Clinical trial NCT04386005: Continuous Glucose Monitoring in At-Risk Newborns
Official title: Continuous Glucose Monitoring in At-Risk Newborns: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Hypoglycemia
Keywords: blood glucose
continuous glucose monitor
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
name: Children's Miracle Network
First posted: 2020-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will have the continuous glucose monitoring device placed.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* At-risk newborns (\<48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria:

  1. Infant of a diabetic mother (IDM, pre-existing or gestational diabetes)
  2. Large for gestational age (LGA, \>90th percentile \[sex-specific\])
  3. Small for gestational age (SGA, \<10th percentile \[sex-specific\])
  4. Late preterm (LPT, 34 0/7 to 36 6/7 weeks' gestation)
* Any newborn undergoing routine blood glucose screening in the newborn nursery per the Neonatal Hypoglycemia protocol (includes newborns of mothers taking oral hypoglycemic agents, beta-blocker medications, or systemic steroids within 7 days before delivery; and newborns with clinical manifestations of hypoglycemia)

Exclusion Criteria:

* Birth weight \<2kg
* hypoxic-ischemic encephalopathy
* a contraindication to oral feeding
* abnormal skin that will preclude placement of the CGM (e.g., skin on the thigh that is not intact)
* chromosomal abnormalities or severe congenital anomalies identified ante- or postnatally
* infants who are not expected to survive or who are in extremis
* additional risk of immunocompromise, including:

  1. Skin infections, such as staphylococcus or streptococcus skin infections and herpes (skin, eye, and mouth disease) infection
  2. Skin diseases that add additional risk, such as epidermolysis bullosa, ichthyosis, peeling skin syndrome, and hemangiomas
  3. Systemic sepsis, viral syndromes
  4. Immune diseases such as severe combined immunodeficiency, cancer, T-cell or B-cell deficiencies, inborn errors of metabolism, chromosomal abnormalities, glycogen storage diseases, genetic diseases
  5. Abdominal wall defects

Primary outcomes:
measure: Agreement of blood glucose concentrations from CGM vs intermittent monitoring
timeFrame: 1-7 days
measure: Likert-scale questionnaire results from parents, nurses, and research team
timeFrame: 7 days
measure: Difference in number of needle sticks with CGM vs intermittent glucose monitoring
timeFrame: 1-7 days
measure: Difference in number of episodes of hypoglycemia diagnosed with CGM vs intermittent glucose monitoring
timeFrame: 1-7 days
Secondary outcomes:
measure: Number of participants with adverse outcomes at the device site
timeFrame: 3 times per day for 1-7 days
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Health Milton S Hershey Medical Center
name: Jeffrey R. Kaiser, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
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