An interventional study of Continuous Glucose Monitoring and Eating Habits Questionnaire in Glucose Metabolism Disorders in Cystic Fibrosis, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's planned enrollment of 30 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Children aged 10 to 17 years diagnosed with cystic fibrosis (CF). 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). Patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+).
Device: Continuous Glucose Monitoring · Other: Eating Habits Questionnaire · Other: Use of an actigraphy watch
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).
A 7-day dietary diary will be completed at M0, M3, and M6.
Participants will wear an actigraphy watch during 7 days at M0, M3 and M6
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (\<70 mg/dL)
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg/dL)
The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (\>140 mg/dL)
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: glycemic variability (%)
The variability of other CGM parameters between M0 and M3: glycemic variability (%)
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg/dL
The variability of other CGM parameters between M0 and M3: number of glucose excursions \>200 mg/dL
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
Time frame: From enrollment to 3 months
The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL),
The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (\<70 mg/dL),
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL),
The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (\>140 mg/dL),
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: glycemic variability (%),
The variability of CGM parameters between M0 and M6: glycemic variability (%),
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL
The variability of CGM parameters between M0 and M6: number of glucose excursions \>200 mg/dL
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
Time frame: From enrollment to 6 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): "time in range" (%) (70-140 mg/dL)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): "time in range" (%) (70-140 mg/dL)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (<70 mg/dL),
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (\<70 mg/dL),
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (>180 mg/dL)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (\>180 mg/dL)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg/dL)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg/dL)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions >200 mg/dL
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions \>200 mg/dL
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to physical activity (percentage of daytime activity) : Variation in the number of steps
The variability of CGM parameters according to physical activity (percentage of daytime activity), Variation in the number of steps
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (body fat percentage)
The variability of CGM parameters according to body composition (body fat percentage) : body fat in kg
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition
The variability of CGM parameters according to body composition (lean mass percentage) : body fat in kg
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm)
The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm) : body fat in kg
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg
The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
Time frame: From enrollment to 3 months ans 6 months
The variability of CGM parameters according to nutritional intake : fats (kg)
The variability of CGM parameters according to nutritional intake : fats (kg)
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : proteins (kg)
The variability of CGM parameters according to nutritional intake : proteins (kg)
Time frame: From enrollment to 3 months and 6 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Hospices Civils de Lyon