Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia

Description

Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in infants with low blood glucose to improve how we care for these infants. To do this we plan on monitoring blood glucose levels with CGMs (instead of only with intermittent bloodsampling) in late-preterm and term infants admitted to the NICU who have had hypoglycemia. To see if using CGMs helps us prevent low blood glucose levels and allows us to find a diagnosis and treat sooner, we will randomize patients into one of two groups: a "CGM group" where the CGM information is made available to the NICU team and a "Standard of Care" group where the CGM information will only be available to the research team. However, if infants in the "Standard of Care" group are noted to have three unrecognized severe low blood glucose levels then the research team will inform the NICU team that this has occurred.

Study Start Date

February 2015

Estimated Completion Date

July 2016

Interventions

  • Device: Continuous Glucose Monitoring

Specialties

  • Pediatrics: Neonatology,Pediatric Endocrinology
  • Endocrinology: Peds Endocrinology

MeSH Terms

  • Continuous Glucose Monitoring
  • Hypoglycemia

Study ID

Children's Hospital Boston -- IRB-P00014699

Status

Unknown

Trial ID

NCT02300285

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

20

Sponsor

Children's Hospital Boston

Inclusion criteria:
  • Age 0-60 days old
  • Late-preterm and term infants (babies born more than 33 weeks and 6 days after the start of the pregnancy)
  • History of low blood sugars (hypoglycemia): two episodes of hypoglycemia more than 1 hour apart (low blood sugar will be defined by age: for those less than 48 hours old a low blood sugar is considered less than 50mg/dL and for those older than 48 hours old less than 70mg/dL)

    Exclusion Criteria

    • Infants with skin disease such that placement of a glucose sensor under the skin would be difficult to secure
    • Infants expected to remain in NICU less than 24 hours
    • Infants on a hypothermic protocol
    • Infants enrolled in a competing clinical trial
    • Family/team have decided to limit or redirect from aggressive NICU technological support
    • infants who are wards of the state
  • Gender

    Both

    Ages

    60 Days and younger

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (1)

    Study Location Distance Name Phone Email
    Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Paulina OrtizRubio MD 617-355-7339 paulina.ortiz-rubio@childrens.harvard.edu

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