Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis (CGMUCODIAB)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Kévin PERGE, Dr
- Telefonnummer: +33 04 72 11 88 90
- E-mail: kevin.perge@chu-lyon.fr
Undersøgelse Kontakt Backup
- Navn: Philippe REIX, Prof
- Telefonnummer: +33 04 27 85 54 70
- E-mail: philippe.reix@chu-lyon.fr
Studiesteder
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Bron, Frankrig, 69677
- Hôpital Femme Mère Enfant (HFME)
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Kontakt:
- Philippe REIX, Prof
- Telefonnummer: +33 04 27 85 54 70
- E-mail: philippe.reix@chu-lyon.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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+). |
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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
Tidsramme: 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)
Tidsramme: 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 (%)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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),
Tidsramme: 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),
Tidsramme: 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 (%),
Tidsramme: 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),
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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),
Tidsramme: 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)
Tidsramme: 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 (%)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Genetiske sygdomme, medfødte
- Metaboliske sygdomme
- Luftvejssygdomme
- Sygdomme i fordøjelsessystemet
- Lungesygdomme
- Spædbarn, Nyfødt, Sygdomme
- Pancreassygdomme
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Ernæringsmæssige og metaboliske sygdomme
- Cystisk fibrose
- Glukosemetabolismeforstyrrelser
- Undersøgelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Blodkemisk analyse
- Klinisk kemi -tests
- Diagnostiske teknikker, endokrine
- Overvågning, fysiologisk
- Kontinuerlig glukoseovervågning
Andre undersøgelses-id-numre
- 69HCL25_1040
- 2026-A00194-47 (Anden identifikator: ID-RCB)
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