations are still low. Being in the research study will not affect a participant's medical care, and will not affect how long he/she needs blood glucose monitoring or treatment. A research team member will place and remove the CGM. Nurses will evaluate the site of the device for signs of irritation, infection, bleeding, and any other issues at least 3 times per day. After discharge from the hospital, data will be collected from the participant's medical record and participant's mother's medical record, including the participant's sex and birth weight, blood glucose values, details of feedings, treatments given for low glucose concentrations, and NICU admission data. Data that will be collected from the participant's mother's medical record includes age and race, prenatal data, medical history, and medication use. The participant's parents will be asked to fill out a short survey about their experience with this device when it is removed.

Research Team

Jeffrey R. Kaiser, MD, MA

Principal Investigator

Penn State Health Milton S Hershey Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The use of a continuous glucose monitoring system in hypoglycemic disorders. [2022]

2. Turkey 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Continuous Glucose Monitoring in Infants at Risk of Hypoglycemia in a Rooming-in Setting. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

The use of CGM to identify hypoglycemia and glycemic patterns in congenital hyperinsulinism. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Performance of a factory-calibrated, real-time continuous glucose monitoring system during elective abdominal surgery. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Accuracy of continuous glucose monitoring in preterm infants: a systematic review and meta-analysis. [2021]