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

25 septembre 2026 mis à jour par: Hospices Civils de Lyon

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • France
      • Bron, France, 69677
        • Hôpital Femme Mère Enfant (HFME)
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

10 ans à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Non-diabetic patient with cystic fibrosis

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+).
Dispositif: 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).

Autre: Eating Habits Questionnaire

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

Autre: Use of an actigraphy watch

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Délai: From enrollment to 3 months

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
Délai: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg/dL)
Délai: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg/dL)
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: glycemic variability (%)
Délai: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: glycemic variability (%)
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
Délai: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg/dL
Délai: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg/dL
From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
Délai: From enrollment to 3 months

The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
From enrollment to 3 months
The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
Délai: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL),
Délai: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL),
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL),
Délai: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL),
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: glycemic variability (%),
Délai: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: glycemic variability (%),
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
Délai: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL
Délai: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL
From enrollment to 6 months
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
Délai: From enrollment to 6 months

The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
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)
Délai: From enrollment to 3 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)
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),
Délai: 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),
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)
Délai: 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)
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 (%)
Délai: 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 (%)
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)
Délai: 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)
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
Délai: 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
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)
Délai: 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)
From enrollment to 3 months
The variability of CGM parameters according to physical activity (percentage of daytime activity) : Variation in the number of steps
Délai: From enrollment to 3 months and 6 months

The variability of CGM parameters according to physical activity (percentage of daytime activity), Variation in the number of steps
From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (body fat percentage)
Délai: From enrollment to 3 months and 6 months

The variability of CGM parameters according to body composition (body fat percentage) : body fat in kg
From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition
Délai: From enrollment to 3 months and 6 months

The variability of CGM parameters according to body composition (lean mass percentage) : body fat in kg
From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm)
Délai: From enrollment to 3 months and 6 months

The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm) : body fat in kg
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
Délai: 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
From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
Délai: From enrollment to 3 months and 6 months

The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
Délai: From enrollment to 3 months ans 6 months

The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
From enrollment to 3 months ans 6 months
The variability of CGM parameters according to nutritional intake : fats (kg)
Délai: From enrollment to 3 months and 6 months

The variability of CGM parameters according to nutritional intake : fats (kg)
From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : proteins (kg)
Délai: From enrollment to 3 months and 6 months

The variability of CGM parameters according to nutritional intake : proteins (kg)
From enrollment to 3 months and 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospices Civils de Lyon

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

1 février 2028

Achèvement de l'étude (Estimé)

1 mai 2028

Dates d'inscription aux études

Première soumission

21 septembre 2026

Première soumission répondant aux critères de contrôle qualité

25 septembre 2026

Première publication (Réel)

1 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 69HCL25_1040
  • 2026-A00194-47 (Autre identifiant: ID-RCB)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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