CompletedNot Applicable

CGM Use in Preterm Infants

United States24 participantsStarted 2022-10-03

Plain-language 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.

Who can participate

Age range

72 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Detection of hypo- and hyperglycemia - CGM device

Timeframe: 10 days post placement of CGM

Detection of hypo- and hyperglycemia - 60 mg/dL

Timeframe: 10 days post placement of CGM

Detection of hypo- and hyperglycemia - 180 mg/dL

Timeframe: 10 days post placement of CGM

Detection of hypo- and hyperglycemia - AEs

Timeframe: 10 days post placement of CGM

Trial details

NCT IDNCT05436925

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02-28

View on ClinicalTrials.gov More Very Low Birth Weight Infant trials

Plain-language summary

Who can participate

Age range

72 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Detection of hypo- and hyperglycemia - CGM device

Timeframe: 10 days post placement of CGM

Detection of hypo- and hyperglycemia - 60 mg/dL

Timeframe: 10 days post placement of CGM

Detection of hypo- and hyperglycemia - 180 mg/dL

Timeframe: 10 days post placement of CGM

Detection of hypo- and hyperglycemia - AEs

Timeframe: 10 days post placement of CGM