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NCT07851831
Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis
Conditions: Glucose Metabolism Disorders in Cystic Fibrosis
Sex: All
Ages: 10 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Hospices Civils de Lyon
Location: Hôpital Femme Mère Enfant (HFME) Bron
Summary
Glucose metabolism disorders in cystic fibrosis (CF-GMD) are common and have a negative clinical impact. Screening currently relies on the oral glucose tolerance test (OGTT); however, this procedure is burdensome and complex for both patients and healthcare providers. Continuous glucose monitoring (CGM) is increasingly used in CF centers for CF-GMD screening, either alone or alongside the OGTT. While long-term (one-year) OGTT reproducibility is known to be poor, the short- and medium-term reproducibility of CGM remains unknown. This examination is poised to become a major tool in CF-GMD investigation, upon which critical therapeutic decisions could be based. The primary objective of this project is to evaluate the short-term variability of CGM data.
Eligibility Criteria
Inclusion Criteria:
* Patients aged 10 to 17 years
* Diagnosed with cystic fibrosis (CF)
* Managed by the pediatric CF care center (CRCM) of the Groupement Hospitalier Est
* Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT)
Exclusion Criteria:
* Patients with treated or untreated diabetes
* Patients presenting with a pulmonary exacerbation and currently receiving antibiotic therapy
* Patients participating in another clinical trial that could interfere, in the investigator's judgment, with the study findings
* Refusal of the patient and/or the legal guardian(s) to participate in the study
* Pregnant, parturient, or breastfeeding women
* Persons deprived of liberty by a judicial or administrative decision
* Persons undergoing psychiatric care
* Persons admitted to a healthcare or social institution for purposes other than research
* Persons not affiliated with a social security scheme or beneficiaries of a similar scheme
Source: ClinicalTrials.gov (NCT07851831). StuddyBuddy aggregates publicly available trial information.