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

perjantai 25. syyskuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

30

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Opiskelupaikat

  • Ranska
      • Bron, Ranska, 69677
        • Hôpital Femme Mère Enfant (HFME)
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

10 vuotta - 17 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Diagnostiikka
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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+).
Laite: 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).

Muut: Eating Habits Questionnaire

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

Muut: Use of an actigraphy watch

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

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
Aikaikkuna: 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)
Aikaikkuna: 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 (%)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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),
Aikaikkuna: 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),
Aikaikkuna: 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 (%),
Aikaikkuna: 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),
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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),
Aikaikkuna: 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)
Aikaikkuna: 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 (%)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Hospices Civils de Lyon

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Ensimmäinen lähetetty

Maanantai 21. syyskuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 25. syyskuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Torstai 1. lokakuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 1. lokakuuta 2026

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Perjantai 25. syyskuuta 2026

Viimeksi vahvistettu

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Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 69HCL25_1040
  • 2026-A00194-47 (Muu tunniste: ID-RCB)

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