Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Continuous Glucose Monitoring: Upon enrollment, patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+). Sensors will be placed on the posterior aspect of the dominant arm at M0, M3, and M6, and additionally on the non-dominant arm at M0 only, in order to evaluate site-dependent variability. At each time point, the sensors will be worn for 7 days to record various CGM parameters, including glycemic variability (analyzed between M0-M3 and M0-M6).

Eating Habits Questionnaire: A 7-day dietary diary will be completed at M0, M3, and M6.

Use of an actigraphy watch: Participants will wear an actigraphy watch during 7 days at M0, M3 and M6

Study 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

Primary outcome measure(s)

• The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3. — From enrollment to 3 months
  The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.

Trial sites (1)

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