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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05436925
Other study ID # PEDS-2022-30647
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 3, 2022
Est. completion date August 30, 2025

Study information

Verified date June 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. The low alarm threshold will be set at 60 mg/dL or 80mg/dL (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. A suggestion will be made to the clinical team to draw a blood glucose to correlate with CGM values ≤60 mg/dL and the infant will be treated according to Neonatal Intensive Care Unit (NICU) protocol for corroborating blood glucose levels. Infants will also be monitored per current NICU protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. Clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date August 30, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 72 Hours
Eligibility Inclusion Criteria: - preterm infants (gestational age (GA) at birth < 31 weeks) - admitted to the University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit - written informed consent can be secured from a parent within 96 hours of birth. Exclusion Criteria: - Infants born at =31 weeks GA - infants with a prenatally diagnosed clinical or genetic condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development - children experiencing severe birth asphyxia, - children enrolled in another nutritional study, - children likely to be transferred out of the NICU

Study Design


Intervention

Device:
Dexcom G6 sensor Continuous Glucose Monitor (CGM)
The device used as part of the study is to obtain results for glucose testing for research only and not for diagnostic purposes.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of hypo- and hyperglycemia - CGM device Proportion of CGM device readings that match blood glucose readings 10 days post placement of CGM
Primary Detection of hypo- and hyperglycemia - 60 mg/dL % time below 60 mg/dL 10 days post placement of CGM
Primary Detection of hypo- and hyperglycemia - 180 mg/dL % time above 180 mg/dL 10 days post placement of CGM
Primary Detection of hypo- and hyperglycemia - AEs % of infants with adverse events secondary to CGM placement or wear 10 days post placement of CGM
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