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

25 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

10 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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+).
Apparaat: 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).

Ander: Eating Habits Questionnaire

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

Ander: Use of an actigraphy watch

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
Tijdsspanne: 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)
Tijdsspanne: 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 (%)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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),
Tijdsspanne: 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),
Tijdsspanne: 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 (%),
Tijdsspanne: 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),
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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),
Tijdsspanne: 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)
Tijdsspanne: 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 (%)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospices Civils de Lyon

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 februari 2028

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

21 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 september 2026

Eerst geplaatst (Werkelijk)

1 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

25 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 69HCL25_1040
  • 2026-A00194-47 (Andere identificatie: ID-RCB)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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