CGM Use in Preterm Infants

Hyperglycemia Clinical Trial

Official title:

Improving Growth and Neurodevelopmental Outcomes in Preterm Infants Experiencing Hyperglycemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436925
• Other study ID #: PEDS-2022-30647
• Status: Recruiting
• Start date: October 3, 2022
• Est. completion date: December 10, 2024

Study information

• Verified date: June 2023
• Source: University of Minnesota
• Contact: Sara Ramel, MD
• Phone: 612-625-8723
• Email: sramel[@]umn.edu
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 60
• Est. completion date: December 10, 2024
• Est. primary completion date: June 10, 2024
• 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

Related Conditions & MeSH terms

• Birth Weight
• Hyperglycemia
• Premature Birth
• Very Low Birth Weight Infant
• Very Preterm Maturity of Infant

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