Status:
TERMINATED
Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia
Lead Sponsor:
Boston Children's Hospital
Conditions:
Hypoglycemia
Newborn Morbidity
Eligibility:
All Genders
Up to 60 years
Phase:
NA
Brief 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 g...
Detailed Description
We aim to evaluate the utility of continuous glucose monitors (CGMs) in improving the diagnosis and management of neonatal hypoglycemia in infants admitted to the neonatal intensive care unit (NICU). ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02300285
Start Date
February 1 2015
End Date
August 30 2018
Last Update
November 1 2021
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115