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Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia

NCT02300285 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-11-01

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

Continuous Glucose Monitoring

Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment. In the Standard of Care group the CGM data will not be visible to the medical team but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia.

Sponsors & Collaborators

Principal Investigators

  • Michael Agus, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
60 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-08-30
Completion
2018-08-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02300285 on ClinicalTrials.gov