Continuous Glucose Monitoring in At-Risk Newborns

Conditions

• Neonatal Hypoglycemia

Eligibility Criteria

Sex

ALL

Age

1 Minute - 2 Weeks

Healthy Volunteers

Not accepted

Interventions

• Continuous Glucose Monitoring Device — DEVICE
  The Dexcom G7 Glucose Monitoring System (San Diego, CA) reports continuous interstitial blood glucose concentrations every 5 minutes, does not require calibration, and involves only 1 needle stick to place the sensor. The manufacturer recommends that a single sensor may be used for up to 10 days. The Dexcom G7 system is the only FDA approved CGM system for children (age \>2 years).

Study Details

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.

Key Dates

Start date

Aug 9, 2021

Status verified

Aug 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Continuous Glucose Monitoring
  All participants will have the continuous glucose monitoring device placed.

Primary Outcome Measure

Agreement of blood glucose concentrations from CGM vs intermittent monitoring [ Time Frame: 1-7 days ]

Central Contacts

• Jeffrey R. Kaiser, MD, MA
  717-531-8413
  [email protected]
• Kerry Deitrick, LPN

Locations (1)

Find similar trials in Hershey, PA

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