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NCT05436925 · ClinicalTrials.gov registry record
CGM Use in Preterm Infants
A clinical trial of Hyperglycemia and Very Low Birth Weight Infant, sponsored by University of Minnesota.
- Completed
- Registry status
- 24
- Enrollment target
- 1
- Study location
NCT05436925: Completed study of Hyperglycemia and Very Low Birth Weight Infant, sponsored by University of Minnesota.
NCT05436925 is a study of Hyperglycemia and Very Low Birth Weight Infant that has completed, run by University of Minnesota. The registered enrollment target is 24 participants, below the 878-participant average among 38 other Hyperglycemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05436925, a study of Hyperglycemia and Very Low Birth Weight Infant, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Proportion of CGM device readings that match blood glucose readings
Conditions Studied
Interventions
- DEVICE Dexcom G6 sensor Continuous Glucose Monitor (CGM)
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2025-08-14 |
What the finished NCT05436925 record still lists
NCT05436925 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 878-participant average among 38 other Hyperglycemia trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Hyperglycemia appearing as the primary indexed condition, and to 1 intervention - of which Dexcom G6 sensor Continuous Glucose Monitor (CGM) is the first listed.
NCT05436925 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05436925 about?
NCT05436925 is a clinical study titled "CGM Use in Preterm Infants". 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 a...
What is the current status of trial NCT05436925?
This trial is currently completed. The enrollment target is 24 participants. The study started on 2022-10-03. Estimated completion is 2025-08-14.
What conditions does trial NCT05436925 study?
This clinical trial studies the following conditions: Hyperglycemia, Very Low Birth Weight Infant, Very Preterm Maturity of Infant.
What interventions are being tested in trial NCT05436925?
The interventions under investigation include: Dexcom G6 sensor Continuous Glucose Monitor (CGM) (DEVICE).
Who is sponsoring clinical trial NCT05436925?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05436925 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05436925's enrollment target sits among peer trials
24 30th of 38 higher than 9 of 38 other Hyperglycemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperglycemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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