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Detecting Neonatal Hypoglycemia Using Real-Time Continuous Glucose Monitoring (CGM)

NCT03032523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-07-29

Study results available
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Summary

Hypoglycemia is the most common metabolic problem faced after birth. The investigators will be studying the utility of using a continuous glucose monitoring(CGM) system to more closely monitor low blood sugars in newborns. The investigators will evaluate the number of hypoglycemic events detected using CGM and compare it to those detected using current standard of care screening methods.

Conditions

  • Neonatal Hypoglycemia

Interventions

DIAGNOSTIC_TEST

Standard of care glucose test

If the CGM in the remote monitoring group detects a blood sugar less than 46mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.

Sponsors & Collaborators

Principal Investigators

  • Laura Nally, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2018-04-01
Completion
2018-04-01

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03032523 on ClinicalTrials.gov