Monitoring blood sugar in youth with cystic fibrosis during lung infections
Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
This study is testing how blood sugar levels change in young people with cystic fibrosis during lung infections to see if these changes affect their treatment and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 25 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06546943 on ClinicalTrials.gov |
What this trial studies
This research investigates how blood sugar levels change in youth with cystic fibrosis (CF) during pulmonary exacerbations (PEx) using continuous glucose monitoring (CGM). The study aims to determine if blood sugar fluctuations are more pronounced during PEx compared to recovery periods and to assess the relationship between these changes and clinical outcomes, such as the need for additional antibiotics. Participants will be monitored both in outpatient settings and during hospital admissions, with data collected through questionnaires and CGM devices. The findings could provide insights into managing cystic fibrosis-related diabetes (CFRD) in this population.
Who should consider this trial
Good fit: Ideal candidates are youth aged 6 to 25 years with a confirmed diagnosis of cystic fibrosis.
Not a fit: Patients with known type 1 or type 2 diabetes or those experiencing critical illness requiring ICU admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of blood sugar levels in youth with cystic fibrosis during pulmonary exacerbations, potentially leading to better clinical outcomes.
How similar studies have performed: While this approach is novel in the context of cystic fibrosis and pulmonary exacerbations, similar studies using continuous glucose monitoring in other populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 6- 25 years old * Confirmed diagnosis of cystic fibrosis (based on sweat chloride and/or two known disease causing CF mutations) * access to a smart phone and/or internet connection and the ability to complete remote telehealth visits Exclusion Criteria: * known type 1 or type 2 diabetes, monogenic diabetes * critical illness requiring admission to the ICU * pregnancy
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado, University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Christine Hovater
- Email: christine.hovater@childrenscolorado.org
- Phone: 720-777-6128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.