Trials / Completed
CompletedNCT05436925
CGM Use in Preterm Infants
Improving Growth and Neurodevelopmental Outcomes in Preterm Infants Experiencing Hyperglycemia
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 24 (actual)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 72 Hours
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-10-03
- Primary completion
- 2025-02-28
- Completion
- 2025-08-14
- First posted
- 2022-06-29
- Last updated
- 2025-09-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05436925. Inclusion in this directory is not an endorsement.